Office of Sponsored Programs
Campus Policies on Human Subjects


Office of Sponsored Programs
E230 Thompson Hall
State University of New York at Fredonia
Fredonia, NY 14063
Ph: (716) 673-3528

Research compliance including Human Subjects (red section)

Current Human Subjects policies are currently being updated, the current policies remain in effect until the new policies are published.

Campus Policy on the Use of Human Subjects

When to Submit a Protocol to the Institutional Review Board for the Protection of Human Subjects

The protection of human subjects is paramount. All research must employ procedures designed to minimize the risk of physical, psychological or social harrn to subjects. The ultimate responsibility for assuring such protection resides with the investigator. Responsibility also resides with the investigator's department chairperson and the Human Subjects Review Committee (HSRC). A research project involving the use of human subjects including one that is conducted in conjunction with a college course may require review by the department chairperson and the HSRC before it can be conducted.

The responsibility for submission of requests for review of a research project is the responsibility of the investigator. Investigators should use the following three categories of research activities as a guideline for determining the extent of HSRC. Questions concerning the classification of a particular study into one of these three categories should be directed to the chair of the HSRC.
 
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CATEGORY I - Exempt Research (No HSRC review required)

Investigators who feel their projects fall under this category must contact the chair of the HSRC for determination of exemption. Descriptions of the sorts of projects that fit this designation follow:

Projects involving collection of data through the use of opinion surveys, questionnaires or interviews (e.g. SOFIS, marketing surveys, exit interviews) for which response is voluntary and completely anonymous. When data gathered concern issues of personal sensitivity (e.g., drug use, criminal behavior, sexual behavior), investigators should file a memorandum with the HSRC which briefly describes the nature of the project and explains how anonymity will be guaranteed at least one week before commencing with the project.

Projects limited to activities involving normal educational practices in commonly accepted educational settings (e.g., in-class demonstration studies, laboratory exercises, studies of curriculum or teaching strategies). Usually any study which requires that subjects be removed from their normal classroom situation for testing is not exempt.

Projects limited to the observation of public behavior for which anonymity of subjects is maintained.

Projects limited to the examination and analysis of existing data or specimens so long as these are publicly available and individual subjects will not be identified in any report of the research.
 
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CATEGORY II - Research Activities Subject to Expedited Review

The project does not meet the criteria for Category I and involves no more than minimal risk to the subject. Minimal risk is defined as "the risks of harm, anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (HHS regulations). Projects that require expedited review include the following:

  1. Most laboratory investigations of cognition, perception, social behavior and personality.
  2. Any long term investigation of the same individuals where identifying information (including coding schemes) must be maintained with the subject's data.
  3. Studies that require the examination of existing data or specimens that are not publicly available.
  4. Studies involving the collection of voice or video recordings.
  5. Studies of healthy individuals involved in moderate exercise.

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CATEGORY III - Research Activities Subject to Full HSRC Review

Projects that do not meet the criteria for Category II because subjects will be exposed to more than minimal risk (e.g., use of invasive techniques or unusual therapeutic techniques such as hypnosis).

Projects requiring the use of deception.

Projects requiring the use of subjects from populations in need of special protection (e.g., prisoners, individuals with disabilities, pregnant women, and children).
 
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The HSRC Review Process

Many exempt projects can be conducted without full HSRC review, but require the filing of a memorandum with the HSRC one week before data collection begins. In these cases, the chair of the HSRC and a designated member of the Committee will evaluate the effectiveness of procedures designed to maintain the anonymity of subjects. If these procedures are not deemed adequate, then specific changes for improving the protection of anonymity will be requested or the investigator will be asked to submit a protocol for HSRC review.

