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

Best Practices for Classroom & Clinical Practica Not Requiring IRB Approval

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

Data Identifiability – Definitions

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

Family Educational Rights and Privacy Act (FERPA): Use of FERPA-regulated Data for Research Purposes

Genetic Information Nondiscrimination Act (GINA)

Grant Congruency Review

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

Human Subjects Research

International Council for Harmonization – Good Clinical Practice (ICH-GCP): Policy & Training Requirements

Informed Consent Process Best Practices

Legally Authorized Representative (Nebraska definitions) & Persons with Impaired Decision-Making Capacity

Lincoln Public Schools (LPS) Approval Processes

Multi-Site Research

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

Privacy vs. Confidentiality

Program Evaluation vs. Evaluation as Research

Research Records Best Practices

Re-Consenting/Re-Assenting Participants

Recruitment/Advertising

Secondary Information and Biospecimens: Use in Research and IRB Applicability

Single Institutional Review Board (sIRB)

Site Permission Documentation

SMART IRB

Social Media

Students as Research Participants in the Classroom Environment

Terms and Conditions (Outside Entities)

Tips for Student Researchers

Waivers of Consent


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:

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.

Best Practices for Classroom & Clinical Practica Not Requiring IRB Approval

All activities meeting the federal definitions of human subjects research carried out at the University of Nebraska-Lincoln or under its auspices must be reviewed and approved by the IRB prior to the start of research. In some cases, students conduct projects as a course assignment or for educational purposes under which IRB approval may not be required. This guidance is intended to provide information on best practices that students and instructors should follow when IRB approval is not required, yet interaction with participants will occur.

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.

Data Identifiability – Definitions

The following guidance looks at definitions related to the identifiability of data. You may see these terms often throughout our policies and in other guidance topics. 

Aggregated Data Data that has been created by combining or compiling individual-level data to identify patterns or make comparisons. 
Anonymous Data Data that is not personally identifiable. Identifiers were never collected and cannot be retrieved by anyone including a collaborator at another institution. 
Coded Data Data that includes identifying information (such as, but not limited to, name, initials, 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 that 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. 
Confidentiality From the IRB perspective, confidentiality is the protection of participant data from unauthorized disclosure and is determined by the agreement (e.g., consent) between investigator and participant as to how identifiable data will be stored, used, and disseminated by investigators. The IRB requires that adequate provisions are provided to protect the confidentiality of participant data, or that participants agree to the sharing of private information. 
Data at Rest Data that is in a destination location (such as a hard drive or an archive) and is not being actively used. 
Data in Motion/Transit Data that is being actively moved from one place to another via digital methods such as e-mail or FTP, or via physical means. 
Data in Use Data that is being actively accessed. 
De-identified Data Data that 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), or the linking code has been destroyed. 
FERPA Identifiers The following items are considered identifiers under the FERPA Guidelines: 
• Student’s name; 
• Name of the student’s parent or family members;
• Address of the student or their family;
• Social security number, student ID number, or biometric record;
• Indirect identifiers such as date of birth, place of birth, and mother’s maiden name;
• Other information that alone or in combination is linked or linkable to a specific student that would allow a reasonable person in the school community who does not have personal knowledge of the relevant circumstances to identify the student with reasonable certainty; or,
• Information requested by a person who the educational agency or institution reasonably believes knows the identity of the student to whom the education record relates. 
HIPAA Identifiers The following 18 items are considered identifiers under the HIPAA Guidelines:
• 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. 
Human Subject A living individual about whom an investigator conducting research:
• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. 
Identifiable data / Identifiable private information Data where the individual can be identified in the data set. This could be by name, unique identifying number, characteristic, or code. 
Obscured/Obfuscated Data Data (often images, video, or photographs) that have been distorted either via blurring/masking or via other cryptographic means to reduce or eliminate the potential for identification. 
Personal Data (EU/UK GDPR) Any information relating to an identified or identifiable natural person.  

Examples of Personal Data:
• a name and surname;
• a home address;
• an email address such as name.surname@company.com;
• an identification card number;
• location data (for example the location data function on a mobile phone);
• an Internet Protocol (IP) address;
• a cookie ID;
• the advertising identifier of your phone;
• data held by a hospital or doctor, which could be a symbol that uniquely identifies a person. 

