Williams Institutional Review Board (IRB)
An institutional review board (IRB) is a committee that has been formally established to approve, monitor, and review biomedical and behavioral research involving humans. The primary purpose of the IRB is to protect the rights and welfare of the human subjects. The IRB is responsible for reviewing research involving human sbujects. The overall purpose of an IRB is to make sure that all the necessary steps are taken to safeguard the privacy, confidentiality, rights, and privileges of those individuals who participate in and share information for the study.
The Williams IRB was established in the summer of 2011 and is registered with the U.S. Department of Health and Human Services Office for Human Research Protections (OHRP). It and the Food and Drug Administration (FDA) regulate IRBs. All IRBs have the authority to approve, disapprove, or require revision of research designed to collect datat from or about individuals. All government research grants require IRB approval. Participation at Williams is voluntary but the Department of Natural Sciences and he Psychology-Sociology Departments require IRB approval. IRBs are governed by the Title 45 Code of Federal Regulations Part 46.
Some research, because of its nature, is exempt from IRB oversight. Exemptions only
means that the research does not pose any threats to the humans involved and
therefore does not need IRB approval. An exemption does not mean the methods of
the research have in any way been “approved” or that subjects can be compelled to
Three questions can be used to determine if research needs IRB approval
1) Are conclusions or generalizations going to be drawn? Of particular interest here is
will the conclusions and generalization affect the participants in the survey.
2) Is there a record being produced that will potentially be available to the public?
3) Will the subject/participant be identifiable after the research has been completed?
In the case of all there of these question a yes or no answer does not automatically
mean the research will or will not be subjected to an IRB for approval.
Activities that do not need IRB approval include but are not limited to:
1. 45 CFR 46.101 (b)(1): Research conducted in established or commonly accepted
educational settings, involving normal educational practices, such as:
a. research on regular and special education instructional strategies, or
b. research on the effectiveness of or the comparison among instructional
techniques, curricula, or classroom management methods.
2. 45 CFR 46.101 (b)(2): Research involving the use of educational tests,
(cognitive, diagnostic, aptitude or achievement), survey procedures, interview
procedures or observation of public behavior, unless:
a. information obtained is recorded in such a manner that human subjects
can be identified, directly or through identifiers linked to the subjects; and
b. any disclosure of the human subjects’ responses outside the research
could reasonably place the subjects at risk of criminal or civil liability or be
damaging to the subjects’ financial standing, employability, or reputation,
For 45 CFR 46 (101) (b)(2), the exemption for research involving
survey or interview procedures or observations of public behavior
DOES NOT apply to research covered by 45 CFR Part 46, Subpart
D (Additional DHHS Protections for Children Involved as Subjects in
Research), except for research involving observation of public
behavior where the investigators do not participate in the activities
3. 45 CFR.46.101(b)(3): Research involving the use of educational tests (cognitive,
diagnostic, aptitude, or achievement), survey procedures, interview procedures,
or observation of public behavior that is not exempt under 45CFR 46.101
a. if the human subjects are elected or appointed public officials or
candidates for public office, or
b. federal statute(s) require(s) without exception that the confidentiality of
the personally identifiable information will be maintained throughout the
research and thereafter.
4. 45 CFR 46.101(b)(4): Research involving the collection or study of existing data,
documents, records, pathological specimens, or diagnostic specimens, if these
sources are publicly available or if the information is recorded by the investigator
in such a manner that subjects cannot be identified, directly or through
identifiers linked to the subjects.
5. 45 CFR 46.101(b)(5): Research and demonstration projects which are conducted
by or subject to the approval of department or agency heads, and which are
designed to study, evaluate, or otherwise examine:
a. Public benefit or service programs
b. Procedures for obtaining benefits or services under those programs
c. Possible changes in or alternatives to those programs or procedures
d. Possible changes in methods or levels of payment for benefits or
services under those programs.
