OFFICE OF SCIENCE POLICY
OFFICE OF EXTRAMURAL RESEARCHINFORMED CONSENTFOR SECONDARYRESEARCH WITHDATA AND
BIOSPECIMENS
Points to Consider and Sample Language for
Future Use and/or Sharing

MAY 2022

Informed Consent for Secondary Research with Data and Biospecimens: Points toConsider and Sample Language for Future Use and/or Sharing
KEY POINTS:

1. The use of this resource is completely voluntary.
2. This resource provides points to consider and sample language for informed consent
documents of research studies which plan to store and share data and/ or biospecimens for
future use.
3. This resource does not address collection, storage, or sharing of data or biospecimens
initially obtained in a non-research context, for example, collected during the course ofclinical care.
4. This resource addresses only consent for the storage and sharing of data and biospecimens
collected during a primary research protocol, for the purposes of future secondary research.
The approval for use of these data and biospecimens in new research studies that areoutside the scope of the primary protocol and consent (i.e., secondary research) will need tobe met through other means. This may include IRB approval of the secondary research
project, and if necessary, re-consent, or a waiver of consent, even if participants haveindicated their agreement to storage and sharing for future use (45 CFR 46.111, 46.116).
Note that under the Common Rule, the consent document for the primary protocol (hereinreferred to as the “primary consent”), should address requirements for notifying research
participants that identifiers may be removed and that the data and samples may be used for
future research without additional consent (45 CFR 46.116(b)(9)(i)).
5. The sample language provided in this resource does not alone satisfy the regulatory
requirements of the broad consent provision of the 2018 revised Common Rule at 45 CFR
46.116(d) and therefore does not provide consent for the future use of collected
biospecimens and data under the exemptions at 45 CFR 46.104(d)(8). Meeting theadditional regulatory requirements will be needed to enable the use of data andbiospecimens for future research under the broad consent provision of the 2018 revised
Common Rule.

I.

Introduction:

As a steward of the nation’s biomedical research enterprise, NIH is dedicated to ensuring that data andbiospecimens are shared for research ethically, securely, and with respect for the privacy, autonomy,
and well-being of research participants and the communities to which they belong. Sharing increases
the scientific utility of the data and biospecimens collected and reduces the burden on research
participants who may be asked to donate data and biospecimens multiple times as part of different
research studies. As part of this commitment, NIH sought input from stakeholders to identify bestpractices to obtain effective consent from prospective research participants about data andbiospecimen sharing for future research, including the potential risks and benefits. The following
resource was developed with substantial input from a wide range of stakeholders and outlines
suggested points to consider when addressing data and biospecimen storage and sharing for future use
in consent language and provides supplemental sample language that could be modified as needed
when developing informed consent documents. Of note, the sample language provided below is1

designed to be incorporated into a primary research consent document. The use of the sample
language by itself does not address federal, state, local, tribal, or international requirements that may
apply to the primary research. Furthermore, this resource is designed for research consent documents;
it does not address the storage and sharing of data and biospecimens initially collected for clinicalpurposes. 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 isdesigned for informed consent documents for research studies that include plans to store and sharecollected data and biospecimens for future use. The use of the suggested language does not obviate theneed for IRB review and approval of any non-exempt secondary research. The sample consent language
provided in the resource does not supplant the primary study’s informed consent document, but rather
is intended to be incorporated into the primary study’s consent document. This resource is not acomprehensive informed consent document, nor is it presented in any specific order. Not all of thecomponents will need to be included in every informed consent document. The sample language willneed to be tailored to institutional and study specific requirements. The sample language does notaddress all possible scenarios for which informed consent may be needed for data and biospecimen
storage and sharing. It is the responsibility of researchers and institutional review boards (IRBs) todetermine the appropriate use of the sample language including which components, if any, are relevant
to a primary consent and the most appropriate section to incorporate the sample language. Researchers
should carefully select language appropriate for the study, and IRBs should ensure that the study’s
primary consent meets all applicable regulatory and policy requirements, including federal, state, local,
Tribal, and international requirements.
Use of this sample language is completely voluntary. This language is being provided as a resource forthe research community, and there are no requirements or expectations that any portion of thelanguage be used in an informed consent document for NIH-supported or -conducted studies.
The scope of this resource encompasses consent for storage and sharing of individually identifiable anddeidentified data and biospecimens. “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).
This resource addresses only consent for the storage and sharing of data and biospecimens collectedduring a primary research protocol, for the purposes of future secondary research. The approval for useof these data and biospecimens in new research studies that are outside the scope of the primary
protocol and consent (i.e., secondary research) will need to be met through other means. This may
include IRB approval of the secondary research project, and if necessary, re-consent, or a waiver ofconsent, even if participants have indicated their agreement to storage and sharing for future use (45CFR 46.111, 46.116). Note that under the Common Rule, the primary consent should address
requirements for notifying research participants that identifiers may be removed and that the data andsamples may be used for future research without additional consent (45 CFR 46.116(b)(9)(i)).