Examples of data not considered personal data:
• a company registration number;
• an email address such as info@company.com;
• anonymous data.  
Personally Identifiable Information / Private Individual Information (PII) A Nebraska resident’s first name or first initial and last name in combination with any one or more of the following data elements that relate to the resident if either the name or the data elements are not encrypted, redacted, or otherwise altered by any method or technology in such a manner that the name or data elements are unreadable: 
• Social security number;
• Motor vehicle operator’s license number or state identification card number;
• Account number or credit or debit card number, in combination with any required security code, access code, or password that would permit access to a resident’s financial account;
• Unique electronic identification number or routing code, in combination with any required security code, access code, or password; or
• Unique biometric data, such as a fingerprint, voice print, or retina or iris image, or other unique physical representation;

A username or email address, in combination with a password or security question and answer, that would permit access to an online account.

Personal information does not include publicly available information that is lawfully made available to the general public from federal, state, or local government records; and
• Redact means to alter or truncate data such that no more than the last four digits of a social security number, motor vehicle operator’s license number, state identification card number, or account number is accessible as part of the personal information.

For more information, please visit the UNL ITS topic regarding SSN and personally identifiable information.  
Primary Data Data collected by the research team directly from first-person accounts (such as interviews, surveys, and questionnaires). 
Primary Source A contemporary or first-hand account of an object or event. 
Private Information 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 (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. 
Protected Health Information (PHI) Per HIPAA (Health Insurance Portability and Accountability Act), is individually identifiable health information held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral. For more information, please refer to the HIPAA A-Z Guidance topic. 
Pseudonymised Data (EU/UK GDPR) Anonymous or coded data that could still be traced back to a particular individual. This data is still considered personal data. 
Record According to the Privacy Act of 1974, refers to any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, [their] education, financial transactions, medical history, and that contains [their] name, or the identifying number, symbol, or other identifying particular assigned to the individual, such as a finger or voice print or a photograph. 
Secondary Data Data (qualitative or quantitative) that has already been collected for an original purpose that is now being used for a different purpose. 
Secondary Research Research that will re-use information and/or biospecimens that are collected for some other “primary” or “initial” activity. This can generally be found by investigators in some type of record or database (in the case of information) or some type of tissue repository (such as a hospital’s department for storing clinical pathology specimens). 

Deception in Research

Deception is a research method in which investigators deliberately mislead participants during research procedures by withholding information or providing false information. As a result, participants are not fully informed about the research when they consent to participate. Deception can occur in different forms and is sometimes necessary to receive an unbiased result, but it should not place any research participant in significant financial, physical, legal, psychological, or social risk. The following describes three types of deception typically utilized in research. 

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 and when participants are informed regarding the deception, projects involving deception can be reviewed at the exempt and expedited levels. For projects involving more than minimal risk, a review by the full board would be required. 

Investigators must be able to justify the reasons for the deception, why the deception is necessary, the benefits of the research with deception, and provide the process of how participants will be debriefed, as applicable. 

Authorized Deception

During the consent process, investigators have the option of informing participants that they will not be made aware of, or misled regarding, the nature or purpose of the research. If participants are made aware of this deception and then consent to participate in the research, this is known as Authorized Deception. Participants can be informed either via language in a consent form or verbally (depending on the nature of the project), and a debriefing process should occur as soon as possible. 

Provided that the project meets the other requirements of Exempt Category 3(iii), projects utilizing authorized deception can be reviewed as Exempt with Limited Review. 

During the consent process, investigators have the option of informing participants that they will not be made aware of, or misled regarding, the nature or purpose of the research. If participants are made aware of this deception and then consent to participate in the research, this is known as Authorized Deception. Participants can be informed either via language in a consent form or verbally (depending on the nature of the project), and a debriefing process should occur as soon as possible. 

Provided that the project meets the other requirements of Exempt Category 3(iii), projects utilizing authorized deception can be reviewed as Exempt with Limited Review. 

Incomplete Disclosure

Depending on the research design, it is possible that participants knowing that they are somehow being deceived could affect the scientific validity of the results. In these situations, investigators may need to withhold the true purpose of the study. This is known as Incomplete Disclosure. Participants should be debriefed regarding the true purpose of the study as soon as possible after participating, unless the debriefing procedure meets one of the exceptions listed under the “Debriefing” section, below. 

