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

Blood Collection and Research Personnel Requirements

Certificates of Confidentiality

Child Abuse Reporting Requirements & Human Subjects Research in Nebraska

Clinical Trials Registration, Consent Form Posting & Data Sharing

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 Process Best Practices

Informed Consent Waivers

Lincoln Public Schools (LPS) Approval Processes

Multi-Site Research

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

Program Evaluation vs. Evaluation as Research

Research Records Best Practices

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):

Key Information:

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

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):

Key Information: 

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:

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:

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

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):

Key Information:

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):

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:

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

Additional Guidance and/or External Resources:

Blood Collection and Research Personnel Requirements

This guidance has been created to assist researchers in identifying the requirements for human subjects research projects involving blood collection and dealing with bloodborne pathogens.

A statute in the State of Nebraska does not exist that stipulates phlebotomists, or those responsible for blood collection, must possess a certain type of or specific certification. However, in order to protect human participants in research involving blood collection, the UNL IRB requires research personnel responsible for collecting blood to be able to provide documentation that they have appropriate experience, licensure, or certification. The type of documentation can be commensurate with the collection method and amount required in order to achieve the research goals.

The responsible personnel, collection method, and amount necessary must be detailed in the IRB application, particularly within the section of the application when it asks about appropriate experience.

The following parameters are specific to research blood collection procedures that are approvable under an expedited category. If the PI proposes different information that does not meet the below parameters, full board review is required for approval.  The collection of blood samples by finger stick, heel stick, ear stick, or venipuncture are as follows:

Other Considerations:

Blood loss due to cumulative diagnostic phlebotomies can result in significant decreases in hemoglobin resulting in anemias. If the subject has a compromised health status, the PI, or the physician connected with the protocol, should review the hemoglobin levels before obtaining blood samples for research purposes. Careful attention must be made to the cardiovascular status, general activity, previous clinical blood draws, and overall status of the subject and as needed, consultation with their primary care provider.  The investigator should consider the blood collection tubes used to ensure collection of the minimum volume needed. It is important to take into consideration the following issues when assessing the risk and benefits of blood draws for research purposes.

It is important to consider the total blood volume of the individual when evaluating their ability to provide blood for research purposes. A reasonable figure for calculation of total blood volume for adults is 70mL/kg of body weight and for infants 80mL/kg.

Depending on the health status of the research subject, the IRB may require the PI to justify the need for volume of blood removed in relation to the expected benefit to the subject and safeguards to protect from undue risks.

In addition, the PI should also detail within the IRB application what plan is in place if an event or emergency were to occur during the process to collect the blood sample(s). For instance, where will the collection take place and what if the participant experiences light-headedness or an episode of fainting (i.e. how will the PI contact emergency services if necessary; what will they do in the interim of help arriving; are snacks/juice available if the participant’s blood sugar is low and/or they are close to fainting?).

A clear plan must be in place and discussed with the research team and those responsible in order to ensure participants are protected appropriately (e.g. ensure another research personnel team member is readily available to assist if an emergency occurs, do not complete blood collection entirely on your own). This is also in consideration that many times participants are required to fast ahead of time in preparation for the blood collection.

The PI must be cognizant of the safeguards available in order to help ensure the protection of human subjects, however, the PI and research team must also be knowledgeable and meet bloodborne pathogen requirements. All clinical/diagnostic, research, and teaching activities involving human samples that are subject to the Bloodborne Pathogens Standard require submission of a protocol to and approval by the UNL Institutional Biosafety Committee (IBC). Please reference the below links for additional information.

Additional Guidance and/or External Resources:

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:

Key Information:

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

Clinical Trials Registration, Consent Form Posting & Data Sharing

Some clinical trials involving human subjects require registration, data sharing, and/or posting of an informed consent form on a government website (https://clinicaltrials.gov or https://www.regulations.gov) due to federal requirements or journal requirements.

At UNL, registration, data sharing, or posting of the consent form can be completed via either of the above websites, however, these requirements are dependent on the parameters of the protocol and must have IRB approval. Please review the full guidance for this topic here: Clinical Trials Registration & Data Sharing Guidance.

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

Additional Guidance and/or External Resources:

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):

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:

Examples of deception:

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

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:

Key Information:

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:

Key Information:

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

UNL Guidance for Exempt Research:

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:

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):

Key Information:

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):

Key Information:

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

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):

Key Information:

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

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

Informed Consent Process Best Practices

This guidance describes the consent process and outlines specific actions that should be taken by investigators to ensure that participants are properly consented before the research begins.

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

UNL Guidance for informed consent best practices:

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:

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:

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:

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

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):

Key Information:

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: 

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:

Research Records Best Practices

This guidance discusses the best practices for investigators to ensure quality research records and data integrity, in both paper and electronic formats.

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

UNL Guidance on research records best practices:

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.