IRB Frequently Asked Questions
About IRB Review - Getting Started
Flexible Review and Oversight
New Research Submissions
Research Informed Consent
Amendments - Changes to IRB Approved Research or Study Documents
Continuation Review - Application for Continued IRB Approval
Reporting - Adverse Events, Unexpected Problems & Non-Compliance
- Standard Consent Requirement for Adult Participants
- Non-English Speaking Participants
- Waiver of Documented (Signed) Consent – Use of a Research Information Sheet
- Parental Permission
- Waiver of Parental Permission
- Emancipated Minor
- Adolescent (ages 13-17) Assent
- Oral Child (ages 7-12) Assent
- Waiver of Assent
IRB stands for “Institutional Review Board”. WSU has five IRB committees, collectively known as the WSU IRB. An IRB reviews research involving human participants in order to ensure that it is conducted in accordance with all federal, institutional, and ethical guidelines. The WSU IRB has the authority to approve, require modifications (to secure approval), or disapprove human research activities at WSU and its affiliate institutions; to suspend or terminate approval of research not being conducted in accordance with pertinent laws, IRB requirements or University policy; and to observe, or have a third party observe, the consent process and other aspects of the conduct of the research.
HHS (Health and Human Services) regulations require IRB review for all research (systematic investigations designed to develop or contribute to generalizable knowledge) involving human participants (living individuals) when either of the following apply:
- Information is obtained through an intervention or interaction with people
- Identifiable private information will be accessed or collected for research purposes
Intervention includes both physical procedures by which data are gathered (e.g..., venipuncture) and manipulations of the participant or the participant’s environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigators and participant. Interactions may occur virtually, for example: an online interaction.
Identifiable 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). This information is identifiable if the identity of an individual is or may readily be ascertained by the investigator or associated with the information.
FDA (Food and Drug Administration) regulations apply, and IRB review is required, when a living human will participate in research either as a recipient of a test article or as a control. A test article is defined as any drug, biologic or medical device for human use, including food additives, color additives, electronic products, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act.
Use this HHS decision chart to determine if a project requires IRB review.
Use the WSU Human Participant Research Determination Tool for documentation that IRB review is not required, or to request assistance in making the determination.
Projects not meeting the definition of research with human participants do not require IRB review. Research not designed to develop or contribute to generalizable knowledge and research that does not involve human participant are project that do not require IRB review. Examples of research that does not require IRB review include the following:
- Research on the policies and practices of institutions or organizations.
- Research using only publicly available sources or existing, de-identified data.
- Some Oral History Projects
- Some Quality Assurance (QA) or Quality Improvement (QI) projects,
- Some Program Evaluation projects do not require IRB review when the they are not designed to develop or contribute to generalizable knowledge.
Additional guidance: See header, "Guidance for Research That May Not Require IRB Review" here
Use the HPR (Human Participant Research) Determination Tool to determine if a project requires IRB review or not.
The Principal Investigator (PI) is the person responsible for the conduct of research with human participants. This individual must have the experience, expertise, professional qualifications, research facilities, and resources necessary to ensure that the rights and welfare of the human participants are protected.
The WSU IRB will only recognize one individual as the Principal Investigator for a study. All other investigators on the protocol are considered “key personnel” and may be designated as “co-investigator” in their research role.
Faculty members can serve as PI on research and WSU will allow a student, fellow, trainee and staff without a faculty appointment to be the PI when a faculty supervisor or sponsor agrees to supervise all compliance per the IRB’s guidelines. A faculty supervisor or sponsor must sign the IRB application where appropriate. Faculty members are not required to have any individual designated as a supervisor or sponsor.
The WSU IRB will review or make determinations only regarding research submitted by investigators who are faculty, students, or staff at WSU or staff at one of the affiliated institutions (The Detroit Medical Center (DMC), Karmanos Cancer Institute (KCI), or John D. Dingell Veterans Affairs Medical Center (VAMC)).
