Except as provided in sections 4, 5, and 6 below, informed consent shall be documented by the use of a written consent form approved by the HSRB and signed by the subject or the subject's legally-authorized representative. A copy shall be given to the person signing the form.

1. Required Content of the Written Informed Consent Document:

a. A statement that the activity involves research and a description of where the research activity will occur.

b. An explanation of the scope, aims, and purposes of the research, and the procedures to be followed (including identification of any treatments or procedures which are experimental) and the nature of the expected duration of the subject's participation.

c. A description of any reasonably foreseeable benefits, if any, to the subjects or others, which may result from the research.

d. A disclosure of appropriate alternative procedures or courses of treatment (in instances where therapeutic procedures are involved), if any, that might be advantageous to the subject(s).

e. A statement describing the extent to which confidentiality of records identifying the subjects will be maintained.

f. An offer to answer any questions the subjects may have about the research, the subject's rights or related matters, and the name of the person (together with address and telephone number) to whom the subjects may direct questions or report an injury.

g. A statement that participation is voluntary, that refusal to participate involves no penalty nor loss of benefit to which the subjects are otherwise entitled, and that the subjects may discontinue participation at any time without penalty or loss to which the subjects are otherwise entitled.

h. For research which may involve more than minimal risk of injury, the subject needs to be informed of the following statement, which must appear in the consent form: (Statement is to be modified for off-campus research.)

"I understand that in the unlikely event of injury resulting from research procedures, Southwestern Adventist University, its agents, and its employees will assume whatever responsibility is required by law. Emergency medical treatment for injuries or illness is available in instances where the injury or illness is incurred in the course of an experiment."

i. A space for the dated signatures of the subject, the principal investigator, and a witness. In the case of a minor (the child must also sign if seven years of age or older) or a person unable to sign, a second authorizing signature is required from the parent, guardian, or other person responsible for the subject. The relationship must be specified. In the event of a subject with whom there is a communication barrier--blind, deaf, language, inability to understand--there must be a means of obtaining appropriate signatures that assures the complete understanding on the part of that subject regarding the implication of participation.

2. Format of the Written Consent Form

a. The consent form should be either printed on a Southwestern Adventist University letterhead or, alternatively, the name of Southwestern Adventist University should be centered at the top of the consent form, together with the name of the investigator's department. In cases where an anonymously-returned questionnaire substitutes as a form of implied consent (See Section 4.b, below), the cover letter accompanying the questionnaire should clearly identify that the research is connected to Southwestern Adventist University.

b. The consent form should clearly indicate the name, address, and telephone number of an individual (the investigator and/or an impartial third party) whom the research-subject may contact for additional information.

c. Places for the dated signatures of the subject (and/or parent/guardian, if applicable), investigator, and witness should be included at the bottom of the consent form.

3. Retention of the Signed Consent Form

a. A copy of the consent form must be returned to the subject or the person legally appointed to sign the consent form, to retain in her/his review and records.

b. The responsibility for retaining signed copies of the consent form lies with the principal investigator(s). The consent forms must be kept in a secure depository, along with the investigator's other records for a reasonable period of time (normally, not to exceed three years from the date of project-completion).

4. Use of Alternate and/or Simplified Consent Forms

Certain situations may justify the use of alternate and/or simplified consent forms. However, in all cases the investigator must demonstrate how the anonymity and/or voluntary participation of the research subject(s) will be maintained.

a. Oral Instructions Presented (Read) to a Group. In the case of no risk or minimal risk research, where instructions are read to a group of subjects (e.g. a questionnaire distributed in a classroom setting), a short form to document the oral instructions presented to the subjects may be used. A witness who heard the oral instructions read to the group must co-sign the short form, along with the investigator. A written copy of the oral instructions which are to be read to the group must be submitted with the protocol. The items-list in Section 1, above, need to be included in the oral instructions.

Research using surveys or questionnaires and dealing with sensitive areas of the respondent's own behavior (illegal conduct, drug/alcohol use, sexual behavior, etc. (See Exempt Review, item 4) require special consideration. Although the purpose and use of surveys and questionnaires in such research may be explained in a classroom-setting (with prior documented permission of the instructor(s) involved), requesting respondents to actually complete the survey instruments in the classroom setting is not appropriate. Alternative methods of collecting forms completed at the discretion of the respondent, and which thus ensure the respondent's anonymity, should be employed.

b. Anonymous Surveys or Questionnaires. In the case of research with no risk or minimal risk, involving the use of surveys or questionnaires which are distributed individually and returned anonymously, the cover-letter explaining the purposes and procedures of the research project may substitute for the consent form. The cover-letter must be submitted with the protocol and must contain reference to the items mentioned in Section 1, above. The investigator must state in the cover-letter, as well as on the survey form itself, that the return of the survey or questionnaire serves as a form of implied consent.

c. Simple Oral Interviews. Investigators conducting simple oral interviews, the content of which qualifies as exempt from review (see Exempt Review, item 4), may submit an alternate form of written documentation in place of a consent form. Such documentation should describe how the interviewer will explain his/her research to the interviewee and how the investigator is prepared to ensure the interviewee's anonymity and the right to refuse participation in the interview.

5. Waiving of Signed Consent Documentation

The HSRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds that either of the following conditions exist:

a. The only record linking the subject and the research would be the consent-document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research. The subject's wishes will govern.

b. The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

6. Waiving the Consent Process

The HSRB may, under certain special circumstances, approve a consent-procedure which does not include nor which alters some or all of the elements mentioned above or may waive the requirement to obtain consent provided the Board verifies and documents each of the following items:

a. The research involves no risk to the subjects.

b. The waiver or alteration of consent will not adversely affect the rights and welfare of the subjects.

c. The research could not practicably be carried out without the waiver or alteration.

d. Whenever appropriate, the subjects will be provided with additional pertinent information, after participation.

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