Written by: Nayaonika Vasistha
Edited by: Isabel Angres
Edited by: Isabel Angres
Blood testing refers to examining the cells, chemicals, proteins, and other substances in the blood. They only take a few minutes to perform and serve as a reliable form of data. There are different types of blood tests, and they do a multitude of functions. These include a complete blood count (CBC), a basic metabolic panel, blood enzyme tests, blood clotting tests, cholesterol tests, and triglyceride tests. They are crucial in determining the presence of certain infections and genetic disorders, checking the optimacy of treatments, and assessing the overall functioning of organs and the general state of health.
Despite its numerous benefits, without proper consent, confidentiality, and access, blood testing can raise several ethical issues. These issues can be present in every phase of laboratory testing: the pre-analytic, analytic, and post-analytic phases. The pre-analytic phase involves issuing the required tests by a certified clinician and the subsequent collection, labeling, handling, and storage of samples until it is tested. The moral rights of a patient can be violated if proper informed consent for tests is not given. The patient should be made aware of all the procedures that will be performed and the resulting outcomes and implications. Additionally, only those tests should be administered that are deemed necessary. All tests performed must benefit the patient and be delivered at reasonable costs. In some cases, if patients wish the results of their testing to be anonymous, test conductors and laboratories should respect the patient’s need for privacy (Aggarwal, N., Kare, P. K. , & Datta, S. K. 2021). During the analytical phase, confidentiality, competency, and quality are expected of the laboratories. Competent testing should be undertaken while ensuring that samples are not tested differently due to race, gender, age, or any other biases. If the patient wishes not to undergo testing upon sample collection, specimens should not be examined, and confidentiality should be maintained. In the post-analytical phase, interpretation of results, storage of samples, and access to data are matters of concern. To prevent the spread of misinformation, test results should be interpreted by trained staff, and accurate information should be conveyed to patients (Aggarwal, N., Kare, P. K. , & Datta, S. K. 2021). Additionally, patients should be made aware of whether their samples will be used in the future.
A survey conducted in 2012 in South Africa sampled 200 clinical research participants and gathered responses regarding the use of biospecimens (Moodley, K., Sibanda, N., February, K. et al. 2014). Nearly half of the survey participants said they would want to be contacted every time their samples were re-used. In the case of using samples for laboratory research, participants have stated that they would like to be kept aware of patents awarded using discoveries made from their DNA samples. In such cases, participants feel they have the right to royalties, and it would be a massive infringement of their rights if they were denied. Ethical issues play a vital role in laboratory testing, and organizations must pay close attention to how they treat their research volunteers.
One can look at HIV testing in prisons as an example of blood testing being done without consent or providing necessary details to patients. A long-standing debate has raged over whether HIV testing of prisoners should be mandatory. Mandatory testing infringes upon prisoners’ rights and leads to the stigmatization of HIV/AIDS. In some countries, HIV testing is conducted on all prisoners upon admission, conviction, before release, or under certain other circumstances, without informed consent. Testing can also be required by legislation or policy. In other cases, the official guidelines provide for “voluntary HIV testing,” but prisoners may be coerced into being tested. For example, prisoners may be treated as if they were HIV-positive and lose privileges unless they submit to HIV testing (Seal, David Wyatt et al. 2010). Such mandatory or compulsory forms of HIV testing violate ethical principles and the fundamental rights of consent, privacy, and bodily integrity. Prisoners are more susceptible to being coerced into HIV testing and to the adverse outcomes of testing. Therefore, additional measures to ensure informed consent are necessary. To give informed consent, prisoners must understand the institutional consequences of a positive HIV test. In particular, they must be informed if the test result will not be treated confidentially, whether they will be segregated if found to be HIV-positive, and whether there is a likelihood that they could be denied access to specific programs, family visits, or jobs. Prisoners should know that they have the right to decline the test; and an opportunity to ask the healthcare provider questions. These are fundamental rights, and bypassing these standards of informed consent and confidentiality should have severe consequences.