2The sample language provided in this resource does not alone satisfy the regulatory requirements of thebroad consent provision of the 2018 revised Common Rule at 45 CFR 46.116(d) and therefore does not
permit the future use of collected biospecimens and data under the exemptions at 45 CFR 46.104(d)(8).
Meeting the additional regulatory requirements will be needed to enable the use of data andbiospecimens for future research under the broad consent provision of the 2018 revised Common Rule.
Some sample language below includes embedded instructions to fill in specific information pertaining to
the research study. These embedded instructions are identified in [grey bold text] and will need to be
removed after study-specific language is inserted.

III.

General Points to Consider:•

There may be separate storage and/or sharing procedures for data versus biospecimens. Some
protocols may require separate consent language to specify how data versus biospecimens are
stored and shared.

•Those writing and approving informed consent documents are always encouraged to consider thereading level of the entire informed consent document, including any additional language
addressing the storage and sharing of data and biospecimens, with the goal of creating
understandable language that conveys the necessary information to the research participants. The
sample language in this resource was crafted to ensure a broad comprehension reading level (withan overall goal of not exceeding an ~8th grade reading level). There are several third-party resourcesthat help with creating understandable consent language, including the National Cancer Institute(NCI) guide to evaluating readability. Researchers may also consider using supplemental strategies
to assist with comprehension (e.g., interactive videos).

•

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 may require additional considerations
regarding the storage and sharing of data and biospecimens. Likewise, additional considerations
may need to be taken into account for studies that involve pregnant persons, fetuses, or neonates.
It is strongly encouraged to seek consultation with the appropriate experts to determine and take
into consideration the applicable laws, policies, and regulations relevant to studies involving these
populations.

•

It is strongly encouraged to seek consultation with the appropriate experts to determine and take
into consideration the applicable laws, policies, and regulations relevant when considering assent
for participants under 18 and the subsequent need for obtaining the participant’s consent when theminor reaches the legal age of majority.

•

Some cultural, donor, and/or 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, policies, and/or regulations governing research that may
impact the storage and sharing of data and biospecimens. It is strongly encouraged to seek
consultation with the appropriate contacts to determine applicable regulations, policies, andcultural preferences or Tribal laws that will need to be taken into consideration prior to storage andsharing of data and biospecimens.

•

Additional considerations may be applicable for research studies that include the storage andsharing of genomic data. It is recommended that those writing and approving informed consent
3documents 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,
as well as international standards on genomic data sharing, such as The International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human Use- E18 Genomic
Sampling and Management of Genomic Data Guidance for Industry.
•

If the primary study limits the future use of data and biospecimens in any way, the specifics of thoselimitations should be outlined in the primary consent language.

•

As coding and deidentifying technologies advance and capabilities for linking disparate data
together evolve, consider the implications for reidentification, privacy, and confidentiality andadjust language as appropriate.

•

Consider whether the data and biospecimens may be particularly sensitive and ensure thatappropriate privacy safeguards are in place and communicated in the informed consent document.

IV.

Sample Language Components:

Introduction-Description

Considerations: The Introduction-Description component is meant to provide prospective research
participants with an introduction to, and description of the planned storage and sharing of data andbiospecimens.
• Consider the appropriate timeframe for data and biospecimen storage. For some, the appropriate
timeframe may be indefinite, while others may have a clear, limited timeframe.
• If identifiers will be retained, deidentification of the data and biospecimens is not feasible, or there
are circumstances in which re-identification may be possible, adjust language as appropriate.
• If there are circumstances under which a code key may be used to re-link identifying information todata and biospecimens, consider including language to address this.
• If there are plans to share datasets with unrestricted access, adjust language to reflect this. Consider
including the phrase: “Your data and biospecimens will be shared in a way where anybody aroundthe world can gain access to them without review.”
Instructions: Adjust language as needed. To use this sample text, include the first two paragraphs
then choose either Option #1 or Option #2. Replace embedded instructions identified in [bold grey
highlighted text] with specific information pertaining to the study. Remember to remove the “Option”
information identified in [bold grey highlighted text].

