Biospecimen Banking for Research: Ethical and Pragmatic Considerations
In clinical practice or biomedical research, significant amount of biospecimens, such as blood or tissue from patients or research participants remains after clinical investigation or research use. These biospecimens are considered valuable resources and can be used in the future research studies if there are existing systematic administration and strategies to maintain these biospecimens in good condition and ready for use in the long term. Such administration and management is a quality process and requires Standard Operating Procedures (SOPs) that meet the international standard. In Thailand, there have not been such SOPs and there are limited numbers of experts in the biobanking field. Center of Ethical Reinforcement for Human Research in Thailand had invited Emeritus Professor Jeanne Grace, RN, PhD from University of Rochester, School of Nursing, New York, USA, a specialist in the biobanking field, to be a speaker in the academic conference session entitled “Biospecimen Banking for Research: Ethical and Pragmatic Considerations” at the Faculty of Medicine Siriraj Hospital, Mahidol University on February 19th, 2013. The author would like to provide FERCIT members the knowledge and information from the session as following.
Benefits of Biobanking for Research
Researches requiring biospecimens from biobanking are basic science researches that study pathology and biomarkers of disordered cells, infected pathogens in tissue or cellular change after therapy. Genetic research and cell line or stem cell development for therapeutic purposes also benefit from the biobanking.
Persons involving in biobanking are usually in the human research field. These include research institute administrators, researchers, biospecimen donors (who are going to be research participants in the future) and human research ethics committee (EC). All will benefit from the biobanking as described below:
1.1 They do not have to spend time finding enough donors for their research, especially for the donors of rare diseases.
1.2 They do not have to ask for the consent from each donor every time for each research project.
1.3 With appropriate coding measures of the biobanking, protection of personal identification and data of the donors is facilitated according to EC criteria.
1.4 They can ask EC to review their research as expedited or exemption review category given that there is not-more-than minimal risk to the donors.
Factors to be considered for Biobanking for Research
Resources including personnel, places, materials and durable articles are to be considered by research institute administrators and included in the institutes’ policies for biobanking. There are needs for adequate administration budgets, specimen collection and maintenance for use, safety in regards to biospecimen and data collection and biosafety in cases dealing with infective agent-related biospecimens.
2.1 Policy for biobanking should include criteria for the donors and the researchers who can use the biospecimens, justified biospecimen allocation, duration of biospecimen collection, biospecimen transfer to other institutes and commercial use of biospecimens.
2.2 SOPs for biobanking should include information sheet and procedures for biospecimen donation and consenting, rights of the donor to consider limited use of the specimen, procedures for blood or tissue procurement from the donor and transportation to the biobanking place, specimen allocation for diagnostic and therapeutic purposes prior to biobanking collection, quality control of specimen transportation and collection, data collection needs in regards to personal and clinical characteristics, coding and personal data protection procedures, persons who have access to different levels of data, maintenance of biospecimens in good condition, measures of specimen collection for future use, specimen delivery protocols, required documents, such as biobanking committee and EC approval forms that address type, number and amount of the specimens, specimen-accessible persons and data relevant to the specimens for delivery.
Designated persons who are in charge in biobanking procedures, such as inviting participants to donate biospecimens and protecting the donors’ personal data, should be trained well. Information sheet should have detailed and adequate information for the participants to make decision about donation and should emphasize that whether the participants decide to donate biospecimens or not will not affect their rights to receive any services including healthcare services.
The detailed contents that should be provided in the information sheet for biospecimen donation and use of biospecimen for research include:
3.1 What the biobanking is
3.2 The purposes of biobanking
3.3 The persons who administer and manage the biobanking
3.4 The reasons why the participants are invited to donate biospecimens
3.5 Biospecimen donation procedures
3.5.1 The screening tests that will be performed to detect infections including syphilis, human immunodeficiency virus infection and viral hepatitis
3.5.2 Type and amount of donated blood and tissue
3.5.3 Procedures for blood and tissue collection that are according to indications for diagnosis and treatment of diseases or research methodology
3.5.4 Whether there will be data retrieval and collection from the donors’ medical records and types of the collected data
3.5.5 Timeline of the data collection (pre- and post-donation period, additional data collection in the future)
3.5.6 Any permission from the donors to contact them for additional consenting to collect more data in the future
3.5.7 Duration that the biospecimens will be kept
3.5.8 Any limited use of the biospecimens requested by the donors, such as limited data transfer to and sharing with other institutes
3.5.9 Benefits and risks of the biospecimen donation
3.5.10 Any research findings/results sent back to the donors
3.5.11 Management of the biospecimens if the donors no longer allow the use of the specimens (returning the specimens to the donors or destroying them)
Given that there are more details about the biobanking, please find additional information from the powerpoint presentation of the speaker permitted for access at www.mu-irb.mahidol.ac.th.
Acknowledgements
The original article was first published in Thai version by Dr. Punkae Mahaisavariya , MD in the Forum for Ethical Review Committee in Thailand (FERCIT) Newletters 2013; 13(2) : p 2-4. (website : www.fercit.org)
The English version was prepared by Dr. Thana Khawcharoenporn, MD for distribution in www.thaitect .org with permission by the author and the Chair of FERCIT.
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