Research Proposal Review Process
Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for the purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. (45 CFR 46, 46.102)
The research proposal review process for the SPC involves several important steps. To ensure that there are minimal delays in the in review process, it will imperative that these steps are taken.
Step One: All students and faculty members that submit a proposal to the HSRC must successfully complete a training program in order for the research proposal to be reviewed by the committee. These training programs are 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 attached to the application as a screenshot or copied and pasted to the online supplemental materials. 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 HIPPA Privacy Rule” at:
Investigators must read, submit and sign the HIPPA Training Verification Form with the proposal packet. This training will need to be renewed every 12 months. The attachment must include the date when the material was read, which must be 12 months prior to the review application.
*If these two items are not submitted with the review application, the entire proposal will be sent back to the principal investigator and the review process will not continue.
Step Two: The principal investigator will need to complete the Human Subjects Review Form, which is available on the forms page. If the investigator is a student, a faculty member from the SPC 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.
Step Three: The investigators will submit all supplemental materials as a SINGLE FILE (typically in Microsoft Word) to the following email address SPCResearch@regent.edu which will store the materials for review and storage. 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 Dr. Lee Underwood, CRB 221.
I did all 3 steps, what happens to my proposal next? After you submit your proposal it will be classified by your department's representative as either
- 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 to students within one week as approved.
- 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 the SPC committee members. Expect a 2 week return rate.
- 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.