VIEWPOINT
By Elizabeth R. Eisenhauer, MLS, RN
Informed Consent and the Use of Biospecimens in Research Ethical implications for nurses of shifting paradigms and technical advancements.
I
magine you are a patient walking into the hosinclude cloning, the creation of chimeras—described pital for an emergency appendectomy. You are by Jamie Shreeve in the New York Times Magazine in pain and frightened. Prior to seeing a physi- as “human–animal amalgamations”—and research cian, you provide your insurance coverage and sign involving in vitro fertilization and preimplantation the consent to treat form. Did you read it? Do you genetic diagnosis, as well as embryonic stem cells. know exactly what it is you just consented to? For Our genetic material is unique to each of us, analoexample, do you know what a chimera is or care if gous to fingerprints. Moreover, DNA is closely interyour DNA could potentially be used to create one? twined with one’s personal and cultural identity. Thus, Biobanking of genetic material has become a huge we must take patients’ personal values into account or industry, with millions of biospecimens preserved in risk repeating situations where researchers have arguprivate and public repositories. Using this material, ably taken advantage of vulnerable individuals or popbiobanks frequently conduct or facilitate research on ulations. For example, in 2010 the Havasupai Indian the possible genetic origins of tribe in Arizona received a setdisease for the purpose of detlement from Arizona State Do methods of consent veloping targeted treatments. University as a result of genetic While the wealth of genetic inresearch that, in part, offended respect the patient’s rights formation gleaned from this their cultural and spiritual beresearch has led to medical adliefs. Likewise, Rebecca Skloot’s and values? vances and may lead to many 2010 book, The Immortal Life more, using a patient’s genetic of Henrietta Lacks, effectively material in research procedures incongruent with her explained how utilizing biospecimens without consent or his personal beliefs may be inconsistent with the can cause distress, even into the next generation. When concept of respectful care. researchers do not provide explicit information about Increasingly, permission to use biospecimens for the uses and purposes of biospecimens and the impliresearch purposes is being built into consent to treat cations and consequences of participation—that is to forms. Patients may or may not be given the choice say, when they do not consider patients’ values—they to check an opt-out box. Even many broad research risk endangering the public’s trust in science and health consent forms often provide little to no information care in general. to help a patient weigh her or his decision and rely Ethical gray areas involving patient consent in bioon the patient’s trust in the intentions of researchers banking research signal potential inconsistencies beor institutions that may use this genetic material. tween what we, as nurses, say we believe and what Are such methods of consent consistent with the we actually do in practice. Are current practices in ethical value of respect for the patient’s rights and valobtaining biobanking consent sufficiently aligned ues, especially when the patient is preoccupied with with the socially sanctioned ethics and values of the her or his medical condition and treatment? Is this renursing profession? Given the rapidly changing and ally informed consent? highly complex research environment, we need to Nursing ethics and patient-centered care call for collectively strengthen our efforts to apply and advonurses to advocate for their patients and to honor the cate for the ethical principles of our profession and values of each individual for whom we provide health the personal values of our patients. One step forward care. In a March 2006 letter in the Lancet Oncolwould be for nurses to examine the current informed ogy, Maschke pointed out that the risks of “digniconsent practices at their institutions and raise awaretary harms”—violation of one’s deeply held personal ness about these important issues. ▼ beliefs—are often overlooked in biospecimen reElizabeth R. Eisenhauer is a doctoral student at the University search. These risks include research activities that are of Michigan School of Nursing, Ann Arbor. Contact author: in conflict with personal values or religious beliefs and [email protected]. The author has disclosed no potential conmay cause moral distress for donors. Examples might flicts of interest, financial or otherwise. [email protected]
AJN ▼ July 2015
▼
Vol. 115, No. 7
11
By Elizabeth R. Eisenhauer, MLS, RN
Informed Consent and the Use of Biospecimens in Research Ethical implications for nurses of shifting paradigms and technical advancements.
I
magine you are a patient walking into the hosinclude cloning, the creation of chimeras—described pital for an emergency appendectomy. You are by Jamie Shreeve in the New York Times Magazine in pain and frightened. Prior to seeing a physi- as “human–animal amalgamations”—and research cian, you provide your insurance coverage and sign involving in vitro fertilization and preimplantation the consent to treat form. Did you read it? Do you genetic diagnosis, as well as embryonic stem cells. know exactly what it is you just consented to? For Our genetic material is unique to each of us, analoexample, do you know what a chimera is or care if gous to fingerprints. Moreover, DNA is closely interyour DNA could potentially be used to create one? twined with one’s personal and cultural identity. Thus, Biobanking of genetic material has become a huge we must take patients’ personal values into account or industry, with millions of biospecimens preserved in risk repeating situations where researchers have arguprivate and public repositories. Using this material, ably taken advantage of vulnerable individuals or popbiobanks frequently conduct or facilitate research on ulations. For example, in 2010 the Havasupai Indian the possible genetic origins of tribe in Arizona received a setdisease for the purpose of detlement from Arizona State Do methods of consent veloping targeted treatments. University as a result of genetic While the wealth of genetic inresearch that, in part, offended respect the patient’s rights formation gleaned from this their cultural and spiritual beresearch has led to medical adliefs. Likewise, Rebecca Skloot’s and values? vances and may lead to many 2010 book, The Immortal Life more, using a patient’s genetic of Henrietta Lacks, effectively material in research procedures incongruent with her explained how utilizing biospecimens without consent or his personal beliefs may be inconsistent with the can cause distress, even into the next generation. When concept of respectful care. researchers do not provide explicit information about Increasingly, permission to use biospecimens for the uses and purposes of biospecimens and the impliresearch purposes is being built into consent to treat cations and consequences of participation—that is to forms. Patients may or may not be given the choice say, when they do not consider patients’ values—they to check an opt-out box. Even many broad research risk endangering the public’s trust in science and health consent forms often provide little to no information care in general. to help a patient weigh her or his decision and rely Ethical gray areas involving patient consent in bioon the patient’s trust in the intentions of researchers banking research signal potential inconsistencies beor institutions that may use this genetic material. tween what we, as nurses, say we believe and what Are such methods of consent consistent with the we actually do in practice. Are current practices in ethical value of respect for the patient’s rights and valobtaining biobanking consent sufficiently aligned ues, especially when the patient is preoccupied with with the socially sanctioned ethics and values of the her or his medical condition and treatment? Is this renursing profession? Given the rapidly changing and ally informed consent? highly complex research environment, we need to Nursing ethics and patient-centered care call for collectively strengthen our efforts to apply and advonurses to advocate for their patients and to honor the cate for the ethical principles of our profession and values of each individual for whom we provide health the personal values of our patients. One step forward care. In a March 2006 letter in the Lancet Oncolwould be for nurses to examine the current informed ogy, Maschke pointed out that the risks of “digniconsent practices at their institutions and raise awaretary harms”—violation of one’s deeply held personal ness about these important issues. ▼ beliefs—are often overlooked in biospecimen reElizabeth R. Eisenhauer is a doctoral student at the University search. These risks include research activities that are of Michigan School of Nursing, Ann Arbor. Contact author: in conflict with personal values or religious beliefs and [email protected]. The author has disclosed no potential conmay cause moral distress for donors. Examples might flicts of interest, financial or otherwise. [email protected]
AJN ▼ July 2015
▼
Vol. 115, No. 7
11
