Element 1 | Invitation, presentation of the study and voluntary participation |
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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) |