Office of Research Compliance Review (ORCR)

About Us

The Office of Research Compliance Review (ORCR) provides objective analysis and evaluation of non-financial research activity compliance for investigator-led research studies, with emphasis on human subjects studies, units of U-M’s Human Research Protection Program (HRPP) and of the HRPP as a whole.

ORCR’s mission is to facilitate safe, ethical, efficient, and high quality research. We accomplish this mission through compliance reviews and additional HRPP initiatives.

ORCR is committed to assisting U-M investigators in their understanding and application of human subjects protections.

Please see our Policies and Procedures page for standard operating procedures pertaining to compliance reviews.

ORCR has developed a number of self-assessment tools for investigators to assist in assessing study conduct. Self-assessment tools are posted on our Self-Assessment Tools page.

Compliance Reviews

The majority of ORCR’s work consists of compliance reviews.  These reviews can be broadly divided into two categories:

  1. Routine review – a proactive not-for-cause review to identify risks of research activities, prevent noncompliance, and assist investigators in correcting any noncompliance. These reviews are generally conducted following IRB approval and after several subjects are enrolled.
  2. For Cause review – a directed review conducted when potential allegations of research noncompliance are received by UMOR. The allegations may arise from the Institutional Review Boards (IRBs) or other U-M compliance oversight committees, the research administration, research subjects, faculty, research support staff, funding or regulatory agencies, or ORCR staff.  In these cases, UMOR refers the review activity to ORCR.  A for-cause review can be at the investigator/study level, the system level, or both.

The majority of ORCR reviews are for individual human subjects studies, but unit or system level reviews may be conducted as well. An example of a system level review would be a review of a U-M IRB, an ancillary committee, or a research service unit.

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Minors in Research Policy Requirements

(SPG 601.34)

Effective 09/13/2021

Review the institutional requirements on the Children on Campus-Research webpage for study team members who interact with children participating in U-M human research studies, and for those who supervise study team members.

Questions?  Email ResearchwithMinors@umich.edu.

Study Start-Up Consultations

A study start-up consultation is to assess a study team’s preparedness to implement the IRB approved protocol, offer suggestions, and establish a forum for frequent communication between ORCR and study team members. ORCR will provide tools and resources to support the conduct of the study, identify practices for ensuring protocol adherence, discuss best practices related to the consenting process and documentation, and share tips and lessons learned from ORCR reviews. These reviews take about an hour and are usually conducted after a study receives initial IRB approval, but prior to enrolling participants.

Self-Assessment Tools for Investigators

Visit the Self-Asessment Tools web page (link) for resources to help you evaluate your approved human subjects study.

ClinicalTrials.Gov Monitoring

ORCR is responsible formonitoring compliance with ClinicalTrials.gov requirements for investigator-initiated studies conducted in U-M units outside of the U-M Medical School.  This includes:

  • Identifying and helping resolve issues with currently registered records
  • Assisting with registering new studies on ClinicalTrials.gov
  • Assisting with submitting results for applicable studies
  • Consulting with faculty and staff regarding ClinicalTrials.gov related questions

U-M Internal Links

Visit our Resources page for a list of helpful internal U-M web links.

For additional information see HRPP guidance:  Clinical Trials Registration and Results Reporting.

See our Resources and Web Links page for related information.

External Web Links

Visit our Resources page for web links to helpful federal websites.

FAQs

How do I reference ClinicalTrials.gov in Informed Consent Documents?

Required Informed Consent Language for Applicable Clinical Trials:

Applicable clinical trials must use the unaltered consent template language provided below in the informed consent document:

Required Informed Consent Language for NIH and other Sponsor Requirements for Registration and Reporting

NIH funded clinical trials that began on or after 1/18/2017 must refer to ClinicalTrials.gov in their informed consent document (unless they are conducted under a grant submitted prior to that date, with no competing renewals on or after 1/18/2017).   Use the below language:

U-M IRB Informed Consent templates contain the above language.  Refer to IRMED Informed Consent Template and IRB HSBS Informed Consent Template

Does the IRB need to review and approve the ClinicalTrials.gov registration?

IRB approval is required for the study, but the IRB does not review the registration record in ClinicalTrials.gov.  Once registration on ClinicalTrials.gov is complete, add the NCT # to the IRB application.

What are the penalties for failing to register a clinical trail?

Failure to register/update a trial/study or providing incomplete, false or misleading registration information may result in:

  • Monetary penalties
  • Withholding of federal research funds
  • Return of grant funds to the sponsor
  • Refusal of consideration by ICJME member (or other) journals
What are potential outcomes of a compliance review?

If non-compliance is identified during a routine review, the investigator may be asked to submit to the IRB specific changes to the protocol, informed consent, the eResearch application, or other study related materials.

If non-compliance is identified during a for cause review, the IRB of Record will craft a Corrective and Preventative Action Plan (CAPA) for the investigator which may include submission of a revised protocol, informed consent, or other materials.  ORCR will collaborate with the IRB to craft the CAPA plan and follow-up on required corrective actions.

For more detailed information, see ORCR SOP 101 (Not for Cause Routine Review) and ORCR SOP 102 (For Cause Review).

Can study team members request study start-up consultation?

Yes. ORCR will consider requests for study start-up consultations. Please contact us at orcr-deptemail@umich.edu.

Questions?

Kate Sasamoto, JD

ORCR Director

orcr-deptemail@umich.edu

734-615-4658