IRB Frequently Asked Questions
IRB eProtocol FAQ
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
IRB eProtocol FAQs
Have an IRB or eProtocol question not listed below? Send an email to irbquestions@wayne.edu
How can I tell if CITI Training is complete for key personnel?
- The Principal Investigator's CITI Training appears under the Personnel Information section.
- To check all other key personnel training click on the individual's name and all completed trainings will appear.
- If an individual has not entered their WSU Access ID for their CITI profile a message will appear stating "no training data is available".
Does key personnel receive alerts to sign-off on Obligations & COI?
- No
- The PI or designated personnel (i.e. research coordinator), will need to reach out to individual key personnel to request Obligations & COI sign off.
Can more than one key personnel log-in and complete Obligations & COI?
- No, only one person can log in at a time. Each person should completely log out of the system when they have completed Obligations & COI.
Will the selected Department Chair/Dean/Authorized signatory received notification for sign-off?
- Yes
- Upon the PI or coordinator selecting "Submit Form" if there are no check for completeness items an email alert is sent to the authorized signatory and the submission is routed to the authorized signatory's dashboard for sign-off.
If the Department Chair/Dean/Authorized signatory completes COI & Obligations is their sign off complete?
- No
- The Department Chair/Dean/Authorized signatory must also complete "Department Certifications" which is authorizing submission of the application to the IRB.
Can the Principal Investigator or faculty supervisor/mentor also be listed as the authorized signatory?
- No
- An individual can only have one assigned role for an eProtocol application.
- A Principal Investigator that is also is the department chair may need to list the authorized signatory at college/dean level for the submission.
- A faculty supervisor who is also the Dean or Chair for their College or Department will need to list another individual designated as an authorized signatory for research within their college/department.
How can I revise/modify the study title for a submission?
- A study title can be modified while the user is in edit mode.
- Go to the Protocol Information-Summary & Purpose section.
- The study title appears in a text box for this section. This text box content can be modified.
- Once changes have been made select "Save" on the Summary & Purpose page and the title will change throughout the application.
For exempt submissions are the addendums for vulnerable populations required?
- No
- when a submission is indicated as exempt, the vulnerable populations addendums will disable in the eProtocol system. However, the applicable CITI training is still required.
Can I submit multiple amendments at the same time?
- No
- eProtocol only allows for one submission/action request at a time.
Are administrative approvals still required for an eProtocol submission (PRMC, DMC, Psychiatry, WSU Dean of Students, Export Control-International Research, Radiation Review)?
- Yes any applicable administrative approvals are still required
- DMC submissions: DMC personnel are administratively added on the eProtocol submission as "Other Personnel" for designated DMC personnel to have access to the eProtocol submission. The DMC application must also be completed. Contact the DMC's Clinical & Translation Research Office for the DMC submissions. The DMC approval letter should be attached to the Protocol Information-Attachments section.
- PRMC approval is required for cancer studies. This approval should be attached for the Protocol Information-Attachments section.
- All other Administrative Approvals should be attached to the Protocol Information-Attachments section.
How do I request a waiver of consent or alteration of consent?
- Protocol Checklist section select the appropriate waiver
- Consent Information section select "Add" and complete the pop-up window
- Type the name of the requested waiver:
- Waiver of Consent
- Waiver of Consent for Screening
- Waiver of Written documentation of consent
- Alteration of Consent.
- Select the appropriate waiver type for the pop-up window:
- Waiver of Consent
- Waiver of Written documentation of Consent
- Alteration of Consent
- Respond to the listed waiver/alteration statements
- Type the name of the requested waiver:
How do I request a waiver of HIPAA Authorization?
- Go to Protocol Checklist section and select the following:
- Protected Health Information will be viewed, created, accessed, used, or disclosed
- HIPAA Authorization
- Waiver of Authorization
- Then go to Protocol Information-HIPAA section
- Complete HIPAA section and select Waiver of HIPAA Authorization for HIPAA
- Please note, a waiver of consent may also be required when requesting a waiver of HIPAA Authorization.
How do I clone a protocol?
