IRB Informed Consent

Consent and the Consent Process

General Issues in Informed Consent

No investigator may involve a human being as a subject, or use their tissue or data, in a research activity unless the investigator has obtained the informed consent of the subject o the subject’s legally authorized representative. There are limited conditions under which this requirement is waived. The IRB has approved a format for consent, parental permission and assent. Please follow the format when writing your consent.

Circumstances Under Which Consent Must be Sought

The consent process is one of the most important elements of all research studies involving human subjects. If consent is not obtained properly then the rights of the individual research subject have been violated.

Consent must be sought under circumstances where the subject or representative is given enough time to consider whether or not to be in the study and that minimize the possibility of coercion or undue influence. Information provided to the subject or representative must be written in simple language, so all aspects of the research (e.g., purpose, risks, benefits) are clearly stated, and an informed decision may be made.

An assessment of capacity to give consent must be performed in ALL subjects.

A. Criteria for a Waiver of Obtaining Informed Consent

There are two main exceptions to the requirement for obtaining consent:

1. When GEORGIA TECH IRB finds that ALL of the following conditions are met:
   • The research involves no more than minimal risk to the subjects;
   • The waiver or alteration will not adversely affect the rights
     and welfare of the subjects;
   • The research could not practicably be carried out without
     the waiver or alteration; and
   • Whenever appropriate, the subjects will be provided with additional pertinent information after participation. An investigator may request a waiver of informed consent by providing evidence that the conditions above are met forhis/her research activity.
2. The Food and Drug Administration (FDA) permits an exception to the informed consent requirement before the emergency use of a test article, under certain conditions. (Exemptions from GEORGIA TECH IRB Approval Requirement) should be reviewed for details.

B. Criteria for a Waiver from the Documentation of Informed Consent

The federal regulations allow for a waiver of the documentation of consent (i.e., a signed consent form) if one of the following conditions is met:

1. That 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, and the subject’s wishes will govern;
2. That 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.

Investigators may specifically request a waiver of the documentation of the informed consent requirement by providing information that supports one of the 2 conditions above. Nonetheless, GEORGIA TECH IRB will still require submission of either a consent ’script’ (i.e., to verbally consent a subject, e.g., over the phone) or a consent letter that does not require the subject to sign, but to, e.g., complete an attached survey. In the latter case, the document is written in letter format (’Dear Subject’), and, rather than requiring the subject’s signature to verify consent, the following text is used to end the letter:

‘If you ____________________(e.g., complete the attached survey, answer these few questions etc.), it means that you have read (or have had read to you) the information contained in this letter, and would like to be a volunteer in this research study. Thank you, (signatures of investigators)’

Both methods will need to comply with federal requirements regarding mandated elements of informed consent.

C. Differences between consent, permission and assent

Consent forms are used to consent subjects 18 years or older. Permission forms are used to obtain permission from parents of subjects 17 years or younger (since the subjects themselves cannot consent to being in the study). Assent forms are used to obtain agreement from the minor subject to be in the study.

D. Obtaining Consent from Non-English Speaking Subjects

An important aspect of the consent process is to provide the information in a language understandable to the subjects. GEORGIA TECH IRB recognizes 2 methods for obtaining consent from non-English speaking subjects:

1. For those consent forms that must be translated into a foreign language, an affidavit of accurate translation must be provided from an appropriate translator who is unaffiliated with the study. The translated consent form and affidavit must be submitted and approved by GEORGIA TECH IRB before use of the consent form.
2. The Office for Human Research Protections offers guidance on ‘Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English’, which GEORGIA TECH IRB formally accepted on February 22, 2001, as adequately protecting the rights of non-English speaking subjects. This method involves use of a GEORGIA TECH IRB-approved English language consent form, a GEORGIA TECH IRB-approved short consent form written in the non-English language, and a witness fluent in both English and the language of the subject. The details are available at: http://www.hhs.gov/ohrp/humansubjects/guidance/ic-non-e.htm.