In accordance with NIH Policy for Data Management and Sharing, and oftentimes as part of the NIDDK terms and conditions of clinical cooperative agreement awards, study groups may not continue to exclusively use or share study generated resources until those resources (data and associated bio/specimens when appropriate) are available to the public via an NIDDK approved repository or other NIDDK-approved public sources in accordance with the approved Data Management and Sharing Plan. The NIDDK Central Repository (NIDDK-CR) is an option provided by NIDDK for some studies to make study generated resources available to the greater scientific community (see NIDDK-CR policy for eligibility).
NIDDK-CR policy requires that studies approved to submit resources to NIDDK-CR include appropriate language in the informed consent documents to allow for future secondary use through NIDDK-CR and for study participants to explicitly consent to sharing resources for secondary research. Accordingly, consenting language should reflect an intent to share resources for future research use, whether via NIDDK-CR or other NIDDK-approved repository, in broad terms, and ensure study participants have a clear understanding of how study generated resources will be used during the active phase of the study and how these may be shared and re-used in future secondary research. Therefore, NIDDK-CR encourages the use of broad informed consent language with minimal, if any, limitations for secondary use in accordance with any federal, state, tribal, and local laws or regulations, and the use of clear standardized ontologies and consent clauses.
NIDDK-CR recommends but does not mandate any specific language, understanding that each IRB may have its own specific guidelines for acceptable informed consent language and, more importantly, that investigators working with special populations or outside the U.S. may have special requirements or restrictions related to consenting language and repositing of study generated resources. However, per NIDDK-CR policy, a study’s informed consent form must be submitted to NIDDK-CR early in the process (before data/specimens are collected) for review before NIDDK will grant approval to submit study generated resources to NIDDK-CR.
The following is a list of the elements that should be present in the informed consent in order for resources to be submitted to NIDDK-CR. Along with the listed elements, NIDDK-CR provides general example language from various IRB-approved or published consensus documents. The language is intended as a guide, and suggestions are based on current guidelines and best practices.
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Provide a description of the Repository
Example: We are planning to analyze data and specimens collected from you during and after this study is complete. After this study is complete, we are planning to send the study data and a portion of the specimens collected from you to NIDDK Central Repository (Repository). The Repository is a research resource supported by the National Institutes of Health. The Repository collects, stores, and distributes research data and associated specimens from people with many kinds of disorders, from unaffected family members, and from other healthy people. The data and associated specimens we send to the Repository will not contain any direct personal identifiable information.
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Provide a description of the purpose of sending resources to the Repository
Example: Sending data and specimens to the Repository may give scientists valuable research material that can help them to develop new diagnostic tests, treatments, or ways to prevent diseases. The purpose of this collection is to make research data and associated specimens available to other qualified researchers for general research use [if not consented for general research, then enter health-related research or specified disease(s)] in the future. There will be an approval process for researchers who want to work with the data or specimens being held under the guardianship of the Repository. They will have to tell the Repository about the research they want to do. They may be required to obtain ethics approval. They will have to sign an agreement stating that they will not try to find out who you are.
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Provide a description of how data and specimens will be handled and distributed after the study has concluded
Example: The data and specimens we send to NIDDK-CR or other NIDDK-approved repositories will not contain any direct personally identifiable information. While this study is active, we will be responsible and care for study data and specimens collected from you, and we may share them with other researchers. After this study is complete, data and specimens sent to NIDDK-CR will be under the guardianship of the Repository, which means the Repository will be responsible for the data and specimens collected from you, they will care for them, and they will make decisions about how they are used. Your data and specimens may remain in the Repository and be shared for secondary research long into the future.
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Provide a description of how the participant’s privacy will be protected
Example: Your privacy is very important to us, and we will take the appropriate measures to protect it. Your study record will not have your name or other personally identifiable information, such as your address or contact information. We will replace this information with a study code. We will limit who has the key that links study codes to names. Data and specimens sent to the Repository will only have this study code and will not have your personally identifiable information. The Repository will keep your data and specimens with data and specimens from all of the people who join this and other studies and will store all of these records securely. The Repository will take measures to protect your privacy, although no guarantee of confidentiality can be absolute. The Repository will not be able to give out information that identifies you to the qualified researchers who receive the data or specimens. However, the Repository and researchers will have some data about you, such as age, sex, diagnosis, [fill in any other data elements], race, and outcomes of the [enter contributing study’s name] study. There is always a very small chance that when different data are combined, it could be used to identify a group you belong to or, less likely, you personally. NIH and NIDDK have strict guidelines that prohibit people who have been granted access to study information from trying to identify you.
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Provide information about potential risks and benefits of secondary research, including any research publications or potential commercialization
Example: You will not receive any direct benefit or payment for sharing your data and specimens, but these may benefit the future health of the community at large [or some particular group]. Researchers will use many methods to analyze your data or specimens, some of which may not even have been invented yet. Because other researchers will not have access to your identity, neither you nor your physician will get the eventual results of future studies that might be performed using your data or specimens. It is possible that data resulting from future secondary analyses may eventually be used in a research publication. In that event, your name or other identifying information will not be included, as this information will not be available to the researchers. It is also possible that future studies result in findings or inventions with commercial value and may be patented or licensed, which could give a company the sole right to make and sell products or offer testing based on the discovery. In that event, you will not receive any financial benefits, nor will NIDDK or the Repository.
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Confirm the voluntary nature of sharing for secondary research use
Some studies may consider the use of resources for secondary research as a requirement for participation, while others may consider the collection optional to study participation. In general, if there is a direct benefit from participating in the study, then opt-in/out options may be necessary.
Example 1: Joining [
contributing study’s name] is voluntary. You can choose to join or not. No matter what you decide, now or in the future, it will not affect your care. You will not lose any benefits or rights and you will not be penalized. If you agree to participate in this study, you agree to sharing your research data and to placing a portion of your specimens into one or more repositories, including the NIDDK Central Repository for future general research use [
or health-related research, or specified disease(s)].
Example 2: Joining [
contributing study’s name] is voluntary. You can choose to join or not. No matter what you decide, now or in the future, it will not affect your care. You will not lose any benefits or rights and will not be penalized. Some parts of this study are optional, and you can choose to participate or not in the optional parts. For example, specimen collection for secondary research is optional. If you choose not to send specimens to the Repository, it will not affect your participation in this study. Please read the statement below and select the option that is right for you:
I agree to sharing a portion of the specimens collected from me with the Repository for use in future research about [for example, general research, health-related research, or specified disease(s)]
Yes _____ (Initials) No ______ (Initials)
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Describe how data and specimens already collected will be managed if a participant withdraws consent to continue participation in the study
Example: You can change your mind and withdraw consent to participate in this study up until the end of the study. When study researchers receive written instructions from you to withdraw consent to continue participation in the study, they will not collect any more data or specimens from you for the purpose of the study. Research data and specimens collected up until the time that you withdraw may be retained and used in order for the study to be scientifically valid. Research data and specimens sent to the NIDDK Central Repository are given a unique code number and directly identifiable information is removed. Because data and specimens that have been stripped of personal identifiers cannot be retrieved, the data or specimens sent to the Repository cannot be withdrawn.
Institutional Review Boards (IRBs) or Ethics Committees may request additional information about the Repository when considering future secondary research use language. The following is a list of informational items about the Repository that might be useful in preparing an IRB application.
