Library: Policy

340:2-39-11.1. Informed consent standards

Issued 9-15-20

(a) Informed consent general requirements.

(1) Research studies submitted for Oklahoma Department of Human Services Institutional Review Board (DHSIRB) consideration must adhere to those requirements necessary to obtain informed consent, per 45 C.F.R. § 46.116.Requirements include, but are not limited to:

(A) obtaining consent prior to involving a human subject in any research study;

(B) providing sufficient time that allows a human subject the opportunity to consider and discuss whether to participate;

(D) information that must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.

(i) The manner in which the key information is described and presented is reasonably determined by the complexity of the research project.Key information elements may include:

(I) a statement that the project is research and participation is voluntary;

(II) a summary of the purpose of the research, procedures, and duration of participation;

(III) reasonable, foreseeable risks or discomforts;

(IV) reasonable, expected benefits; and

(V) alternative procedures or course of treatment, if any.

(ii) The key information elements of the informed consent must be organized and presented in a way that facilitates comprehension.

(iii) Informed consent must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate.

(2) Informed consent may not include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive the subject's legal rights or releases or appears to release the investigator or other party associated with the research study from liability for negligence.

(3) Basic elements of informed consent include:

(A) a statement that the study involves research, an explanation of the research purposes and the expected duration of the subject's participation; a description of the procedures to be followed; and identification of any procedures that are experimental;

(B) a description of any reasonably foreseeable risks of discomforts to the subject;

(D) a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

(E) a statement describing the extent, if any, to which confidentiality of records identifying the subject are maintained;

(F) an explanation for research involving more than minimal risk, 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;

(G) an explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights and in the event of a research-related injury to the subject;

(H) a statement that participation is voluntary, refusal to participate involves 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; and

(I) 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 when identifiers are removed, is not used or distributed for future research studies.

(4) DHSIRB enforces the general requirements for informed consent, per 45 C.F.R. § 46.116.

(5) Except as described in (b) and (c) of this Section, before involving a human subject in research covered by this Part, an investigator obtains the subject's or the subject's legally authorized representative's legally effective informed consent.The minimum requirements of legally effective informed consent are given in the federal regulations at 45 C.F.R. § 46.116(a) through 45 C.F.R. § 46.116(d).

(A) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.This part of the informed consent must be organized and presented in a way that facilitates comprehension.

(B) Informed consent must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate.

(C) An investigator seeks informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether to participate and that minimize the possibility of coercion or undue influence.

(D) The information that is given to the subject or the legally authorized representative is in language understandable to the subject or the legally authorized representative.

(E) The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.

(6) On a case-by-case basis, the DHSIRB may determine that other information, in addition to that specifically mentioned in the federal regulation at 45 C.F.R. § 46.116, is given to the subjects when in the DHSIRB's judgment the additional information would meaningfully add to the subjects' protection of the rights and welfare.

(A) The DHSIRB makes this determination based on the nature of the research as well as the local research context.

(B) If the DHSIRB determines that additional elements are appropriate, this additional information is considered as essential as the basic elements of informed consent described in the federal Department of Health and Human Services (HHS)regulations at45 C.F.R. § 46.116(b).

(b) Broad consent in lieu of informed consent. The DHSIRB may permit broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens, collected for either research studies other than the proposed research or nonresearch purposes, when the:

(1) application specifically declares it is seeking broad consent and contains an adequate description of the broad consent process; and

(2) proposed research project satisfies the requirements of Title 45 C.F.R. § 46.116(d).

(c) Waiver or alteration of consent.When appropriate, an application for a proposed research study may seek a waiver from the requirements to obtain informed consent or it may seek permission to alter the informed consent requirements.Such a waiver or alteration may be permitted by the DHSIRB when the requirements of 45 C.F.R. § 46.116(e) & (f) are met.

(d) Informed consent documentation.

(1) Use of a written informed consent form.Except as provided in (3) of this subsection, informed consent is documented by the use of a written informed consent form, approved by the DHSIRB and signed, including in an electronic format, by the subject or the subject's legally authorized representative.A written copy is given to the person signing the informed consent form.

(2) Written consent form options.Except as provided in (3) of this subsection, the informed consent form may be either (A) or (B).

(A) A written informed consent form that meets the requirements of this Section. The investigator gives the subject or the subject's legally authorized representative adequate opportunity to read the informed consent form before it is signed; alternatively, this form may be read to the subject or the subject's legally authorized representative.

(B) A short written consent form stating the elements of informed consent required by this Section were presented orally to the subject or the subject's legally authorized representative, and that the key information required by 45 C.F.R. § 46.116(a)(5)(i) was presented first to the subject, before other information, if any, was provided.

(i) Informed consent must begin with a concise, organized, and focused presentation of the key information most likely to assist a prospective subject or legally authorized representative understand the reasons why one might, or might not, want to participate in the research.This portion of the informed consent process must be organized and presented in a way that facilitates comprehension.

(ii) The DHSIRB approves a written summary of what is said to the subject or the legally authorized representative.When the short form method is used, there must be a witness to the verbal presentation.Only the short form itself is signed by the subject or the subject's legally authorized representative.The witness signs the short form and a copy of the summary, and the person obtaining consent signs a summary copy.

(iii) Summary and short form copies are given to the subject or the subject's legally authorized representative.

(3) Documentation waiver requirement.

(A) In certain defined circumstances, the DHSIRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects.

(i) The requirement may be waived if the DHSIRB makes a determination that the only record linking the subject and the research would be the informed consent form, and the principal risk would be potential harm resulting from a breach of confidentiality.Each subject or legally authorized representative is asked if the subject wants documentation linking the subject with the research.The subject makes the decision.

(ii) The requirement may be waived if the DHSIRB makes a determination 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.

(iii) The requirement may be waived if the DHSIRB makes a determination that the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm.The DHSIRB must also determine that the research presents no more than minimal risk of harm to subjects, and there is an appropriate alternative mechanism for documenting that informed consent was obtained.

(B) In cases in which the documentation requirement is waived, the DHSIRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.