Institutional Review Board Research Policies

Background

Use of participant incentives is a common research practice. It encourages and recognizes human subjects’ participation in and completion of a research task or sequence of tasks, and it may be key to securing broad participation in a research protocol. Incentives may include cash, checks, gifts and gift cards.

The University of Wisconsin-Eau Claire balances its responsibility to maintain confidentiality of information about human research subjects with record keeping requirements of the University of Wisconsin System, grantor agencies, and the Internal Revenue Service. In situations where confidentiality is not related to human subjects but it is in the best interests of the study to maintain confidentiality, the same procedures outlined below will apply. 

The overarching aims of this document are to ensure:

• The confidentiality of research participants.
• Timely, convenient compensation to participants to facilitate the progress of the study.
• The appropriateness of the incentive for participation in the research study.
• Compliance with relevant institutional, governmental, and grantor policies and practices.

Regulations

When researchers choose to provide incentives to participants or potential participants in their research, they must follow certain regulations designed to ensure participant confidentiality and must follow proper accounting procedures. For instance, in the UW System Financial Administration policy on Prizes, Awards and Gifts (UW System Administrative Policy 330) the use of Program Revenue (not General Program Revenue, e.g.102) or Gift/Grant funds are preferred for incentives, including research incentives. And, for example, under the Internal Revenue Code, when total payments to human subjects for services exceed $600 in a calendar year, they are subject to income reporting requirements on tax form 1099-MISC and information must be collected from research participants including names, social security numbers, mailing addresses, and dates of participation.

Procedures

The Principal Investigator (PI) is responsible for identifying and justifying the use of participant incentives in the research protocol submitted, reviewed, and approved by the IRB prior to performing the research. The protocol must identify the anticipated benefit of offering incentives, specify the dollar amount of incentives, and describe the proposed method of disbursement and timing of all payments. The PI is also responsible for tracking incentives disbursed to research participants.

The Institutional Review Board (IRB) is charged with the responsibility to review and approve both the amounts and methods of incentivizing to ensure that incentives are not coercive and do not present undue influence to participate or to continue participation. The UW System policy specifies that the amount or value of the incentive should be based on the minimum amount reasonably required to achieve the objective of the research and should not exceed $200 per participant.

In accordance with the PI’s request in the research protocol for payments to participants, the IRB will determine which of two levels of confidentiality is needed for making payments to research participants. Level 1 Confidentiality of Payment is used when confidentiality is not needed to protect the identity of the payment recipient; unless otherwise requested by the PI, Level 1 confidentiality is assumed. Level 2 Confidentiality of Paymentis used in cases when it is critical to protect the identity of the payment recipient; when the IRB authorizes Level 2 confidentiality, it will be noted in the IRB’s approval letter to the PI.

Regardless of level of confidentiality, with IRB approval PIs have the discretion to confer non-recurring payments of $50 or less to human subjects without obtaining social security numbers and mailing addresses. Typically, the research protocol would identify that the particular circumstances of the study are such that it would be unreasonably burdensome to collect this information in light of the very low potential for the total payments to the recipient to exceed the Internal Revenue Code threshold of $600 in a calendar year.

The following paragraphs summarize procedures for making payments or giving gifts to research participants.

For Gifts such as stickers, mugs, t-shirts, or other tangible items considered minimal value (less than $10 per person)

The PI must complete a BP Logix eForm Request for Purchase of Gift Cards/Awards/Prizes/Incentives Form. The PI should then purchase the item using the Direct Pay or Procurement Card method, following procurement policies in doing so. The PI is responsible for maintaining a log of the items they distribute and providing that document to the University Controller's Office. The document should include names, items distributed to each participant, estimated value, purpose of gift/incentive, date of distribution, and signature of each participant.

