Results of the Inquiry on Bioethics

Results of the Inquiry on Bioethics
Bioethics Working Group WP6

Manuela M Bergmann ¹,
Marek Bodzioch ²,
Luisa Bonet ³,
Catherine Defoort ⁴,
Georg Lietz ⁵

¹ German Institute of Human Nutrition, Potsdam-Rehbrücke (Germany), Department. of Epidemiology
² The Jagiellonian University (Poland), Medical College, Department of Clinical Biochemistry,
³ University of the Balearic Islands, Palma de Mallorca (Spain), Laboratory of Molecular Biology, Nutrition and Biotechnology
⁴ UMR INSERM (France), Faculté de médicine Timone
⁵ Newcastle University (UK), School of Clinical Medical Sciences, Human Nutrition

Major Purposes

To collect information on ...

• experiences of NuGO scientists with ethical approval for their studies
• opinions of the scientists about the 4 ethical issues
• the most sensitive conflicts between Ethics Committees and scientists

Additional Purposes

To collect information on ...

• existing and applied rules and regulations for ethical approval among NuGO member institutions
• laws and documents used by the Ethics Committees
• the affiliation and the address of the responsible Ethics Committees

Methods

Instruments

• Questionnaire which was online from October 7, 2004 - January 3, 2005
• electronic invitation to fill in the questionnaire
• reminder to those who did not answer:
  • November 8, 2004
  • November 29, 2004
  • January 5, 2005

Study Subjects

• 640 scientists had been registered in the NuGO network (Topshare) on October 1, 2004
• of which 551 were not involved in ethical approval or are not conducting human studies
• leaving 89 eligible scientists who could answer the questionnaire

Structure of the Questionnaire

• Introduction
• General questions
• Issue 1 to 4
  • genotype information,
  • biobanks,
  • exchange of data and samples,
  • informed consent)
• General questions

Online Questionnaire

Response

Response to Single Parts of the Questionnaire

Affiliation of the Ethics Committee

Ethical Approval in Multi-centre Studies

Key Points of the Open Answers

Genotype Information

• Position regarding disclosure of test results varies among EC and among scientists:
  • No disclosure in any case to disclosure must be offered
  • Crucial point, more frequently pointed to by the scientists: Health relevance of the information
• ECs and scientists think: If disclosed, information should only be given on a personal basis via qualified personnel

Biobanks

• The ECs' opinion about the propriety status of the sample vary:
  • The sample is a donation (no one's property),
  • The sample stays the property of the individual,
  • The sample passes over into the possession of the researcher (institution)
• Most ECs stipulates the samples to be stored coded or anonymized
  • However some ECs tolerate nominal storage
• There is confusion among the scientists about the meaning of
  • Anonymous, anonymized, coded, or identified samples.
• Not mentioned at all: the quality management and control of biobanks

Exchange of Data and Samples

• Consensus exists between ECs and scientists: the confidentiality and protection of privacy must be guaranteed
• Exchange of data and samples is proved to be difficult when not subject matter in the initial informed consent
• The information or ex post consenting of the participants often is not feasible
• Scientists want not too strict regulations

Informed Consent

• Required accuracy and degree of detail with which planned tests have to be mentioned in the informed consent
  • Potential field of conflicts between ECs and scientists
• Predefinition of the length of time of sample and data storage (by law, individually)
• Heterogeneous prerequisites for secondary use of samples
  • Renewal of informed consent
  • Anonymization
  • EC's approval (amendment or renewal)
• Controversial rules about what to do with the sample (and data) when consent was withdrawn
  • Can be kept and used/not used
  • Must be destroyed immediately
  • Can be kept until end of the study

Summary

Essential Issues for Researchers

• What laws regulate biobanking, exchange of samples and data and secondary use nationally and internationally
• How rigid are the procedures for extended storage of existing samples (biobanking) and secondary use
• How flexible is the informed consent regarding upcoming tests that have not been foreseen when the study was planned
• What is the optimal design of an informed consent (for future studies)

Essential Issues for the Individual

• Disclosure of genotype information and its consequences
  • Quality of life, health consequences
  • Legal consequences regarding obligation to inform insurances or employers
• To be able to give really free and really informed consent
  • Comprehension of the participant and level of language presented by the researcher
  • Motivation of participation in research
  • Expected benefit due to participation
• If wished, to be able to keep track of what happens to the sample given

Conclusion

• We need...
  • guidelines to follow for NuGO scientists and Ethics Committees
  • education of scientists in these guidelines with the aim to improve the understanding of ethical implications (Seminars, e-learning, counseling for researchers seeking ethical approval etc.)
  • to understand that these guidelines will be dynamic, meaning that they will have to be continuously adapted to new laws, regulations, research methods and findings