Adverse Events, Unanticipated Problems, Protocol Deviations, Noncompliance, and Suspensions or Terminations

DHHS and FDA regulations require prompt reporting to the IRB, appropriate IO, and appropriate federal departments or agency heads of 1) unanticipated problems involving risk to participants or others, 2) any serious or continuing noncompliance with regulations or the requirements of the IRB, and 3) any suspension or terminations of IRB approval.

It is the responsibility of the PI to assess events that occur during the course of a research protocol, and determine which of the following descriptions apply. The IRB will review reports and make a final determination, indicating agreement or disagreement with the PI’s assessment, and why.

Adverse Events

An Adverse Event is an event that occurs during the course of a research protocol that either causes physical or psychological harm, or increases the risk of physical or psychological harm, or results in a loss of privacy and/or confidentiality to a research participant or others (such as family members).

An Anticipated Adverse Event is one that is reasonably expected and/or listed in the protocol and consent form as a risk of participating in the research. Examples of an anticipated adverse event include, but are not limited to, the following:

A participant in an exercise physiology study experiences muscle strain following an exercise session;
A participant in a study with blood draws experiences light headedness or fainting during the blood drawing process;
A participant in a study of post-traumatic stress syndrome becomes upset during the re-telling of the traumatic event and requires a referral to a counselor.

An Unanticipated Adverse Event is one that was not reasonably expected and/or is not listed in the protocol and consent form as a risk of participating in the research. Examples of an unanticipated adverse event include, but are not limited to, the following:

A participant in a study of the benefits of eating strawberries experiences a previously undetected allergy to strawberries;
A child participant in a study of how to improve classroom behavior experiences bullying by other students as a result of her participation in the study;

A Serious adverse event is one whose magnitude or frequency is above expectation.

A Related adverse event is one that, in the opinion of the investigator, is likely caused by or affects the research.

Examples of serious and related adverse events are:

The death of a research participant due to research procedure(s);
Any change to the protocol made without prior IRB review to eliminate apparent immediate hazard to a research participant or others;
Any event that requires prompt reporting according to the protocol or the study sponsor;
A serious breach of privacy or confidentiality of research participants or others (such as family members);
Any publication in the literature, safety monitoring report, interim result, or other finding that indicates an unexpected change to the risks or potential benefits of the research;
Any complaint of a participant that indicates an unanticipated risk or which cannot be resolved by the research staff;
Any other event or other problem which, in the opinion of the PI, was (1) previously unforeseen and (2) presents risks to research participants or others.

Reporting of Adverse Events
Using the Adverse Event Report Form (IRB-4), PIs are required to report to the IRB serious and related events no later than 2 working days after discovery of their occurrence. All other events must be reported within 5 working days after discovery of their occurrence. This policy applies to events that occur at UConn or at an off-campus study site.

Unanticipated Problems, Protocol Deviations and Noncompliance

An Unanticipated Problem is defined as any unforeseen event that involves risk to the participant or others that is related to either a research intervention or interaction, or the conduct of the study in general. Examples of unanticipated problems involving risk include, but are not limited to, the following:

an accidental or unintentional change to the IRB-approved protocol (e.g., administering the wrong dose of a drug, etc.);
a complaint from a participant that indicates an unanticipated risk (e.g., loss of employment due to disclosure of data, etc.);
unexpected changes to the risk/benefit profile of the study (e.g., based on literature, safety reports, interim results or other findings);
unforeseen events involving the research team (e.g., the loss of a laptop computer with identifiable participant information, sudden unavailability of the PI and/or co-investigator, etc.);
unexpected serious adverse events (internal or external) that in the opinion of the PI may be related to the study intervention;
any change to the protocol taken without prior IRB review to eliminate apparent immediate hazard to a research participant when the immediate hazard is, in the opinion of the PI, related to the study.

Protocol Deviations and Noncompliance are defined as any action that is taken or occurs that is not in accordance with an IRB approved study, IRB policies or regulations, or failure to follow the requirements and determinations of the IRB. Protocol deviations and noncompliance may be minor (e.g., a participant is one day late for a study visit due to family emergency and there is no impact on the safety of the participant due to the late visit), or may be considered serious or continuing.

