2006 | Broadly speaking, the response below shows support for the guidelines proposed by Ministry of Health, with attention to: ease of use of system for researchers, information sharing between researcher and participant, continuation of ethics committees into the future, and perhaps the need to re-consider the Privacy Act 1993 provisions regarding merging of databases, to retain consent conditions.
The following response was provided to the Ministry of Health regarding the above discussion document. It is best understood when read in conjunction with that document, which can be found on the Ministry of Health website.
The Royal Society of New Zealand is the independent academy of sciences in New Zealand and has an interest in promoting and advancing science and technology, according to the Royal Society of New Zealand Act 1997. The format of our response is to answer the specific questions raised in the discussion document from the point of view of an organisation that supports scientific and technological research to continue within ethical boundaries acceptable to our society.
The RSNZ response was circulated among relevant constituents using 1) a news item on our weekly ALERT notice, which has a wide circulation in the science and education sectors and 2) specific e-mails to presidents of Constituent Societies whose members deal with human tissues in research. There were no objections received during this consultation to this response.
This response has not yet been ratified by the Council of the Royal Society of New Zealand and is not, therefore, official policy of the RSNZ.
"Do you think it is reasonable for patients and research participants to be able to consent to future unspecified use of their tissues in research?"
Our short answer would be yes.
The long answer includes information that needs to be given to participants (see below). Participants should appreciate that while near-term research projects may be clearly outlined (as to aims, methods etc), in the distant future there are many uncertainties about what may types of research their tissue samples may be used in.
Another caveat is that it is important to ensure that the ethics committee structure remains robust and in place, if samples are provided for future unspecified use under the auspices of future ethics committees.
"What information do you think should be provided to potential research participants?"
Donors should be reassured that all future research projects in NZ would have to be approved by ethics committees that reflect public sentiment through lay representation, but that these ethics committees, collectively, may not hold the same world view as the donor. However, overseas research might not be overseen by ethics committees unless they have similar systems as New Zealand.
Participants need to know whether and when their personal information will be protected, and that there may be situations whereby they may not be contacted in future regarding the use or destruction of their tissue, because of ‘de-linking’ the contact details from the tissue sample (or data obtained from the tissue sample such as DNA sequences). For example an option for consent: may be either to ‘de-link’ personal information from the sample so no further contact will ever be made, OR that the sample may maintain coded personal information so future benefits and/or information can be shared (which may include benefit sharing e.g. from commercialisation of person-specific DNA; or knowledge regarding personalised health treatments; or informing the donor when their sample is destroyed).
If a donor chooses to be completely anonymous they should understand that may mean that if some future research results point to better treatment possibilities for an individual, there will be no way to link that future knowledge to their clinical treatment, (although the likelihood of such findings is currently unknown). Donors should be informed of this potential outcome.
Participants should be informed about all their options: whether they can choose the topics of future research, or opt out of certain no-go areas according to their cultural beliefs; whether or not samples may be sent overseas outside the jurisdiction of NZ ethics committees. (See below)
Below are specific responses to the nine specific questions in the discussion document.
"Do you think the options for consent are reasonable and practicable? What other options could or should be provided to potential research participants?"
Firstly, if any option is not to be made available, then that should be made clear to the participant.
It may be useful under the third option o enable a donor to ‘opt out’ of certain types of research for religious or cultural reasons. These may include studies into contraception, research using embryos or fetal tissue, xenotransplantation, genetic modification or procedures that mix species’ cell parts etc. If a donor has strong feelings on such areas, then they cannot rely on future ethics committees, which may reflect general (future) public sentiment, rather than individual sensibilities.
A note on option 6 (regarding commercial research): In reality, all research in future has the potential to be both international and commercial. The line between research and commercial development is ever blurring, as is the line between knowledge in one country and access to that information from overseas. Some researchers do not publish the results of their (basic) research from the very beginning on the off-chance that there is potential commercial application. Funding agencies and government research institutes have even enforced such attitudes, particularly since science reforms of the 1990s. However, internationally and locally, a swing is beginning toward making public the results of publicly-funded research. Whatever the outcome, it might be prudent for consent always to be obtained for the use of tissues in ‘commercial’ research, even if the main goal is improved healthcare treatments, or knowledge about basic human biology.
Participants should bear some responsibility for maintaining up-to-date contact details if the agreement requires future consent. It may end up that tissue banks are split by the ‘type of donor agreement’, rather than becoming an integrated set of samples.
