Office for Human Research Protections (OHRP)
§46.116 Informed Consent Checklist - Basic and Additional Elements
- A statement that the study involves research
- An explanation of the purposes of the research
- The expected duration of the subject's participation
- A description of the procedures to be followed
- Identification of any procedures which are experimental
- A description of any reasonably foreseeable risks or discomforts to the subject
- A description of any benefits to the subject or to others which may reasonably be expected from the research
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
- 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
- Research, Rights or Injury: 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
- 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
Additional Elements as Appropriate
- A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent
- Any additional costs to the subject that may result from participation in the research
- The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
- A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject
- The approximate number of subjects involved in the study
§46.117 Documentation of Informed Consent Checklist
- Except as provided in paragraph "c" of this section, informed consent shall be documented by the use of a written consent form approved by the IRB, and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.
The consent form may be either of the following:
- A written consent document that embodies the elements of informed consent required by §46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator should give either the subject or the representative adequate opportunity to read it before it is signed.
- A short form written consent document, stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.
Waiver of Requirement for Signed Form
c. 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 a written statement regarding the research.
IRB Latitude to Approve a Consent Procedure that Alters or Waives some or all of the Elements of Consent
§ 46.116 - An IRB may approve a consent procedure, which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent, provided the IRB finds and documents that:
- C: 1.The research or demonstration project is to be conducted by, or subject to the approval of, state or local government officials, and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and
- C: 2.The research could not practicably be carried out without the waiver or alteration.
- D: 1. The research involves no more than minimal risk to the subjects;
- D: 2.The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- D: 3.The research could not practicably be carried out without the waiver or alteration; and
- D: 4.Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Special Requirements - 45 CFR 46 Subpart D - Additional DHHS Protections for Children Involved as Subjects in Research
The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted, or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children, and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances, in which consent may be waived in accord with §46.116 of Subpart A.
- The IRB may find that the permission of one parent is sufficient for research to be conducted under §46.404 or §46.405.
- Where research is covered by §46.406 and §46.407, and permission is to be obtained from parents, both parents must give their permission, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
- 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), it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, state or local law.