Deception

For some projects, the entire research may depend on deceiving participants to study a particular phenomenon, and informing participants prior to participation may affect the scientific validity of results. This process is known as Deception. Participants should be debriefed regarding the true purpose of the research and the reason for the deception as soon as possible after participating, unless the debriefing procedure meets one of the exceptions listed below. 

Debriefing

Except in specific circumstances approved by the IRB, participants should be debriefed following their participation in the study as soon as possible. 

The debriefing language should be simple, clear, and informative, describing the rationale for the design of the study and the methods used. It should also give participants the opportunity to ask questions and to ensure that participants feel they are an important part of the research process. A debriefing template form is available on our Templates page.

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)

This guidance is to be used in the development of or in the review of human subjects research only and is not intended to be used for other areas at UNL that may intersect with the EU GDPR.

In the context of human subjects research, the EU GDPR applies when any investigator is conducting research that involves collecting information or data in-person or online from a participant that is located in an EEA country. This affects people living or traveling in a GDPR regulated county; these regulations are based on location and not citizenship. Additionally, the GDPR applies if “goods or services” are offered, or the behavior of EEA participant behaviors are monitored within the EEA.

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 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, and Sweden.

Notes: (1) Given that the United Kingdom is no longer a member of the EEA, it is therefore not subject to the EU GDPR. However, the United Kingdom now has its own version of the GDPR known as the UK GDPR, which is virtually identical to the EU GDPR. If data is being transferred from the UK, nothing changes in how UNL researchers conduct research subject to EU GDPR. However, if personal data is transferred to the UK, that data must be covered and regulated by an appropriate safeguard, usually a contract. If your research involves transferring personal data to a collaborator in the United Kingdom, be sure to document this in your protocol and be in touch with your IRB coordinator as soon as possible to ensure all requirements are met per the UK GDPR regulations; (2) In February 2021, the European Data Protection Board (the “EDPB”) released new guidance on the application of the European Union General Data Protection Regulation (“GDPR”) to health research. The guidance was issued in the form of answers to questions posed by the European Commission, the executive branch of the European Union. The EDPB did not answer substantively many of the questions posed, instead noted that additional guidance would be forthcoming later this year regarding processing personal data for scientific research purposes. Investigators should be aware of possible changes forthcoming and our office will be sure to update our guidance and templates as needed. The guidance acknowledged important issues to researchers, and a brief overview of those issues can be found on the Ropes & Gray website.

Definitions:

Key Information:

These GDPR regulations strengthen and define the individual rights of participants located in EEA countries. Those rights include:

  1. Right of access (What do you know about me?)
  2. Right to erasure/Right to be forgotten (Remove me from your database.)
  3. Right to Rectification (Amend or correct my details)
  4. Right to Restrict Data Processing (Stop filming/recording me)
  5. Right to withdraw consent (I don’t want to do this survey anymore)
  6. Right of data portability (Move my personal data from one location to another)
  7. Right to prior notification before data collection
  8. Right to reject automated profiling (Ability to reject automated processing used to evaluate personal aspects of an individual, like refusal for insurance based on algorithm)

GDPR requires that consent be: Freely given, specific, informed, and unambiguous. Further it should be a two-step process that includes:

  1. A letter of information (Note: This can be accomplished within the body of the informed consent document)
  2. A 1-2 page consent document that includes affirmation, consent elements, and signature (These elements are found in the Social-Behavioral Adult Participant Informed Consent and Biomedical Adult Participant Informed Consent templates available on the RCS website.)

Based on the regulations, a waiver of consent or a waiver of consent documentation are not acceptable under the GDPR for non-exempt research projects. However, in an exempt project if a consent form contains a check box with “I agree”, where a participant is actively choosing to consent, that would serve as sufficient proactive affirmation of consent.

Additionally, for the processing of genetic, biometric, health and certain other sensitive categories of Personal Data, the individual’s consent must be explicit. The GDPR does not define explicit consent, but provides examples such as a hand-written signature, an electronic signature, an uploaded scanned document carrying a signature or two-stage verification of consent where individual must click on a verification link by email or text message after initially consenting.

