Guidance Topics (A – Z)

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Topics arranged alphabetically from A-Z related to human subjects research with respect to UNL Institutional Review Board (IRB) review, approval, and other activities overseen by the UNL Human Research Protection Program (HRPP) are described below. Each topic below is linked to its page location. Topics may also include links to corresponding policies, guidance and/or templates.  If you are unable to find an answer to your question below, please contact the IRB at irb@unl.edu or 402-472-6965, or through your IRB Coordinator.

List of Topics

118 Determination (Non-definitive Plans for Human Subjects)

Authorization Agreement

Biospecimen/Data Repositories

Certificates of Confidentiality

Child Abuse Reporting Requirements & Human Subjects Research in Nebraska

ClinicalTrials.gov Registration

Compensation/Incentives and Accounting Guidance

Cooperative Research

Deception in Research

Document Version Control

European Union General Data Protection Regulation (EU GDPR)

Exempt Research Guidance and Templates

External Organization IRB Review Request Fee Schedule

Genetic Information Nondiscrimination Act (GINA)

Good Clinical Practice (GCP) & training requirements

Grant Congruency Review

Health Insurance Portability and Accountability Act (HIPAA) and UNL Human Subjects Research

Human Subjects Research

Informed Consent Waivers

IRB Guidebook

Lincoln Public Schools (LPS) Approval Processes

Multi-Site Research

National Institutes of Health (NIH) Proposal Requirements – Human Subjects

Program Evaluation vs. Evaluation as Research

Recruitment/Advertising

Secondary Information and Biospecimens: Use in Research and IRB Applicability

Single Institutional Review Board (sIRB)

Site Permission Documentation

SMART IRB

Social Media

Terms and Conditions (Outside Entities)

Tips for Student Researchers


118 Determination (Non-definitive Plans for Human Subjects)

A “118 Determination” refers to a determination by the IRB for applications or proposals lacking definite plans for involvement of human subjects per the regulatory criteria at 45 CFR 46.118. Specifically, a 118 Determination is made when certain types of applications for grants, cooperative agreements, or contracts are submitted to Federal departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal.

Other Related Term(s):

  • Grant Congruency Review
    • When a funding source is identified on an IRB project form (regardless of whether or not the funding source is Federal), UNL HRPP staff will complete a grant congruency review to ensure the proposal/grant/statement of work or other related document matches or is closely related that of the proposed IRB protocol.

Key Information:

  • When the UNL IRB is contacted by a PI or UNL Sponsored Programs regarding a project, the HRPP staff will conduct a grant review to determine whether or not definitive plans are set forth in the proposal for human subjects research involvement.
  • If no definitive human subjects research plans are detailed, a 118 Determination is issued in writing by the IRB/HRPP staff.

(NO human subjects work can be conducted, including recruitment, until full IRB approval has been obtained.)

  • At least one year or sooner as specified by the IRB Coordinator, from the date of the 118 Determination, the PI is required to either:
    • Verify that the project continues to lack immediate plans for the involvement of human subjects, their data, or their specimens; or
    • Provide documentation to the applicable funding source to demonstrate that IRB approval has been obtained.
  • If it is found that definitive plans do exist in the proposal, HRPP staff, in consultation with the PI, will move forward with the typical process of IRB approval.

UNL Human Research Protection Program (HRPP) Policies and Procedures:

UNL Guidance for UNL HRPP staff grant congruency review:

Health Insurance Portability and Accountability Act (HIPAA) and UNL Human Subjects Research 

The following information is made available to assist UNL research investigators in preparation of research projects involving human subjects that may be subject to HIPAA requirements. This information is not meant to be legal advice or any other form of advice outside of a research project being reviewed by the UNL IRB. If any information made available here is inconsistent with UNL HRPP policies and procedures, policies will supersede this information.

The Health Insurance Portability and Accountability Act’s Privacy Rule, 45 CFR 160 & 164, regulates the use and release of a patient’s personal health information, also known as protected health information (PHI), by a covered entity.

The HIPAA Privacy Rule contains requirements designed to ensure that the PHI of research participants is appropriately used and/or disclosed during the conduct of research. When using or disclosing PHI for research purposes, a signed authorization from the research participant or a waiver of authorization issued by the UNL IRB or a Privacy Board must be obtained as part of the IRB approved project if identifiable information will be obtained.

Other Related Term(s):

  • Covered Entity
    • Defined as (1) health plans, (2) health care clearinghouses, and/or (3) health care providers who electronically transmit any health information in connection with transactions for which Health and Human Services (HHS) has adopted standards.
    • Generally, these transactions concern billing and payment for services or insurance coverage.
    • For example: hospitals, academic medical centers, physicians, and other health care providers who electronically transmit claims transaction information directly or through an intermediary to a health plan are covered entities. Covered entities can be institutions, organizations, or persons.
  • Hybrid Entity
    • A covered entity that engages in both HIPAA covered and non-covered functions.
    • The University of Nebraska-Lincoln is a hybrid entity.
  • Business Associate
    • Defined as a person or entity who, on behalf of a covered entity, performs or assists in performance of a function or activity involving the use or disclosure of individually identifiable health information, such as data analysis, claims processing or administration, utilization review, and quality assurance reviews, or any other function or activity regulated by the HIPAA Administrative Simplification Rules, including the Privacy Rule. Business associates are also persons or entities performing legal, actuarial, accounting, consulting, data aggregation, management, administrative, accreditation, or financial services to or for a covered entity where performing those services involves disclosure of individually identifiable health information by the covered entity or another business associate of the covered entity to that person or entity. A member of a covered entity’s workforce is not one of its business associates. A covered entity may be a business associate of another covered entity.
  • Limited Data Set
    • Defined as PHI that excludes direct identifiers of the individual or of relatives, employers, or household members of the individual. The limited data set must have all identifiers listed below removed, except the following:
      • A unique identifying number, characteristic, or code (e.g., a registry or study number).
        • In this instance, the unique identifying number refers to the code that is associated with the medical record and not a newly assigned research database code.
      • Elements of dates (e.g., birth date).
      • Town, city, state, and ZIP code.
    • A researcher with IRB approval and a Data Use Agreement between the researcher and the covered entity can use and disclose Protected Health Information that contains a limited data set without a HIPAA authorization or a waiver of consent granted by the IRB. The UNL Office of Sponsored Programs assists investigators in the development and execution of Data Use Agreements. Please contact the UNL OSP Awards team if a Data Use or Transfer Agreement is needed.
  • Protected Health Information (PHI)
    • Defined as any individually identifiable health information, whether oral or recorded in any medium that is used or disclosed during the course of any research project whereas the individually identifiable health information was obtained from a covered entity, hybrid entity, or business associate. This information relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual.
    • Self-reported health information is not considered PHI because it is not obtained directly from the covered entity.
  • Individually Identifiable Protected Health Information
    • The information contains one or more of the 18 HIPAA identifiers. If any of the 18 identifiers are associated with the health information, then the information is considered “protected.”
    • De-identification of PHI requires either:
      • Removal of all 18 HIPAA identifiers; or
      • Documentation by an expert statistician describing how he/she determined the risk of participant identification using a subset of identifiers present is very small.

Key Information: 

  • At UNL, the following areas are considered covered entities:
    • Barkley Memorial Center
    • Health Plans (i.e. faculty/staff)
    • Student Health Center

If you are affiliated with the Barkley Memorial Center, please ensure you are meeting your Departmental requirements for HIPAA. If you are designing research that will involve the Barkley Memorial Center, we encourage you to meet with representatives of the Center to discuss your project. The UNL IRB will require that specific permissions are documented as part of your IRB application if involving a patient population from the Barkley Memorial Center.

The 18 HIPAA identifiers are:

  • Names.
  • Postal address information: street address, city, county, precinct, ZIP code (except specified combinations).
  • All elements of dates (except year) related to an individual (e.g., birth, admission, discharge). For participants over 89 years of age, all elements of dates (including year) must be removed.
  • Telephone numbers.
  • Fax numbers.
  • Electronic mail addresses.
  • Social Security numbers.
  • Medical Record numbers.
  • Health plan beneficiary numbers.
  • Account numbers.
  • Certification/license numbers.
  • Vehicle identifiers and serial numbers, including license plate numbers.
  • Device identifiers and serial numbers.
  • Web Universal Resource Locators.
  • Internet Protocols address numbers.
  • Biometric identifiers, including finger and voice prints.
  • Full face photographic images (and any comparable images).
  • Any other unique identifying number, characteristic, or code.

The HIPAA Privacy Rule applies to research use and/or disclosure of PHI, independent of the federal regulations for human subjects research. The following are examples of how the federal regulations for human subjects research (45 CFR 46) and HIPAA (45 CFR 160 & 164) intersect or remain separate:

  • A human subjects research project utilizing PHI to identify eligible subjects or to create a research dataset, may require a waiver of HIPAA authorization. (In this case, the UNL IRB can provide the HIPAA waiver, alongside their review of the human subjects research approval requirements).
  • A faculty member/department is contacted to provide data analysis of PHI on behalf of a covered entity through a contract. The faculty member/department is considered a Business Associate of the covered entity but they are not considered to be engaged in research because their work does not meet the definition of human subjects research. (The faculty member/department would be required to follow the HIPAA Privacy Rule requirements but not required to apply for IRB review and approval. In this case, the UNL IRB would not be involved in the review of the project requirements). If you believe a project you are involved with is similar to the above scenario, we encourage you to seek an official human subjects determination through an IRB application or by contacting the UNL IRB at irb@unl.edu.

