Human Subjects Review Committee (HSRC)

• Research Study planned by faculty or student with faculty (as in dissertation)
• If a dissertation, typically the HSRC is part of the proposal and then submitted to committee for review after the proposal, but this is a decision by the sponsoring faculty chair
• All co-investigators will need to complete and submit certificate of research training as required by SPC of Regent University. Clinical research requires HIPAA training.
• Once planned in detail the HSRC form is submitted with all required attachments in a single document to the relevant chair.

• Exempt and expedited review typically require 2 weeks during a semester
• The HSRC form and attachments should be reviewed & signed off by the sponsoring faculty prior to submission to the HSRC
• The HSRC chair will confirm that all components of the application appear to be included, and what type of review (exempt, expedited or full) will be conducted
• Exempt review is done by one faculty, expedited by 3 and full by 5 faculty. Full review may involve requests for review from experts outside of the SPC faculty and require more time.

• The HSRC may ask for clarifications or revisions of your method or forms
• Your HSRC application is not complete until all revisions are complete, resubmitted and approved by the HSRC.
• You should expect to respond to HSRC questions within a few days of receipt to prevent significant delays.
• You will receive an “approved” letter from the HSRC when your application is approved. You cannot collect any data for your study, or recruit participants, until your HSRC is approved.

• Students submit their application to their sponsoring faculty for approval. After approval upload the current form here. This auto-forwards to the TA assisting with processing the reviews.
• The HSRC chair will review the application for completeness, and for level of review (exempt, expedited or full)
• Faculty will be randomly selected for review unless they have expertise to assist in the ethical review.
• Faculty review within 2 weeks of receipt.
• The HSRC review is for Ethics criteria only. Suggestions for research methods are outside of the scope of this committee work.
• Exempt review is reviewed by one faculty member, typically the chair of HSRC.
• Expedited review is reviewed by 3 faculty within the program of person who submitted it.
• Generally majority rule for decisions. For example in a committee of 3, if one reviewer desires a change, but the other two believe the change is not needed, then the majority can be the decision.  It is also possible that one reviewer will notice some aspect of ethics that needs clarification or revision- and 1 or more other members agree that a revision would be wise (even if they did not comment on it prior).  In this case, the revision would be the majority rule.
• Full review is reviewed by 5 faculty and therefore may require involvement of faculty from outside your program’s faculty. Full review may involve consultation or review by external experts if the internal expertise for ethics in that area of research does not exist within your program/ SPC.  Full review may require convening the committee to meet live to discuss the application.  Applicants should expect a 1 month time frame for full review.
• The HSRC reserves the right to request that studies with high risk ethics will not be reviewed by the HSRC and are required to submit their research to an external IRB company with the consequent expense the responsibility of the researcher.
• Revisions are the responsibility of the submitting researcher. Students should receive approval from the sponsor faculty/chair prior to resubmitting drafts of their HSRC.  Delays in revisions by the researcher are the responsibility of the researcher.  The committee cannot “speed up” their work.
• Revision decisions are made by the HSRC chair. Minor revisions are generally made by the chair exclusively, while larger revisions will be reviewed by the committee and require additional 1-2 weeks to review the revisions.
• The HSRC will set deadlines for the end of each school year for receipt of new HSRC forms, but typically this is mid-June to allow the needed time to review and revise applications before summer classes end. If revisions are needed that HSRC cannot guarantee that a review can be completed prior to University summer break.

An HSRC review will automatically expire after 12 months from receipt of approval by the HSRC.  Any contact or collecting any data from participants after the 12 month point would be an ethical violation.

A renewal form is required for any further data collection or participant contact after the 12 month point.

Any procedural or methodological changes to the research need to be submitted to the HSRC chair prior to implementation.

If there is no further data collection or participant contact, a study can be closed either by informing the HSRC of study closure, or automatically at the 12 month point without notification.

If a study will be conducted on archival research data with a new question asked of old data, but with no further contact with participants AND the study was previously approved by HSRC, or an IRB, then a memo to the HSRC describing the plans for archival data analysis is required prior to engaging in the research.  A full HSRC proposal is not needed. The chair of HSRC will log this research activity and ensure that it fits criteria as described here.

If an archival study is to be conducted and there is no previous Regent HSRC approval or IRB approval for the research, then a full HSRC proposal is needed.

If there has been an unanticipated problem or adverse event in the research, this should be reported to the HSRC committee as soon as possible in writing with an expectation of a follow up conversation for clarity.  The role of the HSRC is to inform and guide researchers regarding ethics when there have been unanticipated problems or adverse events.

The HSRC expects that any electronic data collection (via Qualtrics, Surveymonkey or similar system) would be downloaded and stored securely within 12 months of the end of data collection.  Data should not be perpetually stored in online survey systems.

Federal regulations require research records to be retained for at least 3 years after the completion of the research (45 CFR 46) HSRC recommend that data are kept for at least 5 years. Additional standards from your discipline may also be applicable to your data storage plan. Research that involves identifiable health information is subject to HIPAA regulations, which require records to be retained for at least 6 years after a participant has signed an authorization and may be longer for children depending on the nature of the study. Finally, research sponsors may require longer retention periods.  In sum, you should keep your research records for at least 5 years and possibly longer, depending on the longest applicable standard.  Another good practice is to retain data until there is no reasonable possibility that you will be required to defend against an allegation of scientific misconduct.

Notice that these regulations do not specify when you must destroy data, only state the minimum amount of time you must retain it.  As long as you can guarantee that your research records are secure, you can keep them indefinitely.  Of course, practical considerations of storage space may make this impossible.  When research records are to be destroyed instead of stored securely, you should remember to protect your participants’ confidentiality throughout the process.  Paper records should be shredded and recycled, instead of carelessly tossed in the garbage.  Records stored on a computer hard drive should then be erased using commercial software applications designed to remove all data from the storage device.  Seek IT solutions if needed.