The PI is responsible for submitting a complete protocol and relevant supporting documentation. The required number of copies for each category of review and the types of supporting documentation required are listed in the instructions for the protocol application. Investigators must submit applications using the on-line InfoEd submission process.
For studies using devices or substances not yet approved by the FDA, the IRB may require copies of IND submission and FDA opinions depending on the anticipated risks to participants. All substances used in clinical trials are to be human grade materials, and the PI must provide evidence of compliance with Good Manufacturing Practice. For some studies, especially those involving substances not yet approved by the FDA, substances not requiring FDA approval or substances being used for a purpose other than the approved indication, the IRB may require investigators to strengthen the literature review regarding previous studies and potential side effects.
Eligibility for Principal Investigator (PI) Status
In most cases, only faculty of UConn Storrs (including those at the regional campuses, the School of Law, and School of Social Work) and UConn Health qualify to serve as PIs on IRB protocols. Only one person may be designated as the PI. Students may be designated as co-investigators but not PIs. On occasion, staff members of UConn Storrs may also qualify to serve as PIs on IRB protocols. In rare circumstances, requests by someone not affiliated or employed by the University (a collaborating independent investigator) to serve as PI will be reviewed on a case-by-case basis by the RCC in consultation with the IRB Chair. The intended PI must submit written requests for an exception to the RCC. Such requests will involve two parts. The first part is a request to the RCC from the individual seeking appointment as the PI. The request must include 1) a description of the level and nature of involvement s/he has with the University, 2) how that involvement relates to the mission of the University, 3) appointment of a UConn Storrs faculty member to serve as a co-investigator and 4) if applicable, to what data s/he is requesting access. The RCC will inform the PI via copy of the memo noting the approval, if such a request is approved. In addition, the IRB will enter into an Individual Investigator agreement with the PI, who is acting as a collaborating independent investigator, to extend the applicability of its FWA in accordance with OHRP’s January 31, 2005 guidance. The DRC is a designee of the IO to sign these documents.
Submission of Request for Amendments/Amendments
A PI may amend his/her approved protocol by submitting an IRB-3 Amendment Review form. Requests for amendment must be submitted for IRB review and approval prior to being implemented. The PI is responsible for providing the necessary number of copies and all material requested on the instructions. An exception may be made when the changes are necessary to eliminate apparent immediate hazards to the participants. Such changes must be reported to the IRB using the IRB-6 Protocol Deviation Report form and, when applicable, to the FDA within 5 business days. The Protocol Deviation Report form is to be accompanied by the consent form and any other document affected by or related to the change that was instituted. IRB staff, in consultation with the IRB Chair, will determine whether the change was consistent with ensuring the participant’s continued welfare and will also determine whether the change should be reviewed by the full IRB. The convened IRB will determine whether the event requires reporting as an unanticipated problem or serious or continuing noncompliance if the change is found to be inconsistent with ensuring the welfare of the participant.
Submission of Requests for Continuation (Re-approval)
Continuing review and approval must be obtained prior to the end of the day on which approval expires. Continuing review is required through all follow-up and data analysis activity (data is being maintained, and/or analyzed, and the identity of participants has not been separated from the research data), even if the study is closed to enrollment and research related interventions are complete. Continuing review is also required for studies that have been suspended, in whole or in part. Requests for continuation are submitted using the IRB-2 Re-Approval/Completion form. A request for approval of an amendment may be incorporated into a request for continuation. The PI must indicate that an amendment is being made at time of continuing review and submit the IRB-3 Amendment Review form along with supporting documentation. As a courtesy, the IRB staff will send one reminder notice by e-mail to the PI to request continuation approximately 6 weeks before the study approval expires. The PI retains the responsibility for submitting requests for continuation. A request for continuation requiring full board review that is submitted early will be placed on the agenda of the next regularly scheduled IRB meeting. The approval period by which subsequent continuing review must occur will be adjusted accordingly. Requests for expedited continuation will be forwarded by the IRB staff to the Chair or IRB member for review and approval as they are received.
Submission of Requests for Closure/Completion
A PI may close his/her approved protocol by submitting an IRB-2 Re-Approval/Completion form to the IRB. A summary of the findings must be provided on the form or on an attached document. Requests for completion should be submitted at the time the next continuation application is due or within 30 days after data analysis is complete, the identity of participants has been separated from the research data, and there is no additional research beyond the original intent planned for this data. Requests for completion are typically reviewed by IRB staff.
IRB Decision Appeals Process
In the event that an application is disapproved, suspended, or terminated by the IRB, the PI may appeal the decision in writing to the IRB. The appeal must include information that supports the PI’s position. The appeal may be referred to the full board for consideration.
