This information sheet first published as the Joanna Briggs Institute.

Donation of residual biological samples and consent given for secondary use Best Practice: evidence-based information sheets for health professionals. 2011; 15(9):1-4

Evidence-based information sheets for health professionals

Donation of residual biological samples and consent given for secondary use
Recommendations
Healthcare professionals should be aware that patient consent to the use of their left-over tissues are influenced by many and varied factors. Primarily these factors include: benefits to self and other and trust in research and researchers. (Grade A) Healthcare institutions and regulatory authorities must provide strict safeguards and controls in order to maintain privacy and confidentiality of the patients. (Grade A) Healthcare professionals should be aware that the views on ownership and rights to the tissues will vary between individual patients. (Grade A) Healthcare professionals, institutions and regulatory authorities should be aware that patients have different views on the commercial use of their tissues. (Grade A)

Information Source
This Best Practice information sheet has been derived from a systematic review published in 2011 in the JBI Library of Systematic Reviews. The full text of the systematic review report2 is available from the Joanna Briggs Institute (www.joannabriggs.org).

Background
During a patient's surgery, some biological samples may be removed from the body to aid in the diagnosis and/or treatment of their medical condition. In the majority of these cases, not all of the tissue removed is needed for the primary use of clinical diagnosis and treatment of the condition. Leftover of these human biological materials, which are normally discarded or destroyed, are useful samples for secondary uses such as biomedical research, education and training. Current international statutory laws recognise the autonomy of a patients decision over their body including leftover or residual biological samples. Further, it is agreed that a patients informed consent must be obtained for the secondary use of these leftover or residual biological samples for research.

However, many countries do not have a standard procedure for obtaining a patients consent for donating leftover biological samples. Additionally, the international regulatory regimes for research using residual tissue differ widely between countries. Even where regulations exist, consent regimens may range from highly project specific consent to opt-out presumed consent or even no consent at all. Current established informed consent regimens include the following: specific consent; tiered consent; open or blanket consent; and presumed consent or implicit consent. There is on-going discussion about which consent regimens stated above will best comply with patient preferences. Some authors argue that presumed consent with opt-out is sufficient, while others claim that onetime general consent for all future research will suffice. Additionally, some authors believe that specific consent must be requested from patients for any future use of each and every sample as it provides more control over its use.

Grades of Recommendation
These Grades of Recommendation have been based on the JBI-developed 2006 Grades of Effectiveness1 Grade A Strong support that merits application Grade B Moderate support that warrants consideration of application Grade C Not supported

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Definitions
For the purposes of this information sheet the following definitions were used2: Specific consent also known as Project Specific Consent: patients are asked to consent to donate for one specific research project and are re-contacted for each new use of their specimens that is out of the scope of their original consent. Tiered consent also known as broad consent (as compared to specific consent): patients agree to a menu of options, which may include general or specific consent for future use, whether related or non-related disease, time period, commercial uses, genetic conditions and so on. Open consent also known as one-time general consent, generic or blanket consent: patients consent to an unlimited range of options such as the types of future research and time period/s. Patients are given the explicit choice to opt-out during the initial consent process or to withdraw anytime after they have consented. Presumed consent also known as optout or implicit consent: patients are informed that their specimens will be used for future research unless they deny permission by opting-out. Human biological samples refer to all kinds of human tissues derived from living or cadaveric patients, including solid body tissue, organs, fetuses, blood and other body fluids and their derivatives, cord blood, embryos, gametes (sperm or eggs) or any part or derivatives including DNA and cells. Tissues research refers to the types of research requiring the use tissues include drug or clinical trials, cancer research, genetic research, general knowledge of the body tissue, testing medicine, and genetic cloning.

Objectives
The purpose of this Best Practice Information Sheet is to present the best available evidence on patient experiences of the donation of their residual tissues including experiences with different types of consent, the use(s) of their leftover tissues and how the different types of consent influenced their decision to donate.

Synthesized Finding 1
Healthcare professionals should be aware that patients consent to the use of their left-over tissues are influenced by many and varied factors. Primarily these factors included: benefits to self and other and trust in research and researchers. Some patients donated tissues because they believed there was a direct or indirect benefit to themselves. For example, they may have had medical conditions for which further research may be of direct benefit to them, either at the present time or in the future. Some patients claimed to have trust in the public good paradigm of research for societal progress, and believed researchers were generating public good in the diagnosis and treatment of medical conditions. They also trusted that their tissues would not be misused. Some participants in the studies believed that their donated tissues would benefit society. Some believed that donating their tissues was one way to contribute to medical science and medical education, and thus they considered this tissue donation as a gift to humanity. A group of patients had based their decision on whether to donate their residual tissues on consideration of the types of research to be conducted using their tissues. For example, some patients objected to cloning, or non-therapeutic research or research using stem cells and viewed them as weird research in which they would not participate. Many patients felt that there was no risk and harm to the donor, since the residual tissues to be donated would otherwise be discarded or destroyed if they were not donated for medical research, as it was considered a waste product of the surgery and was of no consequence to the patients.

Focus of the review

This review considered publications that investigated patients experiences of donation of their residual tissues including the patients experiences with different types of consent for the leftover residual tissues and the use of their leftover tissues, as well as how the different types of consent influenced their decision to donate.