If your project requires expedited or full review, then you must submit a protocol to the HSRC. Ordinarily, it takes at least three weeks to complete an expedited review. The expedited review is done by mail ballot. Each member of the HSRC receives a copy of your protocol for review. Members are allowed 3 weeks to register any concerns or objections they might have to the manner in which human subjects will be used. Concerns or objections can often be dealt with by having the investigator respond to the specific concerns. If the concerns/objections warrant, a full HSRC review may be conducted. Full HSRC review includes a formal hearing during which the HSRC members may ask questions directly of the investigators about the need for the planned use of human subjects. During the hearing, investigators may amend their proposal in response to concerns of HSRC members. After the hearing, members of the HSRC vote to either approve or disapprove the proposed project.
 
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How to Prepare a Protocol

In order for the HSRC to have adequate information on which to base their review of a proposed project, the investigator or instructor submitting a proposal must attach a written description of the project. This description must at a minimum specify the following:

  1. The purpose and significance of the project including a statement of hypotheses to be tested and an indication of the theoretical, biomedical, and/or social significance of potential findings.
  2. A description of the population of human subjects that will be used and a description of the procedures that will be used for recruiting subjects, for obtaining informed consent (a copy of the proposed informed consent form must be attached), for assuring the confidentiality of their data and for debriefing them.
  3. A description of the materials to which subjects will be exposed during the course of the study, procedures for conducting the study, and a description of the independent and dependent variables under study.

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Additional Policies

All communications with the HSRC should be submitted to the Research Services Office.

Approved protocols are good for a period of one year. If a project continues beyond one year and the investigator/instructor has not made any significant changes in the procedures outlined in the original protocol, a memorandum requesting reapproval is all that must be submitted. Any significant change requires a new review by the HSRC.

Informed consent forms must be retained by the investigator/instructor for a period of not less than three years following the termination of the project.

At any point during the project, problems arising from the use of human subjects must be reported to the HSRC.

Within thirty (30) days of the conclusion of data collection on an approved project, a memorandum must be filed with the HSRC indicating project termination and specifying any difficulties that occurred with the use of human subjects.
 
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Student Research

All student investigators must have a College supervisor who is responsible for insuring that all procedures of the approval are complied with by the investigator. The faculty supervisor must sign the proposal certifying that the project is under his/her supervision.

Class projects may be reviewed as one proposal, at the discretion of the instructor. If the entire class is not using the same procedure, each student or group of students using a different procedure must submit the required information, but the class project will still be considered one proposal.

In general, it is advisable for students to select research projects which are exempt (Category I) or eligible for "expedited review" (Category II). In this way, approval for the projects will take very little time. Students are not, however, prohibited from conducting research in Category III, but additional time may be required to obtain approval from the full HSRC. In all cases, it is the responsibility of the instructor to ensure that students use only approved procedures.

To further expedite the approval of class projects, the instructor can obtain approval before the semester begins under two circumstances: 1) if all of the students are using the same procedure (e.g., a class survey) and the instructor has established the procedures before the class starts, or 2) the instructor submits a list of alternative procedures for approval and the students are to choose one from the list.

Projects conducted as instructional demonstrations where subjects are not solicited from outside the classroom generally do not need to be reviewed. Care should be taken, however, to protect the rights and welfare of students who act as subjects.
 
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Informed Consent

"Informed consent" means the knowing consent of an individual, or his/her legally authorized representative, who is able to exercise free power of choice without undue inducement or any form of force, fraud, deceit, duress or other form of constraint or coercion. An investigator shall seek consent under the following circumstances:

  1. Sufficient opportunity is provided to the prospective subject, or his/her representative, to consider whether or not to participate;
  2. The possibility of coercion or undue influence is minimized
  3. The information that is given to the prospective subject, or his/her representative, shall be in language understandable to the subject or representative; and
  4. The subject, or his/her representative, cannot be made to waive or appear to waive any of his/her legal rights, or release or appear to release the investigator, the sponsor, the institution or its agents from liability for negligence.

Please Note: Researchers should also review and be familiar with the provisions of the campus policies on Scientific Misconduct  and Conflict of Interest.

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Page modified 8/4/14