Table 2.
Field of application, topics dealt and outcomes resulting from the bibliographic search
| Source | Fields | Relevant topics | Recommendations/suggestions |
|---|---|---|---|
| Ross, 2010 [47] | Newborn genetic screening | - Use of stored samples for research - Parents’ informed consent |
- To seek for the consent from parents for research on stored sample storage and research |
| Simopoulos, 2009 [50] | Newborn genetic screening | - Appropriateness of the investigation | - To protect individuals identified by genetic screening against the psychological and social hazards |
| Glantz et al., 2008 [38] | Biobanks | - Use of stored samples for research - Informed consent for secondary use - Owner of stored samples |
- To establish clear rules on the use of samples in medical research and genetic privacy when information is used by companies - To provide participants the right to withdraw the consent |
| Botkin, 2005 [3] | Newborn genetic screening | - Use of stored samples for research - Appropriateness of the investigation |
- To apply an approach to evaluate screening tests as rigorous as the approach for drugs (phases I to IV) |
| Sheela et al., 2005 [49] | Trials/experimental uses | - Parents’ informed consent - Vulnerable status - Approval from the ethics committee |
- To provide full and appropriate information to parents - To offer adequate time for the parents to absorb information |
| Gelsinger, 2002 [35] | Trials/experimental uses | - Informed consent - Potential benefits, risks and discomforts |
- To provide full and appropriate information - To carefully review paediatric protocols |
| Merz et al., 2002 [43] | Genetic research | - Use of stored samples for research - Parents’ informed consent - Rights of research participants and children |
- To address issues on the control of research results and the sharing of benefits before the research is performed - To involve research participants in decision-making - To develop policies for protecting the interests of subjects |
| Clague, Thomas, 2002 [7] | Newborn genetic screening | - Secondary use of samples for research - Parents’ informed consent for secondary use - Right to privacy and anonymised data - Appropriateness of the investigation |
- To undertake long-term storage, to allow re-evaluation of apparently erroneous results - To perform anonymously research |
| Pschera, 2000 [44] | Trials/experimental uses | - Appropriateness of the investigation | - To enhance the methodology for a safe and broad application of experimental approaches |
| Fox,. 2000 [34] | Trials/experimental uses | - Informed consent for gene therapy trials - Disclosure of conflicts of interest |
- To provide full and appropriate information - To disclosure conflicts of interest |
| During, 1996 [18] | Trials/experimental uses | - Informed consent - Expertise in ethics committees |
- To provide full and appropriate information - To foresee specific expertise in ethics committee on gene therapy |