Category Archives: REAL

Research Ethics in the Academic Literature

Measuring Coercion: Research Ethics in the Academic Literature

When do incentives to participate in research become coercive? The answer to this question may seem to be entirely subjective; that is, each individual faces a unique list of motivators and pressures when confronted with the informed consent process. We are all vulnerable to coercion in different ways and to differing degrees. However, a standardized scale might be useful in measuring the extent to which human subjects feel coerced. With such a scale, a researcher might know when “yes” actually means “no.”

In their recent paper, Measuring coercion to participate in research within a doubly vulnerable population … , Karen Leggett Dugosh, David S. Festinger, Jason R. Croft and Douglas B. Marlowe report the creation and testing of this tool. According to the authors, the Coercion Assessment Scale (CAS) is only the second coercion scale developed for use with human subjects. (A longer list of coercion scales have been developed for use in non-research settings.) The authors developed and tested the instrument to survey the feelings of coercion among “criminally involved substance abusers.” The 84 human subjects were facing or serving sentences in a misdemeanor drug court in Wilmington, Delaware. They were, therefore, “doubly vulnerable”–substance abusers and criminally “involved.” In other words, the subjects were in medical, financial, and legal circumstances that made them into easy targets for coercive pressures to consent to research.

Perhaps one should not be surprised, therefore, that the CAS revealed that many of the 84 subjects felt inappropriately coerced. In addition to the 12 people reporting feeling that they “could not say no to entering the study,” 33% “entered the study mainly for financial reasons,” 51% thought “the judge would like it,” and 51% believed “the study would help” their court case. Running parallel to the evaluation of the CAS, the authors were also studying the impact of research intermediaries in their efforts to improve the consent process and decrease coercive motivators. Lamentably, the effort failed to demonstrate statistically significant improvements in the subjects’ feelings of coercion.

The authors have laid the ground work for a very useful tool. They have also opened the door for ethicists to take a careful look at how prisoners (and other “criminally involved” subjects) are protected from research related harms. Although fraught with ethical complications, medical research within this very vulnerable population is essential to improving health outcomes and social rehabilitation. Although a “coercion assessment scale” will not resolve all the ethical complications of conducting research with prisoners (and others in-and-out of the criminal justice system), it could become a very useful indicator, a tool for uncovering coercion that might otherwise go unreported.

Reference

Dugosh KL, Festinger DS, Croft JR, Marlowe DB. Measuring coercion to participate in research within a doubly vulnerable population: initial development of the coercion assessment scale. J Empir Res Hum Res Ethics. 2010 Mar;5(1):93-102. PubMed PMID: 20235867.

Relalted Literature and Links

Advisory Commission on Human Radiation Experiments. Chapter 9 — Prisoners: A Captive Research Population. DOE Openness: Human Radiation Experiments.

Bioethics | Prisoners as Human Subjects. The University of Texas Health Science Center at Tyler.

Festinger DS, Marlowe DB, Dugosh KL, et al. Higher magnitude cash payments improve research follow-up rates without increasing drug use or perceived coercion. Drug Alcohol Depend. 2008 Jul 1;96(1-2):128-35. Epub 2008 Apr 18. PubMed PMID: 18395365

Gostin, Lawrence O., Cori Vanchieri, and Andrew MacPherson Pope; IOM Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research. Ethical Considerations for Research Involving Prisoners. Washington, D.C.: National Academies Press, 2007.

Lerner BH. Subjects or objects? Prisoners and human experimentation. N Engl J Med. 2007 May 3;356(18):1806-7. PubMed PMID: 17476006.

Moser DJ, Arndt S, Kanz JE, et al. Coercion and informed consent in research involving prisoners. Compr Psychiatry. 2004 Jan-Feb;45(1):1-9. PubMed PMID: 14671730.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, U.S. Reports and recommendations: research involving prisoners. 1976. Available from: https://scholarworks.iupui.edu/handle/1805/565

Office of Extramural Research, NIH. Research Involving Vulnerable Populations.

Office for Human Research Protections, HHS. OHRP Guidance on the Involvement of Prisoners in Research.

