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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.
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.
The majority of ORCR’s work consists of compliance reviews. These reviews can be broadly divided into two categories:
- 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.
- 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.
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.
ORCR is responsible for–monitoring 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
For additional information see HRPP guidance: Clinical Trials Registration and Results Reporting.
See our Resources and Web Links page for related information.
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:
"A description of this clinical trial will be available on http://www.clinicaltrials.gov/(link is external), as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."
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:
- “This trial will be registered and may report results on www.ClinicalTrials.gov(link is external), a publicly available registry of clinical trials.”
U-M IRB Informed Consent templates contain the above language. Refer to IRMED Informed Consent Template and IRB HSBS Informed Consent Template
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.
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
The Principal Investigator (PI) should plan on an initial 60-minute interview with an ORCR reviewer. This discussion will focus on areas of potential study risk. Interview questions may include but are not limited to: roles and responsibilities, recruitment, consenting process, study procedures, record keeping, data management, monitoring, and oversight. The scope of the review may vary and is tailored to the scope, nature, and complexity of the study. Following the initial discussion, the ORCR reviewer will review study records with the study coordinator.
Following the review, the investigator will have an opportunity to review a draft report to verify facts contained in the report. The IRB of record will also have an opportunity to review a draft of the report. The final ORCR report will be sent to the investigator, the IRB of Record, the Research Associate Dean, and Associate Chair for Research or Department Chair.
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.
Yes. ORCR will consider requests for study start-up consultations. Please contact us at email@example.com.