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

Keep in mind that these requirements 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 project form in NUgrant requests information regarding whether or not your proposed project will involve an international site. As a starting point to meeting the 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.

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.

Family Educational Rights and Privacy Act (FERPA): Use of FERPA-regulated Data for Research Purposes

The following guidance utilizes terminology that can be found in our Data Identifiability Definitions A-Z guidance. 

The following information is made available to assist UNL research investigators in preparation of research projects involving human subjects that may be subject to FERPA 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 Family Educational Rights and Privacy Act (FERPA) is a federal law that protects the privacy of student education records. It applies to any educational institution that receives funds from programs administered by the U.S. Department of Education. A student or parent may be the owner of the education record. The law assigns an eligible student, defined as a student who has reached 18 years of age or is attending an institution of postsecondary education, as the owner of their educational record. This means that, at the secondary level, once a student turns 18, all the rights that once belonged to his or her parents transfer to the student. FERPA also provides guidelines on how the educational institution is to use and release protected information. This ensures certain student-centered information is not public information and that the eligible student can control who has access to this information. This law also requires the educator/institution to grant students access to their personal records. Be aware that some private schools do not receive federal funds and therefore may not be subject to FERPA.  

For more information about FERPA and UNL’s implementation, broadly speaking, including definitions of key terms please visit UNL’s FERPA webpage using the link below.  

Key Information:  

As an employee of UNL, all faculty, staff and/or student research investigators must comply with FERPA regulations if the research project being conducted involves education records. As a researcher, access to education records may be achieved through a variety of ways as primary or secondary data and include the following:  

  1. Obtaining records through the Office of the Registrar
  2. Obtaining records through Institutional Effectiveness and Analytics
  3. Obtaining records through student information systems maintained by the Institution (e.g., Obtaining records through the course instructor (who could also serve as the researcher). This could include course assignments, grades, etc.)

Researcher Agreement

In some instances, researchers utilizing student education records may be required to enter into an agreement documenting the following assertions:   

Ethical Access

In many cases, student education records are accessible to and used by instructors, teachers, and administrators for the purposes of conducting the duties of their job. For example, as part of an instructor’s job, there is ethical access to student’s assignments, test scores, and attendance records to evaluate performance and ultimately assign a grade.  However, this same instructor cannot use this ethical access for other intents and purposes, such as research. In other words, simply because an investigator has access to these data as the instructor of a course, it does not mean they can use the data for research purposes without permission. Investigators must have a legitimate educational interest to use the data for something other than its original purpose and may also be required to have written permission if it will be used for research if no exceptions apply. 

Identifiable or De-identified Records 

Education records may be obtained as identifiable or de-identified records. As part of the planning process for all research projects involving education records, researchers must consider whether consent from the parent or eligible student would be a requirement.  

Informed Consent 

Use of or access to identifiable education records will require, with exceptions, signed informed consent by the eligible student and/or parent, as applicable before obtaining the record for research purposes. The IRB does not have the authority to waive the FERPA consent requirement for use of or access to identifiable records, including coded records. 

Exceptions to Informed Consent Requirements for Use of Identifiable Records

The following scenarios or use of education records would be considered exceptions and would not require written consent:  

For additional information about informed consent exceptions, please use the UNL Registrar’s FERPA webpage link below.

FERPA-Compliant Consent Form

The Institutional Review Board requires certain elements to be present in most consent forms, with certain flexibilities allowed by the regulations at 45 CFR 46. If consent is a requirement for the use of and access to education records, certain FERPA elements will be required to be included in the research consent form. In addition, parental consent must be obtained if the student is not an eligible student. Be aware, that while student assent is not a FERPA requirement the school district and/or the IRB may require the assent of the minor or decisionally impaired research subject.  

The following elements must be included in a FERPA-compliant consent form:

Requesting FERPA Data

As described above, FERPA data can be requested in a variety of ways and from several different administrative units, departments and/or offices based on the breadth of the University activities and services. Review the information below to find the most appropriate request process for the data being accessed and/or used for research purposes. If you have questions about accessing student records and do not find your answer below, including where the data may reside, please contact the University Registrar.  