The Privacy Rule also allows, without individual authorization, use and/or disclosure of private health information under a select few additional circumstances:

  • Use/disclosure is solely for purposes preparatory to research, such as assessing the feasibility of conducting a study.
  • Use/disclosure is solely for research on the protected health information of decedents (deceased individuals).
  • Data is de-identified by the covered entity before being made available to the researcher (researcher never views PHI).
  • A limited data set may be used/disclosed under the terms of a written data use agreement.
  • A Waiver of Authorization has been approved by the UNL IRB or a Privacy Board.

Please be aware, even though individual authorization may not be required, additional permissions, approvals, or agreements may be necessary to obtain access to PHI.

UNL Human Research Protection Program (HRPP) Policies and Procedures:

 Additional Guidance and/or External Resources:

Authorization Agreement

Also called a Reliance Agreement, this is the agreement that documents respective authorities, roles, responsibilities, and communication between an institution/organization providing the ethical (IRB) review and a participating site relying on the Single-IRB (sIRB).  UNL typically only completes the Authorization Agreement for non-exempt research (i.e., Expedited or Full Board review).

Other Related Term(s):

  • Cede Review
    • Typically the term that is used when an institution has agreed to allow review to be overseen by another IRB for non-exempt research (i.e., Expedited or Full Board review). UNL requires an Authorization Agreement in these cases.

Key Information:

  • The IRB Institutional Official, or their designee, is the only individual authorized to enter into Authorization Agreements for non-exempt research.
  • An Investigator is NOT authorized to enter into agreements on behalf of the institution or the IRB.
  • UNL holds blanket Authorization Agreements with the University of Nebraska Medical Center and Boys Town. The agreements allow us to meet requirements both under the HHS regulations and the FDA regulations.
  • UNL is a member of SMART IRB, a reliance arrangement for investigator-initiated studies that involve other academic institutions. SMART IRB is an NIH-funded initiative that streamlines IRB reliance through a nationally-adopted reliance agreement, SOPs and tools that support single IRB review. More than 200 institutions across the United States have joined and, if you are collaborating with one of them for IRB review, we may be able to utilize this reliance arrangement for your project.

For more information about requesting that UNL enter into or utilize an existing Authorization Agreement, including SMART IRB, please see the topic Multi-Site Research.

Biospecimen/Data Repositories

Biospecimen and data repositories can take on different forms and serve different purposes depending on how they are created or the parameters surrounding their use. For example, some biorepositories serve as a central storage and distribution point for biospecimens collected from multiple studies for future research use. Other biorepositories originate from a single research protocol designed solely for the purpose of future use. Further, some data repositories are also standalone sources for a single site or protocol while other examples include data repositories that are also linked to biorepositories.

Biospecimen and data repositories must be approved via a new project form submitted to the IRB and the protocol must provide enough information to allow the IRB to satisfy human subjects regulatory requirements at 45 CFR 46. The following guidance is intended to provide best practices for planning and receiving IRB approval for a biospecimen or data repository.

Other Related Term(s):

  • Bio or Data Banking
    • A bio or databank is a type of repository that stores biological or data samples for use in research. Samples in biobanks and the data derived from those samples can often be used by multiple researchers for cross purpose research.

Key Information:

The amount of information and level of detail required to be included in a bio or data repository protocol will vary depending on the specific repository and its planned use. The following are details to include or consider when beginning the development of the repository and ultimately submitting the IRB protocol for approval. This list is not necessarily an exhaustive list but will provide an overview of the amount and types of information the New Project Form will request.

You will find that most of the information will be requested throughout the New Project Form:

  • Overall goals and purpose of the repository.
  • Location of the repository.
  • An explanation of what types of research will be conducted using the repository. This information should be specific, unless the types of future research is not clearly defined at the time of the repository’s creation. In which case, a broad description should be used.
  • Size of the repository (how many specimens/data points).
  • Identifiability of the persons from whom the biospecimens or data were collected.
  • How the biospecimens or data will be collected, stored, and maintained.
  • A description of the collection procedures for the repository. In other words, will the repository store prospective (newly collected or collected in the future) or retrospective (previously collected) biospecimens or data. It should describe how the participants will be recruited and selected if prospective or how the biospecimens/data will be identified and selected for inclusion if retrospective.
    • If the collection is prospective, the protocol should include details regarding the method used to recruit participants, including how and where the consent process will be completed.
    • If the collection is retrospective, the protocol should include how and where the biospecimens or data were obtained and if there was informed consent or a waiver of informed consent.
  • A description of whether or not the repository will include biospecimens or data from unique populations that could include rare diseases, specific ethnic, racial, or social groups, populations that may have unique views about biospecimens (e.g. certain Native American groups), or particular geographic regions.
  • A description of exactly what types of biospecimens or data that will be collected (e.g. information on drug use, past criminal activity, blood, DNA, urine, or tissue/biopsies). It should also explain if biospecimens are collected during the course of routine medical care and that the medical care will not be compromised as a result of the biorepository or biospecimen use/distribution.
  • A description of how any data or data repository specific information will or will not be linked to a biorepository or vice versa.
  • The biorepository department’s requirements, if any, regarding if individual research results may or may not be returned to participants. For example, if an incidental finding was discovered or could include clinically significant information. *NOTE: Individual research results are not normally returned to participants unless directly related to their medical care, they have been clinically validated, or run in a laboratory that is certified under CLIA/CAP requirements.
  • The biorepository department’s requirements, if any, regarding returning aggregate, generalized research findings to participants and how this will be accomplished. *NOTE: There are established guidelines for the depositing of clinical trial data on ClinicalTrials.gov.
  • An explanation regarding whether or not participants would be able to withdraw their biospecimens/data from the repository and if they cannot, what the reasoning is (i.e. the biospecimens or data have been de-identified, or biospecimens/data have already been distributed to other researchers).
  • A description of how the biospecimens or data are linked back to the participant by way of a code, key or honest broker.
  • A description of how biospecimens are labeled (e.g. ID number or barcode). Biospecimens should be labeled without direct participant identifiers whenever possible to avoid breaches of privacy and confidentiality.
  • Emergency backup options if there are problems with freezers shutting down/data access/security breaches. (e.g. a lab in another building has a similar freezer with enough space to temporarily store biospecimens until another freezer can be ordered and installed).
  • An explanation of who will have access to the repository. For example, will biospecimens be stored in a locked freezer or room with restricted access? Will two-factor authentication be required for accessing data?
  • A statement regarding how long the biospecimens or data shall be retained (e.g. 5 years, 10 years, indefinitely).
  • A description of the potential use of the biospecimens in the repository and if DNA or RNA will be tested or if permanent cell lines will be created.
  • A description on whether or not the biospecimens or data will be sent to outside researchers and how that will be accomplished.
    • It should be described if there will be an oversight committee approving requests for access to the repository, if the outside researcher needs IRB approval, and what types of agreements will be used (MTA’s/MOUs).
  • Provide the repository’s Standard Operating Procedures (SOP) via a separate document attachment to the protocol submission in NUgrant. This document should be written in a manner that will delineate the parameters of the project and can be shared with collaborators, external access requests, specific departments, study team, etc.
  • A description of how the participants’ privacy will be protected, including the following items/elements as applicable to the repository:
    • Employee confidentiality agreements
    • Encryption techniques
    • Certificates of Confidentiality
    • Honest brokers
    • Agreements prohibiting re-identification by recipients
    • A plan regarding release of identifiable information, if applicable, to ensure the repository access and use is used consistently with informed consent documentation and tracking
    • An explanation, or plan, regarding what might happen if the repository loses funding or the steward/custodian or repository director leaves UNL

UNL Human Research Protection Program (HRPP) Policies and Procedures:

  • 2018 Policy #8.010 Banking Human Biological Material for Future Research
  • 2018 Policy #8.011 Use of Human Biological Material in Research
  • 2018 Policy #8.012 Participant Registries and Data Repositories

Additional Guidance and/or External Resources:

Office of Human Research Protections (OHRP): Issues to Consider in the Use of Stored Data or Tissues.

Certificates of Confidentiality (CoCs)

CoCs allow researchers to refuse to disclose names or other identifying characteristics of research subjects in response to legal demands. Certificates are issued by NIH and other Federal agencies to researchers to help protect the privacy of human subjects enrolled in research where an individual is identified; or for which there is at least a very small risk, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual. Persons authorized to protect the privacy of research subjects may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify them by name or other identifying characteristic.

The NIH has updated their policy on CoCs effective October 1st, 2017. Specifically, the following has been updated:

  • All research that was commenced or ongoing on or after December 13, 2016 and is within the scope of this Policy is deemed to be issued a Certificate and is therefore required to protect the privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the Public Health Service Act. This Policy will be included in the NIH Grants Policy statement as a standard term and condition of award effective October 1, 2017 for new and non-competing awards.  Institutions and their investigators are responsible for determining whether research they conduct is subject to this Policy and therefore issued a Certificate.  Certificates issued in this manner will not be issued as a separate document.
  • Previously, NIH provided these protections through the issuance of Certificates only upon receipt and approval of a specific Certificate of Confidentiality application. However, in order to comply with the requirement in subsection 301(d) of the Public Health Service Act to minimize the burden to researchers, streamline the process, and reduce the time it takes to comply with the requirements associated with applying for a Certificate, NIH will now provide Certificates automatically to any NIH-funded recipients conducting research applicable to this Policy.

