Investigator Guidelines

All investigators should read the UMM Policy and Procedures for Human Subjects Research, Section II (Investigator Responsibilities) prior to conducting research involving human subjects. Guidelines for IRB application and review are described below.

How to submit an application? What is the timeline for IRB review? How to report unanticipated problems or adverse events? What to do if research extends beyond the IRB expiration date? What are the guidelines for informed consent?

How to submit an application?

To submit an application for IRB review, follow the steps below:

  1. Complete the appropriate application form electronically. a. New Study Application Form b. Protocol Amendment Form c. Continuing Study Application Form
  2. Prepare all relevant materials related to your research protocol in electronic format, including the following:
    1. Informed Consent Form
    2. Questionnaires or survey instruments, interview or focus group guides, or tests
    3. Introductory letter, email, or phone script (introducing the study to potential subjects)
    4. Certificate of completion of CITI online training by investigators
    5. Grant proposal, if applicable
  3. Send the application form and all relevant materials electronically as email attachments to the IRB Chair, Dr. Kevin Athearn, at kathearn@maine.edu.
  4. If you do not receive a reply acknowledging receipt of application within 48 hours or if you have questions about submitting an IRB application, please contact the IRB Chair, Dr. Kevin Athearn (255-1216 or kathearn@maine.edu)

What is the timeline for IRB review?

You can expect the IRB Chair to acknowledge receipt within 2 working days and determine the appropriate review category within 5 working days of receiving the complete application. (Responses may take longer during UMM vacation periods). The IRB Chair’s determination shall place the research protocol into one of the following categories:

  1. Not research;
  2. Exempt from further IRB oversight;
  3. Expedited review;
  4. Full board review by the UMM IRB;
  5. Requires review by a designated, external IRB

The UMM IRB Chair may request additional information before a determination can be made.

If full board review by the UMM IRB is required, the Chair will indicate the date of the meeting at which the IRB will review the application. Typically, full board review will not take place sooner than 10 working days (two weeks) after the complete application is received by the IRB Chair. If an application is submitted less than two weeks prior to a scheduled IRB meeting, it might not be reviewed until the following meeting.

If expedited review is allowed by the IRB Chair, you can expect an IRB response within 15 working days (three weeks) of the date the complete application is received by the IRB Chair.

The UMM IRB is not obligated to convene or review research protocols during the summer (June, July, and August). Please plan accordingly.

How to report unanticipated problems or adverse events?

Investigators must report promptly any unanticipated problems or adverse events to the IRB. The Adverse Event Report Form should be completed electronically and sent as an email attachment to the IRB Chair, Dr. Kevin Athearn, at kathearn@maine.edu.

Please read the OHRP’s Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events http://www.hhs.gov/ohrp/ policy/advevntguid.html

The IRB may require modification of the research protocol or suspension or termination of approval based on review of the adverse event or unanticipated problem.

What are the guidelines for informed consent?

Informed consent must be sought from each prospective subject and documented appropriately as outlined in 45 CFR 46.116 and 46 CFR 46.117. As part of the informed consent procedure, the following information should be provided to prospective subjects:

  1. title of study
  2. purpose of study, including indication that the study involves research
  3. names of principal investigators or research team
  4. study sponsors &/or funding sources
  5. a description of study procedures involving the subject; what the subject will be asked to do (including time required; expected duration of subjects’ participation)
  6. a description of any foreseeable risks or discomforts to the subject
  7. a description of any benefits to the subject or to others which may reasonably be expected from the research
  8. a statement regarding anonymity, confidentiality, or disclosure to others; procedures used to protect confidentiality of records and limit disclosure of personally identifiable information
  9. a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
  10. contact information for questions about the study
  11. contact information for questions about the subjects’ rights as a research participant

In addition, it may be appropriate to include the following information:

  1. How prospective subjects were selected and the approximate number of subjects involved in the study
  2. Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent
  3. any additional costs to the subject that may result from participation in the research

Informed consent language should be easily understandable to subjects, plain, clear and brief, while still covering essential elements.  No exculpatory language may be included.  Typically, a signed consent form is required for each subject.  If the requirement for a signed consent form is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.  Investigators may use the UMM Informed Consent Form Template or the USM Informed Consent Form Template.

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