Key personnel are persons engaged in the conduct of the research activity such that they directly interact with research participants to obtain consent and/or research data, or will have access to participant private and identifiable private information during data collection or data analysis. Key personnel do not have to be affiliated with WSU or an affiliate institution.
Individuals whose regular duties are generally for research endeavors (e.g..., study coordinators and research assistants) are considered key personnel when they meet the above definition. However, some individuals may interact or have access to private identifiable information as part of their regular paid duties (e.g..., phlebotomist, x-ray technician). If involvement in research is limited to performing regular paid duties without contributing to the research endeavor, then these individuals are not considered key personnel. ,
Principal investigators, key personnel, and Department Chairs, Deans or Institute Directors listed on an IRB submission must complete online training through the Collaborative Institutional Training Initiative (CITI) before the protocol can receive IRB approval.
A CITI refresher course or the Basic Course must be completed every 3 years to keep training up to date.
Additional information and instructions for training requirements: http://irb.wayne.edu/mandatory-training.php
Determine the type of review the project requires and then complete the appropriate IRB form with the appropriate study documents. IRB forms are available here.
The Flexible Review and Oversight Policy went into effect March 15, 2016. Research projects that present no more than minimal risk, have no federal funding, are not conducted at the Veterans Affairs (VA) Medical Center, do not target prisoner participants, and have no Food and Drug Administration (FDA) regulated components are potentially eligible for flexible review and oversight with maximum approvals of three years. If a study is sponsored, the researchers must ensure that there are no contractual obligations that require annual IRB review or adherance to federal research regulations.
Some eligible studies that previously required expedited review may now qualify for an exemption from IRB review. The Flexible Review and Oversight Policy established two Wayne State exempt categories.
- WSU IRB Exempt Category 7: Research with adults and/or minors involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, behavioral games, tasks or observation of public behavior, unless: (i) information obtained is recorded in such manner that human participants can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
- WSU IRB Exempt Category 8: Research involving no direct interaction or intervention with human participants that is limited to the study of identifiable data and it is not feasible to obtain consent from participants. If Protected Health Information (PHI) will be used, a HIPAA Waiver of Authorization is still required.
Even though a study cannot propose to target prisoner participants, if research participants become incarcerated after enrolling in projects eligible for flexible review and oversight, federal prisoner research regulations (45 CFR 46 Subpart C) do not apply. In addition, the project does not require IRB review with a prisoner representative when individuals are incarcerated after study enrollment.
Research projects eligible for flexible review and oversight involving pregnant women, fetuses and neonates are still subject to the federal requirements at 45 CFR 46 Subpart B with the exception of the requirement at 45 CFR 46.204(d) which requires the research develop “important biomedical knowledge.”
Federal funding sources include, but are not limited to, the following:
- Department of Health and Human Services (DHHS), which includes:
- Administration for Children and Families (ACF)
- Administration for Community Living.
- National Institutes of Health (NIH), which includes:
- National Cancer Institute (NCI)
- National Eye Institute (NEI)
- National Heart, Lung, and Blood Institute (NHLBI)
- National Human Genome Research Institute (NHGRI)
- National Institute on Aging (NIA)
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- National Institute of Biomedical Imaging and Bioengineering (NIBIB)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- National Institute of Dental and Craniofacial Research (NIDCR)
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- National Institute on Drug Abuse (NIDA)
- National Institute of Environmental Health Sciences (NIEHS)
- National Institute of General Medical Sciences (NIGMS)
- National Institute of Mental Health (NIMH)
- National Institute on Minority Health and Health Disparities (NIMHD)
- National Institute of Neurological Disorders and Stroke (NINDS)
- National Institute of Nursing Research (NINR)
- National Library of Medicine (NLM)
- Center for Information Technology (CIT)
- Center for Scientific Review (CSR)
- Fogarty International Center (FIC)
- National Center for Complementary and Integrative Health (NCCIH)
- National Center for Advancing Translational Sciences (NCATS)
- NIH Clinical Center (CC)
- Department of Agriculture
- Department of Energy (DOE)
- National Aeronautics and Space Administration (NASA)
- Department of Commerce, Consumer Product Safety Commission
- Agency for International Development
- Department of Housing and Urban Development (HUD)
- Department of Justice (DOJ)
- Department of Defense (DoD)
- Department of Education
- Department of Veterans Affairs (VA)
- Environmental Protection Agency (EPA)
- Central Intelligence Agency (CIA)
- Department of Homeland Security
- National Science Foundation (NSF)
- Department of Transportation
All new research projects are considered for eligibility during the initial review. If a study was approved or given an exemption using flexible review, this is indicated on the approval or concurrence of exemption memo. Open studies are considered for flexible review and oversight during the next continuation review.
