McLaren Health Care
Research Guidance Documents

Guidance Documents

The documents on this page are intended to provide you with general guidance in the conduct of research and/or the IRB submission process:

Common Rule

Click here to find up to date information regarding the proposed Common Rule changes

Guidance on QI/QI vs. Research

What is expected of the investigator?


General information regarding the general responsibilities of the Principal Investigator

Investigator Handbook (Pre-2018 Common Rule before 1/21/19)

MHC Investigator Responsibility Policy

GCP Guidelines

What needs to be submitted to the IRB?


These two documents will help in determining those projects that need to be submitted to the IRB and those that do not require IRB approval

IRB Guidance on Case Reports / Case Series

Does my Project Require an IND?


Complete this worksheet to help determine if the FDA will require an Investigational New Drug application for your project.

IND Worksheet

Informed Consent Waiver Examples


Sometimes it is appropriate to request that Informed Consent or the need to document Informed Consent be waived by the IRB. The two documents below provide examples scenarios of each of these types of waivers

Example for Waiver of Informed Consent 1 (2018 Common Rule)

Example Waiver of Informed Consent

Example for Waiver of Documentation of Informed Consent 1 (2018 Common Rule)

Example Waiver of Documentation of Informed Consent

Translating Research Documents for Subjects


This document provide information on translating research documents to for subjects as well as translating medical terms into lay terms.

Translation Requirements - Guidance (2018 Common Rule)

Translation Requirements Guidance

Lay Language Glossary for Medical Terminology

Subject Advertisements


Basic guidelines for research advertisements to be seen by subjects

Subject Advertisement Guidelines

General IRB Information


Information on the composition of the IRB, meeting dates, and submission fees

IRB Fees

IRB Meeting Dates

IRB Roster