Informed Consent

Assent and Parental Permission

Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English

IRB SOP - Translation of Study Documents

Declaration of Translators

Informed Consent
Informed consent is a process. A written informed consent documents this process, but cannot serve as a substitute for it. No subject may be involved in research without the legally effective informed consent of the subject or the subject's legally authorized representative. This consent shall be sought under circumstances that provide sufficient opportunities for the subject to freely consider whether or not to participate. If the subject is a minor, written parental consent or legal guardian consent is required, and the investigator must obtain the assent of the child unless the child is incapable of giving assent.
The information given to the subject, or the subject's legally authorized representative, must be in simple, easily understood language. If the subject population is not English-speaking, the informed consent must be presented in whatever language is appropriate. If a potential subject is illiterate, the investigator will be required to use a competent witness to verify voluntary informed consent.

Written documentation of the consent process is always required unless specifically waived by the IRB. The consent document should be signed by the subject or the subject's legally authorized representative unless this requirement is waived by the IRB.

In some types of projects, it may be important for information pertaining to consent to be provided verbally. In such an instance, a written summary (script) of what the potential subject will be told must be provided to the IRB for review and approval. Investigators should explain the rationale for not obtaining written informed consent in order that the IRB may approve such an exception.
No informed consent, whether oral or written, may waive or limit in appearance or in fact, the subject's legal rights, including any release of the institution or its agents from liability or negligence.

The following information must be a part of all written informed consent documents:

  1. A statement that the project is research and an explanation of the scope, aims and purposes of the research, and the experimental procedures to be followed, including the expected duration of the subject's participation. This statement should include a description of any anticipated benefits the subject or others might reasonably expect.  If there is no direct benefit to the subject, this should be stated.
  2. A description of any reasonable foreseeable risks or discomforts to the subject (including likely results if an experimental treatment should prove ineffective). If the risk potential is currently unknown or cannot be measured, a statement to that effect will be required.
  3. A statement regarding the availability of compensation, medical treatment, or other services if injury occurs will be required for research that involves more than minimal risk. If compensation or medical treatment will be provided, information about whom to contact and the procedure for receiving medical treatment in the event of a research related injury.
  4. A statement that any new information developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided. Related to this, an offer to answer any questions the subject (or the subject's representative) might have regarding the subject's rights shall be included.
  5. A statement describing the method by which confidentiality of records identifying the subject will be maintained, who is entitled to access to those records, how long they will be kept, and the final disposition.
  6. A statement that participation is voluntary and that refusal to participate or a subsequent decision to discontinue participation will not result in penalty or loss of benefits to which the subject is otherwise entitled. This statement should include a description of the consequences, if any, that accompany such a decision to withdraw and should explicitly state methods of withdrawal.
  7. A signed copy of the informed consent shall be provided to the subject or the subject's legally authorized representative.
  8. Federal law mandates that copies of all informed consents be retained for a minimum of three years after completion of the research. The principal investigator is responsible for the maintenance and retention of such records.

Please follow the Informed Consent Checklist when preparing your consent documents.

The information given to the subject, or the subject's legally authorized representative, must be in simple, easily understood language. If the subject population is not English-speaking, the informed consent must be presented in whatever language is appropriate. If a potential subject is illiterate, the investigator will be required to use a competent witness to verify voluntary informed consent. Please see "Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English" below.

Waiver of Informed Consent

There are certain conditions under which the IRB may approve a consent or permission procedure which alters or omits one or all of the required elements, or waive the requirement for informed consent altogether. The research must involve no more than minimal risk, 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 subject will be provided with additional pertinent information after participation (45 CFR 46.116d).

Generally, research involving existing data, documents or specimens may qualify for a waiver of informed consent, provided that the research will not result in any information that should be shared with the subject. In addition, parental permission can be waived if the IRB determines that a 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 subjects (for example, neglected or abused children). An appropriate mechanism for protecting the children who will participate as subjects in the research needs to be provided, and the waiver may not be inconsistent with federal, state, or local law (45 CFR 46.408e). Generally, certain studies of adolescent behavior (such as contraception and/or sexual activity) may qualify for such a waiver.

The IRB may modify or waive written documentation of informed consent. The regulations allow for the use of a modified “short form written consent document” combined with an oral presentation of the required elements provided that, among other requirements, there is a witness to the oral presentation, and the oral presentation follows a IRB approved script (45 CFR 46.117b).

Written documentation of informed consent can be waived entirely if (1) 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; or (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 the research context (45 CFR 46.117c). Examples where the written consent form may present a risk of confidentiality include data collection from individuals who are HIV-positive, or observational and interview research with individuals engaged in illegal behavior.

See Flowchart - Waiver of Consent for help in determining whether you can request a waiver from the IRB.

Please complete the Waiver of HIPAA-Informed Consent form if you are requesting a waiver of informed consent and/or waiver of HIPAA Authorization.

 

Examples of Simple Words

Glossary of LayTerms