Accessing Data From the Registrar 

From a Department/College 

From the Office of Scholarships & Financial Aid 

From Institutional Effectiveness and Analytics 

Record-Keeping Requirements

Each administrative unit of the University of Nebraska has an obligation to keep a record of requests and disclosures of student record information, except when the request is from the student, a university school official with a legitimate educational interest, a request for directory information, or a request to which the student has given a FERPA consent. A student has the right to review the record of requests and disclosures made in relation to his or her education records.  

Research investigators must ensure consent forms, including FERPA-compliant consent forms are available for inspection in the normal course of IRB monitoring. The length of storage will be determined by the IRB approved protocol.  

IRB Review

All research investigators must submit an IRB application through the New Project Form to begin the process of review and approval for use of educational records in research. The IRB application must indicate that FERPA-regulated data will be accessed and used during the research project. The application must include detailed information regarding what specific data variables will be used (e.g., assignments, grades, etc.), if the student record will be created during the research project or if the student record will be used as a secondary data source, as well as a description of the participant privacy and data confidentiality practices.  

Surveys and assessments administered only for research purposes (i.e., will not be graded) are not covered by FERPA because the data collected are not part of a student’s educational record.  

De-identified records may not require IRB approval prior to their use. Please be sure to follow-up with the IRB if there are any questions regarding IRB requirements. If an official IRB review and determination is required to obtain de-identified records from external organizations or other entities, the Determination Form must be submitted.  

Be aware, if an investigator receives IRB approval for a study that involves the use of data obtained from educational records, it may not be the case that the providing entity such as the Registrar’s Office or Institutional Effectiveness and Analytics has the obligation or the resources to provide the data. 

Frequent Example: An investigator asks to use identifiable classroom assignments and grades from previous semesters (Fall 2018, Fall 2017, and Fall 2016) of a particular course. These students may have potentially graduated and there is no way to obtain signed consent. These pieces of the educational record are housed within a specific department and not the Registrar’s Office. The researcher would need to obtain permission from the applicable person in the department by way of a written agreement that includes the required elements as noted above. This document should be uploaded to the IRB application, as well as kept in the investigator’s research records.

Other Related Federal Regulations Applicable to Research with Student Populations

Protection of Pupil Rights Amendment (PPRA). These regulations are additional protections that ensure no student is required to submit, without prior consent, to any psychiatric testing or psychological examination/testing/treatment where the purpose is to reveal information on one or more of the following topics: political affiliations, mental and psychological problems potentially embarrassing, sex behavior and attitudes, illegal/anti-social/self-incriminating/demeaning behaviors, critical appraisals of other individuals with whom the student has close familial relationships, legally recognized privileged and analogous relationships, and income.  

This regulation also gives parents the right to inspect any instrument used to collect information concerning the above-identified topics. Specific information about this right must be included in parental consent form(s), when applicable. Consent form templates are available at the link below.  

In addition to ensuring the consent form accurately describes the ability to inspect instruments, the IRB has the obligation to verify, by acceptance of the school official’s letter of agreement or School IRB approval (when applicable), that compliance with US Department of Education regulations will be maintained. Specifically, schools are required to develop and adopt policies in conjunction with parents regarding the following: 

The above information illustrates one of the many reasons why the IRB requires school permissions to be provided as part of the IRB application prior to research commencing at the performance site.  

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

UNL Guidance and Resources

Additional Guidance and/or External Resources

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.

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:

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

The following guidance utilizes terminology that can be found in our Data Identifiability Definitions A-Z guidance. 

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 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:

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.

Part of conducting ethical human subjects research is ensuring your participants understand the research purpose and procedures, as well as their rights. Consider using a readability test tool to confirm how easy-to-read and comprehend the language is within your consent form. Acceptable readability scores will depend on the targeted population of a specific study. For general populations, a typical score might be around an 8th grade reading level. The IRB may request a readability score if there are concerns related to language used in a consent form. (per UNL HRPP 2018 Policy #9.002).

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

UNL Guidance for informed consent best practices:

Additional Guidance and/or External Resources:

International Council for Harmonization – Good Clinical Practice (ICH-GCP): Policy & Training Requirements

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international non-profit association that works to bring greater harmonization worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner (ICH Official web site. (n.d.). Retrieved September 25, 2020, from https://www.ich.org/page/mission). The ICH sets out a series of guidelines and standards for the conduct and reporting of clinical trials. These guidelines include Quality, Safety, Efficacy (where the Good Clinical Practice guidelines are included) and Multidisciplinary Guidelines along with various reporting standards.

