To assure that the rights and welfare of human subjects involved in research projects are protected and to comply with federal and state regulations and laws, IU’s Human Research Protection Program determines what types of activities constitute research with humans and reviews, approves, or requires modifications to proposed research activities.
Step 1—Protocol submission
Research studies are submitted to the Institutional Review Board for review via the Kuali Protocols IRB online submission system. When you take the Submit action in Kuali Protocols, the system sends an automatic notification to the HRPP to begin the study review process.
HRPP staff review your submission to ensure that all investigator requirements are met. Your submission is then assigned to a screener for pre-review.
The screener conducts pre-review to ensure your submission includes all required information and documents and is compliant with regulatory and institutional requirements. If the screener has any questions or concerns, he or she will notify you by using the Require Revisions action in Kuali Protocols. You will receive an email notifying you that revisions have been requested by the screener. Instructions for accessing and responding to pre-review comments can be found in the Kuali Protocols instructional guides.
Step 4—Review type determined
Based on the nature of your proposed study, the screener will make an initial determination regarding review type:
- Exempt submissions are reviewed by Human Subjects Office staff to ensure completeness and confirm that they qualify for exemption.
- Expedited submissions are reviewed by a single IRB member. Reviewers are given one week to review new studies and return their determinations to Human Subjects Office. Other submissions, such as amendments or renewals, may be reviewed more quickly.
- Full Board (more than minimal risk or not qualifying for exempt or expedited review) protocols require review by the convened IRB committee. Submissions are assigned to IRB members five to seven days before the meeting date. For full board review, you may anticipate about one week between completion of pre-review by HRPP staff and review of your submission by the IRB.
Note – New (not yet approved) study submissions which are inactive in Kuali Protocols for more than six months will be permanently withdrawn (i.e., marked as Abandoned in Kuali Protocols). A new study submission will be required to resume the review process for an Abandoned study.
Step 5—Notification of determination
You will receive of determination of your approval, request for changes, or disapproval via email from the Kuali Protocols system. If your study was provisionally approved, tabled, or disapproved, you can retrieve a copy of the IRB Minutes which includes a summary of the IRB's discussion in the Admin Notes & Files section of Kuali Protocols. Instructions for navigating Kuali Protocols can be found in the Kuali Protocols instructional guides.
IRB criteria for approval
- Risks to subjects are minimized by using procedures that are consistent with sound research design and do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB considers only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB does not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy).
- Selection of subjects is equitable. In making this assessment, the IRB takes into account the purposes of the research and the setting in which the research will be conducted, paying particular attention to the special problems of research involving vulnerable populations (e.g., children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons).
- Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by federal regulations for the protection of human subjects.
- Informed consent will be appropriately documented, in accordance with, and to the extent required by federal regulations for the protection of human subjects.
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons), the IRB looks for additional safeguards included in the study to protect the rights and welfare of these subjects.
Additional review by non-IRB committees
Some human subjects research studies may require review by and approval from regulatory offices or committees other than the IRB. According to both regulatory requirements and Association for the Accreditation of Human Research Protection Programs accreditation standards, IRB approval must be withheld until all approvals have been obtained. Other offices or committees may be either internal or external to IU. For additional information, see the HRPP Guidance on Additional Review by non-IRB Committees.
Indiana University relies on the work of four IRBs; one Social/Behavioral/Educational IRB, one Noncompliance Committee, and one Biomedical IRB, and one emergency/ad hoc IRB. The Human Subjects Office schedules protocols requiring review by the convened IRB for the next available meeting and not based on specific deadlines. Scheduling is dependent on receipt of the complete protocol, completion of pre-review, and expertise or focus of the particular IRB.
The Social/Behavioral/Educational IRB meets on the third Thursday of the month.
The Noncompliance Committee meets on the fourth Friday of the month.
IU’s Biomedical IRB meets ten times a month.
The Indiana University Human Research Protection Program (HRPP) provides administrative support to all IU campuses and maintains physical offices in two locations, Indianapolis and Bloomington.
Indianapolis (Main):Human Research Protection Program (HRPP)
Office of Research Compliance
986 Indiana Avenue, 5th Floor
Indianapolis, Indiana 46202
- Phone: (317) 274-8289
- Email: email@example.com
Bloomington:Human Research Protection Program (HRPP)
Office of Research Compliance
509 E. Third St.
Bloomington, Indiana 47401
- Phone: (812) 856-4242
- Email: firstname.lastname@example.org