Stone, T.H. Prisoners as human subjects: clinical research reference guide. 2004. [PDF – 844 KB]

Wyman BP. Biomedical and behavioral research on juvenile inmates: uninformed choices and coerced participation. J Law Health. 2000-2001;15(1):77-104. PubMed PMID: 11930505.

Other Recent Research Ethics Articles: PubMed – April 2010 | PubMed – May 2010

– J.O.

Peer-Driven Recruitment: Research Ethics in the Academic Literature

In peer-driven recruitment (PDR) research subjects recruit new subjects. These subjects, in turn, may recruit additional subjects. In some cases, the process may repeat for successive waves. Often, subjects are paid or given other incentives to recruit their peers. As an approach to recruitment, PDR can be a very effective tool—some difficult to reach populations (examples might include: sex workers, immigrants, abuse victims, and others) are more likely to participate in a research study when engaged by a “peer.” However, when subjects are recruited by their peers, researchers should be aware of potential ethical problems. For example, if peers are “driven” by money to recruit new subjects from their social networks, they may be tempted to take shortcuts when acquiring consent and conducting other responsible research practices. At the same time, one’s peers (perhaps, particularly when from a tight social network) are not always the best people to entrust with confidential information. Privacy prefers anonymity.

In their recent paper, “Community members as recruiters of human subjects: ethical considerations,” Simon and Mosavel explore these issues and provide an account of a variant version of PDR (Am J Bioeth. 2010 Mar;10(3):3-11. PubMed PMID: 20229402). The authors identify four ethical concerns worth consideration prior to employing peers in subject recruitment: 1) PDR without comprehensive community engagement in the research project can devalue the role of community participation; 2) as “insiders,” peer recruiters may inadvertently bias the sample; 3) maintaining privacy and confidentiality in intimate communities; and 4) “the potential for exploitation of peer recruiters and/or their social networks, particularly in cases where peer recruiters are compensated on a per-capita basis.”

Simon and Mosavel offer what they consider to be a variant version of PDR which (although not without its challenges) is less susceptible to ethical difficulties. In a “resource-poor community” near Cape Town, South Africa, the authors conducted a study of the health knowledge and attitudes of women regarding cervical cancer. With a pre-existing, intensive community engagement program in place, the project hired “community members” to work as research staff. Seven, bilingual women were hired from the neighborhood and received training which included sessions addressing the ethical conduct of research. These new research staff members helped to troubleshoot the study design, revised and translated the informed consent forms, consented subjects, and conducted the research interviews in the subjects’ homes.
Some staff members were emotionally distressed following interviews with women living with illness or in unhealthy environments. To develop stress-related coping strategies, the team met with a trained psychologist, kept diaries, and (when appropriate) distributed a list of local support services to interviewees. Over the three year lifecycle of the research, only one staff member left. When the project was complete, some staff members received help from the PIs in finding new employment opportunities.

Although Simon and Mosavel’s account of a community engaged research project in Cape Town, South Africa is certainly a memorable and instructive narrative, and although their review of the ethical issues inherent in PDR is informative, the article struggles to bring these topics together. The research team hired in Cape Town may have been from the “community,” but they were not “peers”—as staff they were not subjects, nor were they “driven” by incentives to recruit new subjects. This variant of PDR is not “peer,” not “driven” and not really “recruitment.” Nevertheless, Simon and Mosavel’s recommendations are worth considering for future PDR projects and other forms of community-based research employment: ethical training, ongoing support, and the anticipation challenges related to researcher/subject proximity.

Reference:

Simon C, Mosavel M. Community members as recruiters of human subjects: ethical considerations. Am J Bioeth. 2010 Mar;10(3):3-11. PubMed PMID: 20229402.

