Consent forms

The data we share with the general public will not have your name on it, only a code number, so people will not know your name or which data are yours. In addition, we will not share any other information that we think might help people who know you guess which data are yours.

If you change your mind and withdraw your consent to participate in this study (you can call <PI name> at <phone number> to do this), we will not collect any additional data about you. We will delete your data if you withdraw before it was deposited in the database. However, any data and research results already shared with other investigators or the general public cannot be destroyed, withdrawn or recalled.

By agreeing to participate, you will be making a free and generous gift for research that might help others. It is possible that some of the research conducted using your information eventually could lead to the development of new methods for studying the Musculoskeletal System, new diagnostic tests, new drugs or other commercial products. Should this occur, there is no plan to provide you with any part of the profits generated from such products and you will not have any ownership rights in the products.

To the best of our knowledge, the data we release to the general public will not contain information that can directly identify you. The data will not have your name on it, only a code number, so people will not know your name or which data are yours. In addition, the data will not include data that we think might help people who know you guess which data are yours, such as your facial features or the date that you participated. If we write a report or article about this study or share the study data set with others, we will do so in such a way that you cannot be directly identified. However, by using additional data linked to your name (for example medical imaging scans obtained from your medical records) one could potentially associate your imaging or other information in our database back to you. In addition a security breach (break in or cyber attack) might lead to someone being able to link you to your data. This risk is very low because your data are stored in a secure database, and the information about your identity is stored separately from the data themselves, linked only through a code.

We will keep the private portion (name, contact information etc.) of your data in a secure location for at least <x> years. This way if one of the researchers that obtained the data from us will find something in your scans that would have a diagnostic value we will be able to contact you. After this period of time we will destroy this information to protect your privacy.

Letting us use and share your data is voluntary. However, you must be willing to share your data in this way in order to participate in this study. If you are not willing, you cannot participate in this study.

By signing below, you agree to provide your data for future research. You agree that these may be shared with other investigators at other institutions from around the world. The details, results, and implications of these studies are unknown.

Usage and storage of your data
While the collection, use and storage of your data are done for the purpose of conducting the study to which you are currently participating, these data might also be used for other future research projects in the field of musculoskeletal research. This includes data from your musculoskeletal system, and may also include test results from the study you took part in, family and medical history, and also data such as gender and age.
By agreeing to participate, you will be making a free and generous gift for research that might help others. [It is possible that some of the research conducted using your information eventually could lead to the development of new methods for studying the musculoskeletal system, new diagnostic tests, new drugs or other commercial products. Should this occur, there is no plan to provide you with any part of the profits generated from such products and you will not have any ownership rights in the products.] We ask for your consent to this access to your data.

Confidentiality of your data
To the best of our knowledge, the data we release will not contain information that can directly identify you using reasonable means. To protect your privacy, the data will be given a code, so people will not know your name or which data are yours. Your name, but also other information that can directly identify you, will be omitted. Data can only be traced back to you using information only available to the data processor (i.e. people involved in the study). This information will remain safely stored in the local research institute. The data cannot be traced back to you in reports and publications about the study. However, by using additional data linked to your name (for example medical imaging scans obtained from your medical records) one could potentially associate your imaging or other information in our database back to you. The risks of accessing such data from our servers have however been assessed and are considered to be low (see the university/centre Data Privacy Impact Assessment @<URL>).

Access to your data for verification
Some people can access all your data at the research location, including the original data with your name. This is necessary to check whether the study is being conducted in a good and reliable manner and to be able to notify you and your physician in case of any incidental findings resulting from your scans. Persons who have access to your data for review are: the local committee that monitors the safety of the study, the data controller working for the primary investigator of the study, and local, national and international supervisory authorities. They will keep your data confidential.

Retention period of your data
There is no plan to delete your data as they can be re-used for legitimate research interest. We will however re-evaluate every <number of years> years if it is worthwhile keeping them.

Withdrawing consent
You can withdraw your consent to the use of your personal data at any time. This applies to this study and also to the sharing for future research. You have however to understand that once shared with other institutions, it is impossible to remove your data from such copies.

Passing on to countries outside the European Union (EU)
Your encoded data can also be accessed by and sent to countries outside the EU. This is necessary so that non-EU based scientists can run analyses to verify the scientific results produced from this study or for future unrelated research. In those countries, the EU rules on the protection of your personal data do not apply. However, your privacy will be protected at an equal level, by means of a future link provided here Data User Agreement.

More information about your rights regarding processing of the data
For general information about your rights regarding the processing of your personal data, you can consult the website of the <Institution> Data Protection Authority. If you have questions about your rights, please contact the person responsible for the processing of your personal data. For this study, that is: <contact information> (see Appendix for contact details) If you have questions or complaints about the processing of your personal data, we advise you to first contact the research location. You can also contact the Data Protection Officer of <Institution> (see the contact details in Appendix ) or the <Institution> Data Protection Authority.

Date:
Collected by:
Signature:

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, but your data and biospecimens might still be used if they have already been shared.

My de-identified research data may be kept for use in future research to learn about, prevent or treat other health-related problems.

YES

NO

DESCRIPTION

This study is collecting data from you. We would like to make your data 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 to keep your data for [Insert time frame as indicated in the study protocol].

Your data may be shared with researchers around the world. However, the decision to share your data is controlled by [indicate which entity has control]. To get your data, future researchers must seek approval from* [indicate which entity has control]. The researchers must agree not to try to identify you.

Option #1: If the data are coded and can be linked back to the identity of the participant:

We will protect the confidentiality of your information to the extent possible. Your data will be coded to protect your identity before they are shared with other researchers. [indicate which entity has the code key] will have a code key that can be used to link to your identifying information. The code key will be securely stored.

Option #2: If the data cannot be easily linked back to the identity of the participant:

Your name and identifying information will be removed from any data you provide before they are shared with other researchers. Researchers cannot easily link your identifying information to the data.

CONSENT/WITHDRAWAL

Option 1: When sharing of data will be optional (e.g., for studies that have potential benefit):

It is your choice whether or not to let researchers share your data 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, you should contact [insert contact info]. We will do our best to honor your request and to retrieve any data 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 we will not be able to retrieve them. In addition, if the data have already been used for new research, the information from that research may still be used.

Please initial [or sign depending on institutional practice] next to your choice:

______YES, use my data in other research studies

______NO, do NOT use my data in other research studies

Option 2: When sharing of data will not be optional (e.g., where sharing is integral to the purpose of the study):

Participating in this study means you agree to share your data. You can change your mind later, but researchers might still use your data if they have already been shared. If you do not want your data used for other projects, you should not participate in this study.

RISK / BENEFITS

[Risks] We will do our best to protect your data during storage and when 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. In either case, we cannot reduce the risk to zero.

[Benefits] You will not receive any direct benefit from sharing your data. However, sharing your data may contribute to research that could help others in the future.