This document sets forth the standard operating policies and procedures for Research Compliance Services’ (RSC) Human Research Protection Program (HRPP) at the University of Connecticut, Storrs campus, the five regional campuses, the School of Social Work, and the School of Law. The RSC and the Institutional Review Board (IRB) are the institutional entities that implement the HRPP. This document also describes the relationships of the HRPP and IRB with other internal and external agencies. All members of the IRB, IRB staff, and research personnel are expected to be familiar with these policies.
Overview of the Human Research Protection Program
The UConn Storrs Institutional Review Board (IRB) is responsible for the review of all human participants research at the UConn Storrs campus, the five regional campuses, the School of Social Work, and the School of Law (hereafter named UConn Storrs). The primary purpose of the HRPP is to enforce the regulations which govern the protection of research participants enrolled in UConn Storrs studies through oversight by the IRB and IRB staff.
The IRB staff currently consists of the Director of Research Compliance (DRC), Regulatory Compliance Coordinator (RCC), IRB Administrator, and IRB Education and Compliance Monitor (IRB Monitor). The IRB Monitor, Regulatory Compliance Coordinator and the IRB Administrator report to the DRC. The DRC reports directly to the Vice President for Research (hereafter named VPR), the assurance signatory official (IO) for the institution.
Ethical Principles Governing Research
The HRPP supports the advancement of research by creating a collaborative relationship with the research community to ensure that research with human participants is conducted in accordance with the ethical principles of Respect for Persons, Beneficence, and Justice, as put forth in the Belmont Report. The principle of respect for persons is applied through the informed consent process. The principle of beneficence is applied through the risk/benefit analysis which includes a review of the design of the study and the procedures in place to minimize risks. The principle of justice is applied through recruitment strategies and selection of research participants.
These ethical principles are the basis of the regulations which govern the protection of human participants in research, and apply regardless of the regulatory category (i.e., exempt, expedited, or full board) under which a study is approved. Furthermore, UConn assures that equal protections will apply to all research involving human participants, regardless of funding source.
Authority from the Institution
As the IO, the VPR is charged with the responsibility of protecting human participants in research. The VPR empowers the IRB to suspend or terminate any study previously approved by the IRB or to require additional reviews. Suspension or termination may be due to serious and/or unexpected increased risks to participants, or continuing or serious noncompliance of the investigator(s) or other factors that the IRB deems warrant suspension or termination. The VPR cannot influence the decision of the IRB or approve a study that has not been approved by the IRB. The VPR also empowers the IRB to create and implement policy that will serve to protect human participants.
The authority to create, change and implement policy is shared by the IRB and ORC. New policies or changes to policies may be presented to the IRB to solicit input from the committee members. The VPR and DRC may also be asked to review and comment on new or changed policies and to advise the IRB/ORC regarding policy decisions. At the discretion of the VPR or DRC, input may also be sought from those parties that would be affected by the policy.
Every three years the VPR and DRC will review all ORC/IRB policies that are posted on its website, regardless of the date on which the policy was implemented. Such review will include an assessment of the accuracy and relevancy of the policies, a determination as to whether the policies are in-line with institutional policies and whether there is a need for new policies to be developed. Within this document and posted on the IRB website, if an individual policy has been revised, it will show a revision date.
Support from the Institution
The institution provides support to the ORC/IRB and the IRB members in terms of staffing, office space and an operating budget, including educational opportunities. The VPR reviews the ORB/IRB budget annually with the DRC to ensure adequate resources continue to be available.
Assessment of Resources
On an annual basis, corresponding with the budget cycles, the VPR will assess the operations of the ORC/IRB to determine if additional resources are required in terms of supplies, education, staff, and/or equipment. Expenditures from the previous year, response time from the IRB to investigators, number of protocols reviewed per meeting, the number of audits conducted and types of findings, will be among the items included in the assessment. Information may also be solicited from IRB members and staff. The VPR will also take into consideration whether there were any activities, supplies or equipment that were previously forgone due to lack of resources.
Assessment of ORC/IRB Performance
On an annual basis the VPR will review a number of criteria in order to assess the overall performance of the ORC/IRB and when necessary to take action to improve the performance. Criteria to be used in the evaluation include the following:
- The number of new full board studies reviewed by the IRB annually in order to assess whether additional boards are needed due to the volume of work or whether additional expertise is needed in a certain area.
- The findings of the audits conducted by the IRB Monitor to determine if there are common areas of noncompliance that could be improved upon with education, clarification of policy or development of new policies.
- The performance evaluations of IRB members which consider contribution to discussion, attendance, thoroughness of review, volume of work reviewed, and participation in educational activities.
- The performance evaluations of staff members which consider contribution to achieving the goals of the office, level of service provided to faculty, students and staff, and professional development activities.
- The nature, number and outcome of participant complaints to determine if proper action was taken or if improvements can be made.
- The educational opportunities with IRB members and staff attended throughout the year and whether opportunities were foregone due to lack of funding.
- The principal investigators’ (PI) responses to the IRB Research Assessment Tool (RAT) Survey.
It is the policy of UConn Storrs that all research involving human participants conducted by the faculty, students and staff of UConn, or research conducted using UConn facilities, is conducted in accordance with federal regulations, regardless of the funding source. Those regulations include, but are not limited to, the following:
- Code of Federal Regulations, Title 45 Public Welfare, Department of Health and Human Services, National Institutes of Health Office for Protection from Research Risks, Part 46, Protection of Human Participants;
- Code of Federal Regulations, 21 CFR 50, 56, 312, 812, as established by the Food and Drug Administration.
Per 45 CFR 46.103, because UConn Storrs is engaged in human subjects research (not otherwise exempt) that may be conducted or supported by an agency of the U.S. Department of Health and Human Services (HHS), UConn Storrs has an Office of Human Research Protections (OHRP)-approved Federalwide Assurance (FWA) whereby the University agrees to conduct all human subjects research in compliance with the HHS regulations. The UConn Storrs FWA number is 00007125. UConn Storrs also has an FWA with the Department of Defense (DOD)/Navy. The DoD-Navy FWA Addendum number is DoD N-A3167.
IRB Policy & Procedures Manual
The IRB Policies and Procedures (PDF) document sets forth the standard operating policies and procedures for Research Compliance Services’ (RSC) Human Research Protection Program (HRPP) at the University of Connecticut, Storrs campus, the five regional campuses, the School of Social Work, and the School of Law. The ORC and the Institutional Review Board (IRB) are the institutional entities that implement the HRPP.
This document also describes the relationships of the HRPP and IRB with other internal and external agencies. All members of the IRB, IRB staff, and research personnel are expected to be familiar with these policies.