Revised Common Rule: Informed Consent Changes UT IRB University of Texas at Austin

Overview of Changes Concise presentation of key information Changes in basic and additional elements Broad consent option (not at UT) Changes in criteria for waiver of IC

Concise Presentation of Key Information New regs say: Consent begins with concise and focused presentation of key information Most likely to assist in understanding the reasons why one might or might not want to participate in the research Organized and presented in a way that facilitates comprehension

Concise Presentation of Key Information: UT’s Template Consent forms that are less than 3 pages don’t need key information.

Concise Presentation of Key Information Concise and focused KEY information, not necessarily ALL information Procedures Risks More detailed information may be listed later in this form IRB will need to evaluate whether the KEY information is sufficient

Concise Presentation of Key Information Intent is to move important information to the beginning of the ICF This section cannot be waived or altered

New Basic (Required) Element of IC Research collecting identifiable private information and/or identifiable biospecimens must State that collected samples/data may be de-identified and used for future research or be given to another investigator for future research without additional IC, OR State that collected samples/data will not be used or distributed for future research…even if de-identified

New Basic (Required) Element of IC: UT Suggested Language If you are collecting identifiable data or samples, include 1 of the following statements: De-Identified Sharing: We may share these samples/data with other researchers. Your samples/data may be used for future research very different than this research study. If we share your samples/data we will remove any information that would let others know that these samples/data came from you. However, we will not come back to you to ask for your consent if we share your samples. No Sharing: These samples will not be shared with other researchers even if de-identified.

New Additional (Optional) Elements of IC Statement that biospecimens, even if de-identified may be used for commercial profit, and whether/if that profit will be shared

New Additional (Optional) Elements of IC: UT Suggested Language If research involves collection of biospecimens include one of the following statements: Your samples (even if identifiers are removed) may be used for commercial profit. You will not share in this commercial profit. OR Your samples may be used for commercial profit and there are plans to share those profits with you. [Describe conditions for profit sharing.]

New Additional (Optional) Elements of IC Statement regarding whether clinically relevant research results will be given to the subject and under what conditions

New Additional (Optional) Elements of IC: UT Suggested Language

New Additional (Optional) Elements of IC For research involving biospecimens, whether the research will or might include (specifically) whole genome or exome sequencing

New Additional (Optional) Elements of IC: UT Suggested Language

New Conditions of Waiver or Alteration of Consent All of the following conditions must be met: The research involves no more than minimal risk to subjects The research could not practicably be carried out without the waiver or alteration NEW: If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format The waiver or alteration will not adversely affect the rights and welfare of the subjects; AND Whenever appropriate, subjects or LARs will be provided with additional pertinent information after participating The IRB has to determine that the research could not be done without the identifiable information or biospecimens.

Conditions of Waiver or Alteration of Consent for Public Benefit or Service All of the following conditions must be met: The IRB documents that the research or demonstration project is conducted by or subject to the approval of state or local government officials, It is designed to study, evaluate, or otherwise examine: Public benefit or service programs; procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs, AND The research could not practicably be carried out without the waiver or alteration

Screening, Recruiting, or Determining Eligibility: Exception to IC Previously – IRB had to waive consent for collection of identifiable private information or specimens NEW – allows for collection of identifiable information or biospecimens for purposes of screening, recruiting, or determining eligibility of prospective subjects if: The investigator will obtain information through oral or written communication with prospective subject or LAR, OR The investigator will obtain identifiable private information or biospecimens by accessing records or stored identifiable biospecimens

Waiver of Documentation of IC The only record linking the subject and the research would be the ICF and the principal risk would be potential harm resulting from a breach of confidentiality; That the research presents no more than minimal risk of harm and involves no procedures for which written consent is normally required outside of the research context; OR NEW: If the subjects or LARs are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm and provided there is an appropriate alternative mechanism for documenting that IC was obtained.

Implementation at UT Informed consent templates include all new elements IRB forms updated to identify specific study elements related to new consent elements IRB forms updated for new waiver criteria