PRP 3990 Institutional Review Board (IRB) for Human Subjects Research

PRP 3990 Institutional Review Board (IRB) for Human Subjects Research

Issued by: James Mackin, Provost and Vice President for Academic Affairs

Effective Date: Fall, 2008

NOTES: Amended by Institutional Review Board Fall, 2002 Reviewed by Graduate Council, January, 1994 BUCC approved April 13, 1994, Forum approved October 19, 1994 Reviewed by Graduate Council, December 6, 2002 BUCC approved April 16, 2003 Reported to Forum Nov. 17, 2004 Amended by Institutional Review Board, December, 2007, Endorsed by Graduate Council, December 7, 2007. Approved by BUCC February 6, 2008. Reported to Forum

Prior version of this policy

Feb. 27, 2008.

Bloomsburg University recognizes its ethical and legal responsibilities to provide a mechanism to protect individuals involved as subjects in research conducted under the auspices of the University. Research, as defined by the Bloomsburg University Graduate Council Research Committee, is the systematic inquiry/investigation of a specified problem or set of problems with the goal of advancing the discipline. Therefore, all research involving human subjects will be reviewed, prior to the initiation of the research, through the procedures set forth by the University and directed by the Institutional Review Board (IRB). Failure to submit research for review and approval is a violation of Bloomsburg University policy.

Rationale

The University policy entrusts the investigator with the primary responsibility for protection of individual subjects. The University assumes the responsibility for ensuring the conditions for protecting human subjects as required by the National Research Act, Public Law 93-348 and implemented by the Department of Health and Human Services (Title 45 CFR 46, Protection of Human Subjects, as amended and by other Federal agencies with appropriate jurisdiction.) The complete document can be reviewed online at the National Institutes of Health Office of Human Subjects Research, Regulations and Ethical Guidelines.

The University assumes responsibility for encouraging research activities to benefit advancement of knowledge of human conditions and, at the same time, protecting the rights and welfare of human subjects, the investigators, and the University. This includes assuring the scientific validity of the research methodology as it relates to the protection of human subjects. University faculty, staff, and students conducting human subject research are responsible to comply with this policy and all federal regulations. The IRB reserves the authority to suspend or terminate approval of research that is not being conducted in accordance with the Bloomsburg University IRB policy #3990

Structure

The IRB has the responsibility and authority to review and approve all research involving human subjects.

All proposals in the "Exemption from review" category will be processed by the Director of the Office of Research and Sponsored Programs and the Assistant Vice President and Dean of Graduate Studies and Research. They may be aided in the reviews by members of the IRB committee.

IRB Membership

The IRB shall be appointed by the Provost and Vice President for Academic Affairs. Federal guidelines indicate that members should possess a sufficient background to be able to look at ethical issues and the committee should contain a balance of males and females. A committee comprised of the current IRB Chair, the Director of the Office of Research and Sponsored Programs, and the Assistant Vice President and Dean of Graduate Studies and Research, in consultation with the appropriate college dean, will determine the faculty to be recommended to the Provost to fill the five federally required roles. College representatives will be selected by each college dean from the faculty and recommended to the Provost.

All those considered for membership will have a demonstrated record of research/scholarly activity and/or previous IRB experience, and agree to participate fully in the work of the IRB committee. In compliance with federal guidelines, voting members will be appointed to fill the five federally required roles of (1) science representative, (2) non-science representative, (3) ethicist, (4) diversity issues representative, and (5) a representative from outside the university. In addition to those five mandated positions one voting representative from College of Business, College of Professional Studies, College of Science and Technology, and College of Liberal Arts will be appointed. Thus the IRB membership roster will consist of 9 voting positions.

As allowed by the federal guidelines, an alternate will be appointed for each position, bringing the IRB membership list to a total of 18 individuals. These alternate members are encouraged to participate fully in the work of the IRB committee and are eligible to review expedited proposals. Alternates will vote on occasions when a voting member is absent or when the area of expertise needed for the review is closer to that of the alternate than the voting member. All members must complete the National Institutes of Health IRB Computer-Based Training Course or equivalent before being eligible to vote.

The term of office will be staggered two-year terms. The Assistant Vice President and Dean of Graduate Studies and Research and the Director of the Office of Research and Sponsored Programs will serve as ex officio, non-voting, members. The chair will be elected yearly by and from among the voting members of the IRB.

Administration

The University official responsible for carrying out or delegating executive functions is the Provost and Vice President for Academic Affairs. The executive functions include developing and modifying policy to conform to laws and regulations; providing continuing education for personnel with respect to policy; and providing administrative support and legal assistance to the IRB.

