Frequently Asked Questions about the IRB Application
- Is it Human Subjects Research? If yes, what then?
- Applying for IRB Approval
- Who is subject to the purview of the IRB Review Committee?
- Consent Forms, Advertisements, Survey Instruments and Other Supporting Documents
- Amendments to IRB Approved Research Studies
- Scheduled Continuing Review/Renewal of IRB Approval
- Termination of IRB Approval
- Adverse Events (AE) and Other Reportable Information and Occurrences (ORIO)
- Unanticipated Problems
- Risk Level Grid
- Who serves on the IRB?
Is it Human Subjects Research? If yes, what then?
The IRB Operations Manual: http://www.hrpp.umich.edu/om/ offers the researcher essential background information on federal definitions of research and the activities mandated by federal regulation regarding the protection of the human subjects of research.
Applying for IRB Approval
- What kind of research studies require registration with the IRB?
Any research study utilizing human subjects must create an IRB application in the eResearch system. A decision tree assists in deciding if the study qualifies under an exemption category and is eligible for a self-determination of exemption. Studies that do not meet these criteria require IRB review and approval.
- Definitions: A human subject is a living individual about whom an investigator conducting research obtains data and/or identifiable private information through intervention or interaction with an individual. Research is "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."
- How do I apply for IRB approval?
Using the eResearch online application system: www.eresearch.umich.edu
- When can I expect a decision about my IRB application?
Please allow enough time for a thorough IRB review of your project. The length of IRB review depends on the nature and complexity of the study. The IRB will generally issue a decision about an application within 4-6 weeks of receiving the application and all required supporting documents. If an application qualifies for expedited review, this may be shortened to 2-4 weeks. Please contact the IRB Office as soon as possible if your application is time-sensitive. The full board only meets once per month, please see the Full Board Schedule and Submission Deadlines for details.
- How will I be notified when my IRB application is approved?
The notification will be made by email through the eResearch system. Please check your profile in eResearch to make sure your email address is correct.
- How long is my approval good for?
Review the approval period listed on the IRB approval letter.
Who is subject to the purview of the IRB Review Committee?
All research that is conducted by or under the direction of any employee or agent of UM-Flint (faculty, staff, or student) or in connection with his or her institutional responsibilities is under the purview of this committee. This includes all research, regardless of source of funding or the location of the participating human subjects.
a. Faculty, staff, and student initiated research is under the purview of this committee. This includes, but is not limited to, data gathering projects and class assignments involving human subjects.
b. Sole exception: Classroom Activities: Please see guidelines at: http://www.hrpp.umich.edu/initiative/classactivities.html
c. Research initiated or sponsored by UM-Flint faculty/staff/students, that is either funded by or based at UM-Flint, should be submitted to the UM-Flint Human Subjects Committee for approval. This assurance is required even if the research has received approval from a human subjects committee at another institution.
Consent Forms, Advertisements, Survey Instruments and Other Supporting Documents
- I've heard there is a requirement for stamping consent forms and advertisements with approval dates and IRB Numbers. How do I do this?
When your study is approved by the IRB, an activity called Finalize Documents embeds information about the IRB, the approval date, and the version of the study's informed consent documentation.
- Informed Consent: Use the templates to draft your informed consent documents. You can copy and paste any current drafts into a template.
- Advertisements: Guidelines are posted in the sample templates section of this website.
- Is it necessary to have a consent form for a survey?
Yes. Full written informed consent is required unless the IRB approves a waiver of consent or a waiver of documentation. If you desire a waiver, complete the necessary section of the eResearch application.
- What if I only have a draft of my instrument (e.g., survey, questionnaire)?
Indicate this when prompted in the application, and upload your instrument as a "DRAFT" document in order to provide the IRB with an idea of your intended methodology. After you have finalized the instrument, submit an amendment application and upload your final instruments.
Amendments to IRB Approved Research Studies
1. What kinds of changes to my research study necessitate the submission of an amendment application?
ANY change(s) to an approved research study require submission of an amendment application.
