MDHHS IRB Guidance on Informed Consent

The Belmont principles require in most circumstances that research subjects understand research they are asked to participate in, and that subjects voluntarily consent to participate in that research. This guidance discusses the 2018 Common Rule provisions (anticipated to take effect January 21, 2019) but can be followed even before January 21, 2019. Where information in this guidance is new per the 2018 Common Rule, that information is presented in bold.

Before involving someone in research, an investigator must usually obtain the legally effective informed consent of that person or that person’s legally authorized representative. The investigator must do that only under circumstances that provide the subject or the subject’s representative sufficient opportunity to discuss and consider whether or not to participate. The process must occur under circumstances that minimize the possibility of coercion or undue influence. The information provided to facilitate informed consent must be in language understandable to the person being asked for consent. The information provided must include the information a reasonable person would want to have in order to make an informed decision about whether to participate. Information must be presented in a way that doesn’t merely provide isolated facts, but instead facilitates understanding of the reasons one might or might not want to participate in the research. Information presented cannot include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

Regulations include requirements for what an informed consent document used to facilitate the initial informed consent process must include:

1. 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. The suggestions for what to include in that information are as follows:
   1. A statement that the project is research and that participation in the research is voluntary.
   2. A summary describing the research including the:
      1. purpose,
      2. duration of subject involvement, and
      3. types of activities/procedures in which subjects will participate.
   3. Foreseeable risks or discomforts to participants.
   4. Foreseeable and expected benefits to participants.
   5. Alternatives to participation (e.g., procedures or courses of treatment or possible alternative clinical trials) if there are any.
2. Any additional information explaining the purpose of the research, the expected duration of subject participation, and procedures to be followed (including identification of procedures that are experimental) that was not included in the summary statement.
3. Any description of reasonably foreseeable risks or discomforts not included in the summary statement.
4. Any description of the benefits to the subject or to others that may be reasonably expected from the research that weren’t included in the summary statement.
5. Any disclosure of appropriate alternative procedures or courses of treatment that might be advantageous to the subject that weren’t included in the summary statement.
6. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
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.
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. If the research involves the collection of identifiable private information or identifiable biospecimens one of the following statements must be included:
   1. 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 legally authorized representative, if this might be a possibility, or
   2. A statement that 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.

When appropriate to the research, the following elements may also be required within an informed consent document:

1. A statement that the treatment or procedure may involve risks to the subject (or to the embryo or fetus if the subject is or may become pregnant) that are currently unforeseeable.
2. Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s or the legally authorized representative’s consent.
3. Any additional costs to the subject that may result from participation.
4. The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.
5. A statement that significant new findings developed during the course of the research that may relate to the subject’s willingness to continue participation will be provided to the subject.
6. The approximate number of subjects involved.
7. A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
8. A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.
9. For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

There are provisions within the 2018 Common Rule for “broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens.” The MDHHS IRB will address requests to utilize a “broad consent” process on a case by case basis.

Except in limited circumstances, informed consent for research is documented by the use of a written informed consent form signed by the subject or the subject’s legally authorized representative. A copy of the written form is to be given to the person signing the informed consent form.

The signature requirement (although not the requirement for informed consent generally) may be waived by an IRB in the following circumstances:

1. Where the principal risk to subjects would be harm resulting from a breach of confidentiality, and where a signed consent form would be the only record linking the subject and the research. Where this is the reason for waiving the signature requirement, each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern.
2. Where the research is 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.
3. Where the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, and where the research presents no more than minimal risk of harm to subjects. Where this is the reason for waiving the signature requirement, an appropriate alternative mechanism for documenting that informed consent was obtained must by provided.