The more options there are, the more types of agreement will exist. This will make it harder (read more expensive) for researchers to keep track of what samples can be used and what red-tape to go through for each research project. Whatever options donors are given, there need to be low-cost systems in place to enable researchers to comply with those options, such as secure databases encoding contact details, unspecific versus specific kinds of research, whether the sample can be sent overseas etc. Computerised systems will help maintain such details but there would need to be changes to the Privacy Act 1993, to enable databases with personal information to be merged, e.g. when tissue banks are merged. Currently, it is not clear whether NZ regulations enable merging of databases containing personal information (which may include DNA sequences as well as names and addresses of donors) for the use of public, private or commercial research. In addition, computer systems would need a level of future-proofing, or software updating to ensure longevity of consent information. Compliance costs of such systems can become onerous to small research organisations or programmes funded by charities.
Participants should be informed that third party use and overseas use may result in research that is outside the control of NZ ethics committees. However, reassurance may be possible, if samples are sent only to countries that comply with the World Health Organisation ethical guidelines (for the use of human tissues in research), or countries that have comprehensive guidelines already in place, similar to NZ guidelines.
"Do you think there should be any 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?"
One of the basic premises of informed consent is that clinical treatments will not be compromised by participation in research. On the contrary, information derived from tissues may be relevant to the clinical treatment of a patient such as discovery of better health treatments for a patient. In such cases, there may be an ethical requirement to inform the patient and their clinician about the better treatment, or at least the results of the research so they can gauge for themselves whether to proceed with a better treatment. This may be difficult with future unspecified research findings especially when contact details are de-linked from samples.
If a donor has opted to be completely anonymous then such improvements to their clinical care will not be possible. Participants should be informed of this possible outcome when they consent to anonymous donation in the first place.
"Do you agree that there is no need for ethics committees to require any additional safeguards of participants’ interests with respect to New Zealand researchers accessing samples donated for future unspecified research? If you do not agree, what safeguards would you propose?"
The science system in NZ is constantly changing and ownership of organisations that watch over collections may change. Despite government assurances of constant funding for ‘collections and databases’ via Vote Research, Science and Technology, there are possibilities that, in future, policies may change, and ownership may change. There should be an additional safeguard, therefore, to protect the consent conditions for samples in collections when owners (companies) are bought or sold or policies governing collections are changed. In particular, consent conditions for individual samples should be maintained, or any major changes to such policies should be reviewed by a national ethics committee.
"What would constitute a reasonable level of assurance to ethics committees that samples sent overseas will be subject to appropriate governance and ethical review? Is any additional assurance required over and above that currently sought when consent is given for tissues to be sent overseas for specified research?"
It is important for participants in research to understand that some provisions (options) relating to their agreement for use in NZ may not apply overseas (such as benefit-sharing, subsequent contact for future consent or information about future medical treatment etc).
There are two options: ethics committees could require that samples only be sent to countries with similar guidelines as in NZ, with ethical oversight, or countries that comply with the World Health Organisation’s ethical guidelines for biomedical research involving human tissue OR ethics committees could require that participants in research understand that their samples may be sent overseas to collaborators (or others) whose research is not under ethical review. Donors who are thus informed can make informed consent in this regard and may still be happy to donate to future unspecified research.
As mentioned already, there may be options for separate consent for overseas use, with or without identifiers. Overseas use would be riskier with identifiers so donors may need to have their private information disassociated (de-linked) from their tissue sample.
"Do you think it is 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?"
The issues of consent for children’s’ tissues, anonymisation (de-linking), and the rights to withdraw consent when someone comes of age are complex. There may be cases when it is desirable to maintain linked information, such as when a child has a disease for which research results can inform on treatment. Similarly, there are potentially negative outcomes that a minor should be protected from, e.g. later identification in a public forum. Genetic access of data with identifiers may legally fall into the hands of people that may later disadvantage a child (such as health insurance companies or police). It would seem better, therefore to take a precautionary approach for parental consent and allow samples to be anonymised only on a case-by-case basis, considering the potential outcomes for the child. This reiterates the importance of maintaining, in the future, the structure of ethical review and ethics committees for research in NZ.
"Would participants be adequately protected, and should 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?"
Such delegation would obviously enhance research but needs boundaries to define ‘low risk’. We previously suggested that “reassurance be given to participants that ethics committees will approve all future research and will include lay representation, thereby reflecting society’s ethical concerns”.
There may be commercial conflicts of interest in delegating such approval to an ethics committee chair who is also associated with a research organisation or tissue bank.
However, on balance, it would be useful to have lower levels of ‘red tape’ for low risk research, as occurs in other areas of research regulation.
"Are there any additional issues relating to consent for future unspecified research use of human tissue that need to be considered in any guidelines for research? If so, what are they and what considerations would you want to emphasise?"
Future unspecified research will require ongoing maintenance of ethics committees and database systems associated with tissue storage. Changes in future policies on systems and ethics committees would therefore impact on these, and other, guidelines that permit the freedom of research to operate.