Guidelines for Research
with Human subjects
For questions, contact:
Prof. Peggy De Cooke, Chair, Human Subjects Committee
Overview
Policy
Human Subjects Committee
Research Exempt from Review by the Human Subjects Committee
Research Subject to Review by the Human Subjects Committee
Review Procedure
Outline for Proposals to the Human Subjects Committee
Overview
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. This document outlines the guidelines and procedure for research involving human subjects; those planning research with animal subjects are referred to the Institutional Animal Care and Use Committee (IACUC) for the relevant guidelines and procedures.
Policy
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. In addition, certain research involving human subjects must be approved by the Human Subjects Committee before data collection begins. 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 insure the informed and voluntary participation of research subjects; (d) procedures used to insure the confidentiality of research subjects.
Human Subjects Committee
The Human Subjects Committee is the Institutional Review Board (IRB) for human subjects research conducted at Purchase College. The Human Subjects Committee 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 (HHS). HHS 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.
Research Exempt from Review by the Human Subjects Committee
Research done with adult participants by Purchase students, faculty and staff which meets the following criteria is exempt from review by the Human Subjects Committee:
- 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 which are being observed.
Research Subject to Review by the Human Subjects Committee
Any research by Purchase students, faculty or staff that does not meet the criteria for research exempt from review, and all research conducted by outside researchers who wish to use subjects from the Purchase College community must be approved by the Human Subjects Committee. Research by Purchase students, faculty and staff involving "minimal risk" to the subjects involved will receive an expedited review by members of the committee. Research in this category includes procedures which are not specifically exempt from review but which 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 Human Subjects Committee.
Review Procedure
The researcher must submit a brief research proposal along with a memo addressed to the Prof. Peggy De Cooke, Chair of the Human Subjects Committee. The proposal must include the information shown in the outline. Copies of the Statement of Informed Consent and materials used in the research may be 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. It is expected that the research will be carried out as described in the proposal; the researcher is obligated to notify the committee of any substantive changes made in the materials or procedures after the proposal has been approved.
Outline for Proposals to the Human Subjects Committee
Principal Investigator:
Faculty Sponsor (if applicable):
Title:
Date:
Goals of the Research. Describe the goals of the proposed research.
Subjects. Who will the subjects be? How many will there be? How will they be obtained? Will they be compensated in any way for their participation?
Materials and Procedure. Describe the materials to be used in the research; these include tests, questionnaires, and stimulus materials presented to the subjects (e.g., perceptual arrays, texts to be read by the subjects, etc.). If you have created a questionnaire specifically for this research, it should be included as an Appendix to the proposal. Describe the procedure for collection of data. For experimental research, be sure to describe what the subject will be asked to do.
Risks to Subjects. Are there any known risks to the subjects? Risks are not limited to physical harm or risk of legal consequences; they include emotional upset, embarrassment, and damage to reputation, career or financial status. How severe are these risks? How likely are they to occur? Is there another way to do the research that avoids these risks altogether?
Benefits. What benefits are to be derived from this research? What will you learn from doing this research that will be of benefit to the subject or to others?
Procedures for Obtaining Informed Consent. How will you insure that your subjects understand what you are asking them to do, are participating voluntarily, and are aware of their rights? Please note that, in addition to the consent of the subjects themselves, the Informed Consent of a parent or legal guardian is needed if your subjects are minors under the age of 18, or are not considered competent to give informed consent. The Statement of Informed Consent should be included as an Appendix to the proposal.
Procedures for Protecting Subject Confidentiality. How will you insure that your subjects' confidentiality is protected? Who will see the data? Where will the data be stored? If it is necessary to retain the subjects' names or other identifiers, how will you insure that their responses cannot be linked to identifying information?
Procedures for Debriefing and Aftercare. Describe what provisions you will make to insure that your subjects suffer no lasting effects as a result of participation in your research. Include provisions for professional care if there is any risk of lasting consequences.
Updated Nov. 30, 2007