Noncompliance and protocol deviations are considered serious when they create increased risks to participants, adversely affect the rights and welfare of participants, or affect the scientific integrity of a study. Willful violations of IRB policies and/or Federal regulations, including those pertaining to obtaining informed consent, reporting of adverse events, and disclosure to participants of conflicts of interests and risks associated with a study, are also considered examples of serious noncompliance.

Noncompliance is considered to be continuing noncompliance when a pattern of noncompliance exists that, if allowed to continue, is likely to increase risks to participants, adversely affect the rights and welfare of participants, or affect the scientific integrity of the study. It may involve the same mistake being made repeatedly within one study or across studies (e.g., a co-investigator on two of the PI’s approved studies fails to document participant consent) or the same mistake being made after a corrective plan has been issued to the investigator for previous findings of noncompliance. The IRB will make the final determination as to what constitutes continuing noncompliance.

Reporting Unanticipated Problems, Protocol Deviations and Noncompliance
Unanticipated problems are to be reported to the IRB using the Adverse Event Report Form (IRB-4) and must be reported within 5 working days after discovery of their occurrence. This policy applies to events that occur at UConn or at an off-campus study site. The IRB will make the final determination as to whether an incident constitutes an unanticipated problem. Noncompliance and protocol deviations are to be reported to the IRB using the Protocol Deviation Report Form (IRB-6) and must be reported within 5 working days after discovery of their occurrence. The IRB will make the final determination as to whether an incident constitutes serious noncompliance.

IRB Review of Adverse Events, Unanticipated Problems, Protocol Deviations and Noncompliance

Adverse Event Report Forms and Protocol Deviation Report Forms are reviewed by the IRB Chair, Vice Chair, or a designated IRB member. Anticipated Adverse Events, Protocol Deviations, and reports of Noncompliance will be reviewed by the IRB Chair or a designee of the Chair within 5 working days of receipt of the report. If it is determined that the event did not represent an unanticipated problem involving risks to participants or others, a letter of acknowledgement is sent to the PI, and the report is filed.

If an Adverse Event, Unanticipated Problem, or Noncompliance is serious, related and unanticipated, or continuing, the IRB Chair or designated IRB member(s) will review the report within 5 working days of receipt of the report, and determine whether the event requires review by the full board. All reports requiring full board review will be placed on the agenda for the next fully convened meeting of the IRB. If necessary, an emergency meeting may be called. IRB members will be provided with a copy of the report and all supporting documentation to review. Pending review by the full board, the IRB Chair and reviewing member(s) will determine whether immediate action, such as suspension of new enrollment or termination, is warranted.

The IRB votes on whether the event is an Unanticipated, Serious or Related Adverse Event or Protocol Deviation, or Serious or Continuing Noncompliance involving risks to participants or others, and the determination of the IRB is recorded in the minutes. If the IRB determines that an event is an Unanticipated Adverse Event involving risks to participants or others, the procedures outlined in the section of the University’s IRB Policies and Procedures entitled "Reporting of IRB Findings to Federal Agencies" will be followed, and the IRB will consider taking the following actions:

No action;
Modification of the research protocol;
Modification of the information disclosed during the consent process;
Additional information provided to past participants;
Notification of current participants (required when such information may relate to participants’ willingness to continue to take part in the research);
Requirement that current participants re-consent to participation;
Modification of the continuing review schedule;
Monitoring of the research;
Monitoring of the consent;
Suspension or termination of the research;
Confiscation of data;
Referral to other organizational entities (e.g., Assistant Attorney General, Dean, Department Head, IO, or the Office of Sponsored Programs).

If no action is required, a letter of acknowledgement will be sent to the PI, and a copy of the letter filed in the protocol file. If the IRB takes any actions or imposes any requirements, the actions and requirements are documented in the minutes and in a letter to the PI.

Suspensions and Terminations

A Suspension of previously approved research is defined as a temporary hold on any or all research activity associated with a study, or a permanent stop to some portion of a previously approve research activity. For example, a hold placed on additional recruitment pending clarification of an adverse event would be considered a suspension of approval. Suspended protocols remain open and require continuing review.

Termination of previously approved research is defined as a permanent withdrawal of study approval that requires all study related activity to cease.

In the event of an unanticipated problem, serious or continuing noncompliance, or a suspension or termination of approval, the IRB may require corrective or disciplinary action including, but not limited to, the following:

a modification of the protocol or information disclosed in the informed consent document and process;
information be provided to past participants;
current participants be informed if the information may relate to their willingness to participate;
re-consenting of currently enrolled participants;
more frequent continuing review
monitoring of the consent process or research project by a third party;
requiring additional education;
barring an investigator from conducting human participant research.