Open Peer Review Commentaries on Simon and Mosavel:

Landy DC, Sharp RR. Examining the potential for exploitation by local intermediaries. Am J Bioeth. 2010 Mar;10(3):12-3. PubMed PMID: 20229405.
Phillips T. Protecting the subject: PDR and the potential for compromised consent. Am J Bioeth. 2010 Mar;10(3):14-5. PubMed PMID: 20229406.
Fry CL. Ethical implications of peer-driven recruitment: guidelines from public health research. Am J Bioeth. 2010 Mar;10(3):16-7. PubMed PMID: 20229407.
Bean S, Silva DS. Betwixt & between: peer recruiter proximity in community-based research. Am J Bioeth. 2010 Mar;10(3):18-9. PubMed PMID:20229408.
Anderson EE. The role of community-based organizations in the recruitment of human subjects: ethical considerations. Am J Bioeth. 2010 Mar;10(3):20-1. PubMed PMID: 20229409.
Constantine M. Disentangling methodologies: the ethics of traditional sampling methodologies, community-based participatory research, and respondent-driven sampling. Am J Bioeth. 2010 Mar;10(3):22-4. PubMed PMID: 20229410.
Molyneux S, Kamuya D, Marsh V. Community members employed on research projects face crucial, often under-recognized, ethical dilemmas. Am J Bioeth. 2010 Mar;10(3):24-6. PubMed PMID: 20229411.
Simon C, Mosavel M. Response to open peer commentaries on “community members as recruiters of human subjects: ethical considerations”. Am J Bioeth. 2010 Mar;10(3):W1-3. PubMed PMID: 20229401.

Related Links and Literature:

Respondent Driven Sampling [Cornell]
DeJong J, Mahfoud Z, Khoury D, et al. Ethical considerations in HIV/AIDS biobehavioral surveys that use respondent-driven sampling: illustrations from Lebanon. Am J Public Health. 2009 Sep;99(9):1562-7. PubMed PMID: 19608961.
Semaan S, Santibanez S, Garfein RS, et al. Ethical and regulatory considerations in HIV prevention studies employing respondent-driven sampling. Int J Drug Policy. 2009 Jan;20(1):14-27. PubMed PMID: 18243679.
Scott G. “They got their program, and I got mine”: a cautionary tale concerning the ethical implications of using respondent-driven sampling to study injection drug users. Int J Drug Policy. 2008 Feb;19(1):42-51. PubMed PMID: 18226516.
Tiffany JS. Respondent-driven sampling in participatory research contexts: participant-driven recruitment. J Urban Health. 2006 Nov;83(6 Suppl):i113-24. PubMed PMID: 16933100.
Brace-Govan J. Issues in snowball sampling: the lawyer, the model and ethics. Qualitative Research Journal. 2004;4(1):52-60. informit.com.au

Other Recent Research Ethics Articles

- J.O.

Another Look at Stateville Penitentiary: Research Ethics in the Academic Literature

Medical research conducted on prisoners in this country was banned in 1976 and is now regulated by 45 CFR 46 (Subpart C). Although many factors make prisons unlikely places for the ethical conduct of human research, the fact that prisoners have less autonomy to make basic decisions about their lives renders them vulnerable to coercion and other forms of abuse. For example, prisoners might be willing to accept undue risks in exchange for small incentives (a change of scenery, something to do) or prisoners might see participation as a potential way of shortening their sentence (“good behavior”). Thus, in such an environment, research subjects might willingly consent and even actively participate in research, but do so at great costs and for the wrong reasons.

In a recent article published in Studies in History and Philosophy of Biological and Biomedical Sciences, Nathaniel Comfort examines such a case in “The prisoner as model organism: malaria research at Stateville Penitentiary”. Beginning in the1940s (in the middle of the Second World War), the U.S. military funded and conducted research on malaria in Illinois’s Stateville Penitentiary. Given that malaria seriously weakened the U.S. forces, the push for better and more readily available malaria remedies was considered a matter of national security and patriotic devotion. The military did not want to recruit healthy soldiers into risky medical experiments. The prison population, therefore, provided a convenient alternative. The inmates lived in a controlled setting and, as Comfort recounts, they were eager to participate. (In the first day of a call for 200 volunteers, 487 inmates responded.) Furthermore, the prisoners participated in the experiments at all levels. They served as research subjects (receiving variously potent and toxic treatments for malaria), reagents (facilitating recruitment, conducting lab work, and reporting results), and even as research objects (the mosquitoes needed something to eat and the virulent Chesson-strain of Plasmodium vivax needed human hosts).

