Bioethics issues in human studies

Informed consent

Scientists' inquiry

Experiences with Ethics Committees

Specification of single tests vs. more generic information in the informed consent

• Scientists of almost all countries reported their Ethics Committees have been accepting informed consent with more generic information about genotype tests (Germany, France, Italy, Netherlands, Norway, UK) with examples to illustrate the kind of tests (UK).
• Some Ethics Committees requested to mention every single test planned within the study (Germany, France, UK), or to list the tests as detailed as possible (Spain, Poland).
• British scientists reported most frequently that they had to mention every single test planned. One French researcher stated that they had to give a copy of the study protocol to the participant.

Opinion of the scientists

Specification of single tests vs. more generic information in the informed consent

• The major part of the scientists was in favour of giving more generic information (e.g. type of tests) that must be nevertheless held very clear and quoted with an example. The participant should be offered to ask questions.
• One scientist stated if all variants need to be specified one has to approach the participant for every new marker to be studied. This won't be avoidable because many gene variants are still being undiscovered. To contact the participant over and over again would be an unnecessary burden for the participant.
• Another opinion is that tests should be listed if of relevance to personal health together with the offer to disclose the results to the participant.
• One statement regarded the fact that the participants may be confused when too much or too detailed information is given to them.
• Few researchers would like the participants to know details of tests planned as well as the consequences of having one or the other polymorphism.
• The level of knowledge of the participant should be considered (If only RNA is being tested this should be explained such that participants understand the difference between gene sequencing SNP and gene expression analysis).
• One scientist pointed to the problem that until protective legislation is in place to guarantee the right to be health insured regardless of genotype it should in no case be told which tests are conducted. This would need to be explained to the participants.

Minimal information that must be given in the informed consent

Researchers gave more or less detailed topics that should be covered by the informed consent. The answers reached from a very subject point of view ("as much as they want to know but not to the point where their health insurance rights become compromised") to objectively defined issues (such as "aim of the study, procedures, risks etc."). One scientist gave an entire template for informed consent as it is available from their Ethics Committee. The various answers of the other scientists combined look as follows:

• Why the person was chosen for the study
• Aims of the study
• Study design, procedures (e.g. blood sampling, questionnaires, intervention etc.)
• Responsible person, contact information
• Whether the study is commercial or not, intended use of the results
• Benefits and risks (advantages, disadvantages) for the individual and the society, possible adverse events, consequences for the health due to participation, disadvantage of knowing genotype information
• Possibility and point in time at which information will be available; whether the results will be available on the individual or in the group level
• Participation is voluntary, can be withdrawn at any time
• Fate of the sample and data
• Specification of the confidentiality of the data
• Whether they will get something paid, prerequisite for reimbursement, and how much they will be paid
• Notification of the Ethics Committee