Institutional Review Board

Frequently Asked Questions

How long will it take for my project to be reviewed?
It depends on the type of review that is required. See Submission Types & Timelines.

What is the federal definition of research?

Federal regulation 45 CFR §46.102 defines research as:

“A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

Virtually all federally funded research with human subjects is governed by this definition. In addition, all human subjects research conducted under a Federwide Assurance (which USM has) is also governed by this definition.

What is the definition of a Human Subject for purposes of research?

45 CFR §46.102 defines a human subject as:

“A living individual(s) about whom an investigator (whether professional or student) conducting research obtains:

1. data through intervention or interaction with the individual, or
2. identifiable private information.”

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject.

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Note: For research involving health or medical information (and/or the electronic transmission of this type of information) the definition of “private information” is not the same as the definition of “protected health information” (PHI) as defined under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Who must take the NIH Training Module on Human Subject Protection?

All researchers and key personnel must take the NIH training module on the protection of human subjects as a condition of IRB approval or exemption of research. This includes students, faculty, research staff, and anyone who will have contact with identifiable private information on human subjects involved in the research project.

How long will the NIH training module take?

The NIH training module takes approximately 1.5 hours to complete. When you sign on you will create a password (please write down the password) that will allow you to revisit the site and complete the training in small increments and may be used as a general refresher for the concepts covered in the training session.

Do Oral History Research Projects need to be reviewed by the IRB?

It depends.

If the archived data will be made publicly available then the research must be prospectively reviewed and approved by the USM IRB before the research project begins. The IRB requires that the researcher make provisions for obtaining informed consent from all participants and document the process. Participants in oral history projects should be allowed to review the material prior to public archive and decide if they do not wish any or all of the oral history archived.

How often does the IRB meet?

The IRB meets at least once per month. IRB meeting times are posted on the IRB web page.

Are IRB meetings open to the public?

No. The IRB meetings are confidential and frank discussions about the risks and benefits that may be involved in research at USM. The IRB is comprised of members with diverse backgrounds, interests, and expertise that are reflective of the research work performed at USM.

How do I know if my project needs IRB review?

1. Does your project involve human subjects?

As an investigator, will you interact or intervene with a human subject or any identifiable private information on individuals? If yes, see #2 below, if no, then no IRB review is required.

2. Is your project "research" as defined under the Common Rule (45 CFR 46)?

Is your project a systematic investigation designed to contribute to "generalizable" knowledge?

This means the data will be made publicly available either through presentation or publication of some sort (e.g., Web sites, tapes, archives, forum, publications, etc.)? If the answer is yes, then your study involves "human subject research". The project must be reviewed by the IRB or exempted from IRB review by the administration prior to human subject interaction or intervention.

If I know my project is exempt, may I begin interacting or intervening with human subjects?

NO. ONLY THE ADMINSTRATION OR THE IRB MAY EXEMPT A STUDY FROM IRB REVIEW IN STRICT ADHERENCE TO THE COMMON RULE 45 CFR 46. Forms to request an exemption from IRB review are available on this web site at http://www.usm.maine.edu/irb/form_exemption.htm. As soon as you receive a written notification of Exemption from IRB review, you may begin your research.