For Level 1 Confidentiality of Payment with Non-recurring Payments of $50 or Less

Payments can be made to research participants by the PI, who must request a check be issued to themselves by the University through the Miscellaneous Payment Request Process. The PI must first complete a BP Logix eForm Request for Purchase of Gift Cards/Awards/Prizes/Incentives Form. Once the PI is ready for the check to be issued, they should send an email to Accounts Payable. Included in that email, the PI should include the following information: Approved Gift/Incentive eForm, Miscellaneous Payment Request Memo. Accounts Payable will process the request in Workday and it will route through the approvals. The PI will be contacted via email when the check is ready for pick-up with instructions. Once payments have been made to research participants, the PI is required to supply the University Controller's Office with a document that includes names, amount paid to each participant, the purpose of payment, dates of service, and signature of each participant. If all funds issued to the PI were not distributed to research participants (or signed for), the PI is responsible for paying the University back for the unused funds. This can be done with cash or a check made payable to the University – this is to be completed with the University Controller’s office.

Payments may also be made to research participants by the PI in the form of gift cards. The PI must complete a BP Logix eForm Request for Purchase of Gift Cards/Awards/Prizes/Incentives Form and attach the approval to their payment method. These may be purchased using a Procurement Card or they may use the Miscellaneous Payment Request Process to submit a request for funds to themselves. They must supply the University Controller's Office with a document that includes names, amount paid to each participant, the purpose of payment, dates of service, and signature of each participant. If all gift cards purchased by the PI were not distributed to research participants (or signed for), the PI is responsible for paying the University back for the unused gift cards. This can be done with cash or a check made payable to the University – this is to be completed with the University Controller’s office.

Alternatively, payments can be made directly to research participants by Accounts Payable on the standard Payment to Individual Report (PIR) form, which will require names, social security numbers, mailing addresses, and purpose of payment and dates of service. If more than one research participant is being paid, they must be paid individually, each providing a completed and signed W-9 to Accounts Payable, prior to the submission of the PIR. Payment information will be retained by Accounts Payable in the voucher; these documents are considered to be public, potentially open to public review.

For Level 1 Confidentiality of Payment with Non-recurring Payments of More than $50

Payments can be made to research participants by Accounts Payable on the standard Payment to Individual Report (PIR) form, which will require names, social security numbers, mailing addresses, and purpose of payment and dates of service. If more than one research participant is being paid, they must be paid individually, each providing a completed and signed W-9 to Accounts Payable, prior to the submission of the PIR. Payment information will be retained by Accounts Payable in the voucher; these documents are considered to be public, potentially open to public review.
 

For Level 2 Confidentiality of Payment with Non-recurring Payments of $50 or Less

Payments can be made to research participants by the PI, who must request a check be issued to themselves by the University through the Miscellaneous Payment Request Process. The PI must first complete a BP Logix eForm Request for Purchase of Gift Cards/Awards/Prizes/Incentives Form, including a copy of the IRB approval letter, which authorizes Level 2 confidentiality. Once the PI is ready for the check to be issued, they should send an email to Accounts Payable. Included in that email, the PI should include the following information: Approved Gift/Incentive eForm, Miscellaneous Payment Request Memo, and the funding it should be applied against. Accounts Payable will process the request in Workday; it will route through the approvals. The PI will be contacted via email when the check is ready for pick-up with instructions. For each cash payment made to research participants, the PI must obtain signed receipts. The PI shall maintain a record of the research participants’ names and corresponding coded identifications; this will be the only record of the payee names, and it will stay in the control of the PI. Once payments have been made to research participants, the PI is required to supply the University Controller's Office with a document that includes the coded identification, amount paid to each participant, the purpose of payment, and dates of service. If all funds issued to the PI were not distributed to research participants (or signed for), the PI is responsible for paying the University back for the unused funds. This can be done with cash or a check made payable to the University – this is to be completed with the University Controller’s office.

