Have an idea, wondering if it would be a quality improvement project or a research project. Here are some tools that would be of assistance in determining this. As always, you can research us at [email protected] or by phone at 616.252.5020
Remember that HIPAA is a vital aspect of any researcher. Review the HIPAA & Research: Frequently Asked Questions for assistance.
Pre-Submission Tools & Templates
Here are tools to assist you the development of your project:
You now have your project developed; the next step is to have it by UM Health-West’s Protocol Review Committee
This committee made up of physician and nurse representatives will review the incoming studies for feasibility, soundness, and human research determination (if the study needs to be reviewed by the IRB). The committee meets on the third Tuesday of every month at noon.
A full project proposal and the forms below, should be submitted at least one week prior to the committee meeting.
During the meeting, a presenter should expect to give a 5-10 minute presentation about their project and be prepared to field questions from the reviewers.
Protocol Review Committee Submission Forms:
Decision Making Tools
The U.S. Department of Health & Human Services (DHHS) provides “Human Subject Regulations Decision Charts” to help researchers determine the proper level of review needed for their proposal. The following table lists the 11 decision charts with a link directly to each one.
|Is your activity considered research?||Chart 1 Research|
|Exemptions to IRB Review|
|Is your human subjects research eligible for an exempt review by the IRB?||Chart 2, Exempt|
|If yes, what exemption category applies to your project?|
|Chart 3, Conducted in established or commonly accepted educational setting, including normal education practices|
|Chart 4, Only including interactions involving educational tests, surveys, procedures, interviews procedures, or observation of public behavior|
|Chart 5, Involving benign behavioral interventions and collection of information from adults with their agreement|
|Chart 6, Secondary research use of identifiable private information or identifiable biospecimens|
|Chart 7, Studying, evaluating, or examining public benefit or service programs|
|Chart 8, Involving taste and food quality evaluation of consumer acceptance studies|
|Chart 9, Storage or maintenance of identifiable private information or identifiable biospecimens for secondary research use|
|Chart 10, Secondary research for which broad consent is required|
|Is continuing review by the IRB required?||Chart 11, Continuing review required|
|Can informed consent be waived or altered in research involving public benefit and service program approved by State or Local Government||Chart 12, Waiver or alteration of informed consent in research involving public benefit and service programs conducted by or subject to the approval of state or local government officials|
|Can informed consent be waived or altered?||Chart 13, When can informed consent be waived or altered|
|Can documents of informed consent be waived?||Chart 14, Can documentation of informed consent be waived?|