The IRB or IO may seek counsel from other institutional areas (e.g., legal counsel) in determining corrective action plans. The IRB may make recommendations regarding employment status but has no authority over an individual’s employment status.

The AVPR will also review the underlying reason that caused the noncompliance or unanticipated problem to occur or for which a suspension or termination is imposed and may require that additional corrective action be taken to prevent subsequent occurrences. Corrective action may include, but is not limited to, the following:

requiring additional education of the investigator;
clarifying existing policies or implementing new policies;
enhancing overall educational activities provided to investigators.

Suspension or Termination of IRB Approval

The Chair, convened IRB, AVPR, or VPRGE may suspend a study. The authority to suspend studies cannot be delegated to other individual members of the IRB, except the Vice Chair. The convened IRB or VPRGE may terminate a study.

Reasons for imposing a suspension or termination include, but are not limited to, learning of 1) previously unanticipated risks to participants, 2) findings of serious or continuing noncompliance, or 3) findings from the continuing review or internal monitoring process. The IRB or IO may also seek advice from other institutional areas (e.g., legal counsel) in determining whether to impose a suspension or termination of IRB approval. In addition, when imposing a suspension or termination, the IRB or IO will give consideration to the impact that the suspension or termination may have on participant safety and/or welfare. Consideration will include, but is not limited to:

whether participation can be stopped safely;
whether participants should be transferred to another physician for clinical care, if applicable;
whether participants can be kept on study under the same PI;
if kept on study under the same PI, whether additional monitoring is required;
whether participants can be kept on study under another PI.

In the event of a suspension or termination of approval, the IRB or person imposing the suspension or termination will inform the investigator in writing. If immediate action is required, the person imposing the suspension or termination may give the directive verbally to the PI and the letter will follow. Letters to the PI should be sent within 5 working days of the effective date of suspension or termination. Such letters will include:

the effective date of suspension or termination;
if notification was initially done verbally the letter will reference the date of verbal notification;
the reason for the suspension or termination;
for suspension, identification of the research activity, in whole or in part, that must stop;
any corrective action or clarification that must occur;
if the reason for suspension may bear on the participant’s decision to continue participation, a directive that currently enrolled participants be informed of the suspension;
for terminations, a directive that all currently enrolled participants be informed of the termination;
if applicable, a directive of how to deal with any currently enrolled participants; and
a direction to the PI regarding to whom to submit responses.

The person or board imposing the suspension or termination will send a copy of the letter to:

IRB Chair and Vice Chair;
Director of Research Compliance (AVPR);
The IO (VPRGE); and, if applicable
Office for Sponsored Programs;
The Attorney General’s office; and
The Dean of the PI’s school.

Letters issued by the IRB will be prepared by the IRB staff; reviewed, approved and signed by the IRB Chair; and sent by the IRB staff. If imposed by the IO, that individual is responsible for the preparation and sending of the letter. The IRB Chair is responsible for directing IRB staff to include any notice of suspension or termination on the next meeting agenda for presentation to and review by the convened board. The investigator is to direct a written response to the person who imposed the suspension/termination and copy the other individuals noted on the initial suspension/termination letter.

If an activity for which a suspension or termination has been imposed must continue, e.g., a research related treatment because it is in the best interest of the participant, the investigator must write a letter to the IRB Chair. The letter shall include:

a justification as to why continuation is in the best interest of the participant;
a request for approval for continuation of the specific activity either until the suspension is lifted or until alternate arrangements can be made for the participant;
for terminations, confirmation that alternate arrangements are actively being sought and provide the anticipated time frame by which the arrangements should be finalized;
confirmation that the investigator will inform participants that the study has been suspended or terminated but that permission for the activity has been obtained;
confirmation that the investigator will direct participants to continue to report adverse events or unanticipated problems;
confirmation that the investigator will continue to report all activity in accordance with policy.

Lifting a Suspension

Only the IRB can lift a suspension using either the expedited review process or full board review. If the AVPR or VPRGE imposed the suspension, that person is responsible for notifying the IRB Chair in writing when s/he is satisfied that all concerns that led the suspension have been satisfied and to recommend lifting the suspension. That person must attach a copy of the responses from the PI to the letter to the IRB. The IRB Chair may use the expedited review process to lift a suspension:

that was imposed by the Chair;
that was imposed by the IO, providing the documentation noted above is received; or
that was imposed by the convened board when the board specifically delegates to the chair the authority to lift the suspension;
otherwise, the convened IRB will determine whether to lift a suspension.

