Policies and Procedures - Human Subjects

Policies and Procedures Involving Human Subjects

The Committee on the Protection of Human Subjects (COPHS) was established in 1972, pursuant to requirements by the United States Department of Health, Education and Welfare (a.k.a., Health and Human Services). This federal agency specified that all insti tutions of higher learning must create such a committee and further specified strict guidelines for the committee's operation. Under federal regulation, the committee is to be the final authority regarding research involving human subjects on the campus. Failure of a university or college to establish a committee on the prot ection of human subjects and to provide it with the appropriate authority results in the loss by that institution of all federal funding.

Since the committee was established, members of the committee have worked to write and revise institutional policies and practices that would provide true protection for human subjects with minimal interference in academic or research activities. The institutional policies and procedures specified in this document have been approved by the Committee on the Protection of Human Subjects (COPHS) and are operational at this time.

Preamble

All research, experimentation, teaching and other activities involving the use of human subjects conducted under the aegis of Plattsburgh State University of New York are under the jurisdiction of the COPHS. Consequently, all such activities are subject to review and approval by the committee. In deciding whether or not approval will be granted for a particular study or project, the committee will consider:

1. the rights and welfare of the individuals involved,
2. the appropriateness of the methods proposed to be used in obtaining the "informed consent" of the individual involved, and
3. The risks to the human subjects and the potential benefits involved.

Mindful of the profound implications of its charge, the committee is yet concerned that its activities and jurisdiction not obstruct in any way the vigorous implementation of legitimate academic research and teaching programs in which proper attention has been given to the rights and welfare of human subjects who may be involved as participants. It is clear that there will be occasions when these two goals (the committee's responsible discharge of its duty and the freedom of an investigator to organize and conduct a project in the way he/she chooses) come into conflict. Indeed, it is not difficult to conceive of circumstances in which the goals may be mutually exclusive. The committee, in such cases, will make every attempt, with the investigator/s, to ameliorate or to resolve the problem/s. In so co mmitting itself, however, the committee emphasizes that it does have final campus jurisdiction regard to studies in which human subjects are involved.

It is thus incumbent upon those proposing the use of human subjects in projects that may be viewed (by the committee) as compromising the rights and/or welfare of the subjects to persuade the committee that these rights and welfare will be protected under the protocol proposed for use. The institutional practices outlined in this document are designed to both facilitate the development and processing of proposals from members of the faculty, staff and studen t body and to ensure that not only th e letter but the spirit of the Federal regulations governing the use of human subjects in research or teaching projects are met.

A. When to Submit a Protocol to the Committee on 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 harm to subjects. The ultimate responsibility for assuring such protection resides with the investigator. Responsibility also resides with the investigator's department chairperson/supervisor and the committee on the Protection of Human Subjects (COPHS). A research project involving the use of human subjects including on e that is conducted in conjunction with a college course may require review by the department chairperson and COPHS 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 concerning the classification of a particular study into one of these three categories should be directed to the chair of the COPHS.

Category I - Exempt Research (Limited COPHS review required)

Investigators who feel their projects fall under this category must file a memorandum along with a copy of the instruments to be used to the Chair of COPHS which briefly describes the nature of the project and explains how anonymity will be guaranteed at least two weeks before commencing with the project for determination of exemption.

1. Projects involving collection of data through the use of opinion surveys, questionnaires or interviews (e.g., opinion surveys, marketing surveys, exit interviews) for which response is voluntary and completely anonymous. When data gathered concerns issues of personal sensitivity (e.g., drug use, criminal behavior, sexual behavior, or employability, financial standing or reputation) careful attention is needed to assure complete anonymity with no linkable, individually identifiable data.
2. Projects limited to activities involving normal educational practices in commonly accepted educational settings (e.g., in-class demonstration studies, laboratory exercises, and studies of curriculum or teaching strategies).
3. Usually, any study, which requires that subjects be removed from their normal classroom situation for testing, and or involves minor children, is not exempt.
4. Projects limited to the observation of public behavior for which anonymity of subjects is maintained.
5. 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.

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" (Code of Federal 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.

Category III - Research Activities Subject to Full COPHS Review

1. 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).
2. Projects requiring the use of deception.
3. Projects requiring the use of subjects from populations in need of special protection (e.g., prisoners, individuals with disabilities, victims of abuse, pregnant women, and children).

