Table 2.

Generic and Rare Disease Research Specific Core Consent Elements

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