Please check, as each item is completed:

____ 1. UNIVERSITY HEADING Type consent form on a Southwestern Adventist University letterhead or include Southwestern Adventist University and the name of the Department in the heading on the form.

____ 2. CLEAR TITLE OF PROTOCOL Keep the title simple and retain the same title in the consent form.

____ 3. SIMPLIFIED LANGUAGE Avoid technical jargon, using language appropriate to the reader, and understandable at about the eighth grade level. A separate explanation may be required in the subject's primary language. Compose the form using the first person and begin each explanatory paragraph with "I have been told . . .".

____ 4. NO IMPLIED LIABILITY RELEASE No informed consent, whether oral or written, may include any exemption-clauses through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases, or appears to release the investigator, the sponsor, the institution, or its agents from liability or negligence.

____ 5. PURPOSES AND PROCEDURES a. Provide a statement that the study involves research. b. Give an explanation of the purposes of the research. c. State the expected duration of the subject's participation. d. Give a description of the location and procedures to be followed. e. Identify any procedures which are experimental.

____ 6. RISKS EXPLAINED State the nature and degree of any reasonably foreseeable (or potential) risks, stress, discomfort, or invasion of privacy. Risk is defined as the possibility of harm; physical, psychological, sociological or other that may occur as a consequence of any activity which goes beyond the application of the established and accepted methods necessary to meet the subject's needs.

____ 7. BENEFITS DESCRIBED Describe the potential benefits of the study. Several examples follow: "I have been told the benefits to me (to my child or to humanity) are . . ."; "I have been told that because of the experimental nature of this study, it is possible that these benefits may not occur, and that complications and undesirable side effects, which are unknown at this time, including worsening of my condition, may result."

____ 8. PARTICIPANTS VOLUNTARY PARTICIPATION Describe the voluntary nature of participation, the freedom to withdraw at any time without penalty, and the conditions of termination. (Note the following example: "I have been told that refusal to participate in this study will involve no penalties nor loss of benefits to which I am entitled and that I may still receive the following established form's of treatment.")

____ 9. ALTERNATIVE TREATMENTS State the appropriate alternative procedures or courses of treatment that might be advantageous or available to the subject. (If applicable)

____10. CONFIDENTIALITY AND/OR ANONYMITY Indicate the extent of confidentiality or anonymity that will be maintained. "I have been told that my identity in this study will not be disclosed in any published document." (If applicable)

____11. ADDITIONAL COSTS State any additional costs to the subject or a third party that may result from participation in the research.

____12. REIMBURSEMENT OR COMPENSATION Explain if there will be a reimbursement of costs or other inducement. "I have been told that I will be paid the sum of $________ for participating in this study." If no compensation is to be given, this should be stated.

____13. RESEARCH-RELATED INJURY For research involving more than minimal risk, state the following:

a. Plan for handling injury.

b. Nature of compensation, if any.

c. Name, address, and telephone numbers of persons to be contacted.

____14. IMPARTIAL THIRD PARTY CONTRACT Example: "I have been told that if I wish to contact an impartial third party, not associated with this study, regarding any complaint I may have about the study, I may contact (name, address, telephone number) for information and assistance." Or, give information on how to contact the investigator.

____15. INFORMED CONSENT Opportunities for the subject to ask questions must be given before subject-consent is granted. For instance, "I have read the contents of this consent form and have listened to the verbal explanation given by the investigator. My questions concerning this study have been answered to my satisfaction. I hereby give voluntary consent to participate in this study (or for my child to participate in this study). If I have additional questions or concerns, I may contact (Investigator's name, address, telephone)."

____16. COPY OF CONSENT FORM Each person signing the consent form must be given a copy of that form. For example, "I have been given a copy of this consent form." If a copy is not given, state this in the actual consent form.

____17. PREVIOUS RESEARCH PARTICIPATION Use only if needed for your particular study. "I have____/have not____ participated in any research study in the past three months. My participation occurred in (day/month/year) and involved . . .".

____18. DATED SIGNATURES Provide a signature and date-line for each subject, parent, or legal guardian (include relationship), witness, and investigator, as applicable.

Examples:

a. Competent Adult Subject -

b. Subject is a Minor (Child must also sign if aged 7 years or older. -

c. Subject is NOT able to sign.

Subject is unable to sign because: _________________________________________________________________________

d. Signature of Investigator

"I have reviewed the contents of this form with the person(s) signing above. I have explained potential risks and benefits of the study."

____19. INPATIENT STUDIES For all inpatient studies, to ensure that patients receive coordinated care, the primary physician must sign and date (usually just below the investigator) this form as an indication the she/he has knowledge of the research study.

____20. NUMBERING OF ADDITIONAL PAGES If more than one page is used for the consent form, show pages numbered as "Page 1 of 3, Page 2 of 3, etc."