Bioethics issues in human studies

Informed consent

Extended storage, secondary use of samples

Scientists' inquiry

Experiences with Ethics Committees

Extended storage of samples

• Limitation of time of storage of DNA samples or other biological material was reported by German, French, Dutch, British scientists.
• The period of time was either flexible but had to be defined (France, Netherlands, UK) or was confined according to the type of study to 2 to 15 years after the study has ended (Netherlands, Norway, UK), or the life time of the principle investigator (Germany).
• Storage only until the end of the study was researchers permitted in Netherlands, Norway.
• No fixed rules exist but period has to be defined in the informed consent and therefore would need a renewal of informed consent in the case of extension (Germany, Spain, Italy, Netherlands, Norway, Poland), or at least an information about the extension of storage (Sweden).
• No rules exist at all or open ended storage was possible without any consent in France, UK, Italy, Netherlands.

Overall the applied rules by the Ethics Committees even in one country look very heterogeneous, i.e. more or less stringent.

Secondary use of data and samples

• No limitations exist for secondary use when samples and data are anonymized (Germany, Netherlands, UK)
• An amendment to the original study protocol has to be approved by the Ethics Committee without an additional renewal of consent in France and UK.
• Renewal of ethical approval and a new informed consent would be needed in Germany, Spain, France, UK, Netherlands, Poland, Sweden.
• When a new test is intended within the same study for which original informed consent was obtained, the participant only has to be informed (UK).
• A scientist from Ireland reported a wording of the informed consent compatible with secondary research: "5. I understand that future research using the sample I give may include genetic research aimed at the understanding the genetic influences in disease but that such test will not be of predictive/clinical value and that the results of these investigations are unlikely to have any implications for me personally."
• Italian scientists reported both, no new informed consent needed and secondary use not allowed without new consent.
• No problems appear where the secondary use fit within the original aim of the study (Netherlands, UK).
• In principle, samples can't be used for any other study in Norway.

Opinion of the scientists

Extended storage of samples

Although few scientists were in favor of the disposal of the samples after the study has ended, the majority advocates the extended storage of biological material.

• It would be unethical to destroy 'perfect material' and approach further individuals to collect new material.
• When keeping the samples, privacy or confidentiality has to be guaranteed. Unlimited storage of anonymized samples would solve this problem best.
• In France, where a national biobank exists scientists noted that this is a good opportunity to control access to the samples and another scientist pointed out that, since biobanking needs financial resources, extended storage of samples should be decided on a national regulation framework.
• Some scientists thought that the informed consent should include the information on extended storage (with or without opt out clause).

Secondary use of data and samples

The opinion about how to treat the situation of secondary use varied considerably across scientists.

• Whereas some scientists endorse the renewal of the consent where data and samples are stored coded,
• others find it to cumbersome and prefer an Ethics Committee to judge about the ethical implications of the further use without seeking new consent.
• The use of anonymized samples should generally be possible, however it is not clear whether all researchers who stated this opinion mean that ethical approval should be obtained or should not be obtained.
• Some thought that potential secondary use should be included in the initial informed consent whereas few stated that all further use should be specified.
• One opinion was that once permission for use of DNA was given by the Ethics Committee, it should encompass further studies without new consent and ethical approval.
• One researcher commented that it should be well controlled that the existent data and samples are suitable to appropriately answer the new research question.