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Policies and Guidelines

What constitutes human subjects research? All research activities involving human subjects must be reviewed. Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Generalizable knowledge includes results from research, interviews, or surveys involving human subjects that is presented, published, or posted in any context. Participation by UM-Presque Isle faculty, staff, or students in research projects from external sources must be reviewed by the UM-Presque Isle IRB.

How is course-assigned research covered by IRB guidelines? Classroom or instructional activities and evaluation in which students become subjects of study or conduct research projects, even if not conducted or supported under the name of a research program, are subject to review. Instructors who teach courses involving research projects by students (including standard research, surveys, classroom observations, or interviews) that involve human subjects must complete an IRB Application for Approval of Course Required Research before the course syllabus has been distributed to the class.

What is the function of the IRB? The function of the Institutional Review Board at the University of Maine at Presque Isle is to review research projects involving human subjects proposed by any faculty, staff, or student to determine whether and how such research may be conducted. The primary purpose of such review is to protect the rights and welfare of human subjects of research. A secondary purpose is to protect the researcher and the university from legal liability and/or loss of federal funding for research projects.

What policies govern the IRB? The University of Maine System Board of Trustees established policies and procedures for the protection of the human subjects of research, effective January 19, 1990 (http://www.maine.edu/acadaff.html#Anchor17). As stated in that policy document, "Research with human subjects within the UM-System shall be guided by three general ethical principles: respect for persons, beneficence, and justice." The UM-System policies also conform to the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled, Ethical Principles and Guidelines for the Protection of Human Subjects of Research, and to the U.S. Department of Human Services Title 45, part 46 of The Code of Federal Regulations (http://www.nihtraining.com/ohsrsite/guidelines/45cfr46.html). The federal and UM-System rules govern the guidelines and procedures outlined below and constitute the criteria for determining whether and how research with human subjects may be conducted on this campus. Copies of all of these documents are available from the IRB Chair or Executive Secretary.

Who is on the IRB? The Institutional Review Board for the Protection of Human Subjects at UM-Presque Isle is a committee appointed by the President. It is responsible to the Vice President for Academic Affairs. The IRB includes one staff person, three faculty members representing different disciplines (preferably at least one of whom conducts research with human subjects and one from a nonscientific area), and one community member (such as a lawyer, ethicist, or member of the clergy).

What activities are "exempt" from full review? For adult subjects of undiminished capacity, the following categories of research are exempt from IRB full review:

  1. research involving normal educational practices, such as instructional strategies or the effectiveness of or comparison among instructional techniques, curricula, or classroom management methods; and
  2. research involving the use of educational tests, if subjects' identities cannot be linked to results.
  3. course-required research for non-sensitive, non-at-risk populations.

What is "expedited" review? A investigator may request an expedited review of an application for approval of research in any of the following circumstances:

  1. There is no divisional IRB representative and the investigator believes that the research activities proposed are limited to one or more of the categories of exemption cited above.
  2. The investigator proposes only minor changes in previously approved research during the period for which approval is authorized.
  3. The investigator believes that the research activities proposed involve no more than minimal risk to human subjects and that they are limited to one or more of the categories eligible for expedited review established by the Department of Health and Human Services (contact the IRB Chair or the Grants Office for these current categories).

What activities are subject to full IRB review? Research activities that place subjects "at risk" must undergo full Board review. Examples of at-risk studies include an exercise "stress test" on a treadmill or a survey concerning sexual behavior where the subject's anonymity cannot be guaranteed.

What does "at risk" mean? At risk means that the probability and magnitude of harm or discomfort anticipated in the research are greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

If a research project may place subjects at risk, what is the responsibility of the IRB? The Board must determine that:

  1. the rights and welfare of the subject are adequately protected; and
  2. ethical and legally effective informed consent has been obtained; and
  3. the risks are outweighed either by the benefits to the subject or the importance of the knowledge to be gained from the research.

What surveys are subject to full review? If the following conditions apply, a survey is subject to full IRB review:

  1. responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects;
  2. the subject's responses, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability; and
  3. the research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.

All research involving survey or interview procedures is exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office.

What is "informed consent"? Informed consent is the knowing consent of an individual or her/his representative given under free power of choice without undue inducement. Minors (children under age 18) must have parental consent. Consent is given in writing after a fair explanation of the benefits, discomforts, and risks of the procedure, and with the understanding that the subject can withdraw at any time without penalty. For further information about proper informed consent procedures and review, see question #6 of the Application Instructions, consult with the IRB Chair, or contact the Executive Secretary for additional instructions and sample consent forms.

What if my research involves minors (children under age 18) or other vulnerable research populations, such as fetuses, pregnant women, prisoners, or persons of diminished autonomy? Special procedures and rules apply to these populations. Consult the IRB Chair, the UM-System policies and procedures, and fill out Informed Consent forms.

What are the consequences of non-compliance with IRB policies? Any university faculty member, student or employee who neglects, disregards, or violates the UM-System policies regarding protection of human subjects of research risks personal liability for damages from legal suits brought by subjects. Compliance in good faith with these policies insures indemnification of the research investigator by the UM-System against expenses (including attorney fees), judgments, fines, and settlement fees incurred in any legal action.

How do I apply for review of human subject research? Fill out the appropriate application: Application for Review of Human Subjects Research, Part I - Signature Cover Sheet and Part II - Application Instructions or Application for Approval of Course Required Research.

Any IRB representative is available to assist the investigator in the proper preparation of human subjects research proposals. The investigator may submit his/her proposal for review to one of the IRB representatives or directly to the IRB Chair. Applicants should allow enough time for IRB review and response. Proposals needing full Board review will be acted upon within one month of being submitted (during the regular academic year). Expedited review requires a minimum of one week. The investigator will receive a written response with either approval, recommendations for revisions, or disapproval. Records of all reviews will be retained with the Executive Secretary.

Printed application forms are available from the Chairperson or the Executive Secretary. To facilitate the application process you can print IRB forms from the UM-Presque Isle website. Fill out forms following the instructions and submit the application to the IRB Chair. For questions or concerns, contact the current IRB Chair.