Payments may also be made to research participants by the PI in the form of gift cards. The PI must complete a BP Logix eForm Request for Purchase of Gift Cards/Awards/Prizes/Incentives Form, including a copy of the IRB approval letter, which authorizes Level 2 confidentiality, and attach the approval to their payment method. These may be purchased using a Procurement Card or they may use the Miscellaneous Payment Request Process to submit a request for funds to themselves. The PI shall maintain a record of the research participants’ names and corresponding coded identifications; this will be the only record of the payee names, and it will stay in the control of the PI. Once payments have been made to research participants, the PI is required to supply the University Controller's Office with a document that includes the coded identification, amount paid to each participant, the purpose of payment, and dates of service. If all gift cards purchased by the PI were not distributed to research participants (or signed for), the PI is responsiblhttps://universityofwieauclaire.sharepoint.com/sites/university-account… for paying the University back for the unused gift cards. This can be done with cash or a check made payable to the University – this is to be completed with the University Controller’s office.

For Level 2 Confidentiality of Payment with Non-recurring Payments of More than $50

Payments can be made to research participants by Accounts Payable on the standard Payment to Individual Report (PIR) form, which will require names, social security numbers, mailing addresses, and purpose of payment and dates of service. If more than one research participant is being paid, they must be paid individually, each providing a completed and signed W-9 to Accounts Payable, prior to the submission of the PIR. Payment information will be retained by Accounts Payable in the voucher; these documents are considered to be public, potentially open to public review. The informed consent and any applicable HIPPA documents required for use in the research study do not need to describe the collection of information from research participants when that information is solely used to process study payment. Instead, study teams are recommended to have research subjects complete a form to obtain information that also alerts the participant that the payment will be reported by the UW to the IRS; this form should be maintained separately from research records.

Non-Resident Aliens (NRAs) – an individual who is a citizen of any country other than the United States. These individuals are treated differently for tax purposes than US tax residents

Payment to NRA – any dollar amount Contact University Controller

Accounts Payable pays research participants via PIR – additional paperwork and documentation is required.

Recruitment of any research subjects who may be in a status relationship with the investigators raises unique ethical concerns. A status relationship exists when a researcher has authority to make decisions about the subject: e.g., grades, performance evaluation, academic progress, recommendations, etc. At UW-Eau Claire this especially pertains to students, but could also include employees and family members. The existence of a status relationship between a prospective subject and members of the research team may result in a recruitment and consent process that is not completely voluntary and free from undue influence. The concern is that individuals may feel they cannot decline participation in a research study, because they believe that would lead to adverse consequences for their student careers or employment. Students may even “volunteer” due to subconscious pressure to stay in good favor with their faculty. Additionally, enrollment of individuals already known to the research team may heighten the potential for loss of confidentiality for those subjects.

The desire to enroll individuals with a potential status relationship should be declared in the original application to the IRB and justification for the inclusion of these subjects provided. The IRB will then assess, on a case-by-case basis, whether the inclusion is warranted by the protocol, the recruitment and consent process are free from undue influence, and the confidentiality of these subjects is protected adequately. 

The IRB will look for the following factors:

1. The research presents minimal risk to subjects.

2. The consent process should:

a. Address that a status relationship exists, address the potential problems associated with recruiting subjects in a status relationship with the researcher, and document how the researcher intends to minimize the impact of the status relationship.

b. Clarify that participation in the research study, or refusal to do so, will not affect the individual’s status as a student (e.g., grades or class standing) or employment at the university.

3. The consent process should be designed such that the instructor cannot identify who chooses to and who chooses not to participate. This may be achieved by:

a. Recruiting potential subjects through a general communication to a group, not approaching individually or recruiting on a personal basis.

b. A consent process conducted by someone with whom the potential subject does not have a status relationship.

c. Avoiding names and signatures on collected consent documents.

4. Data gathered should, whenever possible, not include information that may be used to identify individuals. While names and birth dates are obvious examples, other seemingly benign variables may be identifying. For example, hair color, class schedule, or handwriting could identify individuals.

a. The research project should be designed such that the collection of identifying variables is minimized.

b. A person who is not in a status relationship with the students could receive data directly from the participants and strip the data of identifiers before providing the information to the researcher.

c. The researcher could wait until course grades have been submitted before analyzing any data that has personal identifiers.

The IRB may consider studies where there may be greater than minimal risk but potential benefit to the subject. Also, the IRB acknowledges that patients have an inherent status relationship with their health care providers and manage these relationships differently than research relationships.

