Wednesday, April 8, 2015
Receiving HRRC Review for your SSD Project
You must receive review and approval for any human subjects research project before enrollment and data collection may begin!
049 JHZ 1 Campus Drive Allendale, MI 49401 Phone: 616-331-3197 Fax: 616-331-6040
1) Do I need HRRC approval for my SSD project?
Definition of Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 45 CFR 46.102 (d)
Key terms: Systematic, Designed, Generalizable
Data Sets - If the data is completely de-identified (i.e., there is no way to determine the personal identity of any person whose data is included in the set), AND the data was not collected directly by or for the researcher expressly for the proposed research study, then HRRC review is typically not required.
If any part of the data is personally identifiable, OR if the data was collected through direct interaction or intervention with the study subjects for the purposes of the proposed study, then HRRC review is required. If the link to de-identified data is maintained, please consult with the HRRC.
Program Evaluations - if the anticipated results found through the evaluation process are generalizable (i.e., the conclusions reached may be applied beyond the specific program or population of study subjects that was evaluated), then HRRC review is required. If the evaluation results are not applicable beyond the specific program evaluated, then HRRC review is not required.
Oral History - if the research intent is specifically limited to reporting or analyzing a small number of persons' lived experiences, then HRRC review is not required.
If multiple oral histories are collected and the analysis is intended to be generalizable to other persons who were not involved in the research, then HRRC review is required.
Class Projects - If the research is intended solely as a learning experience for course members, and the results are never disseminated beyond the members of the course who conducted the project, then HRRC review is not required. If the research is intended as an instructional or educational offering to persons other than the enrolled course members, and the results are generalizable to others outside of the course members, then HRRC review is required.
Theoretical Exercises and Literature Reviews - do not require review. This should be clearly stated on SSD presentation materials.
Engaged in Research - The federal Office of Human Research Protections (OHRP) has developed a guidance on determining whether an institution, through the actions of its staff or students, is engaged in research for purposes of compliance with the federal regulations. See HRRC Guidance #4: G-4: Guidance on engagement in research.
2) Why should I apply for HRRC review?
3) How do I apply for HRRC review?
1. Students should meet with their research advisor and together complete the Student Research Checklist to determine whether the project requires HRRC review and approval. This advisor may be different from their regular academic advisor.
2. If the project requires HRRC approval, determine the level of review that the project requires: Exempt vs. Expedited Review Categories Note: Expedited categories require that the research be no greater than minimal risk. Any research project that does not clearly fit into one of the six exempt categories, or nine expedited categories, or is greater than minimal risk will require full board HRRC review at a regularly scheduled meeting. Minimal risk is defined as the risks normally encountered by health adults or minors in routine activities of daily life, and in routine medical and psychological examinations.
3. Complete the Application for New Protocol Review. In the summary box, please indicate " SSD Project" which will entitle you to a faster review turnaround.
4. Review the HRRC checklist that is appropriate to your requested level of review: ....... Checklist: Exempt Protocol ....... Checklist: Expedited/Full Board Protocol
* Checklists include all of the documents and other information that must be submitted for review.
5. Follow instruction sheet, step-by-step: Submitting a New Protocol.
4) What do I include on my SSD project when I present?
"This research protocol has been approved by the Human Research Review Committee at Grand Valley State University. File No. _____. Expiration: [insert date]."
2. Review Research Advisor Checklist prior to meeting with the student(s). Meet with student researchers to help with HRRC review process.
3. Authorize the project once it has been submitted via IRBNet by signing as the Research Advisor.
If you add or remove a student(s) to your own research project, you must submit a Change in Approved Protocol application.
Complete Change in Approved Protocol application. Follow instruction sheet, step-by-step: Instructions for Submitting a Change in Approved Protocol.