GDS Policy Sample Informed Consent Language
Sample Informed Consent Language Aligned to the NIH Guidance on Consent for Future Research Use and Broad Sharing of Human Genomic and Phenotypic Data Subject to the NIH Genomic Data Sharing Policy
Sample Language Aligned to Informational Elements Outlined by NIH Guidance
Genomic and phenotypic data, and any other data relevant for the study (such as exposure or disease status) will be generated and may be shared broadly and used for future research in a manner consistent with the participant’s informed consent and all applicable federal and state laws and regulations.
*Note: NIH and NHGRI strongly encourages the broadest appropriate future use and sharing of genomic and phenotypic data.
Example 1: Consent for General Research Uses (GRU)
Portions of your samples, genomic data, and health information will be stored for an unlimited period of time to be used in future research. 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.
- Credit: NHGRI Special Considerations for Genomics Research and NIH Sample Language for Data and Biospecimen Sharing
Example 2: Consent for Health/Medica/Biomedical (HMB)
With your consent, we will share the information you give us with a national database for DNA information, called [...] which is controlled by [name of organization]. [Your data] will be used in future studies about human health. The information in this database will be stored permanently.
Example 3: Consent for Disease-specific uses only (DS)
By participating in this study, I agree that my data may be used only for research related to the following disease[s] [list name for diseases].
Prior to submitting the data to an NIH-designated data repository, data will be stripped of identifiers such as name, address, account and other identification numbers and will be deidentified by standards consistent with the Common Rule and HIPAA. Safeguards to protect the data according to Federal standards for information protection will be implemented.
Example 1
Your genomic data and health information will not be labeled with your name or other information that could be used to identify you. Researchers approved to access information in the database will agree not to attempt to identify you.
- Credit: NHGRI Special Considerations for Genomics Research
Example 2
Traditional identifying information like your name, address, telephone number, will NOT be put into the database. The data and any medical information will have a code number.
Access to de-identified, individual-level participant data will be controlled, unless participants explicitly consent to allow unrestricted access to and use of their data for any purpose.
Example 1
Your individual genomic data and health information will be put in a controlled-access database. This means that only researchers who apply for and get permission to use the information for a specific research project will be able to access the information.
- Credit: NHGRI Special Considerations for Genomics Research
Example 2
Other researchers must get permission from a Data Access Committee to be able to use the database.
Aggregate study information (including genomic summary results) and study analyses may be shared in the scientific literature or through other public scientific resources, such as data repositories or other data sharing resources that provide broad or unrestricted access to the information.
Example 1
[For GSR under unrestricted access] Information about all the people (including you) in this study may be combined to create what is called summary information. The summary information may be placed in a database and shared in scientific publications. This information will help the researchers understand if some patterns are more common than others among everyone who was a part of this study. The summary information will be available to anyone without the need for any permission. The risk of anyone identifying you based on this information is very low.
- Credit: NIH Consent Template for use at the NIH Clinical Center (4/15/24)
Example 2
[For 'Sensitive' GSR under controlled-access] Information about all the people (including you) in this study may be combined to create what is called summary information. The summary information may be placed in a database and will be made available to researchers only if they are granted permission. However, the summary information may still be shared in scientific publications without permissions. This information will help the researchers understand if some patterns are more common than others among everyone who was a part of this study. The risk of anyone identifying you based on this information is very low.
- Credit: NIH Consent Template for use at the NIH Clinical Center (4/15/24)
Because it may be possible to re-identify de-identified genomic data, even if access to data is controlled and data security standards are met, confidentiality cannot be guaranteed, and reidentified data could potentially be used to discriminate against or stigmatize participants, their families, or groups. In addition, there may be unknown risks due to computational methods, analytic technologies, or techniques (e.g., generation of information that could allow participants’ identities to be readily ascertained).
Example 1
While neither the public nor the restricted-access databases developed for this project will have information such as your name, address, telephone number, or social security number, it may be possible to identify you based on the information in these databases and other public information (including information you tell people or post about yourself). The risk of this happening is currently very low.
Although your genomic information is unique to you, you do share some genomic information with your children, parents, brothers, sisters, and other blood relatives. Consequently, it may be possible that genomic information from them could be used to help identify you. Similarly, it may be possible that genomic information from you could be used to help identify them.