The importance of informed consent and autonomy over one’s body cannot be stressed enough. Many countries have developed policies and guidelines dealing with the ethical issues prevalent in laboratory medicine. Some of the organizations that have created ethical recommendations for clinical laboratories are the International Federation of Clinical Chemistry (IFCC), the American Association of Clinical Chemistry (AACC), and the International Organization for Standardization (ISO). A notable document in this regard is the International Ethical Guidelines for Health-related Research Involving Humans Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO) (van Delden JJ, van der Graaf R 2017). While the scope of these guidelines are not limited to blood-testing, it is important to note the emphasis placed on informed consent. Consideration of best practices for using biospecimens should begin with exploring participant expectations and appreciation for their bodily autonomy.
References
Moodley, K., Sibanda, N., February, K. et al. “It’s my blood”: ethical complexities in the use, storage and export of biological samples: perspectives from South African research participants. BMC Med Ethics 15, 4 (2014). https://doi.org/10.1186/1472-6939-15-4
Chen D, Rosenstein D, Muthappan P, Hilsenbeck S, Miller F, Emanuel E, Wendler D: Research with stored biological samples - What do research participants want?. Arch Intern Med. 2005, 165: 652-655. 10.1001/archinte.165.6.652.
Aggarwal, Neerja, Kare, Pawan, Datta, Sudip. "Ethics in Laboratory Medicine: An Overview of Considerations for Ethical Issues". Bioethics in Medicine and Society, edited by Thomas Heston, Sujoy Ray, IntechOpen, 2021. 10.5772/intechopen.96122.
Vanstone, King, C., de Vrijer, B., & Nisker, J. (2014). Non-Invasive Prenatal Testing: Ethics and Policy Considerations. Journal of Obstetrics and Gynaecology Canada, 36(6), 515–526. https://doi.org/10.1016/S1701-2163(15)30568-5
Seal, David Wyatt et al. “HIV testing and treatment with correctional populations: people, not prisoners.” Journal of health care for the poor and underserved vol. 21,3 (2010): 977-85. doi:10.1353/hpu.0.0351
van Delden JJ, van der Graaf R. Revised CIOMS International Ethical Guidelines for Health-Related Research Involving Humans. JAMA. 2017 Jan 10;317(2):135-136. doi: 10.1001/jama.2016.18977. PMID: 27923072.
Despite its numerous benefits, without proper consent, confidentiality, and access, blood testing can raise several ethical issues. These issues can be present in every phase of laboratory testing: the pre-analytic, analytic, and post-analytic phases. The pre-analytic phase involves issuing the required tests by a certified clinician and the subsequent collection, labeling, handling, and storage of samples until it is tested. The moral rights of a patient can be violated if proper informed consent for tests is not given. The patient should be made aware of all the procedures that will be performed and the resulting outcomes and implications. Additionally, only those tests should be administered that are deemed necessary. All tests performed must benefit the patient and be delivered at reasonable costs. In some cases, if patients wish the results of their testing to be anonymous, test conductors and laboratories should respect the patient’s need for privacy (Aggarwal, N., Kare, P. K. , & Datta, S. K. 2021). During the analytical phase, confidentiality, competency, and quality are expected of the laboratories. Competent testing should be undertaken while ensuring that samples are not tested differently due to race, gender, age, or any other biases. If the patient wishes not to undergo testing upon sample collection, specimens should not be examined, and confidentiality should be maintained. In the post-analytical phase, interpretation of results, storage of samples, and access to data are matters of concern. To prevent the spread of misinformation, test results should be interpreted by trained staff, and accurate information should be conveyed to patients (Aggarwal, N., Kare, P. K. , & Datta, S. K. 2021). Additionally, patients should be made aware of whether their samples will be used in the future.
A survey conducted in 2012 in South Africa sampled 200 clinical research participants and gathered responses regarding the use of biospecimens (Moodley, K., Sibanda, N., February, K. et al. 2014). Nearly half of the survey participants said they would want to be contacted every time their samples were re-used. In the case of using samples for laboratory research, participants have stated that they would like to be kept aware of patents awarded using discoveries made from their DNA samples. In such cases, participants feel they have the right to royalties, and it would be a massive infringement of their rights if they were denied. Ethical issues play a vital role in laboratory testing, and organizations must pay close attention to how they treat their research volunteers.
