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Office of The Director, National Institutes of Health (OD)

Purpose

NIH is requesting information from stakeholders on the utility and useability of sample language developed for use in informed consent documents for data and biospecimen sharing available below. The comment period on this Notice is 90 days. Response to this Notice is voluntary.

Background

Responsible sharing of data and biospecimens derived from human participants relies on robust informed consent practices that uphold the principles of autonomy and trust in biomedical research. Fundamental to these practices are clear and efficient communication strategies for conveying potential risks and benefits of sharing. NIH has heard from its stakeholders that there is a strong interest in sharing best practices for developing informed consent language to support sharing. To assist in this endeavor, NIH has worked to develop sample language that may be used in informed consents when data and biospecimen sharing may occur, as well as points to consider" for investigators and Institutional Review Board (IRB) when using or modifying the language. The "points to consider" and sample language below are not intended to replace or supplant IRB review and input into consent practices, but rather are intended to serve as a resource for investigators from which they can tailor appropriate informed consent language to their specific study needs. Furthermore, NIH emphasizes that any use of the sample informed consent language is completely voluntary and shall not be required. The language below may be updated after responses to this request for information are considered.

Information Requested

NIH is interested in input on 1) the sample consent language, 2) the "points to consider," and 3) any gaps or additional components that should be included. NIH is also interested in input on any hurdles or barriers to the voluntary use of the sample language and "points to consider" by the community. NIH welcomes input from research investigators, institutional review board members, study participants, professional organizations, associations with a focus on research oversight, and other interested members of the public. Respondents are free to address any or all of the information listed below or any other relevant topic for NIH to consider. Respondents should not feel compelled to address all items.

Resource for Stakeholder Input Follows:

Consent for Data and Biospecimen Sharing for Future Use: Points to Consider and Sample Language

I. Introduction:

As a steward of the nation’s biomedical research enterprise, NIH is dedicated to ensuring that when data and biospecimens are shared, that it is done ethically and securely, and with respect for the privacy, autonomy, and well-being of research participants and the communities to which they belong. As part of this commitment, NIH is working with stakeholders to identify best practices for developing and implementing effective consent practices to inform prospective research participants about potential risks and benefits of data and biospecimen sharing for future research. The following resource outlines suggested points to consider when addressing data and biospecimen storage and sharing in consent language and provides supplemental sample language that could be modified as needed when constructing informed consent forms. Of note, the sample language provided below is intended to serve as a helpful resource and is not a substitute for addressing federal, state, local, or tribal requirements that may apply to informed consent. Use of the information provided in this resource, including sample language, is completely voluntary.

II. Instructions for Use:

This document presents points to consider, instructions for use, and optional sample language that is meant to supplement informed consent forms for research studies that include the storage and sharing of data and biospecimens. This resource is neither a linear nor comprehensive consent template. Additionally, the sample language does not address all possible scenarios for which informed consent may be needed for data and biospecimen storage and sharing. The sample language will need to be tailored to institutional and study specific requirements. It is the responsibility of investigators and institutional review boards (IRBs) to determine the appropriate use of the sample language including which components, if any, are relevant to a specific study’s informed consent and the most appropriate section to incorporate the sample language within when doing so (e.g., the risks of storage and sharing may be included in the study’s informed consent risk section or in another appropriate section). Not all of the components will be appropriate for every informed consent form. Investigators should carefully select language appropriate for the study, and IRBs should ensure that the proposed language meets all applicable regulatory and policy requirements, including federal, state, local, and tribal requirements.

Use of this sample language is completely voluntary. This language is being provided as a resource for the research community and there are no requirements that any portion of the language be used in an informed consent form for an NIH-supported or -conducted study.

This resource consistently refers to data and biospecimens as a means to capture all identifiable information and biospecimens that research participants may contribute as part of a research study. Data and biospecimens includes information collected from, or about a research participant during the course of a primary study (e.g., surveys, medical images, electronic health records, wearable device information) as well as human material (e.g., blood, tissue, urine, extracted DNA).

Some sample language includes embedded instructions to fill in specific information pertaining to the research study. These embedded instructions are identified in [bold, bracketed text] and will need to be replaced after study-specific language is inserted or removed entirely based on the instructions provided.

III. General Points to Consider:

• Data and biospecimens may involve distinct storage and/or sharing procedures. Some protocols may require separate consent language to inform how data versus biospecimens are stored and shared.

• Those responsible for study conduct and oversight are encouraged to consider the reading level of the entire informed consent form, with the goal of creating understandable language that conveys the necessary information. The sample language in this resource was crafted to ensure an appropriate reading level (with a goal of ~8th grade reading level or below). Additional resources on evaluating readability can be found from the National Cancer Institute (NCI).

• Studies that involve a category of participants who are considered vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, or research with pregnant women, fetuses or neonates may require additional considerations regarding the storage and sharing of data and biospecimens. Those responsible for study conduct and oversight are encouraged to revise the sample language to reflect these considerations. We strongly encourage consultation with the appropriate contacts to determine and take into consideration the applicable regulations, policies, and laws relevant to studies involving these populations, including assent for participants under 18, prior to storage and sharing of data and biospecimens.

• Some cultural/donor/sovereign groups may have preferences or requirements regarding how data and biospecimens are handled, including the disposition of biospecimens. For example, sovereign Tribal Nations may have laws/regulations/policies governing research that may impact the storage and sharing of data and biospecimens. We strongly encourage consultation with the appropriate contacts to determine applicable regulations, policies, and cultural preferences or tribal laws that will need to be taken into consideration prior to storage and sharing of data and biospecimens.