The only way to remove a funding source from your study’s IRB record is through an amendment submission. In order to be eligible for flexible review and oversight at the next continuation review, an amendment must be on record that removed the federal funding source. If a study is still being conducted under the auspices of a federal funding source or is currently under a no-cost extension, the study is not eligible for flexible review and oversight. If you no longer have federal funds but are scheduled to receive additional federal funds in the future, the study is not eligible for flexible review and oversight.
Research with human participants is exempt from some or all of the regulations when they are considered minimal risk (the probability or magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [as defined by 45 CFR 46.102(i)]) and when the research is limited to the activities defined in one or more of the Exempt Research categories.
The IRB must review and concur that a project is Exempt per these research categories before the project begins. Exempt research is reviewed by one IRB member and not reviewed at a convened IRB meeting. Exempt research does not expire, but changes to the study design require an amendment submission for IRB approval.
Determine the type of review the project requires and then complete the appropriate IRB form with the appropriate study documents. IRB forms.
Research with human participants qualifies for expedited review when the overall project is considered minimal risk (the probability or magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [as defined by 45 CFR 46.102(i)]) and when the research is limited to the activities defined in one or more of the Expedited Research categories.
The IRB must review and approve all research eligible for expedited review before the project begins. An expedited review means the project is reviewed and approved by one IRB member and not reviewed at a convened IRB meeting. After initial approval, the study must be renewed or closed prior to the expiration date and all changes to the study require an amendment submission for IRB approval.
Determine the type of review the project requires and then complete the appropriate IRB form with the appropriate study documents. IRB forms.
Research not eligible for review as exempt research and not eligible for expedited review must be submitted for full board review. The proposed research will involve activities that are outside of the activities defined in the exempt and expedited research categories, or the research may pose more than minimal risk to research participants, or risks are unknown.
The IRB must be review and approve all research eligible for full board review before the project begins. Full board review means the project is reviewed and approved by an IRB committee at a convened IRB meeting. Check here for IRB meeting dates and submission deadlines. After initial approval, the study must be renewed or closed prior to the expiration date and all changes to the study require an amendment submission for IRB approval.
Determine the type of review the project requires and then complete the appropriate IRB form with the appropriate study documents. IRB forms. See instructions and a checklist for how to submit (PDF)
The WSU IRB must ensure that all research involving human participants (as defined in the regulations) conducted by faculty, students, or staff at WSU or staff at one of the affiliated institutions (The Detroit Medical Center (DMC), Karmanos Cancer Institute (KCI), or John D. Dingell Veterans Affairs Medical Center (VAMC)) has been reviewed by an IRB. Under some circumstances, the WSU IRB may agree to rely on the IRB review of an outside institution. For example, the WSU IRB may agree to rely on an outside IRB’s review if all research activities will take place at that outside institution, no recruitment or research intervention will take place at a WSU affiliated site, the outside IRB has a current FWA and agrees to serve as the IRB of record for the WSU affiliated PI. The WSU PI should submit an Administrative Application, an Authorization to Use Another IRB for Protocol Approval Agreement, and the IRB approval letter from the outside institution.
Research involving human participants (as defined in the regulations) that includes an international setting must adhere to the laws, regulations, and local customs where the research takes place and must have IRB approval before the research activities begin.