Key Information:

  • The National Institutes of Health issue CoCs for NIH Awardees, Other HHS Agencies (Non-NIH), Non-HHS Federal Funders, and Non-Federal Funders.
  • All funded human subjects research projects do not necessarily start out by having a CoC as part of the award terms. Whether or not your project receives a CoC automatically is based on funding:
    • NIH: Only those projects funded wholly or in part by the NIH, whether supported through grants, cooperative agreements, contracts, other transaction awards are automatically granted a CoC. The issuance is part of the terms of award and it is up to the institution to comply, as applicable.
    • Non-NIH funded: These projects may still have access to a CoC, but these must request a CoC through a separate application process rather than having this automatically issued.
  • Specifically, NIH CoCs are used for biomedical, behavioral, clinical or other types of research in which identifiable, sensitive information is collected or used that may include:
  • Human subjects research as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46), including exempt and non-exempt research.
    • An exception to this requirement is if the project is determined to be exempt from all or some of the requirements of 45 CFR 46 and the information obtained is recorded in such a manner that human subjects cannot be identified or the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
  • Research involving the collection or use of biospecimens that are identifiable to an individual or for which there is at least a very small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual;
  • Research that involves the generation of individual level, human genomic data from biospecimens, or the use of such data, regardless of whether the data is recorded in such a manner that human subjects can be identified or the identity of the human subjects can readily be ascertained as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46); or
  • Any other research that involves information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual, as defined in subsection 301(d) of the Public Health Service Act.
  • Some projects may not be applicable for a Certificate of Confidentiality. Projects that are not are those that are:
    • not research,
    • not reviewed and approved by the IRB as required by these guidelines, or
  • Certificates do not authorize researchers to refuse to disclose information about subjects if authorized DHHS personnel request such information for an audit or program evaluation. Neither can researchers refuse to disclose such information if it is required to be disclosed by the Federal Food, Drug, and Cosmetic Act.
  • In the informed consent form, investigators should tell research subjects that a Certificate is in effect. Subjects should be given a fair and clear explanation of the protection that it affords, including the limitations and exceptions.
  • Examples of sensitive research activities include but are not limited to the following:
    • Collecting genetic information;
    • Collecting information on psychological well-being of subjects;
    • Collecting information on subjects’ sexual attitudes, preferences or practices;
    • Collecting data on substance abuse or other illegal risk behaviors;
    • Studies where subjects may be involved in litigation related to exposures under study (e.g., breast implants, environmental or occupational exposures).

UNL Human Research Protection Program (HRPP) Policies and Procedures:

Guidance for UNL Projects that wish to pursue a CoC, have obtained a CoC or been issued a CoC:

Child Abuse Reporting Requirements & Human Subjects Research in Nebraska

ClinicalTrials.gov Registration

Some clinical trials involving human subjects require registration on a government website (https://clinicaltrials.gov) due to federal requirements or journal requirements. UNL is registered through ClinicalTrials.gov through Research Compliance Services as a central location for UNL investigators to complete this registration when required based on the study design or sponsor requirements. ClinicalTrials.gov is a web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. Further guidance on how to complete this requirement is below.

Other Related Term(s):

  • Clinical Trial (definition found at 45 CFR 46.102(b) ~ effective 01/19/2018)
    • Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
  • Clinical Trial (FDA definition)
    • Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of part 58 of this chapter, regarding nonclinical laboratory studies.
  • Clinical Trial (Clinicaltrials.gov)
    • A study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.
  • Clinical Trial (National Institutes of Health)
    • A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. (Visit the NIH website and use their online tool to help determine if your research meets the NIH definition of a clinical trial.)
      • The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.
      • An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.
      • Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.
  • Clinical Trial (International Committee of Medical Journal Editors (ICMJE))
    • The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.

Key Information:

  • All registered UNL Clinical Trials must have been approved by the UNL IRB.
  • The UNL IRB and the Research Compliance Services Director (UNL PRS ClinicalTrials.gov Administrator) are notified of the intent to register a project through the UNL IRB New project form application submission via NUgrant.
  • Form page one will specifically ask about registration of the research project as it relates to any of the definitions above.

UNL Guidance for registration of an applicable clinical trial:

The purpose of this guidance is to provide information on complying with ClinicalTrials.gov registration requirements. It provides a description for UNL human subjects researchers on how to register and update information when they are involved in research requiring this registration.

HOW TO GET STARTED

  1. Search clinicaltrials.gov (CT.gov) to ensure the trial is not already listed. In the case of NIH-sponsored clinical trials and many industry-sponsored trials, the study may already be registered.
  2. If the trial is not already registered, be sure to answer the applicable clinical trial questions within your IRB application as appropriate. If you have questions, please contact the UNL PRS Administrator (Research Compliance Services Director) for help in order to create a CT.gov account. Or, email your request for account creation to: irb@unl.edu and the administrator will register the person responsible for entry of the study.
  3. One you receive your login name from the PRS Administrator and your temporary password from CT.gov, begin the registration process by visiting the clinicaltrials.gov registration site:

Organization: UNebraskaLincoln
UserName: Assigned by the PRS Administrator- this information will be emailed to you
Password: User discretion after using temporary password from CT.gov for initial login

THE SITE WILL REQUEST THE FOLLOWING:

  • Protocol identifier number: Please use the IRB project ID (available on NUgrant)
  • IRB approval number: Please use the date of IRB approval [MM/DD/YYYY]. *NOTE: IRB approval is not yet necessary to register your trial as the CT.gov site allows you to begin the process early and save changes before submission.
  • To complete the protocol template, begin from the “Main Menu,” page; go to “Protocol Record,” and select, “Create.” You can copy and paste information from your protocol into the data fields. A list of all the variables you will be asked to provide can be found on the CT.gov website.
  • When finished with the submission click “Complete” at the top of the page. The PRS Administrator is then notified to review, compare the information with any submitted protocol information, approve and release the submission to ClinicalTrials.gov for their review.
  •  CT.gov will assign an NCT number once the entry is complete and the information will be ready for public release.

*NOTE: while the PRS Administrator will check the site periodically to help ensure compliance, it is the PI’s responsibility to ensure all information is up to date and accurate for the registration and release to the public.

TERMS AND CONDITIONS

  • Only data for studies that are in conformance with applicable human subjects or ethics review regulations (or equivalent) and applicable regulations of the national (or regional) health authority (or equivalent) may be submitted.
    *NOTE: some journals require clinicaltrials.gov registration and follow the International Committee of Medical Journal Editors (ICMJE) expanded definition of a clinical trial. Those who are uncertain whether their trial meets the expanded ICMJE definition should err on the side of registration if they wish to seek publication in an ICMJE journal.
  • The submitting organization, or individual designated as the Responsible Party, is responsible for the completeness and accuracy of the data submitted to ClinicalTrials.gov
  • Study data must be submitted in English.
  • Multiple groups within a single entity (company, university) must share a single Protocol Registration and Results System (PRS) organization account. The Administrator account for UNL is held by the Research Compliance Services Director. Upon request, this person then has the ability to register and create a new user account for each PI. This allows the maintenance of one account along with the ability to track all studies at UNL that require registration.
  • Previous versions of study data will be available to the public, although the default view will be the most recent version.
  • Responsible Parties (PI) should update their records within 30 days of a change to any of the following:
    • Recruitment status
    • Overall recruitment status data elements
    • Completion date
    • Other changes or updates to the records, such as protocol amendments, must be made at least every 12 months
    • It is recommended that the Record Verification Date be updated at least every 6 months for studies that are not yet completed, even if there were no changes to the record

REGISTRATION DEADLINE

The Responsible Party (that is, the sponsor or designated PI) for an Applicable Clinical Trial must submit the required clinical trial information no later than 21 days after enrollment of the first participant.

CLINICAL TRIALS REGISTRATION FAQs & ICMJE INFORMATION

https://www.clinicaltrials.gov/ct2/manage-recs/faq#after

http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html

When will the NCT Number for my study be assigned?

The NCT Number, also called the ClinicalTrials.gov Identifier, is assigned after the protocol information has been Released (submitted) by the Responsible Party and passed review by ClinicalTrials.gov staff. At that time an e-mail notification containing the NCT Number is sent. The record, including its NCT Number, will typically be available on ClinicalTrials.gov within 2–5 business days after it is Released.

Why can’t I find my study on ClinicalTrials.gov?

It might not have been Released (submitted) to ClinicalTrials.gov for processing. After a record has been entered into PRS (or modified) and marked as Complete, it must be Approved and Released by the Responsible Party (see Responsible Party data element on ClinicalTrials.gov).

The study might also be undergoing review. After the Responsible Party Releases (submits) information to ClinicalTrials.gov, that information undergoes a manual review to identify possible errors, deficiencies, or inconsistencies that are not detected automatically during data entry. The Responsible Party will be notified of any issues that need correction, usually within a few days after release of the protocol information. The review of results information may take longer (up to 30 days).

Can I register a study after it has started, has closed to recruitment, or has been completed?

Yes, you can register a study on ClinicalTrials.gov at any time. Please note that, in general, Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant. In addition, the International Committee of Medical Journal Editors and other journals require registration of clinical trials prior to enrollment of the first participant.

Does FDAAA 801 only apply to Industry-sponsored studies?

No. FDAAA 801 applies to any clinical study that meets the definition of an Applicable Clinical Trial and that was initiated after September 27, 2007, or that was initiated on or before that date and was still ongoing as of December 26, 2007. FDAAA 801 does not distinguish between types of sponsors or funding sources in establishing requirements for registration and results submission. https://clinicaltrials.gov/ct2/manage-recs/fdaaa

The Responsible Party for a clinical trial must register the trial and submit results information. The Responsible Party is defined as:

  • The sponsor of the clinical trial or
  • The principal investigator (PI) of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the PI is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of FDAAA’s requirements for the submission of clinical trial information

For complete statutory definitions and more information on the meaning of Responsible Party and sponsor, see the Elaboration of Definitions of Responsible Party and Applicable Clinical Trial (PDF) and the Responsible Party data element on ClinicalTrials.gov.

Which trials must be registered and have results submitted to ClinicalTrials.gov?

