START HERE: Is it human subjects research?
If yes, then proceed to: Investigator Guidelines
|Applications (Word format)||Applications (PDF)|
Research with human subjects at Universities within the University of Maine System (UM System) shall be guided by three general ethical principles: respect for persons, beneficence, and justice. These principles and the rules that may be derived from them shall form the analytical framework for determining whether and how research with human subjects may be conducted. Researchers must respect and protect the rights and privacy and welfare of individuals recruited for and participating in research. More precisely, all human subject research must comply with the US Department of Health and Human Services (DHHS) “Common Rule” 45 CFR 46; 21 CFR 50; the Belmont Report; The Nuremburg Code, and the Declaration of Helsinki.
At the University of Maine at Farmington, the Institutional Review Board (IRB) is the administrative and decision-making body having responsibility for review and approval of research involving human subjects. Before any research involving human subjects can be initiated it must have received IRB review and approval.
All Proposals should be sent directly to Brad Dearden, Chair of IRB, via campus mail or e-mail (firstname.lastname@example.org).
When should I consult with the IRB?
In accordance with University of Maine System policies and Federal regulations, all research involving human subjects must be reviewed by the Institutional Review Board (IRB). This Board has the authority to determine (a) whether a given project can be considered human subjects research and (b) whether any such research is “exempt” from formal review.
In practice, the IRB must rely heavily on the good judgment of faculty to submit projects when appropriate. If a given project is research involving human subjects, the IRB should be consulted.
What is research?
The Code of Federal Regulations defines research as
(a) a systematic investigation designed to
(b) develop or contribute to generalizable knowledge.
The phrase “systematic investigation” can be applied to any project that involves the collection of quantitative or qualitative data in order to answer a question.
Generalizable knowledge is formally defined as “information which has the potential to be expanded beyond the isolated circumstances in which it is acquired to any broader context.” In other words, is there an intent to make a statement or claim that extends beyond the limited number of cases (or “sample”) available to an investigator?
A case study, designed to illuminate the course of a single individual’s life generally will not be considered to be developing or contributing to generalizable knowledge. However, a series of case studies, intended to lead to improvements in the management of a particular circumstance or condition, generally will be considered generalizable knowledge.
The use of inferential statistics in a project virtually guarantees its status as “research” (though it does not require IRB oversight if there are no “human subjects” involved, as defined below). Yet, other quantitative and qualitative analytic techniques may also be classified as research (if the investigator’s intent is to develop or contribute to generalizable knowledge).
Note that system-wide policy explicitly states that risk assessment plays no role in the determination of whether a proposed activity constitutes research.
What is a human subject?
According to the Code of Federal Regulations (CFR), a human subject is “a living individual(s) about whom an investigator (whether professional or student) conducting research obtains:
- Data through intervention or interaction with the individual, or
- Identifiable private information.” [45 CFR 46.102(f)]
Identifiable Private Information includes (but is not limited to)
- Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. [45 CFR 46.102(f)]
- Information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical record). [45 CFR 46.102(f)]
- Private information which is individually identifiable. [45 CFR 46.102(f)]
- Information of a nature that the identity of the subject is or may readily be ascertained by the investigator or associated with the information. [45 CFR 46.102(f)]
- Information which was collected specifically for the proposed project through intervention or interaction with living individuals and is of a nature that the investigator can readily ascertain the identity of the individuals.
When UMF faculty, staff, and students engage in any sort of project, they should ask themselves the following question: can a reasonable person (in any discipline) make a case that the project represents human subjects research? If this answer to this question is “yes,” the IRB should be consulted.
Investigator Guidelines for Research that Includes Human Subjects
I. Where Do I Begin?
UMF faculty, staff, and students who intend to conduct projects involving human participants must seek prospective approval (or an exemption) from the Institutional Review Board (IRB). Depending on the nature of your project, one of three scenarios will unfold:
1) Your project is EXEMPT FROM FURTHER IRB OVERSIGHT. Exempt categories include (but are not limited to): (a) research conducted in established or commonly accepted educational settings, involving normal educational practices (such as the systematic analysis of the efficacy of various instructional strategies) and (b) research involving surveys and interviews (unless the research is conducted in such a manner that human subjects can be identified or the survey/interview responses can potentially damage a participants financial standing, employability or reputation). Additional exemptions are detailed on page 1 of the Request for Exemption form (Microsoft Word; PDF). Only the IRB can determine if a research project is exempt from further IRB oversight.
- If you believe that your project is exempt from further oversight, simply complete a Request for Exemption form (Microsoft Word; PDF). As indicated on this form, your request should include (a) a brief description of your project, (b) a clear account of your “informed consent” procedures (including relevant documents), and (c) all survey and interview questions. Note that the IRB website includes sample “informed consent” forms that you can modify for use in your own study.
