July 1, 2021
Office of The Director, National Institutes of Health (OD)
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.
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.
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
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:
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.
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].
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.
Instructions: Choose either Option #1 or Option #2. Remove [Option#1 and #2 text].
[ Option #1: When sharing of data and biospecimens will be optional (e.g., for studies that have potential benefit)]
It is your choice whether or not to let researchers share your data and biospecimens for research in the future. If you say “yes,” you can change your mind later, but your data and biospecimens might still be used if they have already been shared. If you say “no,” you can still fully participate in this study. Please initial next to your choice:
______YES, use my data and biospecimens in other research studies
______NO, do NOT use my data and biospecimens in other research studies
[ Option #2: When sharing of data and biospecimens will not be optional (e.g., for studies where sharing is integral to the purpose of the study)]
Participating in this study means you agree to share your data and biospecimens. You can change your mind later, but researchers may still use your data and biospecimens that have already been shared. If you do not want your data and biospecimens used for other projects, you should not participate in this study.
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.
You can change your mind about sharing your data and biospecimens at any time. If you change your mind, please contact the study team to let us know. We will not share your data and biospecimens going forward. We will do our best to retrieve all your data and biospecimens that have already been shared, but it may not be possible. For example, if some research with your data and biospecimens has already been done, the information from that research may still be used. We will not know which data and biospecimens are yours if the identifying information was removed. Also, if the data and biospecimens have been shared already with other researchers, it might not be possible to get them back.
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).
Instructions: Adjust language as needed. Remove [ Risks ] and [Benefits] unless needed as a section heading.
[ Risks ] When we share your data and biospecimens, there is a small risk that people may get access to it who are not supposed to. We will protect your data and biospecimens as much as possible during storage and when they are shared. However, there is a small chance your identity could be discovered.
[ Benefits ] You will not receive any direct benefit from sharing your data and biospecimens. However, sharing your data and biospecimens may contribute to research that helps others in the future.
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.
The use of your data and biospecimens may lead to new tests, drugs, devices, or other products or services with commercial value. These products or services could be patented and licensed. There are no plans to provide any payment to you should this occur.
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.
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OD/Division of Clinical and Healthcare Research Policy