Drafting a Consent Form
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Consent forms will be reviewed carefully by the Board to insure that the basic elements of informed consent are included. By following the instructions on the sample consent form, all requirements for informed consent will be met. The Board can require additional elements be included if the information would add to the protection of the rights and welfare of the subject(s). No attempt can be made to coerce or exert undue influence over the subject or the subject's representative to participate in the experiment. The language should be understandable and not contain any exculpatory phrase in which the subject or representative is made to appear to waive any legal rights. The reviewer must be satisfied that the subject has been fully informed and understands the information.
If a project director is submitting his proposal to the Federal Food and Drug Administration for funding, this paragraph should be added to the consent form:
The Federal Food and Drug Administration is requiring that subjects be informed that the "legal right" to privacy that they might expect in other contexts does not apply in the context of regulated research. The FDA need not "seek permission" when the need to inspect such records arises because to do so would, in essence, delegate improperly an authority vested in the agency by Congress.
Consent forms should be no more than two pages and typed on departmental letterhead. The project title should appear on each page and on any tear-off portion of the form.
Waivers or Alterations of Consent Forms
The Board can approve a consent procedure that does not include or that alters some or all of the elements of informed consent if the Board finds and documents that:
| 1. | the research involves no more than minimal risk; |
| 2. | the waiver or alteration will not adversely affect the right and welfare of the subjects; |
| 3. | the research could not reasonably be carried out without the waiver or alteration; |
| 4. | whenever appropriate, subjects will be provided with additional pertinent information after participation; |
| 5. | and, in the case of children, parental or guardian consent may be waived if the research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subject(s) (for example, neglected or abused children), provided an appropriate mechanism for protecting the children who participate as subjects is substituted, and provided that the waiver is not inconsistent with federal, state or local law. |
Documentation of Informed Consent
The Board requires documentation of informed consent and that a copy be given to the persons signing the form. The consent form can be written or read to the subject before it is signed. In either case the subject or the subject's legally authorized representative must be given adequate opportunity to read the form.
Waiver of Documentation
The Board may waive the requirement for obtaining a signed consent form if:
| 1. | the consent form is the only record linking the subject and the subject and the research and the principal risk would be harm resulting from breach of confidentiality. In these instances the subject will be asked if he/she wants documentation linking them to the research. The subjects' wishes will govern. |
| 2. | 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 research context. If documentation is waived, the Board may require the project director to provide subjects with a written statement regarding the research. |
Oral Presentation of Elements of Informed Consent
If the elements of informed consent are presented orally to the subject or to the subject's legally authorized representative, there must be a witness to the presentation who is approved by the Board. To be approved by the Board the witness must be a person who would say "no" to the subject's participation in the proposed research if the project were not fully explained in a language understandable to the subject or if the subject's rights were not protected. The witness must then sign the summary of what is presented. A "short form" consent form must be signed by both subject and witness after the oral presentation of the elements of informed consent.
Consent Form Retention Requirements
The signed summary, the signed "short form" and/or the signed consent form must be kept on campus in either the department office, the project director's office, or the faculty advisor's office for a period of three years beyond the end of the project. In some instances the Board may give approval for the consent form to be kept off campus in an institutional office if the Board feels the consent form will be readily available for a period of three years after the research is completed. The Board may require consent forms for high risk projects be kept in the RAGS office. Under no circumstances should a consent form be kept in the project director's home.
Video/Audio Taping
If a subject is to be video/audio taped a separate consent form is needed. A subject's signature is required for permission to video/audio tape. An additional signature is required to give permission if the tapes will be used for diagnostic purposes, teacher education, and/or presentation to professional meetings.