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. 2021 Sep 27;12:744527. doi: 10.3389/fendo.2021.744527

Table 1.

Issues to be considered in patient information and informed consent forms.

Item Patient information form (PIF)(presented to the participant before donation) Informed consent form (signed by the participant, after considering the information in PIF)
a. Information about the planned study 1. What is the purpose of the study?

  • - Background information and simple description of the study (broad or specific to BMA research)

  • - Clear description of goals and expected results will help to increase the participation rates

  • - Study is approved by Research Ethics Committee/Institutional Review Board

  • 2. What sample material will be collected?

  • - BM sample (tissues/cells)

  • - Reference samples (eg. subcutaneous fat, blood)

  • 3. How it will be collected?

  • - Sampling procedure (surgery/biopsy/aspirate)

  • - Risks and disadvantages related to BM sampling

  • 4. What the sample will be used for?

  • - Broad purpose (unspecified projects) or BMA-specific purpose

  • - General risks related to the sample donation and storage (eg. storage of genetic information)

 Donor has had enough time to familiarize him/herself to the information provided in the PIF
Donor has had a possibility to ask questions after considering the information in the PIF
Donor understands the risks and benefits of participation
Risks

  • - General risks of sample donation

  • - BMA-specific risks (e.g. risks related to the BM sampling procedure), blood sampling, or surgery.

Benefits

  • - No direct health benefits or financial benefits

  • - Indirect benefits via promoting BMA-related research (and e.g. development of novel therapies in the future)

Donor provides information about his/her clinical condition

  • - Current diseases and treatments

  • - Past diseases and treatments

  • - Age, metabolic status and lifestyle habits (according to the study)
b. Sample and data storage 5. Who can access the biological samples and the data obtained?

  • - Only approved research studies (with ethical approval) may have access to the samples

  • - Tissue/cells that is left over from this study will be stored for future research to learn more about BMA

 Donor allows the use of 1) biological samples and 2) the data resulting from the research using these samples.

  • - The permission to store unused samples for possible future research should be separately requested.
c. Anonymization 6. What procedures will be used to protect the privacy and confidentiality of the data?

  • - Explain what personal data is collected and how the data is anonymized

  • - Sample material (and the data resulting from these samples) cannot be traced back to any of the person-related data

 Donor understands 1) what data is collected and 2) how the data will be secured (Data Privacy Statement).

  • Donor understands he/she will not have later access to his/her own data as all data is deidentified.
d. Withdrawal 7. How to withdraw from the study?

  • - Participation is always voluntary

  • - Provide contact information for withdrawal from the study (email, phone number, website)

  • - Explain how the samples and associated data will be destroyed after withdrawal: new data cannot be obtained and that existing data will be maintained in a non-identifiable form

 Sample is donated to biobank voluntarily.
Donor can withdraw from the study later at any time and without any reason.

  • - Explain how the withdrawal should be signaled to the researchers (eg. email, letter, phone call)