GA4GH Model Data Sharing Consent Form
Study : {Study.GUID} / Consent : {Consent.GUID}


Principal Investigator:{Study.Inv1.Name.Full}
Organization Name: {Study.Org.Name.Full}
Funded by:{Study.Funder.List.Name}
Contact Person:{Study.Contact.N,A}


  1. Introduction

    We invite you to be part of the {Study.Name.Full}. This project collaborates with researchers from around the world in studies approved and monitored by {Study.REB.Name.Full}. This project is guided by www.commonaccord.orG/GA4GH/Framework/V01.

    The {Study.Name.Full} will include some or all of the following:
    1. Data collected during the project;
    2. Some data from your medical file or other personal and health information;
    3. Your self-reported health related data; and
    4. Data from your stored tissues.

    Any data that may identify you will be kept in what are called controlled-access databases. This means researchers must have permission from a review committee to use the data that you and other participants have provided (see section 8). Any data that may identify you will be kept in what are called controlled-access databases. How will you protect my privacy? Such approved data may be shared online with researchers around the world. The results of studying your data will also be presented at conferences and in scientific publications. You will NOT be identified.

    You can learn more information about the organization of this project and general results when they become available at: {Study.www.me.com}.

    This project has been reviewed by {Study.REB.Name.Full}

    If you think you might want to participate in this project, please read the rest of this form and take as much time as you need to ask questions. The decision about whether to participate is completely up to you. Your decision to participate in the study will NOT affect your medical care.

  2. Purpose

    Genes are the basic "instruction book" for the cells that make up our bodies. All genes are made of DNA. The DNA of a person is more than 99% the same as the DNA of any other person, but no two people have exactly 100% the same DNA except for identical twins. The complete set of DNA in your body, including all its genes, is called your genome. Although our DNA is very similar to each other, your genomic data is entirely unique. Variations in the genome explain some of the physical differences between people, and partly explain why some develop diseases like cancer, diabetes, asthma, and depression, while others do not. At present, it is generally not possible to predict which changes in DNA lead to disease or health.

    We have also found important differences in DNA between population groups. Only by comparing your DNA and medical data with that of other people can we identify patterns and relationships in the genes, together with the environment, to help us better understand health and disease. Thus, the purpose of the {Study.Name.Full} is to {Study.Description}.

    This requirement indicates that the requestor must agree to collaboration with the primary study investigator(s).

  3. Participation

    We will first ask you a few questions to determine whether you can participate. If yes, we will need Select {3.1.List } is e.g. {3.1.List.123.cl }
    1. access to your medical record,
    2. ask you to complete some questionnaires about ... and
    3. access to data from stored tissue where applicable.

  4. Access to the Data

    Your data will be stored in controlled-access databases (i.e. a server/cloud provider) that meet international security and safety standards. Your data will be used for international research and may be moved and stored in different countries.

    Over the next {Study.Duration.Expected}, researchers will:

    3.1.Sen
    Base:
    Your data will be shared with other researchers around the world and used in future biomedical research projects after ethics approval.
    JTW Variants (Prefix using "3.1.")
    ?
    1. 1.?
      1. Data sharing will not be allowed
      2. Data sharing may be allowed after review of an IRB-approved research protocol.
      3. Data sharing will be allowed after review of an IRB-approved research protocol.
      4. Data sharing will be allowed by authorized users.
      5. Data sharing will be allowed by any user.
    2. 2.?
      1. Data sharing will not be allowed.
      2. Data sharing may be allowed for use in the same therapeutic area.
      3. Data sharing will be allowed for use in the same therapeutic area.
      4. Data sharing may be allowed for use in any therapeutic area.
      5. Data sharing will be allowed for use in any therapeutic area.
    3. 3.?
      1. Data sharing will be allowed with commercial parties for biomedical research purposes.
      2. Data sharing will be allowed with commercial parties for any purposes.
     These projects can take place in universities, hospitals, non-profit groups, companies, and/or government laboratories. All researchers must respect the laws and ethical guidelines for biomedical research.

    Your data will be kept for a period of {Study.PersonalData.Retained.Duration}.