Registration is required for trials that meet the FDAAA 801 definition of an “applicable clinical trial” and were either initiated after September 27, 2007, or initiated on or before that date and were still ongoing as of December 26, 2007. Trials that were ongoing as of September 27, 2007, and reached the Completion Date (see Primary Completion Date data element on ClinicalTrials.gov) before December 26, 2007, are excluded. Applicable Clinical Trials include the following:

  • Trials of drugs and biologics: Controlled clinical investigations, other than phase 1 clinical investigations, of drugs or biological products subject to Food and Drug Administration (FDA) regulation
  • Trials of devices (see note): 1) Controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and 2) pediatric postmarket surveillance required by FDA

Applicable Clinical Trials generally include interventional studies (with one or more arms) of FDA-regulated drugs, biological products, or devices that meet one of the following conditions:

  • The trial has one or more sites in the United States
  • The trial is conducted under an FDA investigational new drug application or investigational device exemption
  • The trial involves a drug, biologic, or device that is manufactured in the United States or its territories and is exported for research

*NOTE: For Applicable Clinical Trials that include a device not previously approved or cleared by FDA for any use and that need to be registered, full posting of the trial information on ClinicalTrials.gov will be delayed until after the device has been approved or cleared, as required by FDAAA 801. See the Delayed Posting data element on ClinicalTrials.gov.

The ICMJE’s clinical trial registration policy is detailed in a series of editorials (see Updates and Editorials and FAQs).

Briefly, the ICMJE requires, and recommends that all medical journal editors require, registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication. Editors requesting inclusion of their journal on the ICMJE website list of publications that follow ICMJE guidance should recognize that the listing implies enforcement by the journal of ICMJE’s trial registration policy.

The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. The ICMJE does not define the timing of first patient enrollment, but best practice dictates registration by the time of first patient consent.

How do I submit results information if the trial is terminated (that is, stopped prematurely) and no data were collected for one or more Outcome Measures?

If no participants were ever enrolled in the trial, set the Overall Recruitment Status to Withdrawn, and no further results information will need to be submitted.

For a trial that was terminated after participants were enrolled, provide any available data. If no data are available for any of the Outcome Measures, specify zero (“0”) for the Number of Participants Analyzed in each Arm/Group, and leave the data fields blank. In this case, provide an explanation in the Analysis Population Description for why zero participants were analyzed and, if appropriate, provide information in the Limitations and Caveats module. Even if data are not entered for Outcome Measures, submit the available data for the enrolled participants in the Participant Flow, Baseline Characteristics, and Adverse Events modules.

Are There Penalties If I Fail to Register or Submit Results?

FDAAA 801 establishes penalties for Responsible Parties who fail to comply with registration or results submission requirements. Penalties include civil monetary penalties and, for federally funded studies, the withholding of grant funds.

In addition, many publishers (see ICMJE Guidelines) will not allow study publications to move forward if PIs are unable to show appropriate CT.gov registration.

Other FDAAA 801 Requirements: NIH and FDA

NIH and FDA have additional certification and informed consent requirements. NIH grantees must certify compliance with FDAAA 801 in their competing applications and noncompeting continuation progress reports for any NIH grant that supports an Applicable Clinical Trial, even if the grantee is not the Responsible Party. An application/submission to FDA for a drug, biological product, or device must be accompanied by a certification indicating that the requirements of FDAAA 801 have been met. In addition, informed consent for Applicable Clinical Trials subject to FDA’s Protection of Human Subjects regulation (Title 21, Part 50) must include a specific statement about trial registration.

Compensation/Incentives and Accounting Guidance

Cooperative Research

Please see the topic Multi-Site Research.

Deception in Research

Deception means to intentionally provide misleading or false information about the research project.

Other Related Term(s):

  • Authorized Deception
    • To inform participants prior to the study that a study will not be described accurately or that some procedures will be deceptive, provides them an opportunity to decide whether or not to participate on these terms.
  • Incomplete Disclosure
    • To withhold information about the true purpose or nature of the research.
  • Concealment
    • To deliberately withhold certain information from research subjects as part of the project design.

Key Information:

The UNL IRB approves research projects involving deception or concealment in accordance with 45 CFR 46. Depending on the project complexity, they can typically be approved using an expedited category or may require review by the full board:

  • Studies involving deception or concealment must meet all criteria for a waiver or alteration of informed consent. For a waiver or alteration of consent, the study must pose no more than minimal risk to subjects, and the waiver or alteration must not adversely affect subjects’ rights and welfare. The nature of the study must necessitate use of deception or concealment and, therefore, the waiver or alteration.
  • Some studies may be deemed to involve more than minimal risk and would then require review by the full board.

Examples of deception:

    • Misinforming subjects about the purpose of study (deception).
    • Withholding specific information about a study (concealment).
    • Fake or rigged instruments or procedures (deception).
    • Misleading play-acting by researchers and others (deception).
    • Informing the participant during the consent process that they will not be told the true purpose of the research. The participant must agree to this deception (authorized deception).

Document Version Control

Version control is a process used to keep track of and communicate, in a standardized manner, different drafts of a document. This process is important as it provides an audit trail for the revision and update of a finalized version. In particular, this process can be most readily utilized by researchers to track different versions of consent forms that may be used in order to ensure the most current, and approved, form is being used.

Investigators are encouraged to implement the use of version numbers to track the most up-to-date document. While there are many ways to approach version control of documents, this is the standard operating procedure used by Research Compliance Services. Please feel free to reference and use this SOP as needed.

UNL Guidance for Document Version Control:

European Union General Data Protection Regulation (EU GDPR)

The EU GDPR impacts several areas of the UNL campus that could process or have access to EEA country information. However, this document is intended to provide guidance regarding the EU GDPR as it pertains to navigating human subjects research.

Effective May 25, 2018, the European Union General Data Protection Regulation (EU GDPR) requires entities that collect, store or process personal data to comply with stricter privacy standards and give EU citizens more access to and control over their own data. The EU GDPR supersedes the EU Data Protection Directive, which was adopted in 1995.  As a regulation of the EU, the GDPR will apply directly to data controllers and data processors in the 28 member states of the EU and in the three additional countries (Iceland, Liechtenstein, and Norway) that, together with the EU, make up the European Economic Area (EEA). The 28 EU member states are: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Ireland, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Spain, Slovakia, Slovenia, Sweden and the United Kingdom.

Definitions:

  • Data controller/processor: broadly interpreted as research investigators, sponsors, or industry collecting applicable information.
  • Personal data: broadly defined as, any information relating to an identified or identifiable natural person.
  • An identifiable person: is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, online identifier, or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural, or social identity of that person.
  • Pseudonymised: is the same as coded/anonymized data and are still considered personal data per the EU GDPR.
  • Goods/Services: broadly interpreted to include things as simple as an EEA person participating in research.

Key Information:

  • If your human subjects research project involves any of the above listed 31 countries, or person(s) living or traveling in or to an EEA country while they are enrolled as a participant, your project may be subject to the EU GDPR.
  • The GDPR will apply extraterritorially in a broader range of circumstances than previous requirements.  Unlike the “Directive,” the GDPR applies to the processing of personal data by a controller or processor not established in the EEA, i.e., that lacks a physical presence in the EEA, when the processing is related to
    • (a) offering goods or services to data subjects in the EEA or
    • (b) the monitoring of behavior of data subjects who are in the EEA.
  • This means that the GDPR will apply directly to, and will directly regulate, much of the U.S.-based use and processing of personal data that have been collected in the EEA for clinical and other research purposes.
  • The category of “personal data” to which the GDPR applies is much more broadly defined than “protected health information” covered by HIPAA or “identifiable private information” as defined in the Common Rule.  Under the GDPR, “personal data” are defined broadly to include:
    • Any information relating to an identified or identifiable natural person (“data subject”); an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, online identifier, or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural, or social identity of that person.
  • Notably, coded data, referred to as “pseudonymised data” in the GDPR, are considered to be “personal data” subject to the protections of the GDPR.  This is in contrast to the Common Rule, which generally does not protect such information as “identifiable private information” provided that certain steps are taken to prevent the investigator from obtaining the means to link the code to the subject’s identity.
  • The Consent process must be distinct in order to ensure your project meets EU GDPR requirements when involving EEA subjects. Current thought among research universities is that consent will be a 2 step process:
    • First, a letter of information (i.e. body of the consent form)
    • Second, a 1-2 page consent document that includes affirmation, consent elements and signature.

Keep in mind that these requirements are new and depart in several ways from how human subjects research is conducted in the US. Guidance regarding standard or best practices have not yet been created at the Federal level or otherwise. Thus, there may not be a clear way forward in how best to accomplish your human subjects research until more detailed guidelines are worked out.

The IRB new application form in NUgrant does already request information regarding whether or not your proposed project will involve an international site. As a starting point to meeting the new GDPR requirements, please be sure to include information in your IRB application regarding any involved EEA countries/citizens. If you have a currently approved IRB protocol involving the above, please contact the IRB.

Templated language to include within informed consent documents for projects needing to meet GDPR requirements can be found on the RCS Templates/Forms web page.

Additional Guidance and/or External Resources:

Exempt Research

In order for research to be categorized as exempt, research must meet the criteria of one or more exempt categories officially documented by Research Compliance Services staff through submission of a new project form via NUgrant.

