Guidelines for Research with Human Subjects

For questions, please contact:
Lynn Winters, Chair, Human Subjects Committee (2014–15)

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 only; 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 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.

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 Human Subjects Committee (HSC) 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 HSC, 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 Human Subjects Committee before data collection begins.

Human Subjects Committee

The Human Subjects Committee (HSC) 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’ 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 HSC 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 HSC is required to monitor compliance with OHRP guidelines and the recommendations of the committee.

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Research Exempt from Review by the Human Subjects Committee

Research done with adult participants by Purchase students, faculty, or staff that meets the following criteria is exempt from review by the Human Subjects Committee:

  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. 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.
  3. 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.
  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 (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.

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, before 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 Human Subjects Committee, 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.

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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 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 HSC. 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 HSC.

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Review Procedure

The researcher must submit a brief research proposal along with a memo addressed to the chair of the HSC. The proposal must include the information shown in the Outline for Proposals to the Human Subjects Committee (Appendix). 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 made in the materials or procedures after the proposal has been approved.

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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 HSC 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 HSC will require verification of compliance from someone other than the principal investigator or faculty sponsor. These cases include 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 committee. In all cases, the approval period will be specified in the notice of approval provided to the investigator(s) by the HSC.

In addition, research participants, research assistants, and others who have direct knowledge of a research project may report to the HSC 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 HSC, and contact information for the committee chair must be provided.

When a report of noncompliance or unanticipated problems is received, the chair of the HSC 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 HSC, who will determine whether approval of the project should be terminated. A report of the complaint and the decision of the HSC 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 HSC 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.

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Appendix: 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 ensure 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.

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Updated June 19, 2014


Updates
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