There also may be other privacy risks that we have not foreseen.
Although we will not give researchers your name, we will give them basic information such as your race, ethnic group, geographic region, age range, and sex [specify demographic variables]. This information may help researchers study whether the factors that lead to health problems are the same in different groups of people. It is possible that such findings could one day help people in the same groups as you.
Example 2
[I]t is also possible that research findings could be used inappropriately to support negative stereotypes, stigmatize, or discriminate against members of the same groups as you..
- Credit: NHGRI Special Considerations for Genomics Research
Example 3
However, it is possible that your genomic information could be used to identify you when combined with other information from other public sources. We believe this is unlikely to happen. […] There is a risk that others will be able to trace the information in databases back to you or close biological relatives. The information may be used to enforce negative stereotypes. There may also be other risks that are not yet known.
- Credit: GREGoR Consortium Consent Topics
No direct benefits to participants are expected from any secondary research on de-identified individual-level data or genomic summary results that may be conducted.
Example 1
You will not receive any direct benefit from sharing your data and biospecimens. However, sharing your data and biospecimens may contribute to research that could help others in the future.
- Credit: NIH Sample Language for Data and Biospecimen Sharing
Participants may withdraw consent for research use of genomic or phenotypic data at any time without penalty or loss of benefits to which the participant is otherwise entitled. In this event, data will be withdrawn from any repository, if possible, but data already distributed for research use will not be retrieved.
Example 1
If you change your mind and no longer wish to have us store or share your data and biospecimens, 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 with other researchers. However, there may be times we cannot. For example, if we do not have 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, the information from that research may still be used. We will [fill in what will happen to the biospecimens after they are retrieved] any biospecimens we have or are able to retrieve.
- Credit: NIH Sample Language for Data and Biospecimen Sharing
Example 2
You may stop your participation in this study at any time. If you decide to withdraw from the study or part of the study, you can contact [Insert Name and Contact Information of Principal Investigator] at [Insert Name of Institution] and he/she will destroy any of your remaining tissue samples and any research data stored at the biobank. The biobank will no longer send out your samples or data. If cell lines have been derived from your samples, we will destroy the remaining cell lines stored in the biobank. However, the samples, cells, and data generated from your samples that have already been sent to other researchers or placed in research databases cannot be withdrawn.
Example 3
You can withdraw your data at any time by contacting [name of relevant person] free of charge at [information]. Data sent to other researchers around the world cannot be withdrawn if already used or published.
The name and contact information of an individual who is affiliated with the institution and familiar with the research and will be available to address participant questions.
The privacy protections, and limitations of those protections, afforded by a Certificate of Confidentiality (CoC) to individual-level data do not apply to summary results.
Example 1
To help us protect your privacy, we have obtained a legal document called a Certificate of Confidentiality. The Certificate of Confidentiality helps us to protect your information from most subpoenas or other legal demands. With your permission, your genomic data and health can still be shared for purposes you agree to, such as with other researchers for research purposes.
Example 2
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that the researchers cannot release or use information, documents, or samples that may identify you in any action or suit unless you say it is okay. They also cannot provide them as evidence unless you have agreed. This protection includes federal, state, or local civil, criminal, administrative, legislative, or other proceedings. An example would be a court subpoena.
There are some important things that you need to know. The Certificate DOES NOT stop reporting that federal, state or local laws require. Some examples are laws that require reporting of child or elder abuse, some communicable diseases, and threats to harm yourself or others. The Certificate CANNOT BE USED to stop a sponsoring United States federal or state government agency from checking records or evaluating programs. The Certificate DOES NOT stop disclosures required by the federal Food and Drug Administration (FDA). The Certificate also DOES NOT prevent your information from being used for other research if allowed by federal regulations.
Researchers may release information about you when you say it is okay. For example, you may give them permission to release information to insurers, medical providers or any other persons not connected with the research. The Certificate of Confidentiality does not stop you from willingly releasing information about your involvement in this research. It also does not prevent you from having access to your own information.
- Credit: NIH CoC Policy Page
Last updated: July 22, 2024