If you have any questions, please contact:

Dr. Michael Axelrod, Chair IRB

Schofield 17, UW-Eau Claire

715-836-2373

The UW-Eau Claire IRB has approved giving course credit or extra credit to students who participate in research projects only when:

1. An acceptable alternative activity is provided
2. The extra credit is not excessive in proportion to overall grade
3. The extra credit is commensurate with the task involved
4. The research project involves minimal risk
5. The student’s anonymity is protected.

Therefore, projects that wish to offer credit or extra credit for participation must clearly document to the IRB that:

• The consent process clearly states the consequences of withdrawing from a project prior to completion (e.g., will credit be given despite a student withdrawing?). Generally, the IRB favors giving at least pro-rated credit even if a subject withdraws.
• Any alternative must be comparable to participation in terms of time, effort, stress, and convenience. For example, a 5-page paper is not an acceptable alternative to participation in a 4 minute survey.
• If evaluated, any alternative project should be graded on a “credit/no credit” scale. The grading criteria should be reasonable and clearly outlined to both the IRB and student. Moreover, alternatives cannot be done ‘in addition to’ participation for ‘double’ the credit.
• Any credit must be small in proportion to a student’s overall grade. A student’s final grade should still reflect his/her mastery of course material, not his/her participation as a research subject.
• The method for documenting participation and assigning credit does not jeopardize the anonymity of the student. It is recommended that researchers use a certificate of completion or a non-unique ‘completion code’.

When the Chair of the IRB or IACUC has a protocol submitted for committee review/approval or is serving as a faculty mentor of a submitted protocol:

The Research Compliance Specialist will appoint an alternate acting Chair for the entire review process.

The Research Compliance Specialist will facilitate all communication, including communication using the eform system, when appropriate, between the acting chair and the IRB/IACUC chair.

The Chair must recuse themselves from all discussions regarding the study protocol by the board/committee.

Because protocols for IRB are submitted electronically through the eform system and must be signed by the Chair, a separate letter must be attached to the eform with the acting Chair’s signature approval. The Research Compliance Specialist will attach the approval letter from the acting Chair to the eform before sending it on to the IRB Chair.

Definitions and Potential Corrective Actions: 

Noncompliance: Any action or activity associated with the conduct or oversight of research involving human subjects, as defined in (CFR 45 §46.102), that fails to comply with either the research plan as approved by the designated Institutional Review Board (IRB) or with federal regulations or institutional policies governing human subject research. Noncompliance includes failure to have protocols reviewed by the IRB prior to beginning research with human subjects or deviations from the protocols approved by the IRB. Noncompliance can result from action or omission and may be minor, serious, and/or continuing. 

Minor Noncompliance: Any behavior, action or omission in the conduct or oversight of research involving human subjects that deviates from the approved research plan, federal regulations, or institutional policies but, because of its nature, the research project, or subject population, does not or did not: 

• harm or pose an increased risk of substantive or considerable harm to a research participant; 

• result in a detrimental change to a participant’s clinical or emotional condition or status; 

• have a substantive or considerable effect on the value of the data collected; and 

• result from willful or knowing misconduct on the part of the investigator(s) or study staff. In general, examples of minor noncompliance include but are not limited to: 

• Implementation of minor changes to or deviations from an approval protocol without IRB approval of the protocol modification. 

• Implementing minor wording changes in study questionnaires without first obtaining IRB approval. Corrective actions for minor noncompliance may include, but are not limited to: 

• Acknowledgement of the report with no further action needed. 

• A warning or reminder to the PI with instructions on how to avoid future incidents, clarifications regarding requirements and rules, etc. 

• Requiring additional human subjects protection training. 

• Requiring submission of an amendment or report of an adverse event/unanticipated problem 

• Requiring the PI to submit a corrective action plan. 

• Directing post-approval monitoring visits. 

• Directing compliance audits. 

