Skip to Main Content

Getting Started in Research

If you plan on conducting human subjects research at University of Michigan Health-West, you’ll need the following information to complete the Institutional Review Board (IRB) required research ethics training.

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 research@umhwest.org or by phone at 616.252.5020

Quality Assurance/Improvement Activities- A Guidance Document


FAQ’s

Remember that HIPAA is a vital aspect of any researcher.  Review the HIPAA & Research: Frequently Asked Questions for assistance.

HIPAA & Research: Frequently Asked Questions


Pre-Submission Tools & Templates

Here are tools to assist you the development of your project:

Case Reports – A Guidance Document

Quality Improvement A3

Protocol Template

Informed Consent Template


Protocol Review

You now have your project developed; the next step is to have it by UM Health-West’s Protocol Review Committee

Process for Resident QI, Research, and Case Reports

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:

Request for Review


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.

Research Activity
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
Continuing Review
Is continuing review by the IRB required?Chart 11, Continuing review required
Informed Consent
Can informed consent be waived or altered in research involving public benefit and service program approved by State or Local GovernmentChart 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?