- Alteration of study design, methodology, or recruitment methods
- Modification of the number of subjects
- Changes to any instruments, including surveys and questionnaires
- Changes to consent documents
- Addition/Deletion of principal investigators or key personnel
- Alteration of Project Title
- Addition/Deletion of research performance sites
2. How do I report a change to an IRB approved research study?
Use the eResearch online application system to submit an amendment to the application. For specifics see the tutorial on creating an amendment. Remember you must modify the consent form if the proposed changes affect the informed consent process. The IRB will review the changes and you will be notified by email. IMPORTANT: You must wait to receive IRB approval before implementing any proposed amendments.
Scheduled Continuing Review/Renewal of IRB Approval
- How often must I renew my IRB approval?
Please check your IRB approval letter for expiration date of approval. If appropriate you will be notified by the IRB when your approval is about to expire and it is time to complete your Scheduled Continuing Review (SCR) in the eResearch system.
- How do I apply for a Scheduled Continuing Review of my approval?
Use the eResearch online application system to submit a Scheduled Continuing Review (SCR) application. The IRB will review your application and you will be notified by email.
- I received an expiration notice from the IRB Office, but I don't intend to seek an extension of my approval (funding expired, data collection and analysis is complete, etc.). What should I do?
Use the eResearch online application system to submit an SCR and indicate "termination".
- Do I need to complete a Scheduled Continuing Review (SCR) of my IRB approval if my funding has ended?
If you are still collecting and/or analyzing data, you must submit a Scheduled Continuing Review (SCR) application, if prompted, using the eResearch online application system. If the funding has ended, data analysis is complete, and the only activity is preparing submissions for publication, you do not need to complete an SCR. In this case, use the eResearch online application system to submit an SCR termination application.
Termination of IRB Approval
- Can I continue to work on my research study if I have received a Final Termination Notice indicating that my approval has expired?
No. After the approval period for your study has expired, you may no longer continue to work on the study, including collection and analysis of data. The IRB Office issues 3 expiration notices to the PI before automatically terminating the IRB approval of a research study. If you have received a final termination notice, and you plan to continue working on your study, contact the IRB Office to discuss your situation.
- I want to terminate my IRB Approval (funding was lost, my study never received funding, data collection and analysis is complete, etc.)?
Use the eResearch online application system to submit an SCR termination application.
- I received an expiration notice from the IRB Office indicating my approval will soon expire. What should I do if I don't intend to renew my approval?
Use the eResearch online application system to submit an SCR termination application.
Adverse Events (AE) and Other Reportable Information and Occurrences (ORIO)
How do I report an adverse event or ORIO?
For instructions on how to report an Adverse event, click here.
What is an Adverse Event? An Adverse Event is when something occurs that is harmful to the research subjects. AEs must be reported immediately to the Flint IRB. 810-762-3384.
What is an Unanticipated Problem? Investigators should understand the nature and significance of unanticipated problems. Although all unanticipated problems are either AEs or ORIOs, not all AEs and ORIOs are unanticipated problems. An unanticipated problem is an occurrence or a data point that has all of the following characteristics:
It is "unexpected" in terms of nature, severity or frequency given procedures described in the study documents and characteristics of the subject population being studied. It is "related" to the research; meaning there is a reasonable possibility that the event may have been caused by the procedures involved in the research. It suggests that the research places subjects or others at greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
What is an ORIO? An ORIO is when something happens that is not an immediate threat to subject safety, such as a minor protocol deviation, facility/data accidents, an audit by a funding agency, a short lapse in IRB approval, and complaints.
Who serves on the IRB?
The IRB is composed of members from different backgrounds to ensure a range of expertise and perspectives. The current members include faculty and staff members from UM-Flint, and a community member who is a physician from the Flint area.
The IRB is not a governing faculty standing committee. Members of the IRB are appointed by the UM-Flint Regulatory Management Institutional Official. Terms are three years long and members typically serve multiple terms. When there is an opening on the board, the IRB Chair recommends new members to the Senior Vice Provost for Academic Affairs.
If you are interested in serving on the IRB or would like more information, please contact the IRB Chair.