Procedure for Submitting a Research Project for Review
All research involving human subjects must be submitted to the IRB. Investigators should request the type of review most appropriate for their study using the IRB Project documents. Proposals are first reviewed by the IRB Chair. If there is any disagreement with the type of review requested, the investigator will be contacted, the reasons for the disagreement explained, and any additional material necessary to continue the review process will be requested by the IRB Chair.
Investigators must submit all information well in advance of the anticipated start date of data collection and, in the case of sponsored research, in advance of submission of the proposal to the agency. Research projects requiring full review must be submitted to the IRB Chair one week before the scheduled meeting date (see IRB Research Proposal Review and Meeting Schedule, 2012). Research proposals requiring expedited or exempt review must be submitted to the IRB Chair two weeks before the start of the research date.
Faculty who allow or require research projects by their students (when such projects involve the use of human subjects) should submit an IRB Project Application Form (Appendix A) for review every fall semester, or as needed, provided the research objectives and methodology are not changed.
The following IRB Project documents must be submitted to the IRB by email (.doc or .docx format only) in order:
IRB Project Application Form (Appendix A)
Informed Consent Form (Appendix B)
Brief Summary of the research project and instruments for collecting information (surveys, etc.)
Amendment/Modification/Renewal Form, if applicable (Appendix C)
Full Grant Proposal, if applicable
NIH Certificate (.pdf, .doc or .docx format only)
- The IRB’s actions, comments, and recommendations will be sent to the Principal Investigator. If a proposal is disapproved, the Principal Investigator may request to attend the next IRB meeting.
- Any changes in a proposal or consent form must be promptly reported in writing to one of the IRB Chair. In most cases these will received an Expedited review.
- All adverse reactions and unexpected side effects must be reported immediately, in writing to the IRB.
- Interim progress reports should be submitted if requested by the IRB to insure that the rights and well being of subjects are protected.
- Annual renewals are mandatory and should be submitted by the Principal Investigator (see Annual Renewal Procedures).
- The Principal Investigator may request that the IRB reconsider the decision made. A written rationale must accompany that request, email preferred.
- If the IRB sustains its decision, the Principal Investigator may appeal to the Vice President of Academic Affairs (VPAA). The VPAA may, but need not, convene an ad hoc review panel to review all materials and make a recommendation back to the VPAA. The VPAA’s decision is final.
Annual Renewal Procedures
Thirty days before the anniversary of the last approval date, the following should be submitted by email to the IRB Chair:
- Human Subjects Project Amendment/Modification/Renewal Form (Appendix C)
- If any changes have been made, submit instruments, the consent form(s), and written explanation of study, with all changes highlighted and noted to the IRB Chair, email preferred.
Completion of Research
When a project is completed, withdrawn, or past the phase involving human subjects, please inform the IRB Chair in writing, email preferred. The following records will be maintained by the IRB for three years:
- Copies of all research proposals reviewed; scientific evaluations, if any, that accompanied the proposal; approved sample consent documents; progress reports and renewals submitted by investigators; and reports of injuries to subjects.
- Minutes of IRB meetings which should be in sufficient detail to show attendance at the meeting, action taken; the vote on these actions including the number voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a summary of the discussion of disputed issues and their resolution.
- Records of continuing review activities.
- Copies of all correspondence between the IRB and the Principal Investigators.
- A list of the IRB members detailing their names, earned degree, representative capacity, indications of experience sufficient to describe each members’ chief anticipated contribution to the IRB, and any employment or other relationship between the member and HPU (e.g. full-time employee).
- A statement of significant new findings provided to subjects, as required by the policy on informed consent, discussed above.