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Table 1 Differences and Similarities in Informed Consent Requirements in DSBR, DSCR and PBR

From: Bridging consent: from toll bridges to lift bridges?

Element 1 Invitation, presentation of the study and voluntary participation
Similarities Study title and location
Names and affiliations of principal investigators and co-investigators
Study type, purposes and justification
Criteria for participant selection and estimated number of participants
Sources and duration of funding
Voluntary participation
Differences Found in DSCR, not in DSBR and PBR
Description of clinical trial
Reasons for testing
Current experience with drug/device
Availability of products and interventions resulting from the research
Element 2 Research protocols
Similarities Duration and timetable of the study
Procedures (physical exams, clinical measurements, samples intake, number of visits, interventions)
Types of data and samples to be collected
Differences Found in DSCR, not in DSBR and PBR
Description of routine, experimental clinical procedures (randomization, blinding, placebo use, biopsy, surgery, etc.)
Expected duration of participation in the study
Circumstances of early termination
Found in DSBR and PBR, not in DSCR
Re-contact procedures
Element 3 Risks
Similarities Known and anticipated physical, emotional and psychological risks and discomforts
Known and anticipated risks associated with breaches of confidentiality
Medical procedures in the event of harm or in the need of treatment of research-related injuries
Differences Found in PBR, not in DSCR and DSBR
Risks of potential group stigmatization
Element 4 Benefits
Similarities Expected direct and indirect benefits to participants, local community and broader scientific community
Information about return of personal or financial benefits to participants (if any)
Differences Found in PBR, not in DSCR and DSBR
Scientific importance of biobanks for the public good
Element 5 Financial compensation, indemnification and costs
Similarities Procedures for incentives and financial compensations
Differences Found in DSCR, not in DSBR and PBR
Costs in case of treatment of research-related injuries
Costs related to participation in research
Element 6 Confidentiality
Similarities Procedures for data protection and maintenance
Limits to confidentiality protection
Differences Found in DSBR and PBR, not in DSCR
Prohibition of data re-identification
Element 7 Data access and data sharing
Similarities Conditions and procedures for internal and external access to data, biological samples and health records (e.g. by researchers, participants or regulatory bodies)
Conditions for secondary or future uses of data and biological samples within the same research area
Differences Found in DSCR, not in DSBR and PBR
Participant's right to place restrictions on specific future uses of data and biological samples
Found in PBR, not in DSCR and DSBR
Requirements for return of samples and research results to the biobank
Element 8 Storage
Similarities Procedures for storage and destruction of data and samples, also in the case of participant withdrawal
Differences Found in PBR, not in DSCR and DSBR
Procedures for use of data and samples after donor's death
Rules regulating the use of data and samples in case of biobank or owner/custodian surrender
Element 9 Return of results
Similarities Procedures for individual return of results to participants/medical records during or after the research
Differences Found in DSBR and PBR, not in DSCR
Procedures for return of general results by means of a Newsletter, web site etc.
Element 10 Commercialization
Similarities Prohibition of samples commercialization
Potential for third-part commercialization of products resulting from the research
Non return of financial benefits to the participants
Differences Found in DSBR, not in DSCR and PBR
Rules for ownership of samples
Element 11 Right to withdraw
Similarities Participant's right to withdraw at any time without penalty or loss of benefits
Differences Found in DSCR, not in DSBR and PBR
Alternatives to participation
Description of established standard treatments
Found in DSBR and PBR, not in DSCR
Placement of data in open or controlled databases
Impossibility to withdraw data already contained in analyses
Element 12 Re-contact
Similarities Re-contact procedures (e.g. frequency, method) if any
Differences Found in DSBR and PBR, not in DSCR
Re-contact procedures for new unanticipated research uses
Element 13 Contact information
Similarities Contact information for principal investigators, co-investigators and sponsoring institutions
Contact information for the Institutional Review Board which granted approval
Element 14 Ethics oversight
Similarities Information about procedures for ethics oversight of current project
Differences Found in DSBR and PBR, not in DSCR
Information about procedures for ethics oversight of future projects
Element 15 Signatures
Similarities Signatures of participant, witness (if the participant is illiterate), principal investigators and translator (if needed)