Informed Consent

Achieving informed consent

Informed consent is a process that begins with the recruitment and screening of a human subject and continues throughout the subject’s involvement in the research. The principles of informed consent rest with respect for persons. Each individual has the right to decide whether to participate in research, and each individual must be given all relevant information and have their questions answered before they make a decision to participate in research. The following information must be provided to subjects, in keeping with federal law (45 CFR 46.116(b)):

  1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
  2. A description of any reasonably foreseeable risks or discomforts to the subject [Understanding Risk];
  3. A description of any benefits to the subject or to others which may reasonably be expected from the research;
  4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
  6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
  7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
  8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
  9. One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:

    (i) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or

    (ii) A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

Informed consent does not end once a subject signs an agreement to participate.  It is, rather, a process that starts with recruitment and continues to the completion of the project.  Researchers make a commitment to ensure that subjects have their questions answered and their concerns addressed at any point in a study and that they continue to consent in their participation.

Documenting informed consent

In most instances, informed consent must be documented by an agreement with each participant in a research project. The law requires that the consent form be signed by the participant or their legal representative, or under appropriate conditions (45 CFR 46.117(b)(2)), presented orally and signed by a witness.

Federal law allows for a waiver of signed consent documentation only in special circumstances. An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

  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; or
  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.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with an oral or written statement regarding the research (45 CFR 46.117(c)). The exception to a signed consent agreement is most often granted in cases of anonymous online surveys that present no more than minimal risk to participants. More information is available at Human Subjects Research and the Internet.  For such surveys, the IRB typically requires a written statement with the necessary information provided to participants prior to the commencement of the survey. Consult the IRB administrator for more information about documentation waivers.

For more information, visit the Informed Consent site of the federal Office of Human Research Protections.