Research Review Process
Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Human subjects are living individuals about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information. (45 CFR 46, 46.102)
- If you are a faculty, staff or student at Regent University and your research involves the use of human subjects and you intend to externally disseminate the results (e.g., via publication, presentation, grant application, etc.) then your research requires human subjects review.
- Assignments which are part of normal, typical coursework that are not intended for dissemination are not required to undergo human subjects review; however, faculty are responsible for informing students of proper procedures regarding the conduct of such research and for monitoring the work done by students. Introductory letters and other informed consent language must identify the course and include a statement that the faculty of record (by name) has reviewed and approved the research design, which includes any associated instrumentation. Additionally, surveys or other data collection efforts for the purpose of program or institutional improvement and are not intended for dissemination are not required to undergo review. Such efforts are still required to be conducted in an ethical manner that includes appropriate participant protections. Human subjects data collected in such activities may not be used in future publications or presentations. There will be no ex post facto approval of such activities to legitimize turning these studies into approved human research.
The human subjects review process involves several important steps. To ensure that there are minimal delays in the in review process, it will imperative that these steps are taken.
- Prior to submitting a human subjects review application, all investigators (whether faculty, staff, or students) must successfully complete a training program in order for the research proposal to be reviewed by the committee. The training program is available online and can be completed at your own pace.
- National Institute of Health through the Human Participants Protection Education for Research Teams course. An attached completion certificate must be included with the application (scans and screenshots are acceptable). This training must be renewed every 5 years. This course can be found at: http://phrp.nihtraining.com/
- Investigators who propose studies with patient populations are required to document HIPAA training.
- Investigators must access the NIH booklet entitled, “Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule” at: http://privacyruleandresearch.nih.gov/pr_02.asp
- Investigators must read, submit and sign the HIPAA Training Verification Form with the proposal packet. This training will need to be verified every 12 months that the researcher has read the material in it's updated form in that time period with a memo. The attachment must include the date when the material was read, which must be 12 months prior to the review application.
- The principal investigator will need to complete the Human Subjects Review Form. If the investigator is a student, a faculty member must serve as the co-investigator. It is strongly encouraged that faculty members serving as co-investigators for students review the final version of the completed template before submitting it to the HSRC. Delays in the review process are typically the result of students requiring clarification on the template information and these questions can typically be resolved prior to the formal review process.
- The investigators will submit all supplemental materials as a SINGLE FILE (typically in Microsoft Word) to the email address associated with your school’s committee member. Supplemental materials include a) a copy of your training/s certificate/s, b) surveys, questionnaires and/or interview instruments, c) informed consent forms or statements, d) letters of approval from cooperative agencies and e) debriefing statements of explanation sheets. If survey or materials cannot be included in a Word document then a copy of the material should be delivered to your school’s committee member.
After you submit your proposal it will be classified by your department's representative as either
- Full committee Review: These are more than minimal risk studies that require a committee to approve them. This includes studies with vulnerable populations (such as children or prisoners) and sensitive questions as well as any study with potential physical risk. These studies are brought to the committee for review and voted on for approval. Expect at least a one month response rate once the application is properly completed.
- Expedited Review: No more than minimal risk studies. These studies include studies such as data collected through non-invasive means, collection of video or voice, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. These studies are reviewed by two committee members. Expect a two week return rate.
- Exempt Review: Lowest risk studies, typically anonymous surveys that do not include highly sensitive information. These studies (if all necessary information is attached) are typically returned within one week.
We know that research is time-sensitive and needs to be completed efficiently. Note that the typical turn around time for submissions assumes that all information submitted was complete and clear to the readers. Additional information gathering or clarifications can add time.
Please direct any questions to your school’s HSR Committee representative. Additional questions may be directed to the HSR Committee Chair, Dr. Jason Baker, at firstname.lastname@example.org or 757-352-4447.