- You will receive feedback within 10 days regarding the status of your proposal. If your project is indeed exempt, no further IRB oversight is required. If your project is not exempt, the review process may take longer (and the IRB Chair may ask the investigator to submit a Request for IRB Review form)
- Note that any project dealing with sensitive information or special populations (as defined below), or presenting greater than minimal risk to participants, will require a full IRB review.
2) Your students are conducting a classroom project involving human subjects (where the purpose of the project is the education of individual students). If you believe that your classroom project is exempt from monitoring by the IRB, you should complete a Course Required Research form (Microsoft Word; PDF) Such submissions will require review at a full IRB meeting, so it is important to submit this form the semester prior to the initiation of the classroom project. Once the project is approved, no subsequent review is required (unless there are changes in the course, the instructor, or the nature of the project). [NOTE: ONLY THE IRB CAN DETERMINE WHETHER STUDENT RESEARCH IS INDEED EXEMPT FROM IRB MONITORING, AND INSTRUCTORS MUST SUBMIT A “COURSE REQUIRED RESEARCH” FORM IN ORDER TO EMPLOY HUMAN SUBJECTS IN CLASSROOM PROJECTS]
The following are examples of student research that may justify the submission of a Course Required Research form:
i. Student research that is not intended to produce “generalizable” information shared beyond the research class, and that does not include sensitive information, pose greater than minimal risk, or study a special population.
ii. Data collected in connection with a class that is undertaken for the purpose of learning research techniques, or professional skills (e.g., patient evaluations for nursing students, law student research techniques, student counseling techniques).
iii. Observation of students performed in commonly accepted educational settings provided the evaluator does not interact with the student (including observation of minors). Studies that focus on normal educational practices, curriculum, instructional techniques, or management strategies are exempt provided that the information is not shared beyond the UMF class or the research context.
iv. Analysis of existing data files in which subjects cannot be identified.
Note: If the results of the research will be disseminated to the general public, or if the project deals with sensitive information, involves interactions with “special populations” (defined below), or constitutes “risk” (of any sort) to the participants, the individual project requires IRB oversight (and it is the instructor’s responsibility to bring the project to the attention of the IRB Chair).
3) Your project requires IRB oversight. If your project does not clearly fall into one of the categories noted above, you should submit a Request for IRB Review (Microsoft Word; PDF). Such research will be reviewed at the next full IRB meeting. All student submissions require the signature of a faculty sponsor.
II. What is the Process of IRB Review?
A. Initial IRB Review
Material for IRB review (or request for exemptions) should be delivered to the chair of the Internal Review Board (Brad Dearden) via campus mail or e-mail (email@example.com). If the submission is made via e-mail, the form can be signed by the principal investigator (or faculty sponsor) at the time the project is approved. The IRB chair will screen all applications to see if the project qualifies as EXEMPT FROM FULL REVIEW (as defined above). If the project does indeed require review, the IRB may:
- Approve the research as submitted.
- Approve the research contingent upon specific revisions.
- Table the protocol for substantive changes.
- Disapprove the research.
- Suspend or terminate research that has not followed IRB conditions of approval.
- Monitor the research for compliance with IRB recommendations.
If the protocol is approved contingent upon minor revisions, the investigator must send a copy of the revised protocol to the IRB Chair.
B. Continuing Review Procedures
Federal Regulations require review of research at least annually, consequently the date of approval always begins form the date of review and extends at the maximum one year from the review date.
Protocol approval automatically expires at the end of the IRB approval period. If a researcher would like to continue research activities past the approval period, the research must submit a Request for Continuing Review (Microsoft Word; PDF)
C. Report of Unforeseen and Adverse Events
All adverse events of physical or psychological harm, threats to privacy or safety of human subjects must be immediately communicated to the chair of the IRB.
Research: Research is defined as a systematic investigation designed to contribute to or develop “generalizable” knowledge (intended to be shared with the general public). This includes research obtained by an investigator through interaction or intervention with a human subject or any research on human subjects that includes identifiable private information. This does not include research in commonly accepted educational settings that does not generate information used beyond the institution (such as course evaluations) unless the subjects can be identified and the information obtained poses a risk to the subject greater than that encountered in daily life. [Note: Only the IRB can determine whether a given project is appropriately classified as “research”]
Minimal Risk: Risk that is not greater than that encountered in every-day life.
Sensitive Information: Includes information that may pose a risk to the subject: psychological, social, medical, legal, economic or quality of life. The following categories exemplify these risks.
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, employability, 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
Special subject populations: Certain populations have additional protections under the Common Rule. Studies that include special subject populations must follow a more rigorous review by the IRB. (Researchers are reminded that USM policies have been written to comply with the Federal Rules that provide additional protection for these populations.)
Subject populations with added protections:
- Minors (under 18 years)
- Pregnant women
- Fetuses or products of labor and delivery
- Individuals with a diminished capacity to give informed consent
For more information visit the Office for Human Subjects Research Protection Website at www.hhs.gov/ohrp/