Guidelines for Research with Human Subjects
All research involving human or animal subjects must be evaluated for its compliance with accepted ethical principles.
All research done by Purchase College faculty, students, and staff involving human or animal subjects must be evaluated for its compliance with accepted ethical principles, as must all research conducted on members of the Purchase College community by researchers from outside of Purchase College. This document outlines the guidelines and procedure for research involving human subjects only.
Research involving human subjects must be evaluated for: (a) potential harm to subjects that may result from their participation; (b) potential benefits of the research for the subject and the community as a whole; (c) procedures used to ensure the informed and voluntary participation of research subjects; (d) procedures used to ensure the confidentiality of research subjects; (e) procedures for aftercare of research subjects when there is some potential for harm to participants resulting from their participation in the research.
Researchers are not allowed to determine whether their own research is exempt from review. Research done by students for a course, independent study, or senior project must be approved by the course instructor or faculty sponsor before data collection begins. It is the faculty member’s responsibility to determine whether the proposed research meets the criteria for research exempt from review by the Institutional Review Board (IRB) or is subject to review by the committee. Criteria for research that is exempt from review are described below. In the case of research conducted by faculty or staff, the chair of the IRB, or an experienced reviewer designated by the committee chair, must make this determination. Research that is not exempt from review must be approved by the IRB before data collection begins.
Institutional Review Board
The Institutional Review Board (IRB) oversees human subjects research conducted at Purchase College. The IRB is a subcommittee of the Faculty Committee on Professional Standards and Awards. As an institution receiving federal support, Purchase College must conform to the guidelines established by the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP). OHRP guidelines stipulate that the IRB be composed of a minimum of five members, including at least one in the sciences, one outside the sciences, one who is familiar with applicable laws and regulations, and one representative of the community who is not otherwise affiliated with the college. The committee reviewing a specific proposal may also include someone with a special interest or expertise in the population under study (e.g., a student, or an expert on child development). Members of the committee may not participate in the review of their own research or research they are sponsoring; in this case, appropriate substitutes will take the place of those committee members.
The IRB has the authority to approve, disapprove, or require modifications in the methods, materials, or procedures used in research involving human subjects, and to suspend research that is not done in accordance with the approved procedures or in which unforeseen problems arise during the course of the research. In addition, the IRB is required to monitor compliance with OHRP guidelines and the recommendations of the committee.
Research Exempt from Review by the Institutional Review Board
Research done with adult participants by Purchase students, faculty, or staff that meets the following criteria is exempt from review by the IRB:
- 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.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, 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.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) survey procedures, interview procedures, or observations of public behavior that is not exempt under paragraph (2)(b) of this section, if: (a) 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.
- 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 (U.S. Dept. of Health and Human Services, 1997).
In addition, evaluation research conducted by agency heads, and taste and food quality research meeting certain guidelines are exempt from review; individuals planning to do such research are referred to the Dept. of Health and Human Services for a complete description of these guidelines. Please note that survey and interview research done with minors under the age of 18 is not exempt, nor is observational research with children if the researcher participates in the activities that are being observed.
According to current guidelines from the OHRP, investigators should not be permitted to decide for themselves whether their own research is exempt from review. Therefore, prior to beginning a study that appears to meet the criteria for research exempt from review, faculty and staff members must submit a brief description of the project to the chair of the Institutional Review Board, who will determine whether a full proposal must be reviewed by the committee. This description must explain clearly how the proposed research meets the criteria for exemption.
Research Subject to Review by the Institutional Review Board
Any research by Purchase students, faculty, or staff that does not meet the criteria for research exempt from review, and all research conducted by researchers who are not otherwise affiliated with the college and who wish to use subjects from the Purchase College community must be approved by the IRB. Research involving “minimal risk” to the subjects involved will receive an expedited review by members of the committee. Research in this category includes procedures that are not specifically exempt from review but are believed to pose little or no risk to the well-being of the research participants. Research poses minimal risk when the risk of harm to the subjects is no greater than the risk inherent in commonplace, everyday activities. All other research is subject to a full review by the IRB.
The researcher must submit a brief research proposal along with a memo addressed to the chair of the IRB. The proposal must include the information shown in the Outline for Proposals to the IRB. Copies of the Statement of Informed Consent; and materials used in the research are typically needed by the committee in order to evaluate the ethical acceptability of the proposed research; additional information may also be requested. All communication with the committee should be done through the committee chair.
The principal investigator and, in the case of student research, the faculty sponsor will be notified of the committee’s decision in writing. The research may be: (a) approved; (b) approved with certain modifications to the materials or procedures to be used; (c) not approved. Approval of the research is customarily given for a one-year period following the review; extensions can be granted if the research will continue beyond the approval period. The research must be carried out as described in the proposal; the researcher is obligated to notify the committee of any substantive changes in the materials or procedures after the proposal has been approved. When extension requests are made, the researcher must provide an updated protocol as well as a report of the number of participants who have been run to date and a report of any adverse events.
Procedures for Verification of Compliance and Reporting of Noncompliance
It is the obligation of the principal investigator (or faculty sponsor, where applicable) to inform the IRB of any substantive changes to the research protocol or unanticipated problems with the research that increase the risk to participants. These include unintended negative effects on the participants as well as breaches of confidentiality. In some cases, the IRB will require verification of compliance from someone other than the principal investigator or faculty sponsor. These cases include, but are not limited to, complex projects that pose greater than usual risks to participants and projects proposed by researchers who have failed to comply with approved research protocols in the past. Such projects may also be subject to approval for periods of less than one year, and so require periodic review by the IRB. In all cases, the approval period will be specified in the notice of approval provided to the investigator(s) by the IRB.
In addition, research participants, research assistants, and others who have direct knowledge of a research project may report to the IRB instances of noncompliance with the approved research protocol or unanticipated problems that occur during the conduct of the research. Statements of Informed Consent must notify the participant that any problems they encounter may be reported to the IRB and contact information for the committee chair must be provided.
When a report of noncompliance or unanticipated problems is received, the chair of the IRB will make a record of the complaint and request appropriate documentation from the individual or individuals who initiated the complaint. In cases where there is serious noncompliance with the approved research protocol or unanticipated problems that increase the risk to participants, the chair of the committee will suspend approval of the project immediately, pending a review of the complaint. All complaints of serious noncompliance or unanticipated risks to participants will be reviewed by the full membership of the IRB, who will determine whether approval of the project should be terminated. A report of the complaint and the decision of the IRB will be made to the principal investigator (and faculty sponsor, where applicable), as well as to the appropriate officer of the college (e.g., dean or provost) and the HHS Office for Human Research Protections. In cases of research funded by a federal agency, a report of the complaint will also be filed with that agency. All complaints received by the IRB will be reviewed in a timely manner and the decisions of the committee will be communicated to the investigators in writing within 30 days of receiving the initial complaint.