The use of human tissue for unspecified future research
Submission on guidelines for use of human tissue for future unspecified research - August 2006
This submission was made to the Ministry of Health in response to their call for submissions on a draft set of guideleines to assist ethics committees when they are asessing research proposals. Click here for the full discussion document from the Ministry of Health website.
NZORD, the New Zealand Organisation for Rare Disorders, is a charitable trust that exists to promote the interests of patients and families affected by rare disorders. Our main activity towards those objectives is to assist rare disease support groups to be more efficient and effective in their operation, help represent and advocate for their common interests, and build partnerships with professionals, researchers and policy makers to improve knowledge of, services for, and research into their disorders.
Part of our activities is the development of a rare disease biobank to gather material from affected patients, carrier relatives, unaffected controls and related animal models, to improve opportunities for research into rare disorders. We have set up a charitable company, the New Zealand Institute for Rare Disease Research Limited, which is wholly owned by NZORD to manage the work of our biobank. We have commenced collection of animal material but not yet proceeded with human tissue collection.
NZORD and the NZ Rare Disease Biobank both have a direct interest in the discussion document on human tissue use and the proposed guidelines. Our first interest is that which we hold as a biobank operator and research promoter. Our second interest is that which comes from representing patient and family interests and the resulting strong interest we have in safety, ethics and standards in research. We suggest that these dual roles give a unique perspective on this debate. We suggest that our perspective should carry significant weight in how the guidelines are formulated and implemented, given that the prime purpose of ethical guidelines is to protect the interests of research subjects/participants.
Summary of key themes in our submission:
A common theme in ethics controls over past decades has been the concept of vulnerability on the part of patients/participants and power on the part of clinicians and researchers. The potential for harm in these circumstances has necessarily lead to very cautious approaches by ethics committees.
As a general approach to guidelines regulating donated tissue use, protection of our interests should not mean overly-cautious regulation, nor excessive restriction of our wish to promote research into our disorders with our own tissue that we have deliberately donated for research purposes.
With the development of patient and family led initiatives in research and tissue donation, ethics committees should take note of a paradigm shift for at least some of the research proposals they will receive in the future. We suggest that proposals coming from support group operated biobanks should be assessed by ethics committees with an added perspective. Facilitation of the wish of tissue donors for research to occur, should be a significant factor guiding the committee’s deliberations and their assessments of any potential risks or harms.
We think the phrase “future unspecified research” may be a bit misleading. We doubt there will ever be donations made with such a very wide authority. It is likely that material may be donated with a broad consent to future research to understand and treat the particular disorder, to understand human health and development, and for comparisons to other disorders. You may intend to refer to future research that did not have a specific proposal available for consideration at the time consent was given, but the phrase seems to suggest something much wider, even open-ended as to future use. We suggest that broad consent given for future use should include general parameters within which the tissue may be used, subject to appropriate ethical approval (whether delegated or not) for each specific use. Thus, a broad consent given for health related research would not permit the tissue use in research to develop cosmetics (for example) unless such use was covered in the parameters of the broad consent given.
We support the approach indicated by the proposed guidelines. They acknowledge the interests and wishes of patients, families and support groups in making contributions to research and helping alleviate the burden of disease in society.
We offer comments on some of the specific questions in the discussion document and on the detail of the proposed guidelines:
Question 1. Is it reasonable to ask patients and research participants to give some form of consent to future unspecified use of their tissues in research?
Clearly our answer to this is yes, even when it is a patient/support group initiative rather than a researcher initiative. Consent is a central aspect of ethical controls. However in the event that you get some submissions suggesting that consent to future use should not be acceptable in research policy, we respond to those theoretical submissions by stating that it would be disempowering, patronising and paternalistic to incorporate such a stance in policy.
Question 2. What information do you think should be provided to potential research participants?
Participants should have good summary information about the purposes to which future research will be directed, where material will be stored, governance arrangements to oversee storage and use, and sufficient other general information to give them confidence in the ethical oversight, privacy provisions and cultural procedures at the centre holding their tissue.
Question 3. What options for consent could or should be provided to potential research participants?
The option to donate or not, and the option to withdraw donated material (subject to practical limitation mentioned below), are obvious options. We think that other options listed regarding identified or de-identified use, third party use, overseas use, use in commercial research collaborations, and any other options, could be suitably covered with a yes/no checklist on the consent form.
Question 4. Should there be requirements on the use of information derived from tissues that are donated for future unspecified research use that are additional to or distinct from those already required in relation to other research with human tissue?
We support provision for reporting back to participants or their health professionals where there may be significant implications for the health of the person and where linked information is held. Apart from those circumstances we think a process for general reporting on the use of material via acknowledgements in published papers, reports to support groups, presentations to support group meetings, and articles in support group newsletters, would be sufficient to keep the donors adequately informed of the use of material and the outcomes of research.
Question 5. Is there a need for ethics committees to require additional safeguards of participants' interests with respect to New Zealand researchers accessing samples donated for future unspecified research?
Question 6. What would constitute a reasonable level of assurance to ethics committees that samples sent overseas will be subject to appropriate governance and ethical review?
The international guidelines proposed in section 5.5 of the guidelines seem adequate. No additional assurance should be required over that needed for specified research.
Question 7. Is it reasonable to permit tissue samples from children to be de-linked or anonymised on the basis of parental proxy consent, even though this will foreclose any possibility of children later withdrawing consent to the use of their tissue for future unspecified research?
Tissue samples without clinical data or health history is of very limited value in research. It is our intention to seek consent for linking of data in as many cases as possible and we expect wide agreement to this from patients and families. Of course there must be provision for consent to linked data to be withheld, but in a practical sense this may be more likely to result in a decision not to donate material at all, rather than a donation of de-linked material.
However in the event of de-linked data being held or used, whether in the centre of collection or in other centres, we do not see any specific problem with the lack of opportunity for the tissue to be withdrawn, either by a donor or by a child for whom proxy consent was given. The reason for this is an argument, though one with contrary views no doubt, is that the de-linking process reduces the significance of the tissue’s association with the particular donor. There seems to be an obvious implication in a donor’s agreement to provide tissue that is de-linked from any identifying data, that control over the storage and use of the tissue will be lost to them once de-linking occurs. The fact that such material may have come from a child through proxy consent, does not indicate the need for any special requirement related to the future maturity and autonomy of that child.
Question 8. Would participants be adequately protected, and would timely review of low-risk research be enhanced, if provision were made for delegated authority to the chair of an ethics committee to include Use of anonymised tissue and Use of tissues where the participant has given consent for future unspecified research use of their tissue?
The proposed guidelines.
NZORD and NZIRDR endorse the principles outlined in the proposed guidelines, but we make the following observations on some of the detail:
6.1.2 seems to assume that consent to future use is likely to occur at the time of collection for some diagnostic or surgical procedure, so provides for separation of consent for collection from consent for future use. In our scenario collection is likely to occur solely for research purposes. It may help to clarify that if consent for research occurs at the time of some other consent process, then separate consents are required.
126.96.36.199.4 relating to withdrawal of consent - this is suitably worded as there may be situations such as de-linked data where withdrawal of material may not be an option.
6.1.4 relating to consent forms - this seems a good way of wording the provision of options. Guidance, rather than a fixed list, is the best way to approach these issues.
Thanks for the opportunity to submit on this important topic. We look forward to completion of these so some certainly can be obtained in this important area.