Quality of the research

18 qualitative research papers were included in the systematic review.2 The 18 studies were included on the basis of obtaining a minimum of six out of ten points using the Joanna Briggs Institute Qualitative Assesment review Instrument quality assessment criteria. Amongst the 18 accepted papers in this review, 8 papers scored 8/10, 7 scored 7/10 and 3 scored 6/10.

Results
Qualitative evidence
The 131 findings from 18 studies included in this review were aggregated into 19 categories. Meta-synthesis of the categories generated four synthesized findings.

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Synthesized Finding 2
Healthcare institutions and regulatory authorities must provide strict safeguards and controls in order to maintain privacy and confidentiality of the patients On the collection and storage of their leftover tissues, patients believed that the research institutions should have a governance system of controls and safeguards to protect patients privacy and confidentiality. Patients believed that research institutions should have strict controls and ethical safeguards on the collection and storage of their leftover tissues and their related genetic and medical information. Patients worried that their private and confidential medical records and genetic information from the tissue identification would be revealed to insurance agents and employers. Patients were concerned about social and financial discrimination once their medical confidentiality was breached and thus believed that there must be safeguards and controls on the medical or genetic information retained by researchers and their organizations. Mistrust in research organizations and their governance was one of the main reasons for the refusal to donate their leftover tissues for research. Others participants were also concerned about the manner and timing in which patients were approached for donation. It was important that they did not feel coerced to donate, or were placed in a vulnerable position where they felt forced to donate.

Synthesized Finding 3
Healthcare professionals should be aware that the views on ownership and rights to the tissues will vary between individual patients On the storage and use of their stored tissues, patients had differing views on the ownership of the donated tissues and their rights on the ethical use of the donated tissues for future research. Most patients agreed that leftover tissues should not be collected, stored, distributed and used for research without the consent of the patients. Other issues mentioned by patients were the question of who should give consent (especially in the case of minors), the use of the stored residual tissues for future research, the length of time of storage and the type of research performed on the same tissues. The types of consent models, whether broad or specific informed consent, were briefly discussed in two papers, but the authors did not conclude which type of consent models that the interviewed patients preferred. One study compared a simple locally introduced consent and a more complex centrally instigated form and concluded that patients had a better quality of informed consent when they were given the simpler consent form rather than the complex form. Some patients considered that they owned their tissue samples as they were once part of their own body and they believed they had the right to know the fate of their tissues. Some patients were not willing to give up the right of ownership of their tissues when donating the tissues to research institutions. Some patients also mentioned that informed consent was not required or unnecessary, and informed consent was not an issue for them. Some patients preferred that they had an option to optout of the donation or possibility to withdraw their donated samples from the tissue repositories, even though they had a sense of trust that the materials were not misused.

Synthesized Finding 4
Healthcare professionals, institutions and regulatory authorities should be aware that patients have different views on the commercial use of their tissues. Patients reported different views on the use of their leftover tissues by commercial companies. As patients were not paid for donating their tissues, the subsequent commercialization of the tissues or utilization of free tissues by commercial companies for the purpose of profit from the results of the research became an issue for some of the patients in terms of distribution of commercial benefits. Patients may be willing to donate for altruistic reasons to a government funded institution for research of public benefit, but they cautioned that such donation should not be used for commercial purpose, because they distrusted 'forprofit' organizations. Patients had a general suspicion of the profiteering motive of private companies compared the motive of a government or public institution funded tissue bank. The reason could be that they were not paid or financially compensated for donating their tissues for research and found it unacceptable for commercial companies to access free tissue and use it for future potential profits. Others viewed commercial company involvement and third party access and usage of the tissues as necessary and as a part of the development of drugs - a "necessary evil", since commercial company may have more research funds and thus be able to advance technology for research.

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Acknowledgments
This Best Practice information sheet was developed by The Joanna Briggs Institute. In addition this Best Practice information sheet has been reviewed by nominees of International Joanna Briggs Collaborating Centres.

References
1. The Joanna Briggs Institute. Levels of evidence and Grades of Recommendations. http://www. joannabriggs.edu.au/About%20Us/JBI%20Approach 2. Chan TW, Mackey SL, Hegney DG. Patients experiences towards the donation of their residual biological samples and the impact of these experiences on the type of consent given for secondary use: A systematic review. JBI Library of Systematic Reviews 2011; 9(42):1714-1781. 3. Pearson A, Wiechula R, Court A, Lockwood C. The JBI model of evidence-based healthcare. Int J of Evid Based Healthc 2005; 3(8):207-215.

The Joanna Briggs Institute The University of Adelaide South Australia 5005 AUSTRALIA www.joannabriggs.org The Joanna Briggs Institute 2011 ph: +61 8 8313 4880 fax: +61 8 8313 4881 email: jbi@adelaide.edu.au Published by Blackwell Publishing The procedures described in Best Practice must only be used by people who have appropriate expertise in the field to which the procedure relates. The applicability of any information must be established before relying on it. While care has been taken to ensure that this edition of Best Practice summarises available research and expert consensus, any loss, damage, cost, expense or liability suffered or incurred as a result of reliance on these procedures (whether arising in contract, negligence or otherwise) is, to the extent permitted by law, excluded.

This Best Practice information sheet presents the best available evidence on this topic. Implications for practice are made with an expectation that health professionals will utilisethis evidence with consideration of their context, their clients preference and theirclinical judgement.3

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