Bioethics issues in human studies

Informed consent

Extended storage, secondary use of samples

State of discussion

In the Preliminary Study on the Collection, Processing, Storage and Use of Human Genetic Data, commentary on guideline 50 (Free and informed consent in research) points out that a system requiring fresh consent for any further study would be extremely cumbersome and could seriously inhibit research [13].

Instead a 'blanket consent' is suggested that would cover all forms of future medical research when generally further use was explicitly mentioned.[13, 33].

This opinion is not un-debated. As discussed by Deschênes et al. [32], the blanket consent, waiver of consent or notification are three options that could overcome the problem of methodological and practical implications with extended storage and particularly with secondary use of samples. However, the blanket consent is ethically the most crucial. Since future potential uses of the samples and data are not known at the time when the individual gives consent, it is questionable whether the participant received enough information to make the consent informed.

The Human Genome Organization Ethics Committee proposed to allow a secondary use of stored samples left from other studies if there is a general notification of such a policy and the participant has not objected, and the samples were anonymized [34].

In general, further consent is a fundamental requirement and can only be waived under defined circumstances. It is obvious that consent can't be obtained when samples are anonymized. This would be a clear situation where fresh consent can be waived [11]. However, some debate whether it is ethical to anonymize samples that are not anonymized at the beginning of research [35].

The Council for International Organizations of Medical Sciences in its International Ethical Guidelines for Biomedical Research Involving Human Subjects [11] realized that secondary use should always be a matter of information in the process of informed consent. Consequently, it is essential that the original consent process anticipate any foreseeable plans for future use of the records or specimens for research. It should be discussed with the participant [11]:

• Whether there will or could be any secondary use and, if so, whether such secondary use will be limited with regard to the type of study that may be performed
• The conditions under which the investigators will be required to contact the research subjects for additional authorization for secondary use
• The investigators' plan, if any, to destroy or to strip off personal identifiers of the records or specimens
• The right of subjects to request destruction or anonymization of biological specimens of records or of parts of records that they might consider particularly sensitive.

Please see also Section 1 (Consent requirements for existing collections)