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Please note the final planned GREGoR website downtime in April:

  • Friday, April 19  at 5 pm PT to Monday April 22 at 8 am PT (63 hours)

During this time the GREGoR website will be down and users will be unable to log into the DCC's AnVIL management web app to link their AnVIL accounts. Please contact the DCC at gregorconsortium@uw.edu if you have questions or need help during the downtime.

GREGoR Consortium Consent Topics

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Elements of Unified Informed Consent Tiger Team, GREGoR Policy Working Group
Date of last update: Feb 23, 2022

A shared, unified consent form for use amongst all sites will not be pursued. Individual centers will have their own consents that address the following elements:

  • Consent explicitly obtained for generating genomic and phenotypic data
  • Consent explicitly obtained for future research use
    • GRU or HMB consent group without any other modifiers or data use limitations
    • Commercial use permitted
  • Consent should specify that data are shared through
    • Unrestricted access
      • Genomic Summary Data
    • Controlled-access
      • Data shared within GREGoR on AnVIL, subject to Consortium-wide rules on access and under the auspices of a signed DTA
      • Data shared outside of GREGoR on AnVIL through controlled access
      • Others? tbd
  • Permission to recontact proband and/or relatives
  • Return of result intentions stated in the consent (none, primary, secondary)
  • Sample sharing within GREGoR, under the auspices of signed MTA
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GREGoR Consortium needs

  • Data shared within GREGoR on AnVIL subject to Consortium-wide rules on access
  • Data shared outside of GREGoR on AnVIL through controlled access
  • GRU or HMB consent group without any other modifiers or data use limitations
  • Genomic Summary Data should be available through unrestricted access
  • Commercial use permitted
  • Permission to recontact proband and/or relatives
  • Return of result intentions stated in the consent (none, primary, secondary)
  • Sample sharing within GREGoR, under the auspices of signed MTA
  • (Use of data is permissible for any human disease or disorder)
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Guidance material: NIH Requirements

  • For studies initiated after the effective date of the GDS Policy, NIH expects investigators to obtain participants’ consent for their genomic and phenotypic data to be used for future research purposes and to be shared broadly. The consent should include an explanation about whether participants’ individual-level data will be shared through unrestricted- or controlled-access repositories.
  • Consent Requirements for Genomic Data Sharing for NIH funding on grants submitted after January 25, 2015 must include all applicable national, tribal, and state laws and regulations, as well as relevant institutional policies.
    • Consent explicitly obtained for generating genomic and phenotypic data
    • Consent explicitly obtained for future research use
    • Consent explicitly obtained for broad sharing of samples and/or data
    • Consent should specify whether individual level data are shared through unrestricted- or controlled-access
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Excerpted Text (from UW) That Could be Used in Institutional Genomic Consents

  • Data & Sample Sharing Within Institution. We will share your clinical and research information and samples with doctors and researchers at (institution), and the information and samples will be connected to your name and date of birth.
  • Data & Sample Sharing Within Mendelian Consortium. We will share your clinical and research information and samples with members of an NIH Mendelian Consortium, and the information and samples will not be connected to your name and date of birth.
  • Data & Sample Sharing Outside Institution and Mendelian Consortium
    • Future Research Projects. The information and/or samples that we obtain from you for this study will be stored indefinitely to use for research studies in the future. We will remove anything that might identify you from the information and specimens so the information and specimens may then be used for future research studies or given to another investigator without getting additional permission from you. However, it is also possible that in the future we may want to use or share study information that might identify you. In that case, a human subject review board will decide whether or not we need to get additional permission from you.
    • National Genetic Databases. To improve human health, research findings need to be useful for health applications, like new medications or tests. To speed up this process, the National Institutes of Health (NIH) encourages researchers to share their study data with other researchers. The NIH has developed data (information) banks that securely store study data for this purpose. If you decide to participate in this study, we will send your coded study data to the NIH. Other researchers will be able to use this information in future studies on any health topic. The researchers could be from government, academic, or commercial institutions. The information from this study will be stored in a public data bank that anyone can use. This public information will not include your name or other information that could identify you. 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. You will not receive any results from data placed in the NIH data banks. You will not be able to withdraw your information after it has been submitted to the NIH data banks. 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.
    • Return of Results
      • Primary. During this research, it is possible that we may discover genetic results that may be related to your diagnosed disease or disorder called “primary findings”. If we discover a primary finding, we will give you this report during a genetic counseling session with a doctor or genetic counselor.
      • Secondary. We may also discover unexpected genetic results. Some of these results may be related to conditions with treatments or management options, thus are called “medically actionable” findings. You have the option of receive these findings or not. Please indicate your choices below. Your answer will have no affect for your health care or participation in research.
        • ________ I would like to receive my medically actionable findings discovered during this study.
        • ________ I would like to receive my carrier status findings discovered during this study.
        • ________ I would NOT like to receive medically actionable or carrier status findings discovered during this study.
    • Publication
      • Papers. It is possible that some information from this study will be published in medical papers. However, your name or date of birth will not be included in these papers. If we wish to publish a photograph of you, we will ask you to read and sign a separate consent form.
      • Teaching. Your genetic data and coded medical information may be used to teach professionals how genetic factors can cause common and unique diseases.
    • Risks. There is potential risk that someone could identify you, or learn something about you, from your unique genetic information. While we think this risk is small today, the risk may increase in the future as technologies advance and more is learned about genetics.
      • Loss of Privacy and Confidentiality Risks. We will make every effort to protect your private information, but it cannot be guaranteed. If a security breach of genetic data occurred, it could cause difficulties in getting certain types of insurance or job opportunities. Unethical access to genetic information could be misused for discriminatory purposes and cause individual or group harm. The federal law “GINA” (Genetic information Nondiscrimination Act) offers some protection from discrimination.
      • Emotional and psychological risks. Some people are also concerned that research about genetic causes of illness may reveal information that is not only about themselves, but also about their relatives and other groups of people who are like them. It is possible that your relatives would be upset to learn that they may be at risk for a condition because of your participation in this research study. It is possible that learning you have a genetic change that causes or contributes to a disease, or that you could pass on a genetic change that causes a condition, could cause emotional or psychological harm. Issues of adoption and parentage (biological fatherhood or motherhood as well as degree of relatedness) may be discovered in the course of this study. If genetic testing shows that a family relationship is different than previously thought, for example if a father is not the biological father, it is our policy not to tell you this information unless it affects the health of you or your family.
    • Benefits. You cannot expect to benefit from your research participation, although it might occur. Your participation may help others by helping science better understand human disease and disorders.
    • Authorization to Disclose/Release Genetic Information. If you lose decision-making capacity or pass away before receiving all genetic results discovered during this study, you have the option of allowing for the disclosure of the results to another person. Your genetic results may be important for your family members to learn as you may share similar genetic information.
      • ________ I authorize the disclosure of my genetic results to the named person below in the event that I should lose decision-making capacity or pass away before receiving all genetic results myself. I understand that once the results I have authorized to be disclosed reach the noted recipient, that person may re-disclose them, at which time they may no longer be protected under privacy laws.
      • Recipient Authorized to Receive Genetic Information:
      • Recipient’s Printed Name:_________________________________________________
      • Relationship to Participant:_________________________________________________
      • Date of Birth:___________________________________________________________
      • Address:_______________________________________________________________
      • Telephone:_____________________________________________________________
      • Email:_________________________________________________________________
    • CERTIFICATE OF CONFIDENTIALITY To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. The researchers can use this Certificate to legally refuse to disclose information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings; for example, if there is a court subpoena.
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