Across Europe, legislation governing the procurement, testing, processing, storage, and distribution of human tissues is the norm. In April 2007, the European Union fully implemented the EU Tissues and Cells Directive, creating a common framework to establish high standards across the EU community.
The U.K. introduced the Human Tissue Act 2004 which was implemented in September 2006. It replaces the Human Tissue Act 1961, the Anatomy Act 1984, and the Human Organ Transplants Act 1989 in England and Wales.
It also replaces the Human Tissue Act (Northern Ireland) 1962, the Human Organ Transplants (Northern Ireland) Order 1989, and the Anatomy (Northern Ireland) Order 1992.
To ensure that researchers comply with the Human Tissue Act, the U.K. established the Human Tissue Authority (HTA) to provide guidance on best practices by developing codes of practice. HTA is also responsible for providing licenses to establishments involved in the following:
- Removal and storage of bodies, tissues, cells and organs.
- Carrying out anatomical or post-mortem examinations (including hospitals and coroner's offices).
The HTA is one of two competent authorities responsible for overseeing the implementation of the EU Directive in the U.K.
What does the Human Tissue Act mean for research in England, Wales, and Ireland?
Under the Act it is illegal to carry out research involving human tissues, organs, and bodily fluids without providing proof that appropriate consent has been obtained. Violating this precept can result in a fine or imprisonment of up to three years. However, there are some exceptions to this rule:
- Use of tissue from "existing holdings," i.e. tissue stored before the Act was implemented in September 2006.
- Use of residual tissue from living beings. This tissue has to be used in an anonymized research project that has ethics board approval or pending approval.
- Use and storage of imported tissue or imported bodies provided that researchers and their sponsors have assured themselves that the donor provided consent and that arrangements for collecting tissue had been ethically reviewed in the country of donation.
- Use of tissue or bodies that are more than 100 years old. This applies mainly to museum collections and exhibitions.
The Act also introduces the practice of licensure. In order to store, use, process, or distribute tissues, whether for clinical purposes or for research, an institution must obtain a license from the HTA.
By having this license, institutions are allowed to work with human tissue and other samples without the need for further ethical review by the National Health Service (NHS) Research Ethics Committees (RECs -- U.K. national IRBs).
Impact on NIH activities in countries implementing this Act
The NHS RECs are not under any legal obligation to perform additional review of proposed research involving the use of human tissue and samples if these activities are to be carried out by institutions licensed by the HTA.
This poses a problem for NIH-supported research. According to HHS regulations (45 CFR 46, Protection of Human Subjects), all institutions need to provide proof of IRB review certification if funds are to be used for human subjects research. Under this Act, this certification would be difficult to come by since the review of human research protocols is no longer within the purview of the NHS RECs.
Another potential issue for NIH-funded programs is that the Act does not make any legal provisions for research using imported human tissue and samples. Although it requires researchers to take into account the Code of Practice on the import and export of tissue (yet to be published by the HTA), this Code will have no legal effect, and any adherence will be on a voluntary basis.
This policy is based on the view that research activities conducted outside the U.K., such as collecting tissue samples for use in the U.K., should be subject to the legal and ethical review process and guidelines of the other country. However, NIH cannot release funds based simply on the researcher's assurance that he or she has followed proper protocol in collecting the samples; IRB certification of these protocols is required before NIH will release funds for the project.
Recommended solutions
The HHS Office for Human Research Protections is in the process of determining the best way to handle problems raised by the conflicting U.K. and U.S. policies. In the interim NIAID's Grants Management Program proposes some solutions to ensure compliance with HHS policies and to prevent a delay in using funds for the research portion involving human tissue use.
U.K. institutions affected by this legislation may do one of the following:
- Establish an IRB and give it the authority to review the protocols not covered in the review by the U.K. REC. This IRB will need to be designated under the institution's Federal Wide Assurance (FWA) registered with the Office of Human Research Protections.
- Sign an agreement with a U.K. REC that is willing to review the research. This IRB will also need to be designated under the institution's FWA.
Links
National Research Ethics Service -- REC standard operating procedures and other guidance
Registering an IRB or IEC
Contact for Article Questions or Comments
Maryam Oladipupo
Office of International Extramural Activities, NIAID International Grants
and Contracts
Email: oladipupom@niaid.nih.gov
Phone: +1 301 451-7372
Visit the NIAID International Grants and Contracts Web site. |
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