Procedures

Researchers must describe their proposed research to the IRB in enough detail that the potential adverse effects and benefits to human subjects can be evaluated. The IRB forms and procedures provide a means for researchers, subjects, the University, and community to communicate clearly and responsibly about the risks and benefits of research involving human subjects and informants. Copies of all IRB forms and corresponding documentation will be stored by the Office of Research and Sponsored Programs and will be available to the IRB Chair, the Assistant Vice President and Dean of Graduate Studies, the Provost and Vice President for Academic Affairs, relevant federal agencies, and others approved by the Provost and Vice President for Academic Affairs.

Three principles guide the review process:

  • Subjects must give their informed consent to participate in research;
  • Researchers must provide and protect subject confidentiality;
  • Potential risks to subjects must be balanced by potential benefits of the research.

The review process uses the concept of minimal risk to decide the extent to which subject interests warrant formal and extensive review of research proposals. Minimum risk is defined as "the risks anticipated in the proposed activity, are not greater than those ordinarily encountered in daily life or during performance of routine physical or psychological tests." Risks to subjects are minimized (1) by using procedures which are consistent with sound research design and which do not unnecessarily expose the subjects to risk, and (2) whenever appropriate, using procedures already being performed on subjects for diagnostic purposes.

The IRB classifies research into three categories based on the need to ensure that research conforms to the above principles. These categories are Full Review, Expedited Review, and Request for Exemption from Review. These review categories are discussed in detail in the Guidelines for Human Subject Research.

Basic features of each category are:

Full Review - A Full Review occurs when the IRB reviews the proposed research and meets with the principal investigators to discuss and evaluate the impact on human subjects. After review IRB members vote to approve or disapprove the proposal. Full Reviews are conducted for proposed research that involves more than minimal risk or where very careful evaluation or risks and benefits is appropriate, minors or vulnerable populations are subjects, or where adverse impact on subjects may occur due to research activities. For example, research exposing subjects to threats to dignity, physical or emotional injury or discomfort, legal liability or arrest, damage to financial or social standing, or procedures in which subjects experience stress or have their behavior, attitudes or beliefs manipulated by researchers must undergo Full Review. Approval is by majority vote in all cases.

Expedited Review - Expedited Review occurs when at least two members of the IRB, designated by the chairperson, review the proposal and independently indicate their approval or disapproval. Researchers are not required to meet with reviewers. Reviewers frequently give written comments advising the researcher on ways to enhance the protection of human subjects. Reviewers may ask for more information or require changes in procedures to enhance the provisions for informed consent, confidentiality and risk/benefit balance. Expedited research involves minimal risk to subjects but involves procedures with potential impact on subjects; such as the collection of body samples or physiological data, video or voice recordings, or studies involving vulnerable populations or sensitive issues.

Exemption from Review - A Request for Exemption from Review may be received by the IRB Researchers must complete and submit the same forms and documents required for the other review categories. These forms provide reviewers with the information needed to evaluate whether the research qualifies for exemption from review. Exempted research involves research on effectiveness of or the comparison among instructional techniques, curricula, or management methods, the use of educational tests, or the study of existing data.

Student Research - Student research activities are governed by both the requirements of good research and the regulations of the Bloomsburg IRB. Student research is any systematic data collection and recording process done by students that is subject to interpretation and dissemination to solve a problem or advance understanding of a discipline. Dissemination occurs whenever information goes beyond registered students or assigned faculty or supervisors for the course. Examples of student research include the collection of data for a thesis, honors paper, or departmental paper or data collected for publication, distribution, presentation, or that is publicly available beyond the course environment. It is the responsibility of faculty members overseeing student research activities to ensure that the students meet the professional standards of the discipline and also conform to Policy 3990 and IRB procedures.

Procedures for Appeal

In the event a proposal is not approved at the exempt or expedited level, the researcher may request a full review of the protocol by the IRB.

Procedures for noncompliance - Investigators are admonished to remember that the university policy entrusts the investigator with the primary responsibility for protection of individual subjects. It is the individual investigator's responsibility to be in compliance with this policy. The IRB is the only body authorized to take action when a researcher is in noncompliance with PRP #3990. Noncompliance includes:

failure to submit applicable research involving human subjects for review and approval to the IRB;

failure to conduct research according to the approved protocol as it relates to the protection of human subjects;

failure to immediately notify the IRB when research activity results in an unexpected adverse impact on the subjects.

Allegations of noncompliance (either written or oral) should be directed to the chair of the IRB. The IRB will investigate allegations of noncompliance, maintaining confidentiality in all matters. Only voting members will participate in the investigation. In the event that allegations are substantiated, the IRB will terminate approval of the research and recommend to the Assistant Vice President for Graduate Studies and Research that the research be terminated. These decisions will be communicated to the researcher and the appropriate federal agency or funding agency, if appropriate, by the Assistant Vice President of Graduate Studies and Research. A decision to terminate research may be appealed to the IRB within 15 days of notification.