The WSU Export Control Office must be contacted for review prior to submitting to the IRB (this includes projects conducted online with an international study population. The IRB submission must include the following:
- Appendix A for International Research. For each international site
- Documentation of WSU Export Control Office review (e.g., e-mail correspondence)
- Documentation of local IRB review, local Ethics Committee review, or a Letter of Support from the research site (if necessary).
International research (PDF)
Letters of support (PDF)
Informed consent is an ongoing process by which a research participant or his/her legal representative voluntarily confirms his or her willingness to participate in a particular research project, after having been informed of all aspects of the research that are relevant to the participant’s decision to participate.
For all non-exempt research requiring IRB review, legally effective informed consent of the individual participating, or consent from the individuals’ legally authorized representative (LAR), must be obtained or waived by the IRB. Informed consent or a waiver of informed consent must be obtained for each participant before that participant begins any aspect of participation in the research.
When the requirement for informed consent is not waived, a written consent document, which includes the required elements of informed consent, must be provided to, and in some cases also read to the individual or their LAR. There must be adequate time for the potential participant or their LAR to read and understand the consent before it is signed.
Written Consent by Fax or Mail
When obtaining a signature is required on the consent form, but the potential participant is not available to sign in person, signed consent can be obtained via Fax or by Mail. If an individual needs additional time to consider participation, they should be able to take the consent document home. In other cases, the consent might be mailed to the homes of potential participants as part of the recruitment plan. In either of these cases, the participant may fax or mail a signed copy to the research site once they have agreed to participate. If a signed consent is faxed, an original signed copy should still be obtained (either at a study visit or by mail). If a consent form is initially mailed, the individual should receive two copies (one to keep and one to return signed). Once the signed informed consent is received it should be signed by the researcher with the date it is received. For any consent not obtained in person, appropriate notes to file must include the process by which consent was obtained, for example, if a phone conversation occurred and if the participant questions were addressed.
Use of a short form consent and oral translation of the English consent is required if: an individual approached for consent is not fluent in English; a written translated version of the full consent is not available; and this was unanticipated.
The WSU IRB has the short form available in 19 languages on the WSU IRB Informed Consent webpage.
If the short form is needed in a language other than these 19, the English version of short form consent must be translated in to that language and its use requires prior IRB approval.
If it is known, or is likely, that eligible participants will include non-English speakers, then an IRB approved translation of the consent and other relevant study documents is required prior to recruitment or inclusion of non-English speakers.
Additional guidance: Research translation requirements for non-English speakers (PDF)
The IRB may waive the requirement for obtaining a participant or LAR signature as documentation of the informed consent process provided the IRB finds that the requirements for a waiver has been met. An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all participants if it finds either:
- That the only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant will be asked whether they want documentation linking them with the research, and their wishes will govern; or
- That the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context.
When the documentation requirement is waived, the IRB usually requires that participants are provided with a written statement regarding the research (use of the Research Information Sheet template is strongly suggested).
Research that will involve minors (individuals under the age of 18) will require either that Parental Permission be sought (and documented with parental/guardian signature(s)) or the IRB waives the requirement for Parental Permission. If parental permission is required, the IRB may find that one parent’s signature is sufficient for research determined to have a 1 or 2 risk level. However, for research that is risk level 3, permission must be obtained from both parents, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
An IRB may waive the requirements for obtaining parental or guardian permission if either of the following two conditions is met:
- The IRB determines and documents that the requirements for informed consent can be waived or altered under either 45 CFR 46.116(c) or (d); or
- The IRB determines that a research protocol is designed to study conditions in children or a participant population for which parental or guardian permission is not a reasonable requirement to protect the participants (for example, neglected or abused children), and the following 2 additional criteria are also met:
- An appropriate mechanism is in place to protect the children, and
- The waiver is not inconsistent with federal, state, or local law.
Parental or Guardian Permission is not required for an emancipated minor. An emancipated minor is an adolescent age 16 or older who is legally recognized as an adult under Michigan law in the following instances: if child 16 or older is married; on active duty with the armed forces; or under a court order.