6. 45 CFR 46.101(b)(6) and 21 CFR 56.104(d): Taste and food quality evaluation
and consumer acceptance studies,
a. if wholesome foods without additives are consumed
b. if a food is consumed that contains a food ingredient at or below the level
and for a use found to be safe, or agricultural chemical or environmental
contaminant at or below the level found to be safe, by the Food and Drug
Administration or approved by the Environmental Protection Agency or
the Food Safety and Inspection Service of the US Department of
NOTE: These categories do not apply to prisoners and categories 1-5 do not apply to FDA regulated research.
In addition research involving students at a college or university raises an additional
issues demonstrated by two opposing point of view: community service versus
student exploitation. One point of view is that research which contributes to the
advancement of science, improvement of the institution or individuals within it, with no
threat of physical or mental harm to the participant then it should be viewed as
public/community service by in participants. This view of research sees participation as
opportunities for community service and implies that the participants are learning to
contribute to their community by participating. However since student, as potential
subjects, are available in large numbers at colleges and universities and since teachers
of the institution are the ones most likely to be conducting the research the potential
problem exists of student s being unwilling laboratory mice.
The key to balancing these two extremes is partially the work of the IRB and partially by
an absolute policy of students always being free to withdraw without fear of penalty.
A caution that must be kept in mind is that merely calling research “community service”
does not make it community service. Research designed to increase knowledge and
understanding on an issue( ie why are some people more include to have an aversion
to bitter food as an adult than other as opposed to a professor doing a survey of sexual
behavior to write a ‘best seller’ for profit.) The first is clearly community services the
second though not illegal or unethical demands oversight to prevent exploitation.
Psychological Harm Definition:
Participation in research may result in undesired changes in thought processes and emotions (e.g., episodes of depression, confusion, or hallucination resulting from drugs, feelings of stress, guilt, and loss of self-esteem). These changes may be transitory, recurrent, or permanent. Most psychological risks are minimal or transitory, but researchers should be aware that some research has the potential for causing serious psychological harm.
Stress and feelings of guilt or embarrassment may arise sim ply from thinking or talking about one’s own behavior or attitudes on sensitive topics. These feelings may be aroused when the subject is being interviewed or filling out a questionnaire.
1. The IRB must have at least five members
a. Including both men and women, as long as they aren’t chosen specifically
for their gender
b. The members of the IRB must not be all of the same profession
c. The IRB must include at least one scientist and at least one non-scientist
d. The IRB must include at least one person who is not affiliated with the
institution or in the immediate family of a person affiliated with the
institution. These are commonly called “Community Members.”
2. IRB members may not vote on their own projects
3. The IRB may include consultants in their discussions to meet requirements for
expertise or diversity, but only actual IRB members may vote
4. The members must have enough experience, expertise, and diversity to make an
informed decision on whether the research is ethical, informed consent is
sufficient, and appropriate safeguards have been put in place
If the IRB works with studies that include vulnerable populations, the IRB should have
members who are familiar with these groups In addition research involving students at a
college or university raises an additional issues demonstrated by two opposing point of view:
community service versus student exploitation. One extreme is point of view that research
which contributed to the advancement of science, improvement of the institution or individuals
within it, with no threat of physical or mental harm to the participant then it should be viewed as public/community service. This view of research participating as opportunities for community
service implies that the participants are learning to contribute to their community by
participating. However since student, as potential subjects, are available in large number at
colleges and universities and since teachers of the institution are the ones most likely to be
conducting the research the potential problem exists of student s being unwilling laboratory
The key to balancing these two extremes is partially the work of the IRB and partially by an absolute policy of the students always being free to withdraw.
A caution that must be kept in mind is that merely calling research “community service” does not make it community service. Research designed to increase knowledge and understanding on an issue (i.e. why are some people more incline to have an aversion to bitter food as an adult than others) as opposed to a professor doing a survey of sexual behavior to write a “best seller” for profit. The first is clearly community service. The second, though not illegal or unethical, demands oversight to prevent exploitation.