  5. Compensation; Reimbursement

    {5.1.sec } select:
    1. 5.1.N.sec
      You will not be reimbursed or paid. Some of the research done with the information stored in the databases may one day lead to the development of software, tests, drugs, or other commercial products. If this happens, you will not receive any of the profits.
    2. 5.1.R.sec
      You will be reimbursed for any inconvenience such as travel time. Some of the research done with the information stored in the databases may one day lead to the development of software, tests, drugs, or other commercial products. If this happens, you will not receive any of the profits.


  6. Benefits of the Research

    You will not benefit personally because research usually takes a long time to produce medically useful results. However, your participation may help others in the future.

  7. Risks of Participation

    Much like fingerprints, it is possible to identify someone if certain data are put together. While we use very strict data security measures to protect your privacy, there is always a small risk that your data may lead to you being re-identified. As technology advances, there may be new ways of linking data back to you that we cannot foresee today. Like other medical information, this may one day affect your insurability or employment.

  8. Privacy

    Your data will be stored online, in controlled-access databases. Only approved researchers will have access. An independent committee will determine whether to grant researchers access to your data. In particular,

    These safeguards make it difficult to know which personal information came from you or any other participant. However, we cannot guarantee that you will never be re-identified.

    Researchers who wish to access the database will be required to apply to {Study.PDO.Name.Full} who will examine their credentials and data security plan. They will also make sure the proposed research project is consistent with your consent. You will not be identified if findings from your data are presented at scientific conferences or appear in scientific publications. {Study.PDO.Name.Full} will notify you immediately in the event of a problem with privacy.

  9. Withdrawal

    You may choose whether or not you wish to take part in this study. You are also free to withdraw at any time from the project. If you withdraw, your data will no longer be used. However, data that has already been used for research i.e. now part of a dataset or is already published cannot be destroyed or removed.

    {9.2.1.Sen }
    1. 9.2.1.PhoneEmail
      You can withdraw by telephone to {Study.Contact.Phone} or by email to {Study.Contact.Email}.
    2. 9.2.1.Mail
      You can withdraw by mail to {Study.Contact.N,A}.
    You will also receive a letter confirming your withdrawal.

  10. Reports

    It will probably take a long time to interpret the data accurately. You can check the project's web site at {Study.www.me.com} to read about the project's progress and to see if there are any general results.

    Include the local policy on return of individual health results/incidental findings and role of physician where applicable

  11. When We May Recontact You

    With your permission, we may re-contact you to invite you to update your questionnaire, to provide additional data, or to be involved in new research projects by other researchers.

  12. Contact Information

    If you have any questions or concerns, please contact {Study.Contact.Name.Full} free of charge at {Study.Contact.Phone} or by mail/email at {Study.Contact.Email}. If you wish to make a complaint about any aspect of this study at any time, please contact {Study.Ombuds.Name.Full} free of charge at {Study.Ombuds.Phone} or by mail/email at {Study.Ombuds.Email}. We take all comments seriously and will get back to you as soon as possible.



Consent to Participate


Consent and Signature

Please read the information below, and sign if you agree.

I have been provided all the information I need to make a decision. I have been able to ask questions if I did not understand the information.

I agree:
  1. that my personal, medical and genetic data can be deposited in online, controlled-access scientific databases;
  2. that my data be studied by researchers from around the world;
  3. that I will not be identified in scientific publications and at conferences;
  4. that I will not receive any profits if commercially valuable product(s) result from these studies;
  5. that my data cannot be removed if it is already used in a dataset or published; and
  6. to give access to data from my stored tissues for study where applicable.


I know that participating is my choice. I understand that I may withdraw at any time without having to give a reason.

I agree to be re-contacted to update my data, or to be involved in new research projects:

{ContactForFutureStudy.Answer } - Yes or No

I agree to be re-contacted if medical information is found that could be useful to me and my doctor:

{ContactForFutureCare.Answer } - {ContactForFutureCare.Yes } or No

Your email/address: {Donor.Email}

Signature: {Donor.xSignature}

Date {Donor.Sign.YMD}

Researcher Signature {Clinician.xSignature}

Date {Clinician.Sign.YMD}

Copy given to participant: {Clinician.Confirm.CopyGivenToSubject!}