In addition, effective January 19, 2018, the IRB has removed the requirement for change requests to be submitted for exempt research projects. Unless the change would involve one of the following, a change request would not need to be submitted:

  • A change in the scope of the project
  • Increased risk to participants
  • A change to the category of the original exemption determination
  • A change in performance site
  • A change in the principle or secondary investigator
  • Or, if the exempt project is approved under a limited review category (effective July 19, 2018)

Key Information:

  • Being categorized as exempt, does not mean the project is exempt from review. This categorization means that the research does not have to meet some of the regulatory requirements present at 45 CFR 46.
  • If a project is categorized as exempt based on the federal regulations, the project must still meet institutional policy requirements such as, for example, providing basic information about the research, submission of some change requests, reporting to the IRB of any new information found during the course of the project. HRPP Policy #12.001: Change Request delineates the types of changes that must be submitted.
  • Beginning January 19, 2018, recruitment materials and informed consent documents for Exempt projects are not stamped and certain changes to the project do not require submission and approval prior to implementation.
  • Because the consent and recruitment documents are not stamped, study teams are encouraged to implement the use of version numbers to track the most up-to-date document. Feel free to review Research Compliance Services Standard Operating Procedure for the use of version numbers available.

UNL Human Research Protection Program (HRPP) Policies and Procedures:

UNL Guidance for Exempt Research:

  • It is recommended to use the consent and recruitment templates that are available on the Templates/Forms webpage.
  • See also our guidance on Recruitment/Advertising and HRPP Policy #3.016: Recruitment of Participants Through Advertisements.

External Organization IRB Review Request Fee Schedule

The UNL IRB can consider becoming the IRB of record for external entities or institutions when they do not have an IRB of their own and/or the use of a commercial IRB is not a viable option. Approval in these cases is limited and the decision on whether or not to provide IRB review is determined on a case-by-case basis involving approval from the UNL Institutional Official and/or RCS Director. Please see our Fee Schedule document for further information and how an outside entity could request IRB review at UNL.

Please download the UNL IRB Fee Schedule for further details.

Genetic Information Nondiscrimination Act (GINA)

GINA defines a genetic test as an analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detect genotypes, mutations, or chromosomal changes. To learn more about GINA, please visit the Office of Human Research Protection’s (OHRP’s) webpage.

GINA defines genetic information as information about:

  • An individual’s genetic tests (including genetic tests done as part of a research study);
  • Genetic tests of an individual’s family members (defined as dependents and up to and including 4th degree relatives);
  • Genetic tests of any fetus of an individual or family member who is a pregnant woman, and genetic tests of any embryo legally held by an individual or family member utilizing assisted reproductive technology;
  • The manifestation of a disease or disorder in an individual’s family members (family history); or
  • Any request for, or receipt of, genetic services or participation in clinical research that includes genetic services (genetic testing, counseling, or education) by an individual or an individual’s family members.

Genetic information does not include information about the sex or age of any individual. Routine tests that do not detect genotypes, mutations, or chromosomal changes, such as complete blood counts, cholesterol tests, and liver enzyme tests, are not considered genetic tests under GINA. Also, under GINA, genetic tests do not include analyses of proteins or metabolites that are directly related to a manifested disease, disorder, or pathological condition that could reasonably be detected by a health care professional with appropriate training and expertise in the field of medicine involved.

Template language to be used for non-exempt genetic research involving human subjects conducted or supported by Health and Human Services (HHS) can be found on our Templates/Forms page.

Good Clinical Practice (GCP) & Training Requirements

According to the International Council for Harmonisation, Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.

Other Related Term(s):

  • Clinical Trial
    • The National Institutes of Health (NIH) define a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Key Information:

  • Any investigator conducting a National Institutes of Health sponsored Clinical Trial must complete GCP training as of January 01, 2017. This training is completed through the Collaborative Institutional Training Initiative (CITI).
  • Any investigator conducting a National Institutes of Health sponsored Clinical Trial must register the clinical trial on CT.gov. For more information about registering your project on CT.gov, please see the topic ClinicalTrials.gov registration
  • GCP training requirements are based on NIH Policy (NOT-OD-16-048).

Grant Congruency Review

When a funding source is identified on an IRB project form (regardless of whether or not the funding source is Federal), UNL HRPP staff will complete a grant congruency review to ensure the proposal/grant/statement of work or other related document matches or is closely related that of the proposed IRB protocol.

Other Related Term(s):

  • 118 Determination
    • This is a specific regulation that could be used during a grant congruency review that allows for IRB approval when there are no definitive plans for human subjects involvement in a proposed project. See topic 118 Determination for more information.

Key Information:

  • The congruency review between the funding proposal document and IRB protocol is completed to confirm that the information provided in the grant proposal matches or is closely related that of the proposed IRB protocol.
  • The IRB protocol must include the research questions, design, and procedures that are provided in the grant proposal, but the protocol may also include additional design and procedures that are not related to the grant.
  • HRPP staff will request revisions to the IRB application or request clarifications from the PI to better identity or clarify any discrepancies between the funding and the IRB applications, as necessary.
  • The UNL Office of Sponsored Programs holds funding awards until all IRB requirements have been satisfied. Specifically, Pre-2018 Federal regulations at 45 CFR 46.103 require that grant applications or proposals for federally funded human subjects research be reviewed and approved by an IRB:
    • “Certification is required when the research is supported by a Federal department or agency and not otherwise waived or exempted. For such research, institutions shall certify that each proposed research study covered by the assurance and this section has been reviewed and approved by the IRB. Such certification must be submitted as prescribed by the Federal department or agency component supporting the research. Under no condition shall research covered by this section be initiated prior to receipt of the certification that the research has been reviewed and approved by the IRB.”

Once the grant congruency review has been completed and any inconsistencies addressed, the HRPP staff will document:

  • Grant congruency review date
  • IRB Coordinator who completed the congruency review
  • Sponsored Programs Project and Form ID numbers

For those projects where funding is not being routed through Sponsored Programs for processing, it is still important to contact the IRB (and other compliance offices: institutional animal care program, export control, conflict of interest, biosafety and radiation safety) in order to ensure appropriate approvals are in place if the project involves any of these components.

The RCS Office provides the following template language for use by any Departments on campus when funding or an award is perhaps internal or not being routed through Sponsored Programs. The language may not fit every scenario but please keep in mind the main intent of the notification is to ensure release of funds does not occur until all applicable compliance areas have been checked.

“In order to ensure use of these funds meets research compliance requirements, please follow up with the respective UNL campus research offices for approval involving human or animal subjects, export controls, conflicts of interest, and biosafety or radiation safety as applicable. The office responsible for administering the award will not authorize release of funds until all compliance checks have been addressed.”

UNL Human Research Protection Program (HRPP) Policies and Procedures:

UNL Guidance for UNL HRPP staff grant congruency review:

Human Subjects Research

Human subjects research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Research must involve a living individual about whom an investigator (whether professional or student) conducting research obtains either data through intervention or interaction with the individual, or identifiable private information.

Other Related Term(s):

  • Intervention
    • Includes both physical procedures by which data are gathered (e.g., drawing blood) and manipulations of the participant or the participant’s environment that are performed for research purposes.
  • Interaction
    • Includes communication or interpersonal contact between investigator and participant.
  • Private Identifiable Information
    • Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual, and which the individual can reasonably expect will not be made public (e.g., medical record information).

Key Information:

  • All human subjects research conducted by UNL faculty, staff, students and/or affiliates must be reviewed and approved by the IRB prior to commencement of the research, including recruitment.

UNL Human Research Protection Program (HRPP) Policies and Procedures:

UNL Guidance for research involving human subjects and the IRB review process:

Informed Consent Waivers

For a non-Exempt (i.e., Expedited or Full Board) human subjects research project, there may be special circumstances in which obtaining consent from subjects or subjects’ parent/legally authorized representative may not be practicable within the study scope and procedures. In this case, the federal regulations allow the IRB to waive or alter some or all of the elements of consent. There are three waivers of consent that can be requested: 1) waiver of informed consent entirely, 2) waiver of an element or alteration of an element of informed consent, and 3) waiver of consent documentation.

Key Information:

  • A waiver in this context refers to the process of the IRB approving to exclude some or all of the elements of consent that are required under the federal regulations. A waiver is not a type of document for participants to sign; rather, it is a decision by the IRB based on specific criteria.
  • The criteria for the Waiver or Alteration of Consent at 45 CFR 46.116(d) are:
    1. The research involves no more than minimal risk; and
      • For this criterion, consider the definition of minimal risk: “the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.”
    2. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
      • For this criterion, consider whether there are other Federal, state, or local laws that provide rights to potential subjects to require informed consent, whether the subjects would consider that their rights were violated if they knew of the waiver, and/or that the waiver has the potential to cause adverse consequences to subject welfare or general well-being.
    3. The research could not practicably be carried out without the waiver or alteration; and
      • For this criterion, consider if the scientific validity of the research would be compromised if informed consent or element of consent were required. Informed consent or an element of consent should not be waived solely for convenience, cost, or speed.
    4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
      • For this criterion, consider if there is a need to debrief or provide study information to the subject after the research is conducted. This may be necessary if the research involves deception or if information is obtained during the study that would directly impact the safety or welfare of the subject.
  • The options for the Waiver of Documentation of Informed Consent at 45 CFR 46.117(c) are:
    1. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject; or
    2. That the research presents no more than the minimal risk of harm to the participants, and involves no procedure for which written consent is normally required outside of the research context.

Informed consent waivers (i.e., a waiver of informed consent entirely, a waiver of an element or alteration of an element of informed consent, and a waiver of consent documentation) may be requested within the Informed Consent section of the New Project Form via NUgrant.

UNL Human Research Protection Program (HRPP) Policies and Procedures:

Additional Guidance and/or External Resources:

IRB Guidebook

The UNL IRB Guidebook – developed to provide quick reference information related to the Institutional Review Board, the Human Research Protection Program, application submission, training requirements and much more.  To the extent this guidebook conflicts with the University of Nebraska-Lincoln Human Research Protection Program Policies and Procedures, the Policies and Procedures will prevail.

