Policy Name: Research Involving Human Subjects/Institutional Review Board
Responsibility for Maintenance: Office of Institutional Planning, Assessment and Research
Date of most recent changes: June 21, 2016
I. Policy Statement
College seeks to maintain high standards of professional ethics in the conduct
of research activities, especially those involving human subjects. Human subjects research conducted by faculty,
staff, students, or external entities and research that includes personally
identifiable data must be reviewed and approved in accordance with the
procedures set forth in this policy. The College utilizes an Institutional Review
Board (IRB) organized and maintained pursuant to 45 CFR Part 46 to review
research requests and to take steps to mitigate or eliminate unreasonable risks
of harm to human subjects who participate in research.
The IRB is comprised
of no fewer than five (5) and no greater than nine (9) members, including the
Vice President for Institutional Planning, Assessment, and Research (IPAR), or
his or her designee; a College Compliance Officer designated by the College President,
who shall serve as chair; one external member selected by the College
President; and, up to six (6) faculty members selected through the faculty
governance process with due attention to maintaining the diversity of the
membership. Under no circumstances may
the IRB be comprised of individuals representing a single gender or
professional background. Moreover, the
IRB is required to include one or more individuals from the sciences and from
disciplines other than the sciences. In
situations where special expertise is required to evaluate a research proposal,
the IRB is authorized to include one or more other individuals in its
deliberations who are knowledgeable about and experienced in working with the
subject matter. Members of the IRB are
prohibited from participating in the review of research proposals in which the
member has a conflict of interest.
II. Reason for Policy
The College seeks to
maintain high ethical standards in conducting research involving human subjects
and to ensure that individuals who participate in an approved research project
are treated in ways that mitigate or eliminate unreasonable risks of harm, participate
voluntarily, and are selected equitably, consistent with federal regulations.
III. Applicability of the Policy
This policy is
applicable to all employees of the College, all students acting as human subjects
research team members, and to all research involving human subjects in which
the College participates in cooperation with other institutions.
IV. Related Documents
| Subject || Office Name || Telephone Number || Email/URL |
of Grants Administration||(315)
| Human Subjects Research || Office of Institutional Planning, Assessment and Research || (315) 498-2500 || firstname.lastname@example.org |
VI. Definitions 
| Term || Definition |
| Research || A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of the HHS regulations, whether or not they are conducted or supported under a program, which is considered research for other purposes. For example, some demonstration and service programs may include research activities. |
| Human Subject || A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. |
| Exempt Research || Six categories of research, as outlined in 45 CFR 46.101(b), that are not subject to federal regulations regarding protection of human subjects. A determination that research is exempt does not imply that investigators have no ethical responsibilities to subjects. |
| Informed Consent || The voluntary choice of an individual to participate in research based on an accurate understanding of its purposes, procedures, risks, benefits, alternatives, and any other factors that may affect a person's decision to participate.” |
| Institutional Review Board || An administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. |
IRB and research investigators shall adhere to the following procedures to
fulfill their responsibilities:
- IRB members will
complete approved training in advance of serving on the IRB.
- Requests for IRB review
will be submitted by the appropriate research investigators to IPAR, which, in
collaboration with the Office of Grants Administration, will create the agenda
for and coordinate IRB meetings; maintain meeting minutes; and, maintain
records for a period of three (3) years of proposals, the actions taken,
correspondence with research investigators, and other appropriate
documentation. Documentation relating to
approved proposals will be maintained for three years following the
conclusion of the approved research or for such longer period as may be
required by College policy or funding agency requirements.
categories of human subjects research defined by federal regulations may be
deemed exempt from IRB monitoring.
Research projects falling within a regulatory exemption from IRB
monitoring are, nonetheless, required to protect the welfare of human subjects,
ensure use of appropriate methods, and maintain the focus that was the basis
for the exemption.
- The IRB will
schedule meetings at least twice each fall and spring semester to conduct the following business: review pending human research proposals;
receive at least annually status reports on approved research projects; and,
develop an annual report to research investigators and the College on the IRB’s
activities. Meetings may be cancelled if
there is no business to conduct.
- Proposed human
subjects research may be deemed exempt from IRB monitoring; approved; approved
contingent upon the making of required modifications; or, disapproved. Decisions of the IRB will be documented in
writing. Written decisions will be
shared with research investigators, and any disapproved project will include
the reasons for the IRB decision and provide an opportunity for the research
investigator to respond in person or in writing.
- Expedited review
of proposed research projects posing minimal risk to human subjects or
requesting minor changes in previously approved research during the annual
period of approval may be conducted by the IRB chair and one other experienced
IRB member selected by the IRB chair.
This expedited review process will include all authority of the full
IRB, except the ability to disapprove the research project. Disapproval of research requires full IRB
review and action consistent with this Policy.
- The IRB will
require research investigators to obtain informed consent from human subjects
in circumstances where the human subject may experience greater than minimal
risk, defined as being no more likely and posing no greater risk of harm or
discomfort than that encountered in daily life or during the performance of
routine physical or psychological examinations or tests. Where informed consent is determined to be
required, the research investigator will collect this informed consent in accordance
with 45 CFR section 46.116, and such other conditions as the IRB may determine,
and submit documentation thereof to IPAR.
requiring follow up review more frequently than annually due to the sensitive
nature of the subject matter or methods to be used, vulnerable populations to
be studied, or other documented reasons, will be identified at the time the
project is approved and scheduled for more frequent status reports to the IRB
to include disclosure of any proposed material changes in research protocol
and, where appropriate, third-party verification of methods implemented.
- All material
changes in approved research protocols must be approved in advance by the IRB,
except where necessary to eliminate apparent immediate hazards to one or more
human subjects. In cases requiring
immediate hazard mitigation, notice of the change in protocol will be provided
to the IRB through IPAR as soon as reasonably practicable under the
- All project investigators are required to
provide prompt notification to the IRB through IPAR of any unanticipated
problems involving risks to human subjects or third parties or any other
serious or continuing noncompliance with this Policy.
- The IRB retains the right to suspend or
terminate approval of research that is not conducted in accordance with federal
regulations or the IRB’s requirements or that has been associated with
unexpected serious harm to subjects.
Such action by the IRB will be promptly reported in writing to the
research investigator, the College President, and, where externally funded
research is involved, the Office of Grants Administration, which will make
appropriate notifications to the involved funding agency.
- The IRB is accountable to the College
President, or his or her designee, who retains the right to review and, where
appropriate, modify the decision of the IRB, except that the President, or his
or her designee, may not approve research that has been disapproved by the IRB.
VIII. Forms/Online Processes
Approved by the OCC Board of Trustees June 17, 2014
Updated and approved by the OCC Board of Trustees June 21, 2016
 Source of Definitions: Code of Federal Regulations, Title 45 Public Welfare, Department of Health and Human Services, Part 46, Protection of Human Subjects http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
 US Department of Health and Human Services Office of Human Research Protection, Institutional Review Board Guidebook, http://www.hhs.gov/ohrp/archive/irb/irb_chapter1.h