For Human Research Protection Program (HRPP) and Institutional Review Board (IRB)

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Human subject means a living individual 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.

Systematic means having or involving a system, method, or plan.

Investigation means a searching inquiry for ascertaining facts or a detailed or careful examination.

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.

Designed means done with purpose or intent.

Develop means to elaborate or expand in detail.

Contribute means to be an important factor in.

Generalizable means relevant beyond the population or program from which it was collected.

Knowledge means truth, facts, or information.

Key Research Personnel are persons who have direct contact with subjects, contribute to the research in a substantive way, have contact with subjects’ identifiable data or biological samples (e.g., tissue, blood, urine, plasma, saliva), or use subjects’ personal information.

Research staff are considered to be persons who 1) obtain data about living individuals for research purposes through intervention or interaction with them; 2) obtain individually identifiable private information for research purposes; and/or 3) obtain informed consent of human research participants.

Engaged in research: In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.

Categories of Sensitive Information

  • Information relating to sexual attitudes, preferences, or practices.
  • Information relating to the use of alcohol, drugs, or other addictive products.
  • Information pertaining to illegal conduct.
  • Information that, if released, could reasonably damage an individual’s financial standing, employ-ability, or reputation within the community.
  • Information that would normally be recorded in a patient’s medical record and the disclosure of which could reasonably lead to social stigmatization or discrimination.
  • Information pertaining to an individual’s psychological well-being or mental health.
  • Genetic information.
  • Minors (under 18 years of age)
  • Fetuses or products of labor and delivery
  • Pregnant women (in studies that may influence maternal health)
  • Prisoners
  • Individuals with a diminished capacity to give informed consent

Refer to policy: HRPP-032 Vulnerable Subjects (pdf)

Research Involving People with Intellectual Disabilities: Paint it Gray (pdf)

University of Maine System and University of Southern Maine HIPAA Policies:

Form Sample Templates:

The Family Educational Rights and Privacy Act of 1974, or FERPA, is a federal law governing the privacy of education records. It grants specific rights to students and sets restrictions on how schools may handle education records.

A University of Maine system student can limit the disclosure of their Directory Information. Contact the Registrar’s Office for any USM student information

Qualtrics (pdf) for assistance contact: help@maine.edu

When proposing to offer a research-related drawing as a form of compensation, researchers should use the following guidelines:

a. Researchers should use the term “drawing” rather than raffle, lottery, contest, or sweepstakes, etc. since the latter terms imply purchase of tickets by participants.

b. For studies conducted in other jurisdictions, researchers should check the law of the jurisdiction.

c. The researcher should explain in the pertinent IRB application materials and consent documents, the drawing process, including:

  • How subjects will be entered. This would encompass individuals who are invited to participate but decline, prospective subjects who are ineligible, and subjects who enroll but later withdraw/are withdrawn by the researchers. Additionally, the protocol should affirm that the drawing may be entered by any individual who asks to be included.
  • Description of the prizes, including estimated value, and the total number of prizes to be awarded.
  • The odds of winning a prize, if known, or explanatory language similar to this: “For any drawing, the odds of winning a prize depend on how many people are entered in the drawing. As we do not know how many people will participate in this study related drawing, we cannot predict what will be the odds of winning a prize.”
  • When the drawing will take place in the time frame of the study (e.g., month/year).
  • How prize winners will be notified.
  • What will happen to participants’ contact information submitted after the drawing has taken place.

How to collect contact information separate from anonymous online surveys:

  • After creating the anonymous survey, create a second survey to collect identifiable information.
  • The Submit button to an online survey can usually be programed to go to another webpage, a “redirect” to the second survey.
  • Entering is voluntary.

28 C.F.R. § 512.19 – Reports

The researcher shall prepare reports of progress on the research and at least one report of findings.

(a) At least once a year, the researcher shall provide the Chief, ORE, with a report on the progress of the research. 

(b) At least 12 working days before any report of findings is to be released, the researcher shall distribute one copy of the report to each of the following: the chairperson of the BRRB, the regional director, and the warden of each institution which provided data or assistance. The researcher shall include an abstract in the report of findings.

28 C.F.R. § 512.20 Publication of results of research project

(a) A researcher may publish in book form and professional journals the results of any research project conducted under this subpart.

(1) In any publication of results, the researcher shall acknowledge the Bureau’s participation in the research project.

(2) The researcher shall expressly disclaim approval or endorsement of the published material as an expression of the policies or views of the Bureau.

(b) Prior to submitting for publication the results of a research project conducted under this subpart, the researcher shall provide two copies of the material, for informational purposes only, to the Chief, Office of Research and Evaluation, Central Office, Bureau of Prisons.

Refer to policy: HRPP-049 Research Supported by Department of Justice (pdf)

A copy of all data must be de-identified and sent to the National Archive of Criminal Justice Data, including copies of the informed consent document, data collection instruments, surveys, or other relevant research materials.

  • At least once a year, the researcher shall provide the Chief, Office of Research and Evaluation, with a report on the progress of the research.
  • At least 12 working days before any report of findings is to be released, the researcher shall distribute one copy of the report to each of the following: the chairperson of the Bureau Research Review Board, the regional director, and the warden of each institution that provided data or assistance. The researcher shall include an abstract in the report of findings.
  • In any publication of results, the researcher shall acknowledge the Bureau’s participation in the research project.
  • The researcher shall expressly disclaim approval or endorsement of the published material as an expression of the policies or views of the Bureau.
  • Prior to submitting for publication the results of a research project conducted under this subpart, the researcher shall provide two copies of the material, for informational purposes only, to the Chief, Office of Research and Evaluation, Central Office, Bureau of Prisons.

Refer to policy: HRPP-049 Research Supported by Department of Justice (pdf)