One can look at HIV testing in prisons as an example of blood testing being done without consent or providing necessary details to patients. A long-standing debate has raged over whether HIV testing of prisoners should be mandatory. Mandatory testing infringes upon prisoners’ rights and leads to the stigmatization of HIV/AIDS. In some countries, HIV testing is conducted on all prisoners upon admission, conviction, before release, or under certain other circumstances, without informed consent. Testing can also be required by legislation or policy. In other cases, the official guidelines provide for “voluntary HIV testing,” but prisoners may be coerced into being tested. For example, prisoners may be treated as if they were HIV-positive and lose privileges unless they submit to HIV testing (Seal, David Wyatt et al. 2010). Such mandatory or compulsory forms of HIV testing violate ethical principles and the fundamental rights of consent, privacy, and bodily integrity. Prisoners are more susceptible to being coerced into HIV testing and to the adverse outcomes of testing. Therefore, additional measures to ensure informed consent are necessary. To give informed consent, prisoners must understand the institutional consequences of a positive HIV test. In particular, they must be informed if the test result will not be treated confidentially, whether they will be segregated if found to be HIV-positive, and whether there is a likelihood that they could be denied access to specific programs, family visits, or jobs. Prisoners should know that they have the right to decline the test; and an opportunity to ask the healthcare provider questions. These are fundamental rights, and bypassing these standards of informed consent and confidentiality should have severe consequences.
The importance of informed consent and autonomy over one’s body cannot be stressed enough. Many countries have developed policies and guidelines dealing with the ethical issues prevalent in laboratory medicine. Some of the organizations that have created ethical recommendations for clinical laboratories are the International Federation of Clinical Chemistry (IFCC), the American Association of Clinical Chemistry (AACC), and the International Organization for Standardization (ISO). A notable document in this regard is the International Ethical Guidelines for Health-related Research Involving Humans Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO) (van Delden JJ, van der Graaf R 2017). While the scope of these guidelines are not limited to blood-testing, it is important to note the emphasis placed on informed consent. Consideration of best practices for using biospecimens should begin with exploring participant expectations and appreciation for their bodily autonomy.
References
Moodley, K., Sibanda, N., February, K. et al. “It’s my blood”: ethical complexities in the use, storage and export of biological samples: perspectives from South African research participants. BMC Med Ethics 15, 4 (2014). https://doi.org/10.1186/1472-6939-15-4
Chen D, Rosenstein D, Muthappan P, Hilsenbeck S, Miller F, Emanuel E, Wendler D: Research with stored biological samples - What do research participants want?. Arch Intern Med. 2005, 165: 652-655. 10.1001/archinte.165.6.652.
Aggarwal, Neerja, Kare, Pawan, Datta, Sudip. "Ethics in Laboratory Medicine: An Overview of Considerations for Ethical Issues". Bioethics in Medicine and Society, edited by Thomas Heston, Sujoy Ray, IntechOpen, 2021. 10.5772/intechopen.96122.
Vanstone, King, C., de Vrijer, B., & Nisker, J. (2014). Non-Invasive Prenatal Testing: Ethics and Policy Considerations. Journal of Obstetrics and Gynaecology Canada, 36(6), 515–526. https://doi.org/10.1016/S1701-2163(15)30568-5
Seal, David Wyatt et al. “HIV testing and treatment with correctional populations: people, not prisoners.” Journal of health care for the poor and underserved vol. 21,3 (2010): 977-85. doi:10.1353/hpu.0.0351
van Delden JJ, van der Graaf R. Revised CIOMS International Ethical Guidelines for Health-Related Research Involving Humans. JAMA. 2017 Jan 10;317(2):135-136. doi: 10.1001/jama.2016.18977. PMID: 27923072.
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