In most cases once parental permission has been obtained, the assent of the child participant is required. “Assent” means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. The assent procedure should reflect a reasonable effort to enable the child to understand, to the degree they are capable, what their participation in research would involve. In the case where child assent is appropriate, if the parent(s) gives permission for the child to be in the study and the child doesn't assent, the child cannot be enrolled in the study.
For adolescents age 13-17, there is a template available to use for obtaining assent, and it is expected that the adolescent will initial each page after having read it, and sign when they agree to participate.
Currently, no template is provided for obtaining oral assent from children ages 7-12. The IRB suggests starting with the Adolescent Assent template which uses,the use of the question and answer format. The content of each section must be written at an age-appropriate level for the intended population. Remove the initial lines on the bottom of each page and the signature lines on the back page. For oral child assent, the child does not sign or initial the document. The person obtaining oral assent must sign the Parental Permission/Research Informed Consent on the appropriate signature line.
A child’s assent can be waived in certain treatment studies where the study offers potentially lifesaving benefits. In the case where child assent is appropriate, however, if the parent(s) gives permission for the child to be in the study and the child doesn't’t assent, the child cannot be enrolled in the study.
If a potential participant or their LAR is legally blind or illiterate, the consent can be read to them, and there must be a witness to the oral presentation. The witness is required to sign the informed consent document (in addition to the individual obtaining consent and the participant or LAR). The witness must be a person who is independent of the research team and cannot be unfairly influenced by people involved with the research, who does not have a coercive relationship with the participant, who attends the informed consent process.
The IRB must review and approve any proposed modification or revision to an IRB-approved research protocol prior to the implementation of those change (unless there is an urgent need for safety reasons to implement the change prior to IRB approval). Revisions requiring IRB approval include any changes that alter the already approved study, such as an updated study design, new and/or revised study documents, additional methods for recruitment, expanded or narrowed study population and so forth.
If there are substantial changes to the original approved version, the IRB may require the submission of a new protocol.
Revisions to an already approved study may be submitted for expedited review when the proposed changes are minor in nature, such that implementation of the changes poses no more than minimal risk to participants, when the existing risks to participants are not increased, when the revisions are not based on a newly identified risk, and when the revision is not a significant alteration of the study design.
Revisions to an already approved study must be submitted for Full board review when the proposed changes are substantive in nature, such that implementation of the changes poses more than minimal risk to participants, when the revisions are based on a newly identified risk, when there is notification of a new risk or new safety information, and when the changes significantly affect the nature of the study.
Revisions requiring full board review must be submitted using the Full Board Medical/Behavioral Amendment Submission Form.
Additions or Deletions of key personnel must be submitted using the Key Personnel Change Form. Use the Additional Key Personnel List only when additional space is needed to add key personnel for an new submission or for a key personnel amendment.
Changes to the Principal Investigator require the Change in PI Form. When there is a new PI for a study originally approved by the full board, with open enrollment and/or with ongoing active intervention, the Change in PI Form must be submitted for full board review.,
Changes only to the Coordinating Center Application or an Administrative Application should be submitted using those initial applications. Select the “Amendment” checkbox and submit for expedited review.
Studies originally approved by the expedited review process or by the full board have an expiration date. The expiration date is on the Approval Memo sent to the PI. Approval for the conduct of the research will end at midnight on the date of expiration. If a study has not been submitted for a continuation review 60 days past the expiration date, then a new submission (using the initial submission process) is required. No research activity can take place if the study has expired. If interruption of all or some of the research activities would jeopardize the health or safety of a currently enrolled participant, the PI should do what is in the best interest of the individual(s) and promptly notify the IRB of any continued research activity.
Studies reviewed as exempt research do not expire and do not have an expiration date on the Concurrence of Exemption Memo sent to the PI.