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. More recently, U.S. regulatory agencies and funding sponsors have begun to require components of the ICH-GCP in the conduct of clinical trials while also expanding the definition of a clinical trial broadly to encompass a larger variety of research including those projects we traditionally think of as social-behavioral research. Based on this expansion, UNL Research Compliance Services in conjunction with the UNL Institutional Review Board have worked together to ensure that all applicable clinical trials conducted at UNL meet the requirements of ICH-GCP E6R2.

For the purpose of compliance with the UNL Human Research Protection Program policy #3.019 titled, “International Conference on Harmonization – Good Clinical Practice (ICH-GCP) E6R2 Compliance,” this guidance will focus on requirements set forth under the Efficacy guidelines specific to GCP.

Other Related Term(s):

Key Information:

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

Additional Guidance and/or External Resources:

Legally Authorized Representative (Nebraska definitions) & Persons with Impaired Decision-Making Capacity

When conducting research involving persons with diminished capacity for judgement and reasoning, there are additional considerations for how investigators will meet the criteria for approval at 45 CFR 46.111(4) Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by, §46.116. Investigators are required to determine whether or not a potential participant has the capacity to provide consent, and if they do not, also make a determination on who might be the most appropriate person to consent on the participant’s behalf.  Generally, this will be a Legally Authorized Representative (LAR).

The following definitions are based on Nebraska Revised Statutes and are important when determining who can consent of behalf of someone else for research purposes. These definitions may vary from state to state and so it is equally important to understand the requirements of each state wherein which your research is conducted if your project will involve persons with impaired decision-making capacity.

A Legally Authorized Representative can be:

An LAR should normally use “substituted judgement” where possible as opposed to “best interests”.

When thinking about who can consent on behalf of someone else, it should be noted that a power of attorney is a physical document that authorizes someone else to handle things like finances or health care, on a person’s behalf. A “power of attorney” is not an actual attorney or person. If a power of attorney is durable, that means it remains in effect if the person becomes incapacitated due to illness or an accident. A power of attorney expires if a person becomes mentally incompetent, while a durable power of attorney includes special wording that makes it effective even if that happens.

In Nebraska, a Power of Attorney is related to property and money and does not authorize that person to make health care (nor research) decisions. Whereas a Power of Attorney for Health Care is its own type of designation and it can be included in a durable power of attorney, or in any other form if it fully complies with Nebraska Revised Statutes.

Investigators should be careful not to confuse a potential participant’s capacity with competence. Capacity is an individual’s ability to make an informed decision. Competence is a legal state, not a medical one, and refers to the degree of mental soundness necessary to make decisions about a specific issue or to carry out a specific act. All adults are presumed to be competent unless adjudicated otherwise by a court.

Other Related Terms:

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:

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:

Privacy vs. Confidentiality

The ideas of privacy and confidentiality are often used interchangeably, but it is important to understand that they are two distinct aspects of human subjects research. While privacy is specific to the person, confidentiality relates to the person’s data, records, or personal information. For IRB approval, as written in 45 CFR 46.111(a)(7), federal regulation stipulates the need for “…adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.”

Privacy relates to the participant as a person and their physical privacy. Maintaining a participant’s privacy could include: Confidentiality is the protection of participant data from unauthorized disclosure. Protecting confidential participant data could include:
• obtaining consent in a private office (not in a busy reception area) • storing documents in a locked file cabinet or on a secure server
• leaving general messages on answering machines (not specific to the research) • making sure only research team members have access to contact information, interview, and survey responses
• making social media post “unshareable” or not tagging someone in a social media post. • deleting audio/video recordings as soon as transcription has been completed, when possible and no longer needed
The privacy of participants is addressed under the Description of Participants section of the new project form. The confidentiality of the data is addressed in the Confidentiality & Data section of the new project form.

Note: While both privacy and confidentiality are part of the criteria for approval, informing participants of the ways in which their data will be kept confidential is one of the required elements of consent. Section 45 CFR 46.116(b)(5) of federal regulation states that informed consent must include “A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.”

