Table 1

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

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)


Budin-Ljøsne et al. BMC Medical Genomics 2011 4:69   doi:10.1186/1755-8794-4-69

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