Study Review

What happens after you submit your study to the IRB?

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.

Process overview

Step 1—Protocol submission

Research studies are submitted to the Institutional Review Board for review via the Kuali Coeus IRB electronic submission system. After submission, the system sends an automatic notification to the Human Subjects Office to begin the study review process.

Step 2—Intake

Human Subjects Office staff review your submission to ensure that all investigator requirements are met. Your protocol is then assigned to a screener for pre-review.

Step 3—Pre-review

The screener conducts the pre-review to ensure your protocol 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 Return to PI action in KC IRB. You will receive an email with guidance on how to respond to the pre-review inquiry.

Step 4—Review type determined

Based on the nature of your proposed study, the screener will make an initial determination regarding review type:

  • Exempt—Exempt submissions are reviewed by Human Subjects Office staff to ensure completeness and confirm that they qualify for exemption.
  • Expedited (minimal risk and research procedures qualify for expedited review)—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 reviewed by the full board are sent to IRB members at least one week before the meeting date. Your screener will advise you of the IRB meeting date when your submission will be reviewed. For full board review, you may anticipate at least a week after pre-review before your submission will be reviewed by the IRB. If your study was previously tabled and the IRB would like you to answer questions, you will be asked attend the IRB meeting at which your study is being reviewed. If you anticipate questions with your study, you may offer to attend the meeting in person or by phone.

Step 5—Notification of determination

You will receive notification of determination of your approval, request for changes, or disapproval via email from the KC IRB system. If your study was provisionally approved, tabled, or disapproved, you can retrieve a summary of the IRB’s discussion under the Protocol Actions tab > Manage Review Attachments.

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 office/committees internal to IU (for example, Radiation Safety Committee):
    • Documentation of submission to the committee must be included in your submission to the IU Human Subjects Office. Submission to the HSO without this documentation will be determined to be incomplete.
    • Except in extraordinary circumstances, an incomplete submission will not be forwarded to a convened IRB or expedited reviewer until documentation is obtained.
    • Documentation of committee approval must be submitted to HSO before final IRB approval will be granted.
  • For committees external to IU (e.g., other IRBs or Ethics Committees at institutions with which IU has subcontracted for human subjects research):
    • Approval from the respective committee should be obtained prior to submission to the IU Human Subjects Office. Submission to the HSO without this approval will be determined to be incomplete until approval is obtained.
    • Except in extraordinary circumstances, any such incomplete submission will not be forwarded to a convened IRB or expedited reviewer until approval is obtained.