PRP 3990 - Institutional Review Board (IRB) for Human Subjects
Research
Issued by: Dr. Carol J. Matteson, Interim Provost and VPAA
Effective Date: October 19, 1994
Notes: Amended by Institutional Review Board Fall, 1993. Reviewed by Graduate Council, January,
1994. BUCC approved April 13, 1994, Forum approved October 19, 1994.
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 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: three from the
College of Business, three from the College of Professional Studies and three from the College of Arts
and Sciences. The term of office will be staggered three years 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.
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:
1. Subjects must give their informed consent to participate in research.
2. Researchers must provide and protect subject confidentiality.
3. 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 (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 of 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, presen-tation, 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.
Procedure 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
1. failure to submit applicable research involving human subjects for review and approval to the
IRB or department, school or college HSRC;
2. failure to conduct research according to the approved protocol as it relates to the protection of
human subjects.
3. failure to immediately notify the IRB when research activity results in an unexpected adverse
impact on the subjects.
Allegations of non compliance (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.