Guidance For Investigators

Assistance for Researchers:

HRPP staff holds office hours to help Researchers including graduate students and residents, who are preparing Institutional Review Board (IRB) submissions and exemption requests. Sessions are intended to help researchers, students and their advisors navigate eProtocol (electronic IRB submission system) and learn about policies and review procedures.

Date:   Mon, Wed, Fri
Time:   1:30pm - 4:30pm
Location:   HRPP Office

No appointment is necessary. Please contact Markeda Richards at (248) 484-4950 or (248) 484-4952 or via email at Markeda.Richards@mclaren.org for questions or more information.

Are you Conducting Research?

are you conducting research?

All non-exempt human subject research carried out at McLaren Health Care and its subsidiary hospitals or under its auspices must be reviewed and approved by the MHC IRB prior to the start of research. Our booklet, “Are you conducting research?” is a quick guide on getting started with your research here at McLaren.

Review Type: What is it and why do I need to know? 

NEW: If you are conducting a prospective investigator-initiated study, please contact McLaren's Center for Research and Innovation at (248) 484-4960 to help you get started with protocol writing and statistical considerations.

Before starting an eProtocol application, investigators must identify the appropriate Review Type. This determines which questions are prompted for on the application.  There are three types of review:  Exempt, Expedited, and Full Board. 

Exempt review

Studies meeting specific criteria. These studies are exempted from IRB continuing review - not from initial review. The IRB determines whether the claim for exemption is appropriate and whether it will be granted. Exemption from IRB continuing review continues unless the protocol is to be modified such that it no longer will meet the criteria for exemption.

NOTE: You can also check out our HRPP policy "Exempt Review of Human Subject Research".

Expedited review

Minimal risk studies meeting specific criteria. Protocols are generally reviewed by one primary IRB reviewer. Protocols approved under Expedited review are subject to IRB continuing review.

NOTE: You can also check out our HRPP policy "Expedited Review of Human Subject Research".

Full Board review

Studies that involve more than minimal risk or do not meet the criteria for Exempt or Expedited. They are reviewed at a convened IRB meeting. Examples of protocols requiring initial regular review are studies using FDA investigational test articles, randomized double-blind placebo-controlled studies, Phase I, II, III and IV clinical trials, and studies using x-rays.

NOTE: You can also check out our HRPP policy "Full Board Review of Human Subject Research".

Confirmation of Scholarly Review for Validity Determination of Non-Human Subject ResearchExample for Waiver of Documentation of Informed ConsentExample for Waiver of Informed Consent RequirementsExternal IRB Request for Modification FormGood Clinical PracticeGuidance on What is Required to be Submitted to the IRBIND WorksheetInvestigator Handbook **REVISED 4/14/16IRB Emergency Use of Test ArticleIRB Guidance on Case Reports/Case SeriesLay Language GlossaryMHC_RP0125 Investigator ResponsibilityModification Request Form When Using an External IRB as an IRB of Record - KarmanosRequest to Use an External IRB as an IRB of RecordRequest to Use an External IRB as an IRB of Record - KarmanosTranslation Requirements – Guidance DocumentWaiver or Alteration of HIPAA Authorization Form—For Use with Request to Use an External IRB