The IRB will send written notification to the PI when the suspension is lifted. The letter will be prepared by the IRB staff, reviewed and signed by the Chair, and sent out by the staff. The IRB staff will also send a copy of the letter lifting the suspension to the individuals identified above.

Reporting of Unanticipated Problems, Noncompliance, Protocol Deviations, Suspensions or Terminations to the IRB

Events that may be considered unanticipated problems involving risk to participants or noncompliance that occurs within the control of the research team, or a suspension or termination of study approval, must be reported to the ORC within five business days of becoming aware of the event and at the time of continuing review. Events are reported to the IRB in one of four ways:

the investigator self reports;
the IO, AVPR or IRB Chair refers an audit finding to the IRB for determination; or
the IO issues a letter of suspension or termination and copies the letter to the IRB.

Self Reporting
Please note that PIs should not undertake any action with an external funding agency regarding an unanticipated problem or noncompliance without contacting the IRB Chair, the AVPR or the ADRC. Unanticipated problems and noncompliance should first be reported to an appropriate institutional official in order to determine the correct course of action.

PIs are to report to the IRB any serious noncompliance that occurs within the control of the study team or any unanticipated problem that may be related to the study within 5 days of becoming aware of the event. All instances of noncompliance or unanticipated problems are also to be reported at the time of continuing review. For example, if a participant is two days late for their visit because the participant canceled an appointment, the deviation would be reported at the time of continuing review. However, if the PI scheduled the participant’s appointment two days outside of the follow-up window the deviation should be reported within 5 days of becoming aware of it. The PI should use the protocol deviation report form for reporting to the IRB, or the adverse event report form, if applicable. If the PI proposes a corrective action that will require a change to the protocol or study related documents the PI must complete, sign and submit a request for approval of amendment form in conjunction with the protocol deviation report form.

Upon receipt of a protocol deviation report form, the IRB staff will forward the report and any supporting documentation to the IRB Chair or Vice Chair for review and determination of action. The IRB staff will also provide the Chair with the complete IRB file of the study to which the event relates. The IRB Chair may determine that the event does not constitute an unanticipated problem, or serious or continuing noncompliance, or the Chair may determine that full board review is required.

If the Chair determines that the event does not constitute an unanticipated problem, or serious or continuing noncompliance, that determination will be presented to the convened board for informational purposes at the next convened meeting. Any member of the board may request that the convened board review the report and corresponding information as noted below. In reviewing the events, the Chair may also require the PI to take corrective actions. Any required actions will be communicated to the PI via the IRB staff (by memo or e-mail) as directed by the Chair.

If full board review is required, the IRB Chair will direct the IRB staff to make additional copies of the form and the supporting documentation for distribution to each member of the IRB as part of the packet for the next regularly scheduled meeting. The Chair will also determine whether any additional supporting documentation is required and direct the staff to make copies accordingly. At a minimum, all IRB members will receive a copy of the protocol deviation report form, a copy of the current approved protocol, and copies of any supporting documentation that was submitted with the protocol deviation report form. The complete IRB file will also be available for review at the meeting. The Chair will lead the discussion of the report at the meeting.

If the protocol deviation report is accompanied by a request for modification form, the IRB staff will note the modification and discussion item on the agenda. Procedures previously described for the submission and review of amendments will be used for review and approval of the modification.

Referral of Adverse Event
When an adverse event is referred to the convened IRB by the IRB Chair, s/he is responsible for preparing the information for the IRB staff for inclusion on the meeting agenda and in the IRB packets. All IRB members will receive at a minimum the complete adverse event report, the informed consent form, the approved protocol, and any additional material that was reviewed by the Chair. The Chair may elect to review additional material, including the protocol. The complete IRB file will be available at the meeting. Adverse events that may constitute unanticipated problems will be reviewed by the convened board. The Chair will lead the discussion of the event at the meeting.