At the discretion of the Chair, the PI may be invited to attend the next regularly scheduled IRB meeting or one convened specifically for the appeal purpose. The PI will explain to the IRB why the appeal is being made, provide justification for the appeal, and approval/reinstatement of approval for the study, and may engage in discussion with the IRB to provide additional information. The PI will be excused prior to deliberations and voting. The PI will be informed in writing of the final decision of the IRB. The letter will be prepared by the IRB staff for signature by the Chair.
When the IRB has determined that serious or continuing noncompliance or issues that expose participants to unnecessary risks are present, the decision of the IRB to terminate or suspend approval of such a study is effective immediately upon such determination. An investigator must comply with the decision, but may make an appeal to the convened IRB to lift the suspension or termination.
The investigator may also appeal modifications required by the IRB for approval. The initial appeal will be through a written response to the requested modifications, explaining why the modifications identified by the IRB are not appropriate. The Chair may elect to agree with the investigator, disagree with the investigator and still require that modifications be addressed, or refer the matter back to a full board meeting for review, e.g., if the Chair and investigator cannot come to an agreement. This procedure also applies to expedited reviews.
Request for Permission to Recruit on Campus
Researchers who are unaffiliated with the University but wish to recruit participants on the UConn Storrs campus, the five regional campuses, the School of Social Work, or the School of Law, must request permission from the IRB before recruiting students or employees on UConn campuses (via poster, flyer, email announcement or newspaper ad).
Unaffiliated researchers must submit one copy of the full packet of materials submitted to the IRB of their own institution, including the letter of IRB approval for the project. The packet should include, but may not be limited to, the IRB protocol application, consent form or information sheet, recruitment flyer or ad, instruments or measures to be used, and any supporting documentation.
The IRB Chair or his/her designee will review the request and issue a letter of permission to recruit on campus. The IRB reserves the right to have requests for permission to recruit on campus go to the full board for review and approval, should the Chair or Vice Chair decide that the nature of the study requires the independent scrutiny of the IRB to protect its students and employees.
Conflicts of Interest
In conducting human participant research, a conflict of interest is defined as a situation in which an investigator or key personnel (or someone in his/her immediate family – spouse, children, and any other person living in the same household) has a significant financial, professional or personal, interest in the approval or outcome of a study and the interest could affect decisions related to either the design, conduct or reporting of the research, or adversely affect the rights and welfare of research subjects. This applies to all research protocols regardless of funding source, including those that are unfunded. Such conflicts must be identified and managed appropriately.
The Financial Conflict of Interest (FCOI) Committee serves as the resource with respect to matters involving individual conflicts of interest in research. Its responsibilities include the identification and management, mitigation or elimination of specific conflicts of interest. The institutional policy on Financial Conflicts of Interest in Research can be viewed in its entirety on the FCOI section of this website. The policy provides guidelines for relationships between the University and its investigators with private industry, federal and state government, and the nonprofit sector that will help to assure the primacy of academic integrity. This Policy applies to all investigators, key personnel, and IRB members.
What Must Be Disclosed by Investigators, Coordinators, Persons Obtaining Consent and Persons Involved in the Design, Conduct or Reporting of the Research
Individuals must disclose interests in public and non-public companies, including interest in the specific article or service being researched. The following interests must be disclosed to the IRB if the individual or an immediate family member holds the interest:
- Any ownership interest, stock options, or other financial interest related to the research unless it meets the following four criteria:
- <$10,000 when aggregated for immediate family
- publicly traded on a stock exchange
- value will not be affected by the outcome of the research
- <5% interest in any one single entity
- Any compensation related to the research unless it meets two tests: Any proprietary interest related to the research including, but not limited to, a patent, trademark, copyright or licensing agreement.
- <$10,000 in the past year when aggregated for immediate family
- the amount will not be affected by the outcome of the research
- Any board or executive relationship related to the research, regardless of compensation
Disclosure and Management Procedures for Investigators, Key Personnel, and Persons Involved in the Design, Conduct or Reporting of the Research
All faculty members must complete the Significant Financial Interest Review Form and submit it to the FCOI. The IRB-1 protocol application asks investigators to disclose whether a significant financial interest has been reported to the FCOI. If “yes”, then a copy of the Significant Financial Interest Review Form(s) must be attached to the IRB-1. The IRB staff will bring it to the attention of the IRB Chair and the primary reviewer. The FCOI will determine whether the conflict represents a significant financial interest and if so, a management plan will be developed. The IRB staff will also provide the FCOI management plan to the Chair and reviewers. Approval for a study cannot be given until a response, and if applicable, a plan has been received from the FCOI and reviewed by the convened IRB. The convened IRB reserves the right impose management strategies in addition to those outlined by the FCOI. The convened IRB also makes the final determination as to whether the conflict can be managed sufficiently to allow for approval of the research.
