Legal drafting issues in medical research

biobankIP Draughts has been reviewing a large number of publicly-accessible documents used in medical research, particularly in the context of what are variously known as tissue libraries or biobanks. In other words, collections of materials taken from patients and intended for use in research. The materials might include body tissue, cancerous cells, or blood. The research might lead to the development  of diagnostic products or therapies for human diseases and conditions.

The documents currently on IP Draughts’ desk include patient consent forms, information leaflets, material transfer agreements, and policy guidance notes. Reading these documents, it is striking how much variation there is in the language used to convey similar ideas, and how difficult it seems to be to communicate clearly and accurately.

IP Draughts doesn’t underestimate how complex the task is. The drafter needs (but often seems to lack) a wide range of skills, including:

  • Regulation. How to comply with and explain complex laws and regulations, such as the Human Tissue Act and Data Protection Act. Often there are several layers of regulation, each with their own vocabulary, including those applying to human tissue, associated data, data protection and medical ethics.
  • Contract drafting. How to draft documents in a legally accurate way. For example, in identifying the parties to an MTA. Organisations such as  “the Loamshire BioRepository” (to anonymise the name in an MTA in front of IP Draughts) doesn’t exist as a legal entity, and is simply a convenient name for a collaboration between Loamshire University and Loamshire Hospital NHS Trust. Referring to the Biorepository as the provider of the materials is unclear. At the end of the document, it is unclear whether the person asking for the materials is an individual researcher or an institution. Failing to identify the parties to a contract is a very basic mistake. In the same document, the drafter clearly doesn’t understand the conventions on using defined terms; he defines the “Material”, then uses the expression ‘Material’ with pointless and weird single inverted commas.
  • Science. How to communicate with researchers, whose focus is likely to be mainly on their scientific projects, and less on the details of compliance with legislation.
  • Donors. How to explain, at a level suitable for the general population, the nuances of the permissions being sought – eg the range of research in which the human materials will be used, the right of the person to withdraw consent, why individual-related information on the outcome of the research will not be provided (it should be done by the patient’s doctor, not by a research team; and anyway, if the research has been anonymised, the researchers won’t know the identity of the patient, etc)
  • Communicating at a time of grief. In the case of material to be taken from a corpse, how to communicate with grieving relatives who are being asked for permission to use the body of a recently-deceased person for medical research, or to confirm their consent to instructions given by the deceased before his or her death

bodyReading through a selection of documents, IP Draughts is left feeling that the drafting of documents within a complex regulatory regime should be a multi-disciplinary team effort, in which the best communicators among doctors, nurses, researchers, regulatory experts and lawyers should be engaged. Instead, the drafting seems often to be left to someone to ‘muddle through’ as best they can.

One of the areas where these issues come up is in relation to IP and property issues arising from the use of materials in research. These issues arise at several levels:

  1. As a matter of public policy and law, it may not be possible for there to be property in body parts, though there seem to be some exceptions to this principle. Similarly under the EU Biotechnology Directive, some aspects of the human body are not patentable. Therefore, referring to a biobank as owning materials, or owning the IP in materials, may or may not be legally meaningful.
  2. Linked to the above points is whether the patient can claim any financial or other interest in, or control over, the exploitation of products derived from research that made use of their materials. If consent forms mention this issue at all, they vary widely in how they cover it.
  3. Should the biobank, in its relationship with the researcher who takes material from the biobank, claim to own those materials? Some do and some don’t. A policy document issue by the UK National Cancer Intelligence Network in June 2009, quoting a recommendation of the Confederation of Cancer Biobanks, suggests that biobanks should waive their IP rights in the materials that they supply to researchers.

noIP is just one of dozens of legal, practical and policy issues that are typically addressed in the documents. It is difficult to know how best to deal with these issues as a researcher or the employer of a researcher. Should one take the terms on offer or try to negotiate them, if only to remove glaring inconsistencies and inappropriate terms? It seems that some biobanks refuse to negotiate the terms of their MTAs, no matter how badly drafted they may be.

Rather than spend a time and money negotiating terms in individual cases, shouldn’t the sector be developing some standard contracts, as has been done for university research contracts (the Lambert agreements) and for clinical trial agreements in NHS hospitals? Although neither of these examples of standard contracts is perfect, at least they provide a way of reducing negotiation time.

 

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Filed under Contract drafting, Legal policy

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