PRP 3990 - Prior Version

PRP 3990 - Prior Version

Issued by: James Matta Ph.D., Interim Provost and Vice President for Academic Affairs

Effective Date: Spring, 2005

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

Bloomsburg University recognized 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 in the Grants Office.

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. The IRB may authorize the establishment of Human Subject Research Committees (HSRC) at the department, school, or college level as an extension of the IRB for the purpose of reviewing and acting upon proposals in the "Exemption from Review" category. The dean, in consultation with department chairs, will decide on which structure will be used within a college. The HSRCs must comply with the procedures and requirements established by the IRB.

The chairperson of the HSRC will maintain a record of all proposals that are exempted from further review, and forward to the IRB all proposals which need further review. The chairperson of the department school or college HSRC shall submit a list of all research approved for exempt status to the IRB chairperson by June 1 of each year.

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. An individual from outside the institution must serve on the committee. Both scientific and nonscientific expertise must be included and, at a minimum, one individual must be an ethicist. Members will be appointed as follows:

two faculty representatives from the College of Business, two faculty representatives from the College of Professional Studies, two faculty representatives from the College of Science and Technology, two faculty representatives from the College of Liberal Arts. The term of office will be staggered three year terms. The Assistant Vice President of Graduate Studies and Research and the Director of Grants will serve as ex officio, non-voting, members. Departmental, school or college HSRC chairpersons will serve as ex officio and voting members on the IRB. The chair will be elected from 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 development of policy and modification to conform with laws and regulations; providing continuing educations 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 for human subjects and informants.

  • 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 of psychological tests." Risks to subjects are minimized (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose the subjects to risk, and (ii) whenever appropriate, by 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. Approval is by majority vote in all cases.

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.
  • Expedited Review - Expedited Review occurs when at least two members of the IRB 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 or an authorized HSRC. 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. An IRB member must approve requests for exemption. 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 his or her 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 or department, school or college HSRC;
  • 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 on 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.