FREQUENTLY ASKED QUESTIONS AND ANSWERS ABOUT OHRCR AND ROUTINE RESEARCH EDUCATION AND REGULATORY REVIEWS [RRERR]

What is OHRCR?

OHRCR is the acronym for the Office of Human Research Compliance Review, which is part of the Office of the Vice-President for Research.  The office is situated on the 11th floor of the 300 North Ingalls Building.  The web site for the office can be accessed at www.research.med.umich.edu/orcr/index.html.

What is the mission of the office?

The mission of UM OHRCR is to facilitate safe, ethical, efficient and high quality human subjects research.

We will accomplish this mission through the following activities relevant to human research regulatory issues:

• Compliance Reviews of research studies and committees
  
  
• Education of individuals and groups engaged in the research enterprise
  
  
• Outreach to the university research community
  
  
• Leadership and knowledge generation

What are the purposes of the Routine Research Education and Regulatory Reviews [RRERR]?

The purposes of RRERRs is stated in the OHRCR Standard Operating Procedures [SOPs] that can be accessed via the SOP icon on this website. These purposes are:

• Contribute to the dynamic research culture at the University of

          Michigan in a way that demonstrates continuing value for the safety,
          rights and welfare of study participants and feedback to the  
          investigators and the organization regarding the current
          implementation of such protections.

• Assist investigators and their staff in: a) identifying areas within their research that are or could become non-compliant with regulatory standards; b) understanding the principles of study participant  protections, and c) methods to meet study participant  protections best practices. This assistance will prevent situations that might place additional risks on study participants.

• Identify standards of excellence and potential areas for improvement in order to enhance the quality of human subjects participant research protections at the University of Michigan.

• Verify that human participant research is being conducted in a compliant fashion.

RRERRs differ from ‘for cause’ reviews in that the review is NOT initiated by any complaint or allegation of problems with the research study by any party.

How does OHRCR differ from my IRB of record?

The Institutional Review Board [IRB] is the body that reviews and approves all regulated human research studies at UM according to regulations established by the Office of Human Research Protections [OHRP], The Food and Drug Administration [FDA] and other federal and state bodies. The role of the IRBs is well described in the UM HRPP Operations Manual Part 2C, page 7 of 15, at http://www.research.umich.edu/hrpp/om/Part2.pdf.  The IRB has the authority to suspend or terminate your study for several reasons including if you are not adhering to your approved protocol.

OHRCR does not approve  the conduct of research of any type. Rather OHRCR functions independently from the IRBs and acts in an oversight role to ensure adherence to regulations and excellence in human subject protection by both individual investigators and the IRBs.  OHRCR cannot overrule a decision made by an IRB in regard to any individual protocol or IRB policy. 

How was I selected for this review?

Each year OHRCR determines a sampling plan for the RRERR system. The intent of the sampling plan is to be as fair and transparent to investigators while ensuring widespread protection of human research subjects of research and adherence to regulations. Thus the sampling plan is based on multiple factors including level of IRB-determined study risk and input from the OHRCR Advisory Committee and the IRBs and senior HRPP officials.  The parameters for the 2007-2008 sample can be found on this web site under RRERR Sampling Plan.

How will the schedule for my review be negotiated with me?

The letter of notice that your study has been selected for review includes details of how to contact us, and the time frame in which we need to have a response from you. Once you have contacted us we can discuss the details of your study and any concerns you have around scheduling.  While we prefer to schedule reviews within two weeks of your being notified of selection, we are sensitive to investigator’s circumstances and will work with you to find a mutually agreeable date and time for both the initial interview and your site visit.   It is preferable to OHRCR that your review start date is not later than one month following your notification of selection.
 

Can I meet with my OHRCR reviewer before the data of my onsite visit?

 You can ask to meet with the OHRCR reviewer prior to the 
 onsite review visit, for the purposes of, for example, asking questions
 about the review or explaining aspects of your study protocol that may be
 complex and impact your onsite visit. 

What can I do to prepare for the review?

Communicate with your OHRCR reviewer in advance so the review is least disruptive to your research.
Assume the site visit may take an entire working day given what OHRCR may need to review
Prepare your team: decide who will liaise with OHRCR staff and be present during the site visit. If you are not going to be present ensure you are readily contactable if necessary.
Prepare a workable desk space for the site visit.
Have your IRB-approved protocol and continuing renewal information at hand.
Have information of any reported AEs and ORIOs at hand.
Have PEERRS certificates on hand.
Plan time in your schedule to attend the closeout meeting at the end of the onsite visit.

How long will the overall review process take?

There is no definite answer to this question. Individuals may have highly variable review lengths, lasting from 36 days to approx. 6 months.  The length of your review will depend on what occurs during the review process and how regulatory findings, if any, of the review need to be handled. During the review OHRCR will communicate with your IRB of record to ensure a seamless review process in the event you need to submit a remediation plan and complete the required changes. If there are no regulatory findings from your review and no required changes [e.g. reporting, amendments] to your IRB-approved protocol needed, your review period will be shorter.  You will have a good idea from the exit interview at the completion of your onsite visit about the information that will be contained in the OHRCR draft report.  The review is officially complete when you receive a close-out letter from OHRCR. 