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Sample Language:
This study is collecting data and biospecimens from you. We would like to make yourdata 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 types of research.
These studies may be done by researchers at this institution or other institutions,
including commercial entities. Our goal is to make more research possible. We plan tokeep your data and biospecimens for [Insert time frame as indicated in the study
protocol].
Your data and biospecimens may be shared with researchers around the world.
However, the decision to share your data and biospecimens is controlled by [indicate
which entity has control]. To get your data and biospecimens, future researchers mustseek approval from [indicate which entity has control]. The researchers must agree not
to try to identify you.
Option #1: If the data and biospecimens are coded and can be linked back to theidentity of the participant:
We will protect the confidentiality of your information to the extent possible. Your data
and biospecimens will be coded to protect your identity before they are shared withother researchers. [indicate which entity has the code key] will have a code key thatcan be used to link to your identifying information. The code key will be securely stored.
Option #2: If the data and biospecimens cannot be easily linked back to the identity ofthe participant:Your name and identifying information will be removed from any data and biospecimens
you provide before they are shared with other researchers. Researchers cannot easily
link your identifying information to the data and biospecimens.

Voluntary Participation and Withdrawal of Consent from Storage and Sharing

Considerations: The Voluntary Participation and Withdrawal component informs prospective research
participants about whether data and biospecimen storage and sharing for future research is voluntary or
required for participation in the primary study. The component also describes what happens if theparticipant initially agreed to the storage and sharing of data and biospecimens, and then changes theirmind about storage and sharing for future use.
Voluntary Participation Considerations:• In general, participants should be given the choice about whether or not they wish to have theirdata and biospecimens stored and shared for future use. Providing options for participants to agree
to data and biospecimen storage and sharing is particularly important in studies that offer theprospect of direct benefit to the participant. Requiring storage and sharing may be considered
undue influence if the participant does not want to agree to sharing of data and biospecimens but
feels compelled to agree anyway to join a possibly beneficial research study.
• If the primary research study offers no prospect of direct benefit, it may be reasonable to consider
requiring storage and sharing in the primary protocol (e.g., if the primary protocol is a repository
protocol with the sole purpose being to collect data and/or biospecimens for future use). In this5

case, there is no reason to participate if the participant does not want to provide consent forstorage and sharing.
Withdrawal of Consent Considerations:• Consider cultural sensitivities around the return and/or destruction of biospecimens when research
participants withdraw their consent for the storage and sharing of data and biospecimens.
• If the data and biospecimens are being stored and shared for FDA-regulated research, adjust
language to reflect that there are cases in which data and biospecimens may need to be maintained.
• If the entity that controls access to data and biospecimens is different than the entity responsible
for holding the code key (e.g., an honest broker), consider adjusting language to reflect this.
Instructions: Adjust language as needed. Choose either Option #1 or Option #2. Replace embedded
instructions identified in [bold grey highlighted text] with specific information pertaining to the study.
Remember to remove “Option” information identified in [bold grey highlighted text].
Sample Language:
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. If you say“no,” you can still fully participate in this study.
If you change your mind and no longer wish to have us store or share your data andbiospecimens, you should contact [insert contact info]. We will do our best to honor
your request and to retrieve any data and biospecimens that have been shared withother researchers. However, there may be times we cannot. For example, if we do nothave a way to identify your data and biospecimens we will not be able to retrieve them.
In addition, if the data and biospecimens have already been used for new research, theinformation from that research may still be used. We will [fill in what will happen to thebiospecimens after they are retrieved] any biospecimens we have or are able toretrieve.
Please initial [or sign depending on institutional practice] 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., wheresharing 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 might still use your data and biospecimens
if they have already been shared. If you do not want your data and biospecimens used
for other projects, you should not participate in this study.

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Risks & Benefits
General Considerations: The Risks & Benefits component describes the reasonably foreseeable risks
and/or discomforts related to storage and sharing of data and biospecimens, and any anticipatedbenefits related to storage and sharing of data and biospecimens.
Considerations- Risks:• If identifying information will be retained, include language that addresses the additional measuresdesigned to safeguard participants’ privacy (e.g., coding of identifiable information, access controls).
• 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.

Sample Language:[Risks] We will do our best to protect your data and biospecimens during storage andwhen they are shared. However, there remains a possibility that someone could identify
you. There is also the possibility that unauthorized people might access your data andbiospecimens. In either case, we cannot reduce the risk to zero.
[Benefits] You will not receive any direct benefit from sharing your data andbiospecimens. However, sharing your data and biospecimens may contribute to researchthat could help others in the future.

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.
Sample Language:
The use of your data and biospecimens may lead to new tests, drugs, devices, or otherproducts 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 thisoccur.

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