The PI must submit a Continuation to request continued IRB approval of a study if any of the following are still occurring:
- Collection of private identifiable information
- Collection of personal information from human participants
- Interactions or interventions with study participants
- Analysis of private identifiable information
The PI should submit a continuation to the IRB well in advance of the protocol expiration date (approximately six weeks before expiration) to allow adequate time for review prior to the expiration date.
The IRB will review using the same criteria for IRB approval which must be satisfied during an initial review.
Studies originally approved by the expedited review process are eligible for expedited continuation review, unless the study has had an amendment reviewed by the full board within the last year, and the committee requested a full board continuation submission.
Studies originally approved by the full board review process are eligible for expedited continuation review if any of the following applies:
- The study is permanently closed to enrollment and all research related interventions are completed but the research needs to remain open for data analysis.
- The study has long-term follow-up without intervention, at the request of the sponsor.
- The full board determined and documented that the research was not subject to FDA regulations, is no more than minimal risk, and eligible for expedited continuing review.
Studies originally approved by the expedited review process must be submitted for full board continuation review if an amendment was reviewed by the full board within the last year, and the committee requested a full board continuation submission.
Studies originally approved by the full board review process must be submitted for full board continuation review if any of the following applies:
- The study has begun enrollment, AND research related intervention is ongoing.
- A new risk has been identified within the current approval period.
Humanitarian Use Device (HUD) studies are not eligible for expedited continuation review and must be submitted for full board continuation review.
A Continuation form is available on the IRB website. The type of review requested (expedited or full board) should be selected on the first page.
Any study document previously approved by the IRB that is still in use and includes an IRB Approval Stamp with the expiration date must be included with the continuation submission. These previously approved documents will be updated with the new expiration date once approved. Therefore, two copies of these documents must be submitted with the Continuation Form. One copy will remain on file at the IRB and one will be returned to the PI. Any document not stamped (e.g... the written proposal) or stamped with an approval date and no expiration date (e.g... standard measure/questionnaire) does not need to be submitted with the continuation form.
Principal investigators must report any occurrence of non-compliance or unexpected problems (including some adverse events) to the IRB. Reporting to the IRB is required so that the IRB can make appropriate determinations regarding the protection of human participants involved in research at WSU-affiliated sites.Principal investigators must report any of the above to the IRB as soon as possible, but in all cases within 5 working days.
Non-compliance is the failure to comply with federal regulations (including Veteran’s Administration regulations and guidance), state and local requirements, WSU Policy and determinations of the IRB. Examples of reportable non-compliance includes deviating from the IRB-approved protocol and failure to properly obtain or document consent (unless waived).
Serious non-compliance is the failure to comply with federal regulations (including Veteran’s Administration regulations and guidance), state, and local requirements, WSU Policy and determinations of the IRB involving one or more of the following:
- Harm to research participants
- Research participants are exposed to a significant risk of substantive harm
- Compromised privacy or confidentiality of research participants
- Damage to scientific integrity of the research data
- Willful or knowing non-compliance on the part of the investigator
- An adverse impact on ethical principles
Continuing non-compliance is a repeated pattern of non-compliance by an individual investigator or research staff member either on a single protocol or multiple protocols.
A problem in the conduct of human participant research that is unforeseen and indicates that participants or others are at increased risk of harm. The occurrence of the problem must be BOTH unexpected and related (either definitely related, probably related, or more likely than not related) to the research to require reporting to the IRB.
An adverse event (AE) is any harm experienced by a research participant regardless of whether the event was internal (on-site) or external (off-site). Only AE’s that meet the definition of an Unexpected Problem are reportable to the IRB.
Decision chart: When is an Adverse Event Reportable as an Unexpected Problem (PDF)
Unexpected Problems, and adverse events meeting the WSU reporting guidelines are submitted using the Unexpected Problem Report Form and should be submitted as soon as possible but within 5 working days of the PI becoming aware of the occurrence. Protocol deviations and violations of the regulations or WSU policies may also be reported using this form.
If additional information about a reportable event is obtained after the initial reporting, use the Unexpected Problem Follow-up Form to submit the additional information.
last updated 08/2016