This table contains a detailed time frame for the conduct of reviews, and can be found at http://www.research.umich.edu/orcr/sops.doc. The day of the site visit is deemed Day 1 of your review.  The timing of your site visit depends on your negotiations with OHRCR following receipt of your notice of selection for review [see  ‘How will the schedule for my review be negotiated with me?’ (above)].

Not-for-Cause Review Schedule for Post-review Completion Activities

Review Activity	**Occurs   Within	Review Day
Onsite Review complete	1	1
Investigator receives Draft Report of Observations to confirm facts	7 days	8
Investigator returns Draft report to OHRCR	7 days	15
Investigator, IRB of record and Research Associate Dean receive final Report  of Observations	10 days	25
Investigator submits Corrective Plan to OHRCR	14 days	39
Investigator, IRB of record and Research Associate Dean receive OHRCR response to Corrective Plan	10 days	49
OHRCR does follow-up to confirm implementation of Corrective Plan	variable max of 6 months
OHRCR submits Close-out Letter to Investigator, IRB, and Associate Dean for Research***	variable

 

 

 

 

 

 

 

 

The OHRCR reviewer/s will arrive at the arranged time and speak briefly with you and research staff, if any, that you elect to have present. We will ask you for various types of documentation relevant to the protocol we are reviewing. We will then spend considerable time over the course of the day reviewing research records. From time to time we may need to ask you or a member of you research team a question to clarify information or ask to see additional documentation.  When we complete our work we will spend time with you to give you what feedback we are able at that point.

What can I expect will happen during the site visit?

The OHRCR reviewer will spend some time getting acquainted with you and you study team members [e.g. roles on study], where relevant. If an interview related to specific aspects of the protocol [e.g. the informed consent process] is needed it will occur early in the day.  For most of the day the reviewer will work intensively with the materials under review and from time to time may seek your help, or that of your designated study team member, to clarify aspects of material under review. At the end of the onsite visit the reviewer will provide you with a verbal overview of the observations that you can expect to see in the written Draft of Observations.

What research records and processes will be reviewed?

Various methods of review may be used. Methods may vary by type of research and by disciplinary use of methods.  They may inlude interview, observation [of, for example, privacy and confidentiality measures review of research records, and review of clinical records or clinical charts for studies that use clinical records.

OHRCR may complete a systematic, thorough review of all phases of a research study, or may complete a focused review of some or the phases of the study. For example, a simple focused review might involve a review of the informed consent process whereas a high risk study might involve a systematic, thorough review of all types of study processes and documentation.

The review foci for this year are available on this website under ‘Focus of RRERR for 2007-2008’.

Will you want to contact my study participants?

It is unlikely that we will want to contact any of your study participants because the aims of the reviews in 2007-2008 can be achieved without doing so. If, during the course of a review, OHRCR considered it necessary to make contact with study subjects, this would be discussed fully with you prior to any contact being made. 

How will I be notified of the outcome of my review?

You will receive a formal draft report of observations by email seven [7] working days after your onsite visit, followed by a hard copy letter via campus mail.  The timetable of what occurs after that is detailed in the table of review activities under the question ‘How long will the overall review process take?’ [above].

What can I do if I do not agree with the observations made by OHRCR?

Throughout the review process and the implementation and evaluation of corrective actions, OHRCR will make every effort to address investigator concerns in an appropriate and timely fashion. However, the investigator may appeal interpretations made by OHRCR directly to the Institutional Official (the VP for Research or his or her designee the deputy institutional official). The Institutional Official may convene an ad hoc panel to address the investigator’s concern(s).

Who will know my study has been reviewed?

The list of research studies selected for review is confidential and details of individual investigators will not be disclosed by OHRCR to anyone but the IRB of record for the study and the Research Associate Dean of your school or department. In any OHRCR RRERR activities reports only aggregate data will be presented.
 Your IRB of record needs to know the study is under review to ensure that OHRCR obtains the correct information about your study protocol and approvals and, if a corrective plan is necessary, that the process is seamless between you, OHRCR and the IRB.   The Associate Dean for Research needs to be appraised of research reviews occurring within his/her domain of responsibility. 
The Associate Dean for Research may elect to forward the report to your chairperson if corrective actions require departmental support or if a faculty status issue is at stake. Similarly, the associate dean may elect to notify the dean of your school or college when faculty status, funding, or noncompliance issues may affect the school or college.

What will happen if, during the course of a study review, OHRCR finds evidence of serious and/or continuing non-compliance?

For an overview of what constitutes ‘serious and/or continuing noncompliance’ and full details of outcomes relating to this, refer to the OHRCR Standard Operating Procedures [SOPs] on this website, Section 305, parts 1-4. If during the course of a study review, we observe noncompliance that is thought to be serious or continuing noncompliance, the following will occur:

• we will immediately notify you, as PI and/or discuss the findings with you.
• after notifying you, we will promptly notify the IRB chair, and the OHRCR director, regarding the reviewer’s observations.

At any time during a review in which observations that could be serious or
continuing noncompliance have been observed, OHRCR may contact
OVPR.

If no regulatory issues are found with my study will I receive any recognition for having done a good job in protecting human subjects?

 You will receive a closeout letter from OHRCR congratulating you. Your Associate Dean for Research and your IRB will also be aware of your efforts.  No other recognition is planned but if you feel this is important please let OHRCR know and feel free to make suggestions about what might be meaningful.