Informed Consent Centrality And Inadequacy Of The Ideal

Informed consent is one of the most important doctrines of bioethics. It was introduced in the 1947 Nuremberg Code, following revelations during the Nuremberg trials of Nazi medical experimentation in concentration camps. It developed through inclusion in the United Nations' Universal Declaration of Human Rights in 1948 and the World Medical Association' s Declaration of Helsinki in 1964. Informed consent is incorporated in all prominent medical, research, and institutional ethics codes, and is protected by laws worldwide.

The purpose of informed consent in research can be viewed as twofold: to minimize harm to research subjects and to protect their autonomous choice. Informed consent requires researchers to ensure that research participants consent voluntarily to participation in research and that they be fully informed of the risks and benefits. The focus of informed consent has slowly shifted: from disclosure by health professionals toward the voluntary consent of the individual based on the person's understanding of the research and expression of their own values and assessments [32]. Simultaneously, health research has shifted from predominantly individual investigator- designed protocols with specific research questions to multiple investigator and institution projects that gather many forms of data and samples to understand complex phenomena and test emerging hypotheses. Further, informed consent as a protection for autonomy has become important in arguments about reproductive autonomy. Informed consent has been described as representing the dividing line between "good" genetics and "sinful" eugenics [32].


Unprecedented computational power now makes it possible to network and analyze large amounts of information, making large-scale population biobanks, and genetic epidemiology studies more promising than ever before. This research context raises the stakes of research ethics, making it more difficult to achieve individual consent and protect privacy while serving as the basis for strong claims of individualized and population health benefits. Large-scale biobanks and cohorts by their very nature cannot predict the exact uses to which samples will be put ahead of time. The ideal of voluntary participation based on knowledge of the research appears to require new informed consent for every emergent hypothesis that was not part of the original informed consent. The practicality of such an ideal approach is less than clear.

Genetic testing can also use samples that were not originally collected for genetic studies. Tissue biopsies collected for clinical diagnosis are now providing information for gene expression studies [33]. The precise nature of future technologies that will extract new information from existing samples cannot be predicted. On the other hand, seeking repeated consent from biobank donors is a costly and cumbersome process for researchers that can impede or even undermine research. Response rates for data collection (e.g., questionnaires) in any large population may vary between 50 and over 90%. The need for renewed consent could therefore reduce participation in a project and introduce selection bias [34]. Repeat consent may also be unnecessarily intrusive to the lives of donors or their next of kin.

Other forms of consent have been suggested and implemented for biobanking purposes. These include consent with several options for research use: presumed consent, broad consent, and blanket consent. Many European guidelines, including a memorandum from the Council of Europe Steering Committee on Bioethics, laws in Sweden, Iceland, and Estonia, and the European Society for Human Genetics guidelines, consider broad consent for unknown future uses to be acceptable as long as such future projects gain approval from Research Ethics Boards and people retain the right to withdraw samples at any time [ 30]. The U.S. Office for Human Research Protection went one step further in 2004, proposing to broaden the definition of noniden-tifiable samples, upon which research is allowed under U.S. federal regulations without the requirement of informed consent.

The problem is that no informed consent mechanism—narrow or broad— can address all ethical concerns surrounding the biobanking of human DNA and data [35]. Such concerns include the aggregate effects of individual consent upon society as a whole and upon family and community members given the inherently "shared" nature of genetic material. If people are given full choice as to which diseases their samples can be used to research, and they choose only to donate for well-known diseases such as cancer, rare disease may be neglected. The discovery that Ashkenazi Jews may have particular mutations predisposing them to breast, ovarian, and colon cancer has generated fears that they could become the target of discrimination [36].

Concerns include irreconcilable trade-offs between donor desires for privacy (best achieved by unlinking samples), control over the manner in which their body parts and personal information are used (samples can be withdrawn from a biobank only if a link exists), and access to clinically relevant information discovered in the course of research. For some individuals and communities, cultural or religious beliefs dictate or restrict the research purposes for which their samples can be used. The Nuu-chah-nulth nations of Vancouver Island became angry in 2000 after discovering that their samples, collected years before for arthritis research, had been used for the entirely different purpose of migration research [ 37,38]. In some cases, a history of colonialism and abusive research makes a group demand that their samples be used for research that benefits their community directly.

Complete anonymization of samples containing human DNA is technically impossible, given both the unique nature of a person ^ DNA and its shared characteristics. Consequently, in 2003, the Icelandic Supreme Court ruled that the transfer of 18-year-old student Ragnhildur Gudmundsdottir's dead father's health data infringed her privacy rights: "The court said that including the records in the database might allow her to be identified as an individual at risk of any heritable disease her father might be found to have had—even though the data would be made anonymous and encrypted" [39]. Reasonable privacy protection in a biobanking context is tough to achieve, extending to the technological capacity to protect privacy through linked or unlinked anonymized samples without risk of error.

Informed consent cannot provide a basis for participants to evaluate the likelihood of benefit arising from their participation in a biobank when these merits are contested by experts. Critics of UK Biobank, for example, have little faith in the value and power of such prospective cohort studies, compared to traditional case-control studies, for isolating biomarkers and determining genetic risk factors. Supporters argue that the biobank will be a resource from which researchers can compile nested case-control studies. Critics claim that it will only be useful for study of the most common cancers, those that occur with enough frequency among donors. Others claim that even UK Biobank's intended 500,000 participants cannot provide reliable information about the genetic causes of a disease without a study of familial correlations [12] .

Informed consent is inadequate as a solution for ensuring that the impacts of biobanking and related research will be beneficial to individuals and society, will uphold the autonomy of the individual, or will facilitate justice. Given its historical importance and bureaucratic and legal dependence [ 40], it is not surprising that informed consent remains central to contemporary discussions of ethical and social implications of biobanking, biomarkers, and biomedical research. Unfortunately, the substance of such debates centers upon the inadequacy of both ideal and current procedures. As Hoeyer points out in reference to Medical Biobank run by Uman Genomics in northern Sweden, informed consent offers an illusion of choice without real consideration of the


implications of such choices, "by constructing a diffuse arrangement of donors who can only be semiaccountable agents" [41].

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