Comfort explores the subtle and not-so-subtle ways that the prison/research system transformed the inmates into “model organisms”. He relies on the accounts of a doctor, Ernest Beutler, and a prisoner, Nathan Leopold (of the “Leopold and Loeb” duo). Beutler remembered that it felt like working in a hospital and that the prisoners “really were volunteers”; but Leopold (who had two heart attacks during the research and later died of heart failure) boasted, “No man was coerced or even persuaded … Every man who went on the project at Stateville did so because he wanted to, almost because he insisted on it.” As for the public … the research was anything but secretive, Life magazine ran a photo essay on the work in 1945 and another on Leopold in 1957, radio stations interviewed the prisoners, and, according to Comfort, the prisoners “became something of heroes; their sacrifices for the war effort were celebrated … the project’s ethical lapses were hidden in plain sight, and its morally therapeutic qualities were stressed”. At Stateville, the line between biomedical research and criminal punishment (or “rehabilitation”) blurred. As Comfort writes, “The suffering the prisoners would endure would be counted as part of their punishment, would be credited against their debt to society”. With a cooperative, but not truly autonomous, population at hand, the doctors, the military, the prison, and the public supported a project which ran counter to the (yet to be adopted) Nuremberg Code. Clearly, as at Stateville Penitentiary, willing participants, noble causes, and even a supportive public are not sufficient markers of an ethically conducted research study.

Reference:

Comfort N. The prisoner as model organism: malaria research at Stateville Penitentiary. Stud Hist Philos Biol Biomed Sci. 2009 Sep;40(3):190-203. PubMed PMID: 19720327

Related:

45 CFR 46 (Subpart C). Additional protections pertaining to biomedical and behavioral research involving prisoners as subjects. Available from: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartc

Advisory Committee on Human Radiation Experiments. Prisoners: a captive research population. In The Final Report of the Advisory Committee on Human Radiation Experiments. Available from: http://www.hss.energy.gov/HealthSafety/ohre/roadmap/achre/chap9.html

Chwang E. Against risk-benefit review of prisoner research. Bioethics. 2010 Jan;24(1):14-22. PubMed PMID: 20017743.

Elger BS, Spaulding A. Research on prisoners – a comparison between the IOM Committee recommendations (2006) and European regulations. Bioethics. 2010 Jan;24(1):1-13. PubMed PMID: 20017742.

Elger BS. Research involving prisoners: consensus and controversies in international and European regulations. Bioethics. 2008 May;22(4):224-38. PubMed PMID: 18405321.

Gostin, Lawrence O., Cori Vanchieri, and Andrew MacPherson Pope. Ethical considerations for research involving prisoners. Washington, D.C.: National Academies Press, 2007. Available from: http://www.nap.edu/catalog.php?record_id=11692

Smoyer A, Belt B. Compensation for incarcerated research subjects: a state-by-state analysis. Center for Interdisciplinary Research on AIDS (CIRA), Yale University; 2008. Available from: http://cira.med.yale.edu/law_policy_ethics/cfirs_asbsa.pdf

Sound Ethics: Using prisoners for medical research. Sound Medicine, September 3, 2006. Description | Audio file [RealPlayer]

Thomas DL. Prisoner research – looking back or looking forward? Bioethics. 2010 Jan;24(1):23-6. PubMed PMID: 20017744.

Other Research Ethics Articles: PubMed – November | PubMed -December | PubMed – January

- J.O.

Virtue Ethics for CBPR? Research Ethics in the Academic Literature

Community-based participatory research (CBPR), by definition, includes communities as partners in the research process. Therefore, although individual research participants (also known as “human subjects”) may be sufficiently protected, the barriers and risks of full community participation will also need to be addressed. Are the ethical principles of “autonomy,” “nonmaleficence,” “beneficence,” and “justice” enough or do we need more than the principles-based approach of the Belmont Report to resolve the ethical issues in CBPR?

In “A virtue ethics guide to best practices for community-based participatory research”, Marjorie A. Schaffer proposes the addition of a virtues approach to the ethics toolbox. A list of relevant virtues might vary depending on the context, but Schaffer chooses to focus on six: compassion, courage, honesty, humility, justice, and practical reasoning. For example, Schaffer observes: “The compassionate researcher will imagine what the research experience is like for community partners and participants.” Likewise, the author advocates for humility because it can “guide the researcher to examine the inadequacies in their own understanding of community experiences and viewpoints as well as examine both knowledge and lack of knowledge in implementing the research process.” Schaffer devotes the most attention to justice, which, among other things, “means including vulnerable and disadvantaged populations in one’s research agenda, planning research that will benefit these groups (based on their input), and using research findings to contribute to improved social conditions.”

In this paper, Schaffer provides a good overview (with plenty of references) of the value of the virtues to the practice of ethical research in the community. In addition, the table of “best practices” walks through the CBPR steps and marks the places in which the virtues can assist. It seems to me, however, that a few issues will need to be addressed before a virtue ethics approach can be widely recognized and explicitly employed in CBPR. First, how do we teach (Schaffer suggests mentoring) and systematize the virtues? Is it really possible? Second, which virtues do we chose and why? And finally, Schaffer notes that “virtue ethics supports a collaborative approach”, but it might be more accurate to say that a collaborative approach requires or even instills the virtues in its practitioners. In other words, which comes first, the ethics or the eggs?

Reference:

Schaffer MA. A virtue ethics guide to best practices for community-based participatory research. Progress in Community Health Partnerships: Research, Education, and Action. 2009 3(1), 83-90. DOI: 10.1353/cpr.0.0053

Related:

Frey WJ. Teaching virtue: pedagogical implications of moral psychology. Sci Eng Ethics. 2009 Sep 1. PMID: 19728163.

Holland S. The virtue ethics approach to bioethics. Bioethics. 2009 Aug 25. PMID: 19709078.

Shore N, Wong KA, Seifer SD, Grignon J, Gamble VN. Introduction to special issue: advancing the ethics of community-based participatory research. J Empir Res Hum Res Ethics. 2008 Jun;3(2):1-4. PMID: 19385741.

Other Recent Research Ethics Articles (October 2009)

- J.O.

Syphilis, Lead Paint and the IRB: Research Ethics in the Academic Literature

Many of the current human subject protections were formed with the disastrous consequences of the well-known Tuskegee Syphilis Study in mind. While we all hope that these rules have made the practice of human subjects research safer, they cannot prevent future disasters without the reliable performance of the individuals and organizations. The Kennedy Krieger Institute Lead-Based Paint Study (KKI), in which researchers measured the blood lead levels of children living in homes that received differing methods of lead abatement, for example, became a public scandal and legal disaster many years after Tuskegee, even though the study was reviewed by institutional review boards (IRBs). Will IRBs fail to stop similar studies in the future? What can institutions do to decrease the likelihood of seeing another Tuskegee or KKI debacle in the future?

To begin to answer these questions, Barry Bozeman, Catherine Slade and Paul Hirsch in “Understanding Bureaucracy in Health Science Ethics: Toward a Better Institutional Review Board” propose studying the organizational behavior of IRBs. The authors assert that IRBs as organizational systems are functioning well with a large number of low-risk, routine decisions, but are more likely to fail when confronting idiosyncratic and novel decisions. The authors point to the KKI case as an example and note: “There is no evidence that IRB procedures differed significantly in this case from hundreds of other instances, ones that drew less attention and escaped the wrath of the press and the public.” In other words, the day the KKI study was approved, the IRB was just doing its job, but (we know now) that clearly was not enough.

Before addressing these potential vulnerabilities in IRB decision making, the authors propose that IRBs themselves become the subject of future behavioral research studies. They propose three well-used methods: case studies, survey research, and experiments or simulations. While IRB members and the institutions they serve might resist studies of their decision making behavior, the authors remind us: “There is no reason to assume that IRB processes should prove a more intractable learning environment than, say, corporate board rooms, air control towers, space centers, or war rooms.”

Reference:

Bozeman B, Slade C, Hirsch P. Understanding bureaucracy in health science ethics: toward a better institutional review board. Am J Public Health. 2009 Sep;99(9):1549-56. PMID: 19608947

Related:

Bozeman B, Hirsch P. Science ethics as a bureaucratic problem: IRBs, rules, and failures of control. Policy Sci. 2006; 38:269–291. doi:10.1007/s11077-006-9010-y

Buchanan DR, Miller FG. Justice and fairness in the Kennedy Krieger Institute lead paint study: the ethics of public health research on less expensive, less effective interventions. Am J Public Health. 2006 May;96(5):781-7. PMID: 16571697

Candilis PJ, Lidz CW, Arnold RM. The need to understand IRB deliberations. IRB. 2006 Jan-Feb;28(1):1-5. PMID: 16680872

Other Recent Research Ethics Articles (September 2009)

– J. O.

Disclosing Adverse Clinical Trials Results: Research Ethics in the Academic Literature

In a recent “target article” for an AJOB Open Peer Commentary, S. Matthew Liao, Mark Sheehan and Steve Clarke make a case for a moral duty to disclose all adverse clinical trial results to potential participants. They argue, in short, that consent is not “informed” when participants lack risk information. Pharmaceutical companies, however, have an interest in protecting information about the development of new products. Although the authors believe the safety of human subjects should be protected even when intellectual property may be disclosed, their analysis concludes that current regulatory practices “fail to promote the duty to disclose adverse clinical trial results and … fail to ensure that sensitive information are not passed on to commercial competitors”. They point to both the US FDA Modernization Act (FDAMA) of 1997 and the US FDA Amendments Act of  (FDAAA) 2007 as inadequate. The Modernization Act makes “no requirement to disclose any adverse trials results to trial participants.” Likewise, the Amendments Act of 2007 does not require the disclosure of safety tests conducted in phase I and phase II trials. At the same time, the authors assert, these regulations make no effort to protect commercial interests. To remedy these inadequacies, the authors propose a database of adverse clinical trial results administered by an oversight body. Additionally, the authors argue for legally binding agreements to protect human subjects and pharmaceutical companies:

Pharmaceutical companies would face appropriate penalties for failure to make disclosure of adverse clinical trial results. Prospective participants would be required to sign a confidentiality agreement regarding the information that has been disclosed to them by the oversight body and would face appropriate penalties for any breaches of this agreement.

Reference:

Liao, S. Matthew; Sheehan, Mark; Clarke, Steve. “The Duty to Disclose Adverse Clinical Trial Results” The American Journal of Bioethics 9.8 (2009). 19 Aug. 2009. DOI: 10.1080/15265160902984988

Peer Commentaries:

Hassoun N. The Duty to Disclose (Even More) Adverse Clinical Trial Results. AJOB 2009; 9(8):33.

McGoey L. Compounding Risks to Patients: Selective Disclosure is Not an Option. AJOB 2009; 9(8):35.

Shah KR, Batzer FR. Improving Subject Recruitment by Maintaining Truly Informed Consent: A Practical Benefit of Disclosing Adverse Clinical Trial Results. AJOB 2009; 9(8):36.

Oakley J. Respecting Participant Autonomy and the Disclosure of Clinical Trial Results. AJOB 2009; 9(8):38.

Banja JD, Dunlop B. Enhancing Informed Consent in Clinical Trials and Exploring Resistances to Disclosing Adverse Clinical Trial Results. AJOB 2009; 9(8):39.

Saunders PT. The Duty to Register Phase I Trials. AJOB 2009; 9(8):41.

Wu KC. Precautionary Harm Disclosure in Clinical Trials. AJOB 2009; 9(8):43.

Vernillo A. Disclosure of Adverse Clinical Trial Results—Should Legal Immunity Be Granted to Drug Companies? AJOB 2009; 9(8):45.

Related Links:

ClinicalStudyResults.org

ClinicalTrials.gov

[ClinicalTrials.gov Protocol Registration System] PRS and U.S. Public Law 110-85

ClinicalStudyResults.org

Food and Drug Administration Amendments Act (FDAAA) of 2007

Food and Drug Administration Modernization Act (FDAMA) of 1997

WHO International Clinical Trials Registry Platform

Other Recent Research Ethics Articles (August 2009)

Pediatric Biobanks: Research Ethics in the Academic Literature

