UNIVERSITY OF WASHINGTON
HUMAN SUBJECTS DIVISION

ELEMENTS OF CONSENT

1. that the study involves research; an explanation of the purposes of the research and the expected duration of the subject's participation; a description of the procedures to be followed; and identification of any procedures which are experimental.
2. any reasonably foreseeable risks or discomfort to the subject.
3. any benefits to the subject or to others which may reasonably be expected from the research.
4. appropriate alternative procedures or courses of treatment that might be advantageous to the subject.
5. the extent, if any, to which confidentiality of records identifying the subjects will be maintained.
6. for research involving more than minimal risk, whether any compensation and/or medical treatments are available if injury occurs and, if so, what they consist of or where further information may be obtained.
7. whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
8. that participation is voluntary, that refusal to participate or withdrawing from participation will involve no penalty or loss of benefits to which the subject is otherwise entitled.

1. University of Washington heading.
2. name, position, department, and telephone number of the investigator(s).
3. costs the subject may ultimately be forced to bear.
4. reimbursement of costs or other inducements the subject will receive.
5. that the researcher has explained the study to the subject.
6. that the subject has had an opportunity to ask questions before consenting.
7. signature and date lines to be completed by the investigator, the subject, and, when appropriate, the guardian or subject-advocate.

1. that the particular treatment or procedure may involve unforeseeable risks to the subject (or to the embryo or fetus, if the subject is, or may become, pregnant).
2. anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
3. the consequences of a subject's decision to withdraw from the research, and procedures for orderly termination of participation by the subject.
4. that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.
5. the approximate number of subjects involved in the study.
6. for Questionnaires, Scales, Inventories, and Interviews: the nature of the questions to be asked, including the most personal and sensitive questions; that the subject may refuse to answer any question; estimate of the length of time needed to complete the activity.
7. for Recordings, Photographs, Videotapes, Audiotapes of the Subject: what recordings will be made; how long the recordings will be retained before being destroyed and how confidentiality will be maintained ; how the recordings will be used outside the research group and that the subjects will be provided an opportunity to delete portions of the recordings they consider personally damaging.
8. for Medical Records: what data will be drawn from the records.
9. for Data on Illegal or Socially Sensitive Activities: how the confidentiality of the data will be maintained and how immune the data are from subpoena.
10. for Drug, Alcohol, and Investigational Device Studies: name of the drug/device, dosage, how administered, frequency, for what duration, possible side effects, cautionary statements on concurrent use of other drugs/alcohol ; that subjects might receive placebo; that, as with any drug (or device), there may be unanticipated adverse effects; for action to be taken in the event of an adverse effect; a 24-hour emergency telephone number for subjects to call in the event of an adverse effect; cautionary statements about the operation of machinery or motor vehicles; that a drug company will have access to the study data or to subjects' personal medical records; the phase of testing; whether the number of subjects is limited, and that the FDA has allowed use of the drug or device for research; whether the drug or device will be available at the conclusion of the study for the subject if it is found to be effective for the subject; that the FDA may inspect the records of the research.
11. for Studies Involving Radiation: an estimate of the hazard in terms readily understandable to the layman, e.g., a multiple of the background radiation to which people are exposed in one year, or as comparable to the exposure allowed radiation workers in one year.
12. for Studies Involving Electrical Equipment: any special risks that may be associated with the equipment; what equipment will be used and how it will be used in the research.
13. for Studies Involving the Bureau of Prisons: that participation in the research project will have no effect on the inmate-participant's release date or parole eligibility; the purpose of each procedure.

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