Ethical Principles guiding the Athlome consortium and biobanking

The rise of biobanking has brought about a whole range of issues that are not all wholly relevant to the Athlome project. Nevertheless, certain key principles must be noted here that will inform the governance framework for Athlome: (i) the consortia are global in reach but there is no universal agreement on the precise nature of ethically justifiable governance for biobanking; (ii) given the globality of the consortia, no single regional (e.g., European, American) framework ought to be adopted; (iii) a general framework drawing on widely shared principles should be discussed and adopted. Chief among the concerns, but only one among several, is the problem of consent.

Each of the projects that comprise Athlome are existing bio-guardians with a duty to protect the rights of participants who have contributed their samples to the individual projects noted above. The collection, storage, access to and use by researchers of those samples has been approved by relevant regulatory authorities (e.g., IRBs, RECs National Health Services Research Ethics Services) appropriate to the lead institution of the individual projects/consortia. Existing procedures do not currently extend to the sharing of samples beyond the study, since consent models are prospective (i.e., the guide future actions of researchers) and typically entail a form of specificity and the specific consent obtained varies between project partners. No retrospective consent is feasible and this is a widely shared problem for biobank development. Since the form of collaboration Athlome envisages was not laid out before participants gave their consent, it might be concluded that the sharing of data beyond the original research group and its stated purposes invalidates that consent. The problem for Athlome is not an uncommon one for biobank collaborations since it seeks retrospective extension of the consent model.

An ethical solution to this problem and related consent problems for new participants is to consider the use of a technique such as “broad consent”. The nomenclature here is important since this notion is variously described as “broad consent”, “blanket consent”, “future consent”, “hypothetical consent”, “passive/tacit/silent consent”, or “waived consent.” This would entail asking participants to agree to future unspecified uses of their data that are und(er)determined in the consent process and relevant forms. Without sufficient grasp of the uses of the data or with whom it might be shared, this process fails the test of “comprehension” a user must understand sufficiently what they are agreeing to. Another possibility going forward would be “meta-consent” where consent is sought for broad categories of unspecified future research. Others have argued with respect to biobanking that the ethical issues entailed (e.g., privacy, confidentiality, ownership of access to the data) may be sufficiently assuaged by rigorous anonymisation and associated practices of data storage, though this is far from universally agreed upon.

The Athlome project will develop principles and protocols for safeguarding participants rights to access, confidentiality, privacy of data, and assurances that there is no significant mission drift of the kind of which is permitted under some conceptions of broad consent (or its similies). This would, for example, prohibit commercialization of participants’ data. In order to preserve the integrity of this process and the principles, rigorous anonymisation processes will be developed by a partner institution that does not have any direct role in data collection, storage or analysis. This will assure independence and integrity to the process. This is especially important in this case since some of the research participants are public figures, which increases the likelihood that someone might be interested in re-identifying their data and genomic sequences. The independent institution would also have an oversight of each new proposal for the Athlome project going forward in order to ensure compliance with those principles and protocols.

In summary, the intention of the Athlome consortium is to globalise the field of sports genomics and enhance collaboration initiatives with other research groups worldwide. The combined power of these studies will present a unique chance to study the biology of the best elite athletes, irrespective of ethnicity. Evidence continues to grow that physical activity and fitness are inversely associated with the risk of major cardiometabolic diseases, several cancer types and Alzheimer’s disease. Studying the genes of elite athletes, a population enriched for the end-point of the human fitness continuum, offers a unique chance to gain insight into gene function, fitness and metabolism. Identifying genetic markers of exercise capacity, adaptation to exercise programmes, predisposition to injury and disease will provide a platform for the personification of treatment and prevention in 21st century medicine.