Lincoln Public Schools (LPS) Approval Processes

The University of Nebraska – Lincoln (UNL) and the Lincoln Public Schools (LPS) District have a long standing relationship and commitment of working together to achieve classroom success for all students, including the use of research to learn how to increase those successes.  One important step in advancing research within the LPS District is to ensure all the correct approvals and permissions are obtained before any work (including access to buildings) begins.

The key information section gives a general overview, while the guidance document below will provide specific information regarding requirements, restrictions, and step-by-step instructions on how the UNL Institutional Review Board and the LPS Evaluation and Assessment Office has worked together to streamline the approval process for research conducted within the District.

Key Information:

  • All projects, including class projects, must be reviewed by the LPS District through the Director of Assessment and Evaluation prior to conducting any procedures within the LPS District and/or with LPS students, staff or faculty regardless of the UNL IRB review requirement. If your project does not require UNL IRB review, which most class projects do not, please contact the LPS Assessment and Evaluation office directly to inquire about the review and approval process.
  • All projects being conducted within a LPS associated program (before or after school) will require review and approval by the LPS District through the Director of Assessment and Evaluation.
  • Projects requesting to recruit directly through LPS require approval by the LPS District through the Director of Assessment and Evaluation.
  • Research, including recruitment, cannot begin until the fourth week of school.
  • No new research, including recruitment only protocols, can start during the fourth quarter.
    • Ongoing research should try to avoid new data collection during the fourth quarter. Please review the LPS calendar for specific dates.
  • All research projects that require UNL IRB review and LPS District review are reviewed through NUgrant.
  • A background check may be required.
  • A form of student assent will be required.
  • Compensation during contract/school hours is restricted.
  • Food items are restricted based on federal requirements.

UNL and LPS Guidance for research requiring both UNL IRB and LPS District review:

  • UNL/LPS Research Review and Approval Steps – This guidance describes the steps all UNL researchers must take in order to receive approval through the UNL IRB and LPS District if your project involves human subjects. Please read this guidance document carefully as there is important information regarding dates, submission requirements and miscellaneous personnel requirements including background check requirements and building access.
  • Lincoln Public Schools Guidelines for conducting research within LPS – this guidance describes requirements overseen by Lincoln Public Schools to conduct research within the District.

Multi-Site Research

UNL investigators oftentimes engage in research with project partners at other institutions. This includes multi-site research.

Multi-Site Research is defined by the National Institutes of Health (NIH) as research or a study that uses the same protocol to conduct non-exempt (i.e. Expedited, Full Board) human subjects research at more than one site.

More specifically, Public Responsibility in Research & Medicine (PRIM&R) defines multi-site or multi-center research as research conducted at multiple, varied sites by one or more investigators. Multi-site or multi-center studies use the same overall research plan that outlines the procedures for conduct of the study, as well as the collection and storage of study materials. An overall study principal investigator is typically designated to oversee the study at each site. The primary site typically provides materials (e.g. protocol, consent form, investigator’s brochure, etc.) to participating sites.

Other Related Term(s):

  • Cooperative Research
    • Health & Human Services regulations at 45 CFR 46.114 use the term Cooperative Research to describe and define requirements for research that involves more than one institution. In general, Cooperative Research involves two or more sites working on different components of a single project and not necessarily using the same research protocol. As an example, Institution A is responsible for data analysis, while Institution B is responsible for recruitment and data collection.
    • Note: Please know that changes to the Common Rule will impact the applicability of the definitions of Cooperative Research and Multi-Site Research.
  • Multi-Site/Multi-Center Trial
    • The NIH guidelines describe multi-center research as non-exempt human subjects research conducted according to a single protocol but at more than one site, and, therefore, carried out by more than one investigator.
  • Authorization/Reliance Agreement
    • This is the agreement that documents respective authorities, roles, responsibilities, and communication between an institution/organization providing the ethical review and a participating site relying on a Single IRB (sIRB). In the case of Exempt human subjects research, regardless of funding source, the UNL IRB will not act as the Reviewing IRB for a non-UNL research site or cede review of a project to another institution’s IRB, except when special arrangements must be made.
  • Single IRB (sIRB)
    • The sIRB of record that has been selected to carry out the IRB review requirements at 45 CFR Part 46 for participating sites of the multi-site study.
  • Participating site
    • A domestic entity that will rely on the sIRB to carry out the site’s initial and continuing IRB review of human subjects research for the multi-site study.

Key Information:

  • As of January 25, 2018, the NIH requires an sIRB of record to be identified for all multi-site studies funded by or supported by the NIH. Please be aware, the compliance date for sIRB of record requirements for all cooperative research under the Common Rule is January 20, 2020.
  • International participating sites are not required to comply with sIRB requirements even after the dates identified above. Typically, local ethics committee review is completed to ensure local customs and norms are addressed.
  • If an Investigator will be proposing or participating in non-exempt multi-site research they should let the IRB know as soon as possible. The IRB can be notified through several different avenues (i.e. email, phone, OSP, etc.)
  • Initial contact and continuing communication with other institutions during the time of agreement negotiation will always be completed by the IRB point of contact.
  • The IRB Institutional Official, or their designee, is the only individual authorized to enter into Authorization Agreements for non-exempt research on behalf of UNL.
  • An Investigator is not authorized to enter into agreements or commit Human Research Protection Program (HRPP) resources on behalf of the institution or the IRB.
  • Typically the lead institution, or Prime Awardee, in a multi-site research project is also the Reviewing IRB, or sIRB-of-record.
  • Request to rely on another institution’s IRB (cede review) should be submitted via a NUgrant Determination Form. All approved project documents, including the final IRB approval letter, must be provided to the UNL IRB.
  • UNL holds multiple blanket Authorization Agreements with the University of Nebraska Medical Center and Boys Town. The agreements allow us to meet requirements both under the HHS regulations and the FDA regulations.
  • UNL is a member of SMART IRB, an electronic reliance arrangement system for investigator-initiated studies that involve other academic institutions. If a partnering institution is a member of SMART IRB, UNL may require the use of this system to manage the agreement process.

UNL Human Research Protection Program (HRPP) Policies and Procedures:

UNL Guidance related to decision-making and participation in multi-site research with respect to UNL IRB as either the Reviewing or Relying IRB:

The following flowchart represents the most common process during the course of deciding which institution is designated as a Reviewing or Relying IRB. Many other factors could change the outcome of this decision such as complexity of the project, IRB expertise needed to complete the review, number of collaborating sites, etc. Always be sure to discuss any multi-site projects with the IRB prior to any agreements being made regarding Reviewing or Relying IRBs. Only the Institutional Official has the authority to enter into Reliance Agreements on behalf of the institution.

Authorization Agreement Workflow

In addition, UNL and UNMC, as well as UNL and Boys Town, have standing master agreements to fluidly cede review to the respective institutions without having to sign study specific agreements. Decisions to to serve as a Relying or Reviewing IRB are made on a case-by-case basis. The following procedures have been established between UNL and both of these specific entities to ensure both organizations have all required documents for records purposes regardless of whether UNL or UNMC/Boys Town is the Reviewing or Relying IRB. (This does not imply that Boys Town and UNMC have a master agreement between their organizations.)

The following steps must be completed to ensure the respective IRB has all the documents needed: 

  • Submit all required IRB application materials to the Reviewing IRB via the appropriate system.
    • UNL submissions must be completed through the NUgrant system at https://nugrant.unl.edu
      • If UNL is the reviewing institution, all research team members affiliated with the respective institution must complete affiliation with UNL in order for them to be searchable via NUgrant. Affiliation should be completed through investigator home department, but can also be completed through the Office of Research, if applicable.
      • Submissions by Boys Town’s Youth Care division must be submitted to the Youth Care IRB.
    • Submissions by Boys Town’s Health Care division must be submitted to the BTNRH IRB.
    • UNMC submissions must be completed through the UNMC Research Support System (RSS) at https://net.unmc.edu/rss.
  • Please notify the Relying IRB staff (at the contact information above) regarding investigator’s intent to use this agreement at the earliest possibility.
  • Once approval has been received through the Reviewing IRB, copies of all research application materials, including the approved protocol, consent document and any relevant supporting documents must be submitted to the Relying IRB for acceptance. As a reminder, the Relying IRB still reserves the right to conduct its own review upon receipt of approved study materials.
    • If UNL is the Relying IRB, a determination form must be submitted. The Determination Form can be accessed in NUgrant by clicking on “Add a New Project” within the IRB module.
    • If UNL is the Relying IRB, only the UNL affiliated persons need be listed on the protocol “shell” application.
  • An acceptance letter citing this agreement will be provided by the Relying IRB.

Research can only begin if all other required approvals have been obtained (i.e. radiation safety, bio-safety, conflict of interest, etc.). For questions related to multi-site or cooperative research agreements the point of contact is Rachel Wenzl. Email her at irb@unl.edu, or call 402-472-6965.

National Institutes of Health (NIH) Proposal Requirements – Human Subjects

This guidance has been created to assist researchers in meeting the new 2018 NIH funding submission requirements. It does not address every aspect of the proposal questions that focus on human subjects research, rather, it is meant to help address the questions or requirements that the NIH has changed or required further clarification at the time of proposal.

We have also created language to assist PI’s in communicating dissemination plans and IRB policy requirements regarding clinical trial related questions that appear in the grant proposal.