• Additional considerations may be applicable for research studies that include the storage and sharing of genomic data. We recommend that those responsible for study conduct and oversight review community standards, such as NIH resources provided by the National Human Genome Research Institute (NHGRI) on informed consent and the NIH Genomic Data Sharing Policy.

• If the future use of data and biospecimens will be limited, this information should be specified in the consent language.

• As technology advances for coding and deidentifying data and biospecimens, consider the implications for privacy and confidentiality and adjust language as appropriate.

IV. Sample Language Components:

Component 1: Introduction - Description

Considerations for those responsible for study conduct and oversight: The Introduction-Description component is meant to provide prospective research participants with an introduction to, and description of the storage and sharing of data and biospecimens in the study.

• If participants may be re-contacted to collect new or replacement data or biospecimens, include language to address re-contacting.

• Those responsible for study conduct and oversight will need to consider the appropriate timeframe for data and biospecimen storage based on their study and anticipated uses. For some, the appropriate timeframe may be indefinite, while others may have a clear, limited timeframe.

Instructions for those responsible for study conduct and oversight: See sample language below for the Introduction-Description component. If using this sample language, include the first three paragraphs then choose either Option #1 or Option #2. Replace embedded instructions identified in [bold, bracketed text] with specific information pertaining to the study and remove [Option #1 and #2 text].

Sample Language: This study is collecting data and biospecimens from you. We would like to make your data and biospecimens available for other research studies that may be done in the future. The research may be about similar diseases or conditions to this study. However, research could also be about unrelated diseases, conditions, or other aspects of health. These studies may be done by researchers at other institutions, including commercial entities. Our goal is to make more research possible to learn about health and disease. Your data and biospecimens will be stored [indicate the name of the institution where they will be stored, including any biobanks to be utilized]. We plan to keep your data and biospecimens for [indicate time frame or indefinitely, or until used completely, etc.]. Your data and biospecimens may be shared with investigators around the world. However, access to the data and biospecimens is controlled by [indicate which entity has control]. To use your data and biospecimens, researchers must get approval and they must agree not to try to identify you. [Option #1: If the data/biospecimens are coded and can be linked back to the participant] We will protect the confidentiality of your information to the extent possible. Your name and other identifying information will not be on any data and biospecimens you provide. The data and biospecimens will have a code that links to your identifying information. The code key will be kept in a locked location separate from your information. The code key can only be accessed by people who have permission. [Option #2: If the data and biospecimens are completely delinked from identifiers and cannot be linked back to the participant] Your name and identifying information will not be on any data and biospecimens you provide. Investigators cannot link your identifying information to the data and biospecimens.

Component 2: Voluntary Participation

Considerations: The Voluntary Participation component informs prospective research participants about the voluntary nature of data and biospecimen storage and sharing.

• In general, participants should be given the option to agree to, or opt out of, having their data and biospecimens stored and shared for future research. Providing options for participants to agree to, or opt out of, having their data and biospecimens stored and shared is particularly important in studies that offer the prospect of direct benefit to the participant. Mandating agreement to storage and sharing may be considered coercive if the participant does not want to agree to sharing of data and biospecimens but feels compelled to agree anyway in order to join a possibly beneficial clinical trial. If the research protocol offers no prospect of direct benefit, then it may be reasonable for storage and sharing not to be optional.

• If the protocol is a repository protocol with the sole intent of collecting data and/or biospecimens for future use, no opt out mechanism is necessary.

Instructions: Choose either Option #1 or Option #2. Remove [Option#1 and #2 text].

Component 3: Discontinuation/Withdrawal

Considerations: The Discontinuation/Withdrawal component describes what will happen if the participant changes their mind about storage and sharing.

Instructions: Adjust language as necessary.

Component 4: Risks & Benefits

General Considerations: The Risks & Benefits component describes the reasonably foreseeable risks/discomforts related to storage and sharing of data and biospecimens, and any benefits related to storage and sharing of data and biospecimens that prospective participants may receive.

Considerations - Risks: If identifying information (e.g., key to the code) will remain with the data and biospecimens during storage and sharing, include language that addresses the additional measures designed to safeguard participants privacy (e.g., access controls).

• Ensure that the safeguards listed are consistent with language addressing the storage and sharing of data and biospecimens in the introduction.

• Adjust language if there is a specific risk associated with loss of privacy due to storage and sharing, such as stigma or the ability to obtain certain types of insurance.

Instructions: Adjust language as needed. Remove [ Risks ] and [Benefits] unless needed as a section heading.

Component 5: Commercial Application

Considerations: The Commercial Application component informs prospective participants about whether their data and biospecimens may contribute to products with commercial value. If research participants will receive any payments related to commercial or product development, adjust language in the last sentence to reflect this.

Instructions: Adjust language as needed.

Submitting a Response

Comments should be submitted electronically by September 29, 2021, using the form at https://osp.od.nih.gov/rfi-comment-informed-consent-sharing/.

You may provide comments to one or all of the topics in the comment boxes. Comments received will be posted at https://osp.od.nih.gov/clinical-research/informed-consent/ without change after NIH has reviewed all of the comments received. Please do not include any proprietary, classified, confidential, or sensitive information in your response.

This Request for Information (RFI) is for planning purposes only and should not be construed as a policy, solicitation for applications, or as an obligation on the part of the Government to provide support for any ideas identified in response to it. NIH may use information gathered by this RFI to inform development or modification of websites, policies and practices, processes and procedures, and supporting documentation.

Inquiries

Please direct all inquiries to:

NIH Office of Science Policy
OD/Division of Clinical and Healthcare Research Policy
Telephone: 301-496-9838
Email: [email protected]