Normally, clinical and health information was collected by means of questionnaires and samples eg, blood sample, urine sample. Some studies included more in-depth medical examinations eg, ECG. Consents can be categorized into two main types. Broad consent is defined as asking the research participants to consent to a wide range of future research, 34 whereas specific consent is limited to a specific research.
For instance, in some informed consent forms from Norway and Sweden, research participants were given the option to cross out items they did not want to give their consent to eg, extraction of DNA, recontact for further investigation, merging of results with other registers.
Failure to mention possible secondary use does not necessarily preclude such use, as the national ethical—legal frameworks may not explicitly prohibit it. However, the fate of the data and samples on withdrawal is not dealt with uniformly. They can be destroyed, removed, or kept in the biobank. In about one-third of the studies, in which withdrawal is mentioned, the procedure to be followed is not specified. Four studies mention explicitly that such recontact implies that a new consent will be obtained. Among these, two address the issue of informing minors of their participation in the study or obtaining new consent once they have matured or reached legal age.
In the second study, researchers inform the minor of data storage and of the possibility of withdrawal. In the remaining 49 studies, this issue is not addressed. In most cases, it is mentioned that the data will be deidentified eg, coded or that the participant's identity will not be traceable anonymized. This consent corresponds to the overall research objectives of ENGAGE for the majority of research participants of the 52 cohort studies analyzed. Nevertheless, the practical management of change of status death, incapacity, reaching legal age, or withdrawal from the study , the secure exchange of data across institutions and borders, and the risk for reidentification represent important challenges for ENGAGE.
Because national legislation differs from one country to another, managing data exchange in ENGAGE requires knowledge of existing regulations and a continuous follow-up of international norms. When entering the project, all partners were responsible for ensuring that their data would be used in accordance with the consent given by the research participants.
Difficulties may still occur when seeking a renewed consent or approval from a local research ethics committee or data inspectorate. These challenges are not addressed in the consent forms.
Striving to generalize these results to other consortia is outside the scope of our focus and may not be very relevant because of inherent scientific differences between consortia. Retrospective research also needs a harmonized governance framework such as that developed for prospective research see UK Ethics and Governance Framework However, scientific complexity, together with a multiplicity of international and national factors, could impede such an initiative.
This article has been cited by other articles in PMC. Abstract The rapid emergence of large-scale genetic databases raises issues at the nexus of medical law and ethics, as well as the need, at both national and international levels, for an appropriate and effective framework for their governance.
Biobank research in perspective The last decade has seen the rise of research consortia — the result of a convergence of needs, multidisciplinary collaboration, combined expertise, and larger cohorts. Part I. Historical, legal, and ethical biobanking issues: international policy perspectives The rapid growth of biobanks has been followed by a concomitant growth of international, national, and professional guidelines, as well as recommendations, laws, and regulations.
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A Consent in international guidelines from to barriers? B Consent in international guidelines solutions? Part II. Open in a separate window. Figure 1. Figure 2. Notes The authors declare no conflict of interest. Knoppers BM. Genomics and policymaking: from static models to complex systems.
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Hum Genet. Ries NM. Growing up as a research subject: ethical and legal issues in birth cohort studies involving genetic research. Health Law J. Mauron A. Oviedo: Council of Europe; Paris: Organisation for Economic Co-operation and Development; Biobanks and longitudinal studies: where are the children. Burke W, Diekema DS. Ethical issues arising from the participation of children in genetic research. J Pediatr. Children and population biobanks. Geneva: World Health Organisation; Washington: World Medical Association; Rockville: National Bioethics Advisory Commission; London: Human Genome Organisation; Dutch government Act of 17 November amending the Civil Code and other legislation in connection with the incorporation of provisions concerning contract to provide medical treatment The Hague; s.
Washington: Office for Human Research Protections; Hofmann B. Broadening consent — and diluting ethics. J Med Ethics. The EML is used by many countries to set drug purchasing priorities for their national health systems and so they put a premium on getting these medicines affordably typically there is a corresponding national list that is occasionally amended. I think an essential point with patented medicines and price, whether or not a medicines is on the EML, is that in many cases they simply do not have to cost what they do, particularly for poor populations.
Retrospective access to data: the ENGAGE consent experience
In many case, if a newer medicine is on patent and therefore fails in being cost-effective, that would be due to a failure to take into account the fact that the price is somewhat arbitrary, particularly for a country that could issues a compulsory license and bring the price down through WTO rules. Perhaps one way to think about changes to the EML would be that WHO should put a greater emphasis on proactively helping to remove patent and other IP barriers to needed medicines for poor countries.
This could create a better evaluation of medicines based on medical need. I think from a legal prospect, some of the issues with intellectual property and its impact on access to medicine stems from the continuos blurring the courts have allowed with patentable subject matter. Originally, a person could not patent things that already existed in nature because the courts were concerned with allowing a monopoly to one person over things that are naturally available to everyone.
Later the courts redefined the general rule to allow all "man made" creations whether living or non-living to become patentable, which includes bacteria and other living organisms. This is the state of the law now that allows the patentability and monopoly over many human genes and strands of DNA. The monopoly over these "products" prevents other companies and even other countries fair access to essential components for independent development of cures for many diseases, like cancer.
Thankfully, though, the USPTO is widely seen to have overstepped the mark in allowing gene sequences to be patented, and is being reigned back by the courts. This ruling is under appeal. A similar test case to invalidate the same patent claims has since been launched in Australia. What confounds the expectations of most ordinary people is that the patents were not granted over a genetic treatment, but over the isolated gene sequences themselves.
As a result, nobody could even test for those genetic sequences, without infringing Myriad's patent. It's estimated that 20 percent of the human genome has been patented. This obviously has serious implications for downstream research and innovation. If the future of medicine is personalized treatment, it's extremely important to focus on properly identifying and weeding out claimed inventions that don't qualify as patentable subject matter.
This question maybe fits in one of the other threads better but I'll flag it here: what are the opportunities for tackling the patentable subject matter question short of trying to influence legislation or submitting amicus briefs in the rare patent cases? Of course it's not clear just how much influence one can have on these types of matters by simply submitting position statements, but it's a start I frequently find that in discussion of IP and access to medicines, the focus tends to be mainly, if not entirely, on patents.
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For traditional small molecule drugs eg: drugs that can be chemically synthesized , I believe that patents are a critical issue determining access because they are main impediment to generic production. With regard to biologics, and particularly vaccines, I would argue that patents are not the sole, or even main barrier to access. Rather, I believe that data exclusivity and trade secret protections are critical impediments to access.
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I also believe that an IP activist community that has traditionally focused on patents needs to expand their focus and expertise to cover these two issues in order to be effective in promoting access to new vaccines and biologics. With regard to vaccines, historically it has taken 15 to 20 years to introduce new vaccines into poor countries after their introduction in high-income markets. This situation is clearly not acceptable.
There are a number of underlying causes, but vaccine cost is undoubtedly a critically important issue. In general, the best approach to sustainably ensuring affordable drug prices is generic production. In the case of vaccines, it is likewise clear that the existence of multiple developing country vaccine manufacturers is crucial to achieving affordable vaccine prices.
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