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Table 2 Generic and Rare Disease Research Specific Core Consent Elements

From: Model consent clauses for rare disease research

Generic Core Elements:
 General information/Introduction (name of researchers, hospital/institution, funders/sponsors, etc.)
 Nature and objectives of the study
 Voluntariness of participation
 Procedures involved in participation (what will happen during the study) /types of data and samples that will be collected
 Possibility of large scale genome-wide sequencing techniques
 Potential physical, psychological, social and informational risks
 Potential benefits of participation
 Protections in place [locally] to ensure security/privacy/confidentiality
 Duration/place of data/sample storage
 Hosting of data in an open access database
 Access to data/samples for research purposes (who will have access, types of access, governance framework, procedures in place – ex. data access committee), including access by pharma/industry, if applicable
 Access to data/samples for purposes of auditing, validation, control, etc.
 Return of research results/incidental findings (processes and potential inclusion in medical records)
 Withdrawal procedures (sample/data retrieval, destruction, no further contact, no further access, unlink, no further use, etc.)
 Compensation/reimbursement
 Prospects for commercialization and intellectual property procedures
 Study dissemination/publication
 Assent (where applicable)
 Re-contact
 Study oversight (IRB/REC/REB)
Core Elements (Rare Disease Research Specific):
 Rare Disease Research Introductory Clause
 Familial Participation
 Audio/Visual Imaging
 Collecting, storing, sharing of rare disease data
 Recontact for matching
 Data Linkage
 Return of Results to Family Members
 Incapacity/Death
 Risks and Benefits