At the convened meeting the IRB will discuss disclosures of conflicts and the measures in place to manage, reduce or eliminate the conflict. The convened IRB is responsible for taking the appropriate action(s), i.e.:
- Reviewing the nature of the conflict and the management plan developed by the COI.
- Determining whether the FCOI plan is sufficient to properly oversee and manage the conflict(s), or whether additional management strategies are required, taking into consideration the possible remedies as outlined below.
- Determining whether the conflict can be sufficiently managed to ensure protection of participants is not affected and to allow for approval of the research.
- Informing the investigator and the FCOI of the actions and decisions of the IRB, including restrictions.
Restrictions that might be imposed to manage a conflict of interest to prevent it from adversely affecting the rights and welfare of participants, include, but are not limited to:
- Monitoring of the research by independent reviewers;
- Modification of the research plan;
- Disqualification from participation in all or a portion of the activities affected by the conflict;
- Divestiture of significant financial interests, or;
- Severance of relationships that create the conflict.
Any financial benefit to the investigator must be disclosed in the consent form and during the consent process. However, disclosure alone is not sufficient to manage a conflict that might affect the rights and welfare of participants.
Failure of an investigator to comply with the requirements of disclosure or a management plan may lead to disciplinary action. Such actions may include, but are not limited to:
- Letter or reprimand;
- Notification to funding agencies and/or professional journals or societies;
- Reassignment of duties;
- Suspension or termination of a research project;
- Recommendations for suspension or termination of employment.
In determining the appropriate course of action, consideration will be given to whether the Noncompliance has biased the design, conduct or reporting of the research or compromised the safety or welfare of participants. The IRB may make recommendations for suspension or termination of employment but cannot impose that action.
What Must Be Disclosed by IRB Members
- All items listed above for investigators and key personnel;
- Any involvement of the IRB member or the member’s family member in the design, conduct or reporting of the research;
- Other reasons for which an IRB member believes he or she cannot objectively review the research, e.g. a sponsor is a client of a community member’s law firm.
- The subordinate / supervisor relationship, or someone’s departmental or center affiliation with a project, does not necessarily create a conflict of interest. The IRB member is expected to exercise his/her judgment and is encouraged to solicit advice from the IRB to determine whether or not to review/vote on a study.
Procedure for Disclosing and Managing IRB Member Conflict of Interest
An IRB member or consultant may not participate in the IRB’s initial or continuing review of any project in which the member or consultant has a conflict of interest, except to provide information requested by the IRB.
A conflict of interest of an IRB member (or consultant) generally includes the following. The aggregate interest of the member (or consultant) and his/her immediate family (investigator’s spouse, minor children, and any other persons living in the same household) is considered.
- Participation in a project (IRB member is listed as an investigator on the project or is a member of the research team);
- Supervision of a project (IRB member is a faculty sponsor of the Protocol Director, or a situation in which any investigator must report to or is under the professional supervision of the IRB member);
- Significant financial interest as described in the University of Connecticut Financial Disclosure Policy;
- Personal relationship with investigator (IRB member has an immediate family relationship or other close personal relationship with the investigator);
- Fiduciary relationship to sponsor (IRB member serves as a consultant to a company sponsoring the research, or serves on the company’s board of directors);
- Other non-financial interests that may be conflicting interests, such as (a) the IRB member has an interest that he/she believes conflicts with the member’s ability to review a project objectively; or (b) the IRB member is in direct competition with the investigator for limited resources, funding, sponsorship, or research participants, or the IRB member is considered a personal or professional adversary of the investigators (for (b), the IRB member must disclose the circumstances to the IRB Chair or DRC for a determination of whether a conflict of interest exists);
- Any other reason for which the IRB member believes he or she has a conflict of interest with the research.
IRB members will determine if a conflict exists by reviewing the agenda that lists the names of all investigators and sponsors. The following statement is read at the start of each convened meeting by the IRB Chair or Vice-Chair, and it is also printed on the meeting agenda:
“Any member who has a conflict with any of the protocols discussed at this meeting should either recuse her/himself from the discussion and vote for that protocol or else abstain from the vote. If you are unsure whether you have an actual conflict, or are unsure as to what constitutes a conflict, you are welcome to discuss it with me (IRB Chair) in private and our conversation will be considered confidential.”
Members will make disclosures orally and the IRB staff will note them in the minutes. If a conflict is disclosed, when the study is reviewed, the member with the conflict is required to leave the meeting for the deliberation and voting. If assigned as a reviewer for a study in which the member has a conflict, the member is responsible for contacting the IRB Office so that another reviewer may be assigned. This policy also pertains to reviews conducted through the expedited process.
IRB members receive initial and on-going education to ensure their awareness of institutional policies regarding non-financial conflicts of interest.