Referral of Audit Findings
The IRB Monitor, who prepares the final audit correspondence for signature by the IRB Chair, is responsible for ensuring that audit letters containing a referral to the IRB are provided to the IRB staff for inclusion on the meeting agenda and in the packets distributed to members. All members will receive, at a minimum, the audit letter and the current consent form. The Monitor will coordinate with the IRB Chair to determine whether additional documentation should be included. The Chair may elect to review additional material, including the protocol. The complete IRB file will be available at the meeting. The Chair will lead the discussion of the audit finding at the meeting.

Reporting Unanticipated Problems, Serious or Continuing Noncompliance, Protocol Deviations, Suspensions or Terminations to Institutional Officials and External Agencies

Study suspensions or terminations, or determinations of unanticipated problems or serious or continuing noncompliance are communicated to the IO in one of two ways: via copy of a suspension or termination letter, and/or via copy of the IRB minutes. IRB staff complete and forward the minutes to the IO within one week of the meeting date.

The IO will report in letter format to the OHRP within the DHHS and when applicable to the FDA or other regulatory agency with oversight due to conduct or an assurance of compliance. The IO will copy the IRB Chair or Vice Chair, the PI, the AVPR and ORC on such letters. The letter may be written by the IO or delegated to ORC staff with review, approval and signature of the IO. The letter will be mailed by the ORC staff. The letter will contain:

the protocol number and title of the study;
the name of the PI;
a summary description of the problem and the cause;
the date of occurrence;
the corrective actions taken or to be taken;
and any plans for ongoing monitoring.

Reporting to federal agencies is not required if the agency is already made aware of the event through other mechanisms, such as reporting by the investigator, sponsor or another organization. Letters will be issued within two weeks of the IRB determination, suspension or termination. The AVPR will be responsible for informing any funding agencies.

Undue Influence

The AVPR shall report to the IO any instance of an individual(s) attempting to influence the IRB staff, any IRB member or the IRB if, in the opinion of the AVPR, the attempt to create the influence is willful and knowing. The AVPR may exercise the authority to conduct an audit or investigation, suspend or terminate studies previously approved for that individual, or to suspend that individual’s involvement in studies for which s/he is not the PI. The AVPR may also take other appropriate actions based on the findings, including recommending disciplinary action to the IO, including termination of employment. Such instances may be reportable as issues of serious noncompliance. If the AVPR is the individual creating undue influence, the report is to be filed directly to the IO.

Allegations of Noncompliance with ORC/IRB Requirements

The ORC has the responsibility of dealing with reports of any known or suspected violations of laws, regulations, standards, policies and procedures that apply to UConn if the concern pertains to a human participant protection issue. The ORC retains the responsibility for ensuring that: 1) all activities are carried out in a fair and unbiased manner; 2) those reporting concerns are treated fairly and that their confidentiality is protected to the extent possible; and 3) no retaliation takes place.

Allegations of noncompliance with policies pertaining to human participant protection may be filed with the ADRC, IRB Chair, or AVPR.

Procedures for Filing an Allegation
Individuals can submit reports in writing or orally. Reports may be submitted anonymously. If a phone call is the initial method of communication, the person receiving the call will inform the caller that the content of the conversation is being documented and that while efforts will be made to protect the caller’s identity, protection cannot be 100% guaranteed. The reporting individual’s identity may become known during the normal course of an investigation. If the concern is received by the Chair, the Chair will share the information with the AVPR and vice versa.

Allegations may encompass, but are not limited to, the following areas:

performance of research on human participants without IRB approval;

failure to conduct research in accordance with the terms of the IRB’s approval;

failure to conduct research in accordance with regulatory requirements;

failure to obtain informed consent from participants prior to involvement in the study;

failure to report unanticipated problems or noncompliance in accordance with policy;

failure of the IRB to act in accordance with its responsibilities to protect human participants; or

failure of study personnel to act in accordance with their responsibilities to protect human participants.

Processing an Allegation
The ORC will process allegations to:

Evaluate the nature of the complaint to determine if participants may be at risk.

If participants may be at risk, an immediate suspension will be placed on the relevant research activities by notifying the PI. Policy for imposing a suspension will be followed and required reporting will occur.

Exercise one of three options:

Act alone to resolve the issue. The AVPR or IRB Chair may exercise this option if the nature of the allegation is such that participants are not at risk, the integrity of the data is not compromised, or the resolution appears to be a simple matter of clarifying the issue with the investigator, and there does not appear to be knowing or willful noncompliance on the part of the investigator. The AVPR or IRB Chair may still elect to exercise the options noted below after having exercised this option.

