B14: Research Involving Human Subjects/Institutional Review Board

Responsibility for Maintenance: Grants Administration; Institutional Planning, Assessment and Research

Date of most recent changes: June 21, 2016

I. Policy Statement

Onondaga Community 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

V. Contacts

Subject Office Name Telephone Number Email/URL
Sponsored Projects Grants Administration (315) 498-2692 occgrants@sunyocc.edu
Human Subjects Research Institutional Planning, Assessment and Research (315) 498-2500

ipar@sunyocc.edu

occirb@sunyocc.edu 

 

VI. Definitions [1]

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.

 

The following activities are deemed not to be research:  

(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.  

(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance.  

(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.  

(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions. 
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 Eight categories of research, as outlined in 45 CFR 46.104(d), 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.[2]

 

VII. Procedures

The IRB and research investigators shall adhere to the following procedures to fulfill their responsibilities:

  1. IRB members will complete approved training in advance of serving on the IRB.
  2. 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.
  3. Certain categories of human subjects research defined by federal regulations may be deemed exempt from IRB monitoring, as outlined in 45 CFR 46.104 (d).  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.
  4. 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.  
  5. 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.
  6. Expedited review of proposed research projects posing minimal risk to human subjects, projects requesting minor changes in previously approved research during the annual period of approval, or research for which limited IRB review is a condition of exemption 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. 
  7. If the college participates in cooperative research involving more than one institution, each institution is responsible for safeguarding the rights and welfare of human subjects. For cooperative research, the collaborating institutions must rely on approval by a single IRB for that portion of the research conducted in the United States, unless more than single IRB review is required by law, or research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context. For research not subject to single IRB review, the college may enter into a joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort. 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.
  8. Projects 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.  
    1. 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 circumstances.
    2. 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.
    3. 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.
    4. 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

 

[1] 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

[2] US Department of Health and Human Services Office of Human Research Protection, Institutional Review Board Guidebook.