GUIDE FOR PREPARING THE INTERNAL PROCESSING FORM
FOR REVIEW OF RESEARCH INVOLVING HUMAN SUBJECTS
 

ForewordThe responsibility of the Committee on Research Involving Human Subjects is to review proposed research procedures to ensure that the investigator is aware of and is taking adequate precautions against risk to participants in research, their privacy, their rights, and their welfare for the duration of the research and in the future. The official function of the committee is advisory to the Departmental Chairperson.It is recognized that project review by the committee may restrict freedom of research procedure for the investigator. However, review is important to our professional reputation and to the growing concern for human rights and welfare. There is no way to definitely ascertain what the future uses of research reports will be or what the consequences to individuals and groups might be. It is also recognized that the privacy of participants in most behavioral research projects is necessarily invaded to some extent.

Because there has been some disregard for the privacy, rights, and welfare of research participants in the past, some pressure has arisen to enact legislative controls on research procedures. Arbitrary restrictions of this sort could unduly hamper research involving human subjects and still not adequately protect participants and groups. Research can be carried out more effectively without such arbitrary controls, and many projects need to be carefully considered in terms of their own merits and unique design features. It behooves researchers to respect the privacy and rights of participants and groups for their own protection, as well as for the protection of those from whom information is obtained.

The committee hopes to learn along with the investigators how best to build safeguards and ethical considerations into research projects. If a proposal is returned to the investigator, it will often be for clarification. Our judgment is neither absolute nor necessarily better than that of others, but the committee attempts to carry out its responsibility with due regard for the best interests of all relevant parties.

Procedure The Internal Processing Form will be reviewed by the committee in order to determine the following:

1. that the research project:
a. involves no foreseeable possibility of risk to individuals or groups involved or
b. has incorporated into its design adequate safeguards against such possible risk.

2. that adequate means of obtaining informed consent from individuals and groups have been established,

3. that due regard for the rights and welfare of individuals and groups is apparent.

The committee-approved form will be submitted to the Departmental Chairperson for official approval before it is sent to the Office of Research Services for final approval.

The form is to be submitted in triplicate in order to expedite review, which ordinarily takes at least two weeks. If faster review is required, the committee should be so notified. It may save time to furnish the committee with copies of the research proposal, any instruments to be used, and the exact wording by which “informed consent” is to be obtained.

If the investigator is a student, the advisor (or instructor) should review and sign the form before it is submitted. In the event that the committee elects not to approve the form as it stands, it will be returned to the investigator. After appropriate additions, clarifications, or revisions have been made, the committee will again review the form.

It is essential that the investigator consider the many possible results and repercussions of his or her research procedures and report the means of minimizing the probability of undesirable consequences to individuals or groups involved. Every effort should be made to prevent such consequences. (The Committee is aware that it may be impossible to optimally guard against all risk and still do research involving human subjects.) It is advisable to review the Principles of Professional Responsibility of the American Anthropological Association.

Research participants should not be named in research records or reports. If group identity or identifying information is to be made generally available, this should be adequately justified, especially if identity is apparent in title or abstract. One reason for this is protection of the group. Another is to protect individuals who might be identified or suspected if group identity is apparent. The investigator should have particular concern for protecting anonymity in any case where illegal or negatively sanctioned activities, intentions, or beliefs might be involved. It is necessary to consider the possibility of a court subpoena of raw data, records, or unpublished reports and of other legal requirements to divulge identities or information.

It is essential that each individual participant be informed as fully as possible of the nature of the research in which that participant is to be involved and that fully informed consent is obtained before participation begins. Each individual should be made aware of any possible consequences of the research which can be foreseen as being undesirable. This is in addition to obtaining fully informed consent from legitimate representatives of any organized group which is involved in the research project. (In reply to question 3 on the processing form, specifically state what the participants are to be told.)