Serious Noncompliance: Any behavior, action or omission in the conduct or oversight of human subjects research that has been determined to: • adversely affect the rights and welfare of a research participant; 

• harm or pose an increased risk of substantive or considerable harm to a research participant; 

• result in a detrimental change to a participant’s clinical or emotional condition or status 

• compromise the integrity or validity of the research; or 

• result from willful or knowing misconduct on the part of the investigator(s) or study staff. Acts that are determined to be flagrant or intentional violations of IRB requirements may also constitute serious noncompliance. 

The IRB will consider the circumstances surrounding the case when making a decision related to serious noncompliance. In general, examples of serious noncompliance include but are not limited to: 

• Failure to obtain IRB approval or determination of exemption prior to initiating research activities with human subjects, especially if the research potentially poses more than minimal risk. 

• Allowing unqualified or untrained individuals to perform research procedures or monitor subject safety. 

• Failure to obtain informed consent or failure to provide participants with all information necessary to constitute meaningful informed consent unless a waiver has been previously granted by the IRB. 

• Enrolling a child in a research study without the informed consent of a parent or legal guardian unless parental consent was previously waived by the IRB. 

• Enrolling subjects from a vulnerable population (i.e., children, prisoners, cognitively impaired individuals, subordinates, etc.) when their inclusion is not described in the IRB-approved protocol or appropriate protections are not in place. 

• Enrolling subjects who do not meet the approved eligibility criteria when doing so compromises the safety or well-being of the subjects. 

• Failure to follow approved measures for protecting privacy and confidentiality when the failure presents any risk of harm to the research subject (such as harm to their reputation, social or psychological harm, risks of legal or civil liability, embarrassment, harm to workplace or family relationships, etc.). 

• Implementing unapproved changes to research activities that increase risks to participants or adversely affect their rights, safety, or welfare (e.g., adding survey questions that collect sensitive information, substantially increasing the duration or intensity of exercise activities, adding plans to collect data from private records without subject consent, changes to confidentiality protections, etc.).

 • Failure to report serious adverse events or unanticipated problems involving risks to subjects or others as required by IRB policy. • Instructing or knowingly allowing subordinates (e.g., research assistants, employees, students, etc.) to engage in activities that are contrary to IRB or institutional policies or regulatory requirements. 

• Providing false or intentionally misleading information to the IRB. 

• Multiple issues suggesting a lack of oversight, inaction, or negligence such that research subjects’ rights, safety, or welfare could be adversely affected. 

Corrective actions for serious noncompliance may include but are not limited to: 

• Remediation or educational measures required of the research team. 

• Monitoring of research activities by a designated person(s). • Monitoring of the informed consent process by a designated person(s). 

• Notification of past or current research participants. 

• Re-consenting of participants. 

• Modification of the research protocol. 

• Increased reporting by the PI of his/her human participants’ research activities to the IRB. 

• More frequent continuing review (renewal of approval) schedule. 

• Periodic audits by the IRB administrator or appointed member of the IRB. 

• Restrictions to the PI’s research practice, such as limiting the privilege to minimal risk or supervised projects. 

• Requiring the PI to submit a corrective action plan. 

• Suspension of approval for one or more of the PI’s studies. 

• Termination of approval for one or more of the PI’s studies. 

• Referral to other University authorities or committees for possible further review and resolution by those bodies including possible disciplinary action up to and including termination in accordance with the appropriate disciplinary procedures for faculty, staff, and students.

Continuing Noncompliance: A pattern of noncompliance that: 

• indicates a lack of understanding or a disregard for the regulations or institutional requirements that protect the rights and welfare of participants; 

• suggests a likelihood that noncompliance will continue without intervention; or 

• involves frequent instances of minor noncompliance, such as repeated protocol deviations. 

Continuing noncompliance is characterized by the frequency rather than the magnitude of the noncompliance. Examples of continuing noncompliance include but are not limited to: 

• Repeated failure to obtain IRB approval prior to initiating human subjects research activities. 

• Continuing to engage in noncompliant activities after being notified or advised of concerns. 

