FREQUENTLY ASKED QUESTIONS

 

What kind of research requires IRB review?
Some research activities are not regulated by the under OHRP or FDA regulations (e.g., case studies, analyses of publicly available datasets, research on organizations, quality assurance/improvement activities, standard public health surveillance, oral histories, journalism, etc.).  Importantly, these projects may still be subject to HIPAA regulations.  Please contact the IRB for assistance in determining whether your project requires review.

What is PEERRS and do I have to complete PEERRS training in order to conduct research?
The Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS) is a web-based instruction and certification program.  The UM Office of the Vice President for Research (OVPR) requires PEERRS certification for all PIs, Co-Is, faculty advisors, and study coordinators who conduct research with human subjects.  Certification is obtained by passing a short quiz that covers required modules.

Does the University of Michigan require a conflict of interest disclosure?
Yes, beginning August 29, 2011 all members of the study team, except administrative staff, will now be required to accept their role on eResearch IRB applications and answer a set of short, general COI (Conflict of Interest) questions.  Only those individuals who are identified as having a possible COI based on their responses to these questions will be contacted by the appropriate COI review committee to answer additional, more detailed questions.

How do I submit an application to the IRB?
Applications are managed through the eResearch system at: www.eresearch.umich.edu.  Tutorials and help features are available within eResearch to assist you.  Additionally, you are encouraged to practice in “The Sandbox” (a copy of eResearch designed to orient new users to the system).

Should my application be reviewed by IRBMED or IRB-HSBS?
If your primary appointment is with the Health System, Medical School, Dental School, or School of Nursing or your research involves the health system patients or facilities, IRBMED would have jurisdiction over your application.  IRB jurisdiction may also depend on the nature of the research and/or the expertise required to conduct a review.

What application type should I select?
Most studies will require a standard, non-exempt application.  Studies involving secondary analysis of identifiable data should select the secondary use application type.  Information is posted in the “help” section of eResearch under Section 1-1 to assist you in selecting the correct application type.

Does IRBMED require the use of standardized informed consent templates?
No, but sample templates that contain all necessary regulatory information are available for http://med.umich.edu/irbmed/ict.htm

Why do some studies require full board review?
According to federal regulations, studies that pose greater than minimal risk to subjects must be reviewed by the full board.  Sensitive or complex studies, as well as those involving vulnerable populations, might also require full board review.

When can I expect a decision about my IRB application?
Within 4-8 weeks for full board review, and 2-4 weeks for expedited review. Please alert the IRB if your application is time-sensitive.

How will I be notified when my IRB application is approved?
Approval letters are issued via eResearch.  You will receive an email notification with a link to your approved study in eResearch.

May I begin my research if the IRB approves it with contingencies?
No.  You may begin only after the IRB has determined that all contingencies have been resolved (as evidenced by an approval letter).

What kinds of changes require an amendment?
Any change to an approved, non-exempt study requires submission of an amendment application via eResearch.  Examples of such changes include, but are not limited to:

You are not required to submit an amendment regarding exempt studies unless the proposed change exceeds the scope of the exemption category or if ancillary review is indicated.

How do I submit an amendment to an approved study?
Go to your application within eResearch and click “New Amendment” under “Create New Submission.” Please do not delete existing information; simply add the new information.  It is helpful to offset new information with dated headers.  Track changes versions of revised documents are also appreciated.  The IRB will review the changes and notify you via eResearch when the amendment has been approved.

How long is my approval valid?
Most IRB approvals are valid for one year from the date of approval; however, exceptions may occur. Please see the IRB Exemption Guidelines and OVPR demonstration projects for further information.

How often must I renew my IRB approval?
You are not required to renew exempt studies.  For all other studies, federal regulations require the IRB to conduct a continuing review at least once per year (unless you have received a two-year approval through the demonstration project).

How do I apply for a Scheduled Continuing Review?
eResearch sends notifications prior to expiration of study approval (at 90, 60, and 30 day intervals). To submit a Scheduled Continuing Review (SCR), go to your application within eResearch and click “New Continuing Review” under “Create New Submission.” The IRB will review your application and notify you of the outcome via eResearch.

What happens if my approval expires before I submit the renewal?
If IRB approval expires, researchers must (a) discontinue all activities involving human subjects, including recruitment and enrollment, data collection or intervention, and data analysis, and (b) promptly submit a renewal, along with an Other Reportable Information or Occurrence (ORIO) report in eResearch to detail the cause of the lapse.  Investigators may resume research activities once continuing review and approval has occurred.

Lapses of IRB approval on a single study, or a pattern of lapses across multiple studies raise serious concerns.  Non-compliance with federal or institutional requirements to maintain continuous IRB approval for human subjects research may require corrective action including: review by the full IRB, additional education of the PI and study team, study monitoring, suspension of IRB approval status, and/or referral to higher institutional authorities or federal agencies. Suspension or termination of IRB approval is reportable to OVPR (Office of the Vice President for Research), DRDA (Division of Research and Administration) and may be reported to external regulatory agencies under federal regulations.

What is an ORIO? When should I submit an ORIO report?
An ORIO is a way to tell the IRB about information or occurrences, other than adverse events, related to the conduct of your research. Please visit the following website for more information: http://med.umich.edu/irbmed/ae_orio/orio_guidance.html

Do I need to tell the IRB when I am finished with my research?
Yes. You should submit a termination report via eResearch (i.e., create a new continuing review report (SCR) and select “Termination Report”).  If you wish to engage human subjects in research after a study is terminated, a new eResearch application must be submitted.

 

Page created 9/25/2012