Direct the IRB Monitor to conduct a for-cause audit (refer to monitoring of approved studies section). This option may be exercised by the AVPR or IRB Chair if the nature of the allegation is such that participants may be placed at risk, the integrity of the data may be compromised, or the noncompliance appears to be knowing and willful. The AVPR or IRB Chair may still elect to exercise the option noted below after having exercised this option.

Conduct a full investigation. The AVPR or IRB Chair may exercise this option based upon audit findings that appear to substantiate an allegation of willful and knowing noncompliance, or based upon the nature of the allegation and consideration as to whether similar allegation have been reported concerning the same individual. The AVPR or IRB Chair may consult with the full board and/or counsel in determining whether to proceed with an investigation.

Option a or b is to be exercised within 5 business days of becoming aware of the event.

In general, when the option to investigate is exercised, the AVPR or VPRGE will appoint an ad-hoc committee of at least three members to perform the investigation. One member will be charged with leading the investigation and may delegate tasks and determine how to approach the investigation, e.g., to have the entire committee interview study personnel, to have one committee member interview personnel and one review data, or to involve or not involve external collaborators or consultants in the investigation process. The committee will be comprised of individuals knowledgeable of the research topic and the regulations and ethical principles governing human research. The approach to be used must be approved by the AVPR prior to starting the investigation. The investigation must start within 2 weeks of the date the decision to investigate is made.

Individuals about whom the allegation was made will be notified in writing by the AVPR (or VPRGE if applicable) that the investigation is to be initiated and will be provided with an explanation of the allegations. Investigations may encompass a review of all files (electronic and paper), and data that are relevant to the allegation, interviews with relevant personnel, or any other area deemed necessary to conduct the investigation.

Individuals about whom the allegation is made have the right to give testimony on all aspects of the report and on all of the evidence acquired by the investigation committee, to call witnesses and to be represented by legal counsel.

The AVPR will instruct the committee to conduct the investigation in a confidential manner. In most circumstances, investigations should not exceed a two month period based on the date of initiation. If a longer time period is required, the reasons will be explained in the final report. The final report will be prepared and signed by the Chair of the investigative committee and sent to the VPRGE and AVPR. The report will contain a summary of the allegation, a description of the investigative process, the findings, supporting information, and the suspected cause for the occurrence (e.g., deliberate choice by the investigator, lack of training of the investigator, confusing policies, etc.). If an allegation is unsubstantiated, the AVPR will report back to the individual against whom the allegation was made via memo, with copy to the IRB Chair. If a suspension had been imposed, the letter will also be copied to the individuals identified in the section regarding imposing suspensions and the AVPR will recommend lifting the suspension to the IRB.

If an allegation is substantiated via audit or investigation, the AVPR will forward the final report from the audit or the investigation to the IRB staff for inclusion as a discussion item on the next agenda of the convened IRB. The final report from either the AVPR or the investigative committee will be presented in memo format and will contain the information noted above. The IRB staff will distribute the final report and the currently approved consent form to all members of the IRB as part of the meeting packet. The Chair will facilitate the discussion at the meeting. The convened IRB will determine if the finding is one of serious or continuing noncompliance or unanticipated problems involving risks to participants or others. The IRB will also determine the course of corrective action and may recommend disciplinary action. Any member of the IRB may request additional material from the investigator, to review the complete IRB file, or previous meeting minutes.

Corrective actions include, but are not limited to, the following:

modification of the protocol or information disclosed in the informed consent process;

additional information be provided to past participants;

current participants be informed if the information may relate to their willingness to participate;

re-consenting of currently enrolled participants;

more frequent continuing review;

monitoring of the consent process or research project by a third party.

Any requirements for corrective action will be communicated to the investigator via memo from the Chair. The memo will be prepared by the IRB staff, reviewed and signed by the IRB Chair and sent by the IRB staff. The IRB staff will document required actions in the IRB minutes. Any corrective action requiring a change to the approved protocol must be submitted by the investigator via a request for approval of an amendment to the IRB. The IRB may also seek counsel from other institutional areas in determining a course of action (e.g., legal counsel). The VPRGE will follow through with any required reporting.

The AVPR will review under what circumstances the situation occurred and when possible will take corrective action, such as developing or clarifying policies or providing additional training to investigators, to prevent similar occurrences.

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