• Recurring late submissions of continuing review applications resulting in repeated lapses in approval. 

• Multiple instances of serious or minor noncompliance; this includes multiple incidents within a single project or multiple incidents by a single investigator across more than one project. 

• Failure to respond to incidents of noncompliance or failure to enact required corrective actions. Corrective actions for continuing noncompliance may include but are not limited to those listed above under minor noncompliance and serious noncompliance. 

Procedures: 

Initial Report of Potential Noncompliance

Upon receipt of a report or query regarding potential noncompliance, IRB staff forward the information to the IRB Chair/designee. The IRB Chair/designee will promptly review the report/query and inform the Director of the Office of Research and Sponsored Programs (ORSP) and the Institutional Official. 

If the report/query does not seem to involve serious harm to subjects, the IRB Chair/designee will proceed with an initial inquiry (described in the next section). If the report/query involves allegations of serious harm to subjects or requires immediate action to prevent such harm, the IRB Chair/designee will immediately inform the Director of the Office of Research and Sponsored Programs (ORSP) and the Institutional Official, halt study activity, and proceed with an initial inquiry. 

Initial Inquiry of Report of Potential Noncompliance 

The IRB Chair/designee will promptly undertake an inquiry of the allegation(s). The primary purpose of the inquiry is fact-finding, that is, to determine whether there is evidence to substantiate a claim of noncompliance with institutional, UW System, state, or federal policies/regulations regarding human subjects research. The inquiry may involve examination of study records and discussion with the research team, other personnel, research participants, witnesses, the complainant (if not anonymous), and others as appropriate. 

If the report/query is made by someone other than the Principal Investigator (PI), the IRB Chair/designee will notify the PI in writing of the allegation. The PI will have an opportunity to respond to the allegation(s) during this initial inquiry. The results of the inquiry will be shared in writing with the ORSP Director, the Provost/Institutional Official, and others as deemed necessary. 

If the allegation/concern is unsubstantiated, no additional action is needed. 

If the allegation appears to be substantiated, i.e., the initial inquiry suggests that the actions are in violation of institutional, UW System, state, or federal policies/regulations regarding human subjects research, one of two actions follow. If the allegation is determined to be a clear case of minor noncompliance and is not considered continuing noncompliance by the IRB Chair/designee, and the ORSP Director and Provost/Institutional Official agree with the determination, the ORSP Director in collaboration with the IRB Chair/designee and the Provost/Institutional Official determines corrective action and communicates the outcome in writing to the PI, with a copy to the PI’s chair/supervisor, the PI’s Dean, the IRB Chair, and the Provost/Institutional Official. If the allegation is not a clear case of minor noncompliance, an IRB Subcommittee investigation ensues. Temporary suspension of study activities may be enacted for the protection of research subjects.

IRB Subcommittee Investigation 

If the inquiry reveals noncompliance with institutional, UW System, state, or federal policies/regulations regarding human subjects research that is other than a clear case of minor noncompliance, the IRB Chair/designee will form an IRB Subcommittee of at least two members of the IRB to conduct an investigation. The IRB Subcommittee reviews the report/query, the inquiry report, any related materials, and decides what further information is needed; this information may include meeting with the research team, other personnel, research participants, witnesses, the complainant (if not anonymous), and others as appropriate. The purpose of the investigation is to determine whether the reported incident constitutes noncompliance and if so, whether it is minor noncompliance, serious noncompliance, and/or continuing noncompliance. 

The IRB Subcommittee prepares a written report for the IRB Chair/designee, indicating whether the reported incident constitutes noncompliance, and if so, identifying and justifying the action(s) as minor noncompliance, serious noncompliance, and/or continuing noncompliance and recommending specific corrective actions. The IRB Chair/designee reviews the report and shares it with the ORSP Director and the Provost/Institutional Official. If no noncompliance is found, the IRB Chair/designee communicates the outcome in writing to the PI, the ORSP Director, and the Provost/Institutional Official, and shares the outcome with the IRB Committee. 