*NOTE: Please remember that age of majority in Nebraska is 19 y/o. Thus, those younger than 19 are considered to be children and your project and IRB determination must address the vulnerable population information in the proposal if children are included.*

UNL Guidance and/or Resources:

Program Evaluation vs. Evaluation as Research

It can be difficult to discern between Program Evaluation and Evaluation as a form of research. These terms are used interchangeably. The differences may be subtle, but are especially important considering IRB approval is only necessary when a project meets the definition of both human subjects and research. Varying disciplines may have different definitions for program evaluation, evaluation, as well as research. The UNL IRB refers to U.S. Health and Human Services Office for Human Research Protections (OHRP) and The Centers for Disease Control and Prevention (CDC) for guidance to ensure consistency across project determinations.

Key Information:

  • OHRP defines research as, “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” By definition, this includes evaluation. Additionally, OHRP recognizes that things like quality improvement activities (program evaluation) are typically not seen as research subject to human subjects regulations. However, there are some cases where these activities are “designed to accomplish a research purpose as well as the purpose of improving the quality of care,” and in these cases, the regulations for the protection of subjects in research may apply.
  • The CDC recognizes evaluation as a broad term that can be defined as research; and while program evaluations are a subset of evaluations, by their definition, they are generally not research. To help further clarify, the CDC Policy Distinguishing Public Health Research and Public Health Nonresearch states:
    1. When the purpose of an evaluation is to test a new, modified, or previously untested intervention, service, or program to determine whether it is effective, the evaluation is research. The systematic comparison of standard or nonstandard interventions in an experimental-type design is research. In these cases, the knowledge gained is applicable beyond the individual, specific program. Thus, the purpose is to generate new knowledge or contribute to the knowledge in the scientific literature. Further, it is intended to apply the knowledge to other sites or populations.”
    2. When the purpose is to assess the success of an established program in achieving its objectives in a specific population and the information gained from the evaluation will be used to provide feedback to that program, the evaluation, referred to as program evaluation, is nonresearch. In the nonresearch scenario, the evaluation is used as a management tool to monitor and improve the program. The evaluation activity is often a component of the regular, ongoing program. Information learned from the evaluation has immediate benefit for the program or the clients receiving the services or interventions. Interventions and services that are evaluated are never experimental or new; they are known (either from empirical data or through consensus) to be effective.”

Contact the IRB to assist with any decisions regarding whether or not a project is Program Evaluation. If an official decision is needed from the IRB, please submit a Determination Form via NUgrant.

UNL Human Research Protection Program (HRPP) Policies and Procedures:

Additional Guidance and/or External Resources:

Recruitment/Advertising

Forms of recruitment/advertisements can take on many modes and vary greatly depending on the specific project or goals of the research. Recruitment could be completed through fliers in the student union or departmental bulletin boards, newspaper, radio or television ads, direct mailings, email announcements, website postings, press releases, social media postings, brochures, postcards and verbal scripts, to name a few.

Key Information:

  • Per human subjects regulatory requirements at 45 CFR 46, the UNL IRB is required to review and approve recruitment material/advertisements prior to use in order to ensure the protection of human subjects, equitable selection of subjects, and ensure the advertisements are free from coercive information or language.
    • For Exempt projects only, the UNL IRB no longer stamps informed consent or recruitment documents. This means that members of our University and community could see documents (recruitment fliers posted on bulletin boards, etc.) that do not have an IRB approval stamp on them, if the project is certified as Exempt. If the document was revised based on a change made for an exempt project, the IRB may not require review, approval and stamping of the document. However, the specific document should still be appropriate for the project and should still be written in consideration of the “Dos and Don’ts” below.
  • When using recruitment material/advertisements DO:
    • Spell out acronyms
    • Consider readability for communicating with the public
    • Make updates to keep information current
    • Provide balanced information
    • Provide accurate information in alignment with the approved protocol
  • When using recruitment material/advertisements DON’T:
    • Use coercive or overly inductive content (threatening scenarios, glowing testimonies, overly positive or negative photos/images)
    • Overemphasize payment (use larger/bolder font to call out remuneration amount)
    • Use font or script that is difficult to read
    • Post or utilize the advertisement without IRB approval (most will be stamped after approval)
    • Use endorsements from other entities outside the NU system

UNL Human Research Protection Program (HRPP) Policies and Procedures:

UNL Guidance related to recruitment and advertising:

Secondary Information and Biospecimens: Use in Research and IRB Applicability

Research utilizing secondary information and/or biospecimens that were previously collected for research or non-research purposes and will now be used in the proposed research study may require IRB approval. Determining whether IRB review and approval of research involving secondary information and/or biospecimens is required is dependent on the availability or access to identifiers (directly or indirectly) and can be complicated. If you do not find an answer to your question in the below information, please contact an IRB coordinator.

Research utilizing secondary information and/or biospecimens may or may not be considered human subjects research. To determine whether or not IRB approval is necessary, you must first determine how the information and/or biospecimen is stored with respect to access to identifiers. Information and/or biospecimens are either de-identified, coded, or identifiable (see definitions below).

Other Related Term(s):

  • Publicly accessible data
    • Can be downloaded from the web or accessed through agencies with no requirements or special permissions.
  • Private information
    • Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
  • Identifiable private information
    • Is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
  • Identifiable biospecimen
    • Is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
  • Anonymous data
    • Is not personally identifiable. Identifiable data was never collected or not retained and cannot be retrieved by anyone including a collaborator at another institution.
  • De-identified data
    • Does not include any identifiable information. There is no way to link the data to a person through codes or deductive disclosure (e.g, through a combination of the data variables such as demographics, you cannot figure out the person’s identity). The linking code has been destroyed.
  • Coded data
    • Is when identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., code); and a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.
  • Identifiable data
    • Is when the individual can be identified from the data set. This could be by name, unique identifying number, characteristic, or code.
  • Protected Health Information (PHI)
  • Personally Identifiable Information (PII)
    • Per FERPA (Family Educational Rights and Privacy Act Regulations), refers to identifiable information that is maintained in education records and includes direct identifiers such as a student’s name or identification number, indirect identifiers, such as a student’s date of birth, or other information which can be used to distinguish or trace an individual’s identity either directly or indirectly through linkages with other information.  For more information related to PII and FEPRA, please visit the FERPA page at the U.S. Department of Education.

Key Information:

  • A few questions to ask yourself when trying to decide if IRB approval or other agreements are necessary:
    • How was the information and/or biospecimen originally collected?
    • If a colleague originally collected the information and/or biospecimen, are they providing it to you with any restrictions? Did they collect the information and/or biospecimen under an IRB approved protocol?
    • Are there sponsor, contractual or institutional restrictions on the use of the information and/or biospecimen?
    • Is the information and/or biospecimen identifiable, coded, de-identified, or anonymous?
    • Does the organization/agency that holds the information and/or biospecimen require IRB approval?
    • Did the informed consent form that was originally signed by the participants allow for the sharing of the information and/or biospecimen?
    • Is a Materials Transfer Agreement (MTA), Data Use Agreement, or Data Transfer Agreement required?
      • If your research requires a data use/data transfer agreement, please contact the Office of Sponsored Programs Awards Coordination Team at: UNLOSPAwards@unl.edu

Guidance on how to submit a request for secondary analysis of information and/or biospecimen only:

With the above definitions in mind regarding the type of data with respect to identifiability, IRB review and approval is required when conducting research with human subjects (including identifiable information and/or biospecimens).

Only projects that meet the definition of research and human subjects require IRB approval. See the Guidance Topic: Human Subjects Research for specific definitions of research and human subjects. The Human Subjects Regulations Decision Charts are also available through the Office of Human Research Protections to illustrate IRB applicability. If a project does not require IRB approval, investigators are not required to submit an IRB application; however please be aware, IRB approval may not be granted if the research has already started or been conducted and the determination of IRB applicability was made incorrectly by the investigator.

When submitting an application for IRB approval using only secondary information and/or biospecimens the current application might not be as conducive to secondary research. The following tips might be helpful when drafting the application:

  • Human subjects research projects must be submitted via NUgrant.
  • Any sections that do not seem to apply to the research project because they are related to a primary data collection process should be answered as N/A if the section is an open textbox and is truly not applicable to the research.
  • If the answer is a close-ended response (e.g., yes or no), then the question must be answered as best it can.
  • Any clarifications that may be necessary regarding an N/A, yes, or no response can be submitted on page nine of the form.
  • HRPP office/IRB will determine the appropriate category and review level upon project submission. For more information about review categories and the process, please see Review, Approval, and Post-Approval Requirements.

UNL Human Research Protection Program (HRPP) Policies and Procedures:

Additional Guidance and/or External Resources:

Single Institutional Review Board (sIRB)

A sIRB is the IRB that has been selected to carry out the review requirements at 45 CFR Part 46 for participating sites of a multi-site study.

For more information about investigator participation in multi-site research with respect to IRB approval, please see the topic Multi-Site Research.

Site Permission Documentation

Site permission documentation is required for both performance sites and for recruitment sites.

  • Performance sites are those in which the investigators are using the site services, facilities, or personnel for research study purposes, such as data collection or consent.
  • Recruitment sites are those where the investigators are simply providing research study information to individuals, and are not considered performance sites.

Key Information:

  • Performance Site Permission Documentation Requirements:
    • All performance sites must be identified and updated in the NUgrant IRB application. The performance sites will also be listed in the official IRB approval letter.
    • Documentation of appropriate performance site permission, also known as site letters of agreement or endorsement, may come in different forms. This documentation is required to be uploaded within the IRB application before you are approved to start work at the site.
      • Letters of support received for a grant are generally not considered to be sufficient as site permission documentation.
    • The documentation should include acknowledgement of any specifications regarding the site’s own participation in the research project and what access, services, facilities, and/or personnel they are providing for the research project.
    • A specific format is not required and may vary among the sites, such as a formal letter on organizational letterhead or a response to an email.
      • Email documentation should be legitimate. In other words, we will not accept the email copied and pasted into a Word document. The email should be uploaded as a PDF and include the appropriate signature line, title, and/or credentials of the signatory official/site administrator.
  • Recruitment Site Permission Documentation Requirements:
    • Recruitment site permission documentation is expected to be obtained by the research team through appropriate mechanisms and stored by the research team within the research records.
  • If Lincoln Public Schools (LPS) is a performance or recruitment site for the project, please see the Lincoln Public Schools (LPS) Approval Processes
  • If Barkley Memorial Center (BKC) is a performance or recruitment site for the project, you must provide an official permission letter from the BKC Director.
  • If the UNL Athletic Department is a performance or recruitment site for the project, you must provide official permission documentation from the appropriate individual within the Department of Athletics. It is recommended to begin discussions with the Director of Nebraska Athletic Performance Lab (NAPL) to help navigate the correct permission route.

