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POLICY STATEMENT REGARDING THE USE OF HUMAN SUBJECTS AND INFORMED CONSENT

Medicine & Science in Sports & Exercise: October 1996 - Volume 28 - Issue 10 - p 125
Policy Statement Regarding the Use of Human Subjects and Informed Consent
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By law, any experimental subject or clinical patient who is exposed to possible physical, psychological, or social injury must give informed consent prior to participating in a proposed project. Informed consent can be defined as the knowing consent of an individual or his legally authorized representative so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion.

The Editorial Board of MEDICINE AND SCIENCE IN SPORTS AND EXERCISE requires that all appropriate steps be taken in obtaining the informed consent of any and all human subjects employed by investigators submitting manuscripts for review and possible publication. In most cases, informed consent should be obtained by having the subject read a document (an Informed Consent Form) presenting all information pertinent to the investigation or project and affixing a signature indicating that the document has been read and consent given to participation under the conditions described therein. The document should be written so that it is easily understood by the subjects and provided in a language in which the subjects are fluent.

Investigators are requested to consider the following items for inclusion in an Informed Consent Form as appropriate to the particular project:

  1. A general statement of the background of the project and the project objectives.
  2. A fair explanation of the procedures to be followed and their purposes, identification of any procedures which are experimental, and description of any and all risks attendant to the procedures.
  3. A description of any benefits to be reasonably expected and, in the case of treatment, disclosure of any appropriate alternative procedures that might be advantageous to the subject.
  4. An offer to answer any queries of the subject concerning procedures or other aspects of the project.
  5. An instruction that the subject is free to withdraw consent and to discontinue participation in the project or activity at any time without prejudice to the subject.
  6. An instruction that, in the case of questionnaires and interviews, the subject is free to deny answer to specific items or questions.
  7. An instruction that, if services or treatment are involved in the setting or context of the project, they will be neither enhanced nor diminished as a result of the subject's decision to volunteer or not to volunteer participation in the project.
  8. An explanation of the procedures to be taken to insure the confidentiality of the data and information to be derived from the subject. If subjects are to be identified by name in the manuscript, permission for same should be obtained in the Informed Consent Form or obtained in writing at a later date.

If the subject is to be videotaped or photographed in any manner, this must be disclosed in the Informed Consent Form. The subject must be advised as to who will have custody of such videotapes or photographs, who will have access to the tapes or photographs, how the tapes or photographs are to be used, and what will be done with them when the study is completed.

The informed consent document must not contain any exculpatory language or any other waiver of legal rights releasing, or appearing to release, an investigator, project director, or institution from liability. At the bottom of the form, provision should be made for the signature of the subject (and/or a legally authorized representative) and the date. It is generally advisable to precede this with a statement to the effect that the subject and/or representative have read the statement and understand it. In the case of minors, one or both parents should sign (as appropriate). For minors of sufficient maturity, signatures should be obtained from the subject and the parent(s).

The Editorial Board endorses the Declaration of Helsinki of the World Medical Association as regards the conduct of clinical research. Physicians are expected to comply with the principles set forth in this declaration when research involves the use of patients. In the case of psychological research, investigators will be expected to comply with the principles established by the American Psychological Association. These principles are presented in the publication, “Ethical Principles in the Conduct of Research with Human Participants” (American Psychological Association, Washington, D.C., 1982).

It will not be necessary for an author to describe in the manuscript the specific steps that were taken to obtain informed consent, to insure confidentiality of results, or to protect the privacy rights of participating subjects. It will be satisfactory for the author to indicate that,“Informed consent was obtained from the subject”, or by similar wording. It will be understood by the editors that such a statement indicates the author's guarantee of compliance with the directives presented above.

©1996The American College of Sports Medicine