If the determination is minor noncompliance, the IRB Chair/designee refers the matter to the ORSP Director. The ORSP Director in collaboration with the IRB Chair/designee and the Provost/Institutional Official determines the corrective action and communicates the outcome in writing to the PI with a copy to the PI’s chair/supervisor, the IRB Chair, and the Provost/Institutional Official. The IRB Chair shares the outcome with the IRB Committee. 

If the determination is serious noncompliance and/or continuing noncompliance, the IRB Chair/designee refers the matter to the ORSP Director and the Provost/Institutional Official. The Provost/Institutional Official in collaboration with the ORSP Director (and potentially the IRB Chair/designee) determines corrective action and communicates the outcome in writing to the PI, with a copy to the PI’s chair/supervisor, the PI’s Dean, the IRB Chair, and the ORSP Director. 

If there is uncertainty or disagreement in the IRB Subcommittee about the determination or type of noncompliance, the IRB Chair/designee refers the matter to the ORSP Director. The ORSP Director in collaboration with the IRB Chair/designee and the Institutional Official undertakes further investigation, if needed, and makes a determination regarding the noncompliance. Procedures described above then followed. 

When a determination of noncompliance requires corrective action, the PI must provide written documentation of completion of any corrective action to the IRB within 30 days of being notified, unless otherwise specified. The IRB will provide written confirmation that the corrective action is sufficient and will document all information regarding the incident in the IRB records. 

Follow-Up 

Principal investigators are responsible for ensuring the corrective actions outlined in the final noncompliance report are implemented by the timeframes established in the report. The ORSP Director will monitor as needed. Failure to meet the conditions established in the report may result in additional sanctions. 

Referrals for Additional Review

If information obtained during the initial inquiry or investigation suggest that the activity/activities may potentially violate other University policies, such as research misconduct or financial mismanagement, the IRB will share or refer the complaint to the appropriate University officials. The IRB will cooperate and coordinate its reviews with other University officials, as appropriate. 

External Reporting 

Incidents of serious noncompliance and/or continuing noncompliance—as well as suspension or termination of IRB approval and/or unanticipated problems involving risks to subjects or others—must be reported to the Office of Human Research Protections per requirements set forth in 45 CFR 46 and the funding agency or sponsor in accordance with their requirements. Similarly, reports of serious or continuing noncompliance must be provided to the Food and Drug Administration for FDA-regulated research in accordance with 21 CFR 56.108(b), 21 CFR 56.113, 21 CFR 812.150. When appropriate, preliminary reports may be filed pending final resolution of the case. 

In addition, in cases of serious noncompliance and/or continuing noncompliance, if the study involves other institutions, the IRB administrators and/or collaborating individuals of those institutions will be notified. 

Research Conducted Without Prior IRB Approval 

No mechanism exists under 45 CFR 46 or UWEC policy for retroactive IRB approval (or disapproval) of a project. Therefore, if the IRB becomes aware of research that has already been conducted without IRB review and approval, the inquiry and investigation processes described above apply. Project activity will be paused, and data collected may not be used for any purposes pending the outcome of the inquiry and/or investigation and subsequent IRB review and approval. 

Appeal of Noncompliance Decisions 

Appeals of determinations of noncompliance must be made in writing within 10 business days of the date of the report communicating the outcome of the investigation to the ORSP Director or the Provost/Institutional Official, whoever has communicated the decision in writing to the PI. The appeal will be communicated to the IRB Chair/designee, and the IRB Chair/designee will have the IRB Committee review the appeal at the next regularly convened IRB meeting. The PI may attend the IRB meeting at which the appeal is discussed. The IRB Chair/designee will communicate the outcome of the appeal in writing to the PI, with a copy to the PI’s chair/supervisor, the PI’s Dean, the ORSP Director, and the Institutional Official. 

If the PI is not satisfied with the appeal decision of the full IRB Committee, the PI may appeal the decision to the Provost/Institutional Official in writing within 10 days of the date of the communication of the IRB’s review of the appeal. The decision of the Provost/Institutional Official is final. 

Last Updated April 8, 2024