All of the information and forms you will need to apply for HRRC review are available on the HRRC web site and at IRBNet.org, our electronic submission system.
Protocols no longer are submitted on paper forms. All protocols must be submitted via IRBNet. See the HRRC web page for information.
Deadline for consideration at a convened HRRC board meeting is eight (8) working days prior to the meeting. Meeting schedules are posted on the HRRC web page. No exceptions to this deadline can be made.
The following information is needed for every investigator involved in the project:
* Degree, certification, qualifications, if any * Electronic Mail Address * Department * Title * Street or Campus Address City, State, Zip Office/Home Phone
Student Investigators should also include:
* Status (undergraduate, masters level graduate, or doctoral level graduate) * Level of involvement (assisting faculty research, thesis, dissertation, or specify other)
If there are more investigators than will fit in the space provided on the form, use attached pages. Signatures for the PI, advisor and unit head, as applicable are required on all submitted forms.
Some sites of research activity, such as hospitals, community mental health organizations, and other universities, have IRBs to review the research conducted at that site. If the site of your research has an IRB, both the site IRB and GVSU HRRC must approve your project prior to implementation. If the site organization has an IRB Authorization Agreement (IAA) with GVSU, then only one IRB review is required. Currently GVSU is considering formulating IAAs with some institutions but none are yet established.
Submission to both IRBs simultaneously is permitted. Each IRB may request different revisions based on its interpretations of the federal regulations. It is your responsibility as the investigator to notify each board of the decision of the other board. You must also submit any revisions to both boards and you must receive approval from both boards before implementing any aspect of the research. Only one consent form and one protocol application can be approved and it must satisfy the requirements of both IRBs.
If the site of the research does not have an IRB, a letter from official(s) at the research site must be included with the HRRC submission. This letter must indicate that official(s) from the site have read the protocol and grant the investigator(s) permission to conduct the research at that particular site.
Yes. Federal Regulations stipulate that the HRRC must review the relevant parts of the grant application in addition to the research protocol to assure that the project is described in substantially similar ways, and to provide a check for conflicts of interest.
Some sponsors (funding sources) have specific guidelines for the protection of human research subjects. The HRRC must review your proposal using those guidelines or the sponsor may not accept the decision of the HRRC.
In addition, each sponsor has a specific deadline for submission for institutional regulatory approvals. Some sponsors require the original HRRC approval letters to accompany the proposal submission; other sponsors require the approval letter to be forwarded within 30, 60, or 90 days. The HRRC is aware of these deadlines and will make every reasonable effort to meet them. The HRRC does not inform the sponsor of project approvals; that is the responsibility of the investigator(s).