B. The COPHS Review Process

Many exempt projects (Category I) can be conducted without full COPHS review, but require the filing of a memorandum explaining the proposed research and attaching a complete copy of the instrument/s to be used with COPHS two weeks before data collection begins. In these cases, the chair of COPHS 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 COPHS review.

If the project requires expedited (Category II) or full review (Category III), then you must submit a protocol to the COPHS.

Ordinarily, it takes at least three weeks to complete an expedited (Category II) review. The expedited review is done by mail ballot. Each member of the COPHS receives a copy of the 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 COPHS review may be conducted.

Full COPHS review (Category III), includes a formal hearing during which the COPHS members may ask questions directly of the investigator/s about the need for the planned use of human subjects. During the hearing, investigator/s may amend their proposal in response to concerns of COPHS members. After the hearing, COPHS members vote to either approve or disapprove the proposed project.

If an Application for the Use of Human Subjects is not approved by COPHS, the investigator may resubmit an application taking into account the recommendations made by COPHS. No activity involving the use of human subjects may proceed without the approval of COPHS. All work must immediately cease with all copies of all related material s surrendered to the Chair of COPHS for destruction. Failure to comply with this policy may result in a recommendation for disciplinary action on accordance with the relevant collective bargaining agreement, Board of Trustees Policies, and institutional policies.

C. How to Prepare a Protocol

In order for the COPHS 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.
4. Complete the Application for the USE of Human Subjects and respond to all questions on the face page and page two.

D. Additional Policies

1. All communications with the COPHS should be submitted to the Office of Sponsored Research and Programs, 815 Kehoe Building.
2. 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 re-approval is all that must be submitted. Any significant change requires a new review by the COPHS.
3. 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. Informed consent forms must always be securely stored separately from the research/study data and under the protection of the investigator.
4. At any point during the project, problems arising from the use of human subjects must be reported to COPHS.
5. Within thirty (30) days of the conclusion of data collection on an approved project, a memorandum must be filed with COPHS indicating project termination and specifying any difficulties that occurred with the use of human subjects.

E. 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 it agents from liability for negligence.

In projects where subjects are determined to be at risk, the actual procedure utilized in obtaining "legally effective informed consent" must be fully documented. This is accomplished by using a written consent form embodying all of the elements of information required for the project. The consent form must be read by or to the subject or his/her legally authorized representative and signed by the person giving consent. A copy of the consent form must be given to the person signing the form and the signed form must be maintained in the investigator's files for a period of three years following the completion of the study. Special rules govern the giving consent of and/or child or mentally challenged individuals, and require parental or legal guardian consent.

Basic elements of information necessary to such consent are:

1. A statement that the study involves research, an explanation of the purpose of the research and the expected duration of the subject's participation and a description of the procedures to be followed;
2. A description of any foreseeable risks or discomforts to the subject;
3. A statement describing the extent to which confidentiality of records identifying the subject will be maintained;
4. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights;
5. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled and the subject may discontinue participation at any time.

COPHS has available sample forms which can be used as a guide in preparing the consent form that will actually be used in a research project or activity. Please note that the final form that will be administered to subjects must first be approved by COPHS before it can be legally administered.

In some cases, COPHS may approve a consent procedure which does not include, or which alters some or all of the elements of informed consent or may entirely waive the requirement to obtain informed consent. In rare cases, where these procedures will surely invalidate important objectives of a project, COPHS approval of modified procedures may be sought. Some research projects may require more restrictive policies as determined by COPHS.

F. 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 COPHS. 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 must be taken, however, to protect the rights and welfare of students who act as subjects.

All individuals wishing to engage in Human Subjects Research must take and pass the Plattsburgh State Human Subjects Certification Program prior to applying for review of the application. All investigators must have certification to engage in research involving human participants.

Human Subjects Research Education Site

• SUNY CITI Course
• Download Human Subjects Form Note: this 26kb PDF document requires latest version of the Adobe Acrobat Reader, which is available as a free download

Contact Information

Office: Kehoe 815
Phone: (518) 564-2155
Fax: (518) 564-2157

Research Foundation at SUNY Plattsburgh
Kehoe 815
101 Broad Street
Plattsburgh, NY 12901