University of Michigan - Flint

This slide presentation 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.

1. What kind of research studies require IRB approval?
   Any research studies utilizing human subjects require IRB Approval. The definition of 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 the individual.
2. How do I apply for IRB approval?
   You may apply using the eResearch online application system.
3. When can I expect a decision about my IRB application?
   The length of IRB review depends on the nature 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. During the eResearch transition, it may take longer to process and review applications and their accompanying supporting documents. Please contact the IRB Office if your application is time-sensitive.
4. How will I be notified when my IRB application is approved?
   The IRB Office will issue an approval notification by email when the decision is made.
5. How long is my approval good for?
   Most IRB approvals expire one year from the date of approval (exceptions may occur). However, some research may be considered EXEMPT from continuing IRB review and will not be required to submit a scheduled continuation review (renewal) application on an annual basis. See the IRB Exemption Guidelines for additional information.

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: Research conducted in the classroom involving only students enrolled in the course and carried out only for instructional purposes may be undertaken with the understanding that the instructor assumes responsibility for its ethical nature and for the protection of the rights and welfare of students involved. If an instructor has questions concerning these issues, this committee is available for consultation.

c.  Research conducted in the classroom using any students besides those enrolled in the course, and course-associated research conducted outside the classroom, come under the purview of this committee.

d.  Research initiated or sponsored by UM-Flint faculty/staff/students, that is neither funded by nor 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.

1. I've heard there is a new 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. In order for this information to be embedded in your informed consent, merge fields must be present in your informed consent documents.
   • Informed Consent: Use this template (link to DOC) to draft your informed consent documents. The template contains the required fields in the header of the document. You can copy and paste any current drafts into this template.
   • Advertisements: This template is currently under development. Contact the IRB Office for instructions.
2. 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 application.
3. 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.

To create a document with merge fields: 

1. Open eResearch
2. Login (using your Kerberos password)
3. Go to section 10-1.1 of the application
4. The third item listed (or second hyper link) is: Informed consent documents must contain merge fields. Place you cursor on the “merge fields” and click.
5. This opens a page with Templates – go to IRB-Flint and place your cursor on “link to DOC” and click – then click “open”
6. A blank page (with a header) should appear. Use this page to copy and paste your informed consent form, recruitment forms and any document that you wish to have finalized with information about your approval such as study number, date op approval, etc.
7. Save this to your desktop.
8. To upload your documents, go back to the application, and go to Sec. 10-1.1. Follow the directions just below the ‘merge fields’ tab and located under: Important information about naming, editing, uploading, and downloading documents.

For further assistance, please call the IRB office (810-762-3383) or email Sally Conley.

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.

This includes:

• Alteration of study design, methodology, or recruitment methods
• 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. 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.

1. How often must I renew my IRB approval?
   Federal regulations require that the Institutional Review Board conduct a continuing review of human subject research at least once per year. The continuation of subject recruitment, data collection, or data analysis without IRB approval is prohibited after the expiration date assigned to the project by the IRB. 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.
2. 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.
3. 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 a termination application.
4. 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 Continuning Review (SCR) application 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 a termination application.

1. 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.
2. 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 a termination application.
3. 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 a termination application.

How do I report an adverse event?

See: Adverse Event Reporting

For additional information and to submit your Adverse Event Report, use the eResearch system.