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

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:

Re-Consenting/Re-Assenting Participants

Obtaining informed consent/assent is an ongoing process, not simply a document signed by the participant during enrollment in the research. To ensure the voluntary nature of participation in research, and to exhibit respect for the individual, as noted in 45 CFR 46.116(c)(5), there are times when participants must be provided new information when changes are made to the research that could affect their continued willingness to participate. The following guidance provides information on when re-consent might be necessary and the methods by which re-consent could occur. 

Key Information: 

The following are examples provided by the Office for Human Research Protections of circumstances where a participant’s continued willingness to participate in the research may be affected. These include, but are not limited to: 

In these circumstances, participants, both current and future, must be notified. The method of notification must be approved via a change request submitted through the approved IRB protocol. Depending on what phase the project is in, as well as the potential severity of the circumstances, the following approaches may be used: 

An addendum document should note the following information, at minimum: 

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:

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

The following guidance utilizes terminology that can be found in our Data Identifiability Definitions A-Z guidance. 

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.

Key Information:

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:

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.

Key Information:

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):

Key Information:

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:

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:

Students as Research Participants in the Classroom Environment

Students as research participants, in the classroom environment, introduce unique challenges depending on who is conducting the research, how recruitment occurs, and what information will be used and/or collected. Instructors, other researchers, and even other students could be conducting research in the classroom. The following is intended to provide items to think about when designing research in the classroom. Students as research participants could be participating as (a) members of a specific class in which the instructor or researchers are assessing learning process and outcomes from the class, or (b) as a convenient sample to collect data on a study not related to the specific class.

Other related term(s):

Key Information:

When the instructor is also the researcher, unique challenges exist in protecting the student participants. Faculty are in a position of authority. Students might feel pressured to enroll in the study simply because their professor is the researcher, or because their peers are participating. In these circumstances, undue influence could be perceived, even if it is unintentional. Following are items to think through and include in the research proposal and/or informed consent documents.

Regardless of what procedures are used, student participants need to understand and feel comfortable that they can decline participation and their grade will not be impacted.

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

Additional Guidance and/or External Resources:

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:

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:

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

 UNL Guidance for IRB Approval:

Waivers of Consent

The following guidance is written using the Revised Common Rule under the 2018 Requirements. If your research is ongoing under the Pre-2018 requirements and has either been granted a waiver, or will request one in the future, please refer to the Pre-2018 Requirements policy linked below.

For non-Exempt (i.e., Expedited or Full Board) human subjects research projects, there may be circumstances where a research project calls for a waiver of consent or consent documentation. In these circumstances, federal regulations at 45 CFR 46.116 allow the IRB to approve a consent procedure that omits some, or alters some or all, of the elements of informed consent, and the federal regulations at 45 CFR 46.117 allow the IRB to waive consent documentation requirement of obtaining a signed consent form.

Key Information:

The IRB has the authority to grant three types of waivers:

  1. Waiver of the informed consent process altogether, including child assent, participant consent, or parental consent;
  2. Waiver or alteration of an element of informed consent such as the purpose of the research if the project involves a form of deception or the duration of participation; and/or
  3. Waiver of consent documentation (i.e., signature).

A waiver is not a type of document for participants to sign; rather in the context of IRB review of research involving human subjects, a waiver refers to a decision made by the IRB to allow the researcher to not obtain consent or alter consent elements.

If your research proposes to waive or alter consent, justification meeting certain criteria is required. In accordance with 45 CFR 46.116(f)(3)(i-v), to qualify for a Waiver or Alteration of Consent, your research must meet all of the following requirements, as applicable:

There also may be circumstances in which your research may qualify for a waiver of consent documentation, or where consent signature may not be required.  In these circumstances, in accordance with 45 CFR 46.117(c)(1)(i-iii), the IRB may waive the requirement for investigators to obtain a signed informed consent form when:

Note: Even though participants will not be signing documentation if this waiver is granted, the IRB per 45 CFR 46.117(c)(2) may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research. This may be in the form of a copy of the consent information or, in the case of online surveys, a statement indicating that participants can print a copy of the informed consent form for their records.

Any of the above informed consent waivers can 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: