Common Rule Changes to Consent and Template Patrick Herbison, MEd, CIP Assistant Director of Compliance Office of Human Research (OHR)

Common Rule Common Rule = The Federal Policy for the Protection of Human Subjects (1991) 45 CFR 46 (Title 45 Code of Federal Regulations Part 46) Signed onto by about 15 government departments/agencies New revision published January 19, 2017 Most of it was due to become effective January 19, 2018 Now most of it is due to become effective July 19, 2018 One of the Changes: NEW Requirements for Informed Consent including New Elements of Consent (mostly 45 CFR 46.116) – Now in Effect

Common Rule – 45 CFR 46.116 b: Basic Elements Basic Elements that Must be in a Consent Form: Explain that the study involves research Purpose of the study Duration of the subject’s participation Procedures that will be done Experimental procedures Risks Possible benefits

Common Rule – 45 CFR 46.116 b: Basic Elements Basic Elements that Must be in a Consent Form: Alternatives to participating in the study Confidentiality (HIPAA) Compensation/Treatment in case of injury Contact info (study, injury, rights as a research subject) That participation is voluntary Subject may chose not to participate or to withdraw without penalty

Common Rule – 45 CFR 46.116 b: Basic Elements 1 New Basic Element – Summary b 9: For research involving the collection of identifiable private information/specimens: Identifiable = the identity of the subject may readily be ascertained by the investigator or associated with the information/specimen. Must include ONE of the Following Options: i: A statement that identifiers might be removed and the info/specimens used for future research and shared with other researchers without the subject’s permission. OR That this won’t happen.

Common Rule – 45 CFR 46.116 b: Basic Elements 1 New Basic Element – FULL TEXT b 9: Informed consent must contain 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  

Common Rule – 45 CFR 46.116 b: Basic Elements 1 New Basic Element – FULL TEXT b 9: Informed consent must contain one of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: 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.

Common Rule – 45 CFR 46.116 c: Additional Elements Additional Elements that Must be in a Consent Form: Unforeseeable risks to subject, embryo, or fetus The possibility of ending the study without the subject’s consent What will happen if the subject leaves the study early Any cost to the subject That significant new findings will be provided to the subject Number of subjects in the study There are 3 new additional elements

Common Rule – 45 CFR 46.116 c: Additional Elements Additional Elements – NEW c 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.

Common Rule – 45 CFR 46.116 c: Additional Elements Additional Elements – NEW c 8: A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.

Common Rule – 45 CFR 46.116 c: Additional Elements Additional Elements – NEW c 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).

Common Rule – 45 CFR 46.116 New Elements All new elements (or prompts for them) have been added to the revised Consent Template (OHR-8) and the IRB Reviewer Questionnaires (RQ-1, RQ-E1). It is the responsibility of the reviewer to ensure that all appropriate elements are included in the consent.

Common Rule – 45 CFR 46.116 a: General Requirements NEW a 4 (summary): The subject must have an opportunity to discuss the informed consent information. a 4 (full text): 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.

Common Rule – 45 CFR 46.116 a: General Requirements NEW a 5 i (summary): Informed consent must begin with a short, clear presentation of the key information needed to understand why you may or may not participate. a 5 i (full text): 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.

Common Rule – 45 CFR 46.116 a: General Requirements NEW a 5 ii (summary): Informed consent should not just be an isolated list of facts. It should show the big picture. a 5 ii (full text): Informed consent as a whole 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.

Common Rule – 45 CFR 46.116: Consent Template The Consent Template (OHR-8): 1. Table - short, clear presentation of the key information. For more involved elements of consent, the table refers to more complete sections. 2. The additional sections include: Procedures Risks Alternatives Compensation and Treatment for Injury Privacy and Confidentiality Contacts

Common Rule – 45 CFR 46.116: Consent Template The Consent Template (OHR-8): What’s the difference??? Old New Number of Pages 11 Reading Grade Level 10 9

Review of the Consent Template (OHR-8) Benefits A complete review of the OHR-8 with the intention of making it easier to understand Legal sections simplified (Research Related Injury, HIPAA) Meets the requirement to begin with a short, clear presentation of the key information Easier for subject and person obtaining consent. Use 2 – 3 page summary table. Refer to additional sections. Review of the Consent Template (OHR-8)

Questions? Comments?