UNL HRPP Policies and External Resources for Site Permission Requirements:

SMART IRB

SMART IRB is an NIH-funded initiative that streamlines IRB reliance through a nationally-adopted reliance agreement, standard operating procedure, and helpful tools that support Single IRB (sIRB) review. Several hundred institutions across the United States have joined and if you are collaborating with one of them for IRB review, we may be able to utilize this system for your project. Please be sure to contact the UNL IRB office before moving forward in this process.

Other Related Term(s):

  • Single IRB (sIRB)
    • The sIRB of record that has been selected to carry out the IRB review requirements at 45 CFR Part 46 for participating sites of a multi-site study.

Key Information:

  • It is important to note that SMART IRB is not another IRB, but rather an online reliance agreement tracking system and communication tool for IRB administrators.
  • PI’s will need to register in order to gain access. This process takes about 2 business days to approve, so advance notice and planning will be important.
  • If a partnering institution is a member of SMART IRB, UNL may require the use of this system to manage the agreement process.
  • PI’s can see if collaborators are registered members by checking the SMART IRB website.

UNL Human Research Protection Program (HRPP) Policies and Procedures:

Additional Guidance and/or External Resources:

Social Media

These types of platforms allow the user to share and consume information across their social network(s) and to join, create, and participate in a variety of groups or online communities. Examples of different social media sites include: Facebook, LinkedIn, Google+, Vimeo, Twitter, Digg, Flickr, and Pinterest.

*NOTE: The following information has been developed in reference to National Institutes of Health resources on Social Media and also with consultation and review from a UNL IRB sub-committee on Social Media.*

Key Information:

Use of social media is an important and somewhat new tool in conducting research involving human subjects (recruitment, data mining etc). However, it should be noted that use of social media in research is much different than the other tools frequently used such as printed advertisements, posters, or radio/television ads. Information contained in non-social media tools are typically controlled text or in a template format that does not allow for a great deal of variation.

Social media tools, on the other hand, allow for greater manipulation and variation of context, information, and how audiences or individuals are targeted to receive research information. With this in mind, the UNL IRB does not want to hinder or restrict research involving the use of social media but does require further details in the project application regarding the plan for use of social media in a given project.

Depending on the project parameters and how social media will be used (i.e., recruitment only vs. data collection), the PI will be asked to detail or consider some or all of the following within the IRB application:

  • Investigators are not permitted to accept “friend requests,” nor “friend” others.
  • Provide a description of the general message that will be sent to potential participants.
  • What specific information is going to be collected?
    • Demographic information?
    • Status updates?
    • Pictures?
  • How is the information going to be collected?
  • How is the information going to be used?
  • What is the usefulness of this data collection method?
    • Why is use of social media important for this research (scientific justification)?
  • What are the strategies for maintaining participant confidentiality?
    • How will third party information be handled?
    • Consider access to public profiles vs. private profiles
  • How will participant informed consent be gained?
    • Will third party participants be informed of the research?
    • If so, describe the procedures that will be followed.
  • What is the length of time that will be needed for proper data collection, (e.g. two weeks, one month, six months)?
  • Will minors be included in the data collection? (In the state of Nebraska, age of majority is 19 years).
  • Description of any experimental design features that will be utilized.
  • What is your typical access to this population and data?
    • Could this population and data be accessed by other methods?
    • Is there an alternate research design that wouldn’t use social media sites?
  • Is social media being used as a recruitment method?
  • Is this data being used as a secondary data set?

Additional Guidance and/or Resources:

The National Institutes of Health also provides the following questions to use as a guide when planning to use social media as a tool to conduct human subjects research:

  • Have I considered the full implications of privacy in this new and less-controlled environment?
    • The Principal Investigator (PI) and Institutional Review Boards (IRB) should assure the procedures followed adequately protect the rights and welfare of the prospective subjects as well as the accuracy of information for decision making standards.
  • I need to carefully consider how my materials will be used.
    • Although there has been a historic division between ads that are “purely informational” and “recruitment” ads, in the social media environment, this is much harder to distinguish and monitor. The outreach itself to groups or individuals with disease-specific interest may already allow for intrusion into personal privacy and result in disclosure of personal medical information not only to the PI but others.
  • Have I controlled my informational data in a locked format?
    • With interactive media, the location of the information is not static — (as it is in printed posters, flyers, web sites), so it is recommended that this information be provided in a controlled pdf, or other locked format, for distribution.
  • Have I made the contact for further information site protected for the privacy of interested individuals?
    • Any contact information (such as a web mailbox) should bring the interested person behind a security wall for any further information exchange.
  • Do I clearly understand that the interactive nature of social media escalates the speed of interaction, allowing for greater opportunities for errors in protecting private information? Have I planned to obviate those errors?
  • Have I accounted for problems related to the portability and secure handling of information, including the encryption of all government laptops, the encryption of sensitive information during transport, including but not limited to transport across the network or on portable media, and the reporting of unintended breaches of sensitive personal information in the government’s possession?
  • Have I included my complete strategy for use of the social media and my strategies for protection of privacy and strategies for informed consent explicitly in my proposal to the IRB?
  • Have my team and I clearly understood the invasive nature of joining groups (i.e., support groups, disease groups, advocacy groups, etc.) for the purpose of recruitment?

Terms and Conditions (Outside Entities)

Research projects involving human subjects can often involve interactions with external entities (companies, institutions, or websites) outside of the University of Nebraska (NU) system. If a proposed project is being reviewed by the IRB that could potentially violate the Terms and Conditions of an outside entity, the UNL IRB will review the request, in consultation with NU General Counsel’s Office, and determine whether or not the project can move forward as proposed. Terms and Conditions (T&C’s) is language that is included in a contract or agreement that stipulates what a user/person can and cannot do and what the entity can and cannot do.

It is not the practice of the IRB to approve projects that violate the Terms and Conditions of another entity.

Other Related Term(s):

Also referred to as Terms of Service (TOS).

 Examples:

  • The T&C’s of a university library stipulates a maximum amount of research article archives that can be downloaded by a single user. A user downloads more archives than permitted and is considered to be in breach of contract.
  • The TOS of a website stipulates fake accounts cannot be created. A user creates a fake account for research purposes and is considered to have violated the TOS of the website.

Tips for Student Researchers 

Students often complete projects that involve human subjects research through, for example, a capstone, thesis, or dissertation which require IRB approval. The below information is intended to provide basic steps and assistance for student researchers to accomplish their project(s) in the time allotted. Please remember that class projects typically do not require IRB approval because they do not meet the regulatory definition of research at 45 CFR 46.102.

Please review the topics available through the IRB website drop down menu to find further information regarding definitions, when IRB review and approval is required, and what review categories are applicable (Exempt, Expedited, Full Board).

Key Information:

  • The overall IRB review process for students does not deviate from the normal process followed for faculty or staff projects requiring IRB review. Each student researcher is expected to follow all current IRB policies and procedures for IRB initial approval, continuing review, change requests, and other project matters.
  • Students are allowed to function as the Principal Investigator (PI) and may be listed on the application/protocol as the PI. However, a UNL faculty member-advisor must provide appropriate oversight of the project and be listed as the Supervising Investigator (i.e., Secondary Investigator as described in the IRB application).
  • While the PI listed for an IRB project typically assumes overall responsibility, it is the Supervising Investigator’s responsibility to supervise the project and provide necessary advice regarding the design and conduct of the study along with advising on applicable IRB requirements and federal regulations. Faculty who assign or supervise research conducted by students or staff have an obligation to consider carefully whether those individuals are qualified and have the training to adequately safeguard the rights and welfare of participants.
  • In addition, the IRB recognizes the time constraints associated with student projects that must begin and be completed within a single semester. While the IRB will make every effort to work with students and Supervising Investigators to process review and approvals promptly, it is recommended that those submitting for IRB approval, plan for and allow adequate time for the review process (anywhere from 2 weeks to two months depending on the project parameters, review type (Exempt vs. Expedited vs. Full Board) and adequacy of the submission).

UNL Human Research Protection Program (HRPP) Policies and Procedures:

 UNL Guidance for IRB Approval:

  • Identify a Supervising Investigator. Typically this is the Committee Chair, but every department might be a little different as to who may qualify for the role as a Supervising Investigator on the IRB application.
  • Meet with your Supervising Investigator to formulate your research question and study design.
    • This could include development of survey questions, survey instruments, and interview questions, identifying your subject population, recruitment strategies, and data analysis plans. *NOTE: while IRB staff are happy to help clarify what information is required for IRB approval, it is not the staff’s responsibility to assist in the design of your project. This should be developed in conjunction with your advisor and/or Supervising Investigator/committee.
  • Begin your IRB application in NUgrant (URL: https://nugrant.unl.edu), the electronic research system at UNL.
  • Review the UNL IRB webpage Review, Approval and Post-Approval Requirements for detailed, step-by-step instructions on how to submit an application, what happens during a review, after approval, and investigator responsibilities after approval.