To clone a protocol:
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Log into the eProtocol system under the Investigator Role
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Make sure the IRB tab is selected
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Select "Clone Protocol"
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Select the radio button for the protocol ID to be cloned
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Select "Clone Protocol" again
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Select "Yes" to the question "Do you want to clone the selected Protocol?"
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The protocol will then copy and assign a new IRB number
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All key personnel will need to sign off on the submission including the PI.
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The submission can then go through the check for completeness and authorized signatory sign-off process by selecting "Submit Form"
About IRB Review - Getting Started
What is the IRB and what is IRB review?
When does a research project require IRB review?
What kind of projects do not require IRB review?
What is a Principal Investigator (PI) and who is allowed to serve as PI?
What are "key personnel" and who needs to be approved by the IRB?
Are there training requirements before submitting for IRB review?
How do I submit for IRB review?
Flexible Review and Oversight
What is flexible review and oversight?
What is considered federal funding?
How can researchers request flexible review and oversight of a study?
New Research Submissions
When does a study qualify for exempt review?
When does a study qualify for expedited review?
When must a study be submitted full board review?
Are there special requirements if a study is conducted outside of the U.S.?
Research Informed Consent
When must Informed Consent be obtained?
What are permissible options for obtaining Informed Consent?
Standard Consent Requirement for Adult Participants
Non-English Speaking Participants
Waiver of Documented (Signed) Consent Use of a Research Information Sheet
How is informed consent obtained for minor (under age 18)?
Adolescent (ages 13-17) Assent
How can consent be obtained from someone who is blind or illiterate?
Amendments - Changes to IRB Approved Research or Study Documents
Can a study or project be changed after IRB approval?
When can study changes or revisions be submitted for expedited review?
When must study changes or revisions be submitted for full board review?
How are changes or revisions submitted for IRB review?
Continuation Review - Application for Continued IRB Approval
How can a study be continued after the initial expiration date?
When can a study continuation be submitted for expedited review?
When must a study continuation be submitted for full board review?
How is a request for study continuation submitted for IRB review?
Reporting - Adverse Events, Unexpected Problems & Non-Compliance
What are IRB Reporting Requirements?
What is an Unexpected Problem (UP)?
What is an Adverse Event (AE)?
How are Unexpected Problems, Adverse Events and Non-Compliance reported to the IRB?
About IRB Review - Getting Started
What is the IRB and what is IRB review?
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.
When does a research project require IRB review?
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. This tool is available on the IRB's Forms and Submissions website.
What kind of projects do not require IRB review?
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."
Use the HPR (Human Participant Research) Determination Tool to determine if a project requires IRB review or not.
What is a Principal Investigator (PI) and who is allowed to serve as PI?
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)).
What are "key personnel" and who needs to be approved by the IRB?
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.
Are there training requirements before submitting for IRB review?
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 is available.
How do I submit for IRB review?
New projects are submitted as either exempt research, research eligible for expedited review, or research requiring full board review.
Determine the type of review the project requires and then complete the eProtocol submission Form. eProtocol instructions are available on the IRB Forms and Submission Requirements website.
Flexible Review and Oversight
What is flexible review and oversight?
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 adherence to federal research regulations.
Research eligible for Flexible Review under this policy will be reviewed by the WSU IRB using expedited review procedures unless the IRB reviewer determines that review by the convened board is warranted
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."
Research projects eligible for flexible review and oversight are not subject to the same federal reporting requirements as federally sponsored projects. For projects conducted under this policy, the WSU IRB follows internal reporting requirements for serious or continuing non-compliance, suspensions or terminations, or reporting of unanticipated problems involving risk to subjects or others.
What is considered federal funding?
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
How can researchers request flexible review and oversight of a study?
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.
If a study previously had federal funding but no longer receives any federal funds, is it eligible for flexible review and oversight?
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.
IRB Submissions - New Research Projects
When does a study qualify for exempt review?
Research with human participants is exempt from some or all of the regulations when the proposed research activities limited to the activities defined in one or more of the Exempt Research categories. If the proposed research activities 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)])
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 (eProtocol submission) with the appropriate study documents. IRB forms.
Concurrence of Exemption obtained after January 21, 2019 are required to submit a status update report to the IRB. See the Status Update Report Guidance Tool for assistance.
When does a study qualify for expedited review?
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.
Expedited submissions approved after January 21, 2019 no longer require continuing review if the following circumstances apply:
i. Research eligible for expedited review in accordance with 46.110
ii. Research reviewed by the IRB in accordance with the limited IRB review described in 46.104
iii. Research that has progressed to the point that it involves one or both of the following which are part of the IRB-approved study:
a. Data analysis, including analysis of identifiable private information or identifiable biospecimens
b. Accessing follow-up clinical data from procedures that are performed as a part of the standard clinical care.
Expedited submissions meeting this criteria is required to submit a status update report. See the Status Update Report Guidance Tool for assistance.
When must a study be submitted full board review?
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.
When a project will be conducted at an outside institution, does the WSU IRB need to review the research proposal?
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.
Are there special requirements if a study is conducted outside of the U.S.?
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:
- International Research Addendum
- 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).
Additional guidance:
Research translation requirements for non-English speakers
Research Informed Consent
When must Informed Consent be obtained?
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.
What are permissible options for obtaining Informed Consent?
Standard Consent Requirement for Adult Participants
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.
Use of these templates for adults strongly recommended.
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.
Non-English Speaking Participants
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
Waiver of Documented (Signed) Consent - Use of a Research Information Sheet
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).
How is informed consent obtained for minors (under age 18)?
Parental Permission
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.
Waiver of Parental Permission
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.
Emancipated Minor
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.
Assent
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.
Adolescent (ages 13-17) Assent
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.
Use of these templates for adolescents strongly recommended.
Oral Child (ages 7-12) Assent
See the IRB's Oral Assent template provided for obtaining oral assent from children ages 7-12. ,The IRB suggests the use of a question and answer format. The content of each section must be written at an age-appropriate level for the intended population. 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.
Waiver of Assent
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 assent, the child cannot be enrolled in the study.
How can consent be obtained from someone who is blind or illiterate?
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.
Amendment Review - Changes to IRB Approved Research or Study Documents
Can a study or project be changed after IRB approval?
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.
When can study changes or revisions be submitted for expedited review?
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.
When must study changes or revisions be submitted for full board review?
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.
How are changes or revisions (amendments) submitted for IRB review?
Submissions initially reviewed and approved via eProtocol select the active protocol and complete the amendment form available via eProtocol.
Submissions not review via eProtocol following are revisions submission instructions:
Revisions eligible for expedited review must be submitted using the Expedited Medical/Behavioral Amendment Submission Form.
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. Submissions reviewed via eProtocol where the WSU is the Coordinating Center, the Coordinating Center Application should be attached to eProtocol.
Continuation Review - Application for Continued IRB Approval
Does IRB approval expire?
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.
Concurrence of Exemptions and Expedited studies approved after January 21, 2019 require submission of a status update report. See the Status Update Report Guidance Tool for assistance.
How can a study be continued after the initial expiration date?
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.
When can a study continuation be submitted for expedited 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.
When must a study continuation be submitted for full board 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.
How is a request for study continuation submitted for IRB review?
Non eProtocol submission must use the Continuation form available on the IRB website. eProtocol submission must select the Continuation Form on the users Active protocol listing. 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.
Reporting - Adverse Events, Unexpected Problems, & Non-Compliance
What are IRB Reporting Requirements?
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.
What is non-compliance?
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.
What is an Unanticipated Problem (UP)?
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.
What is an Adverse Event (AE)?
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
How are Unanticipated Problems, Adverse Events and Non-Compliance reported to the IRB?
Unanticipated Problems, and adverse events meeting the WSU reporting guidelines are submitted using the Unanticipated Problems and Event Reporting 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.
For eProtocol submissions the Unanticipated Problems and Event Reporting Form must be submitted via eProtocol
Non eProtocol submissions must submit the Unanticipated Problems and Event Reporting Form to eIRBManager@wayne.edu
If additional information about a reportable event is obtained after the initial reporting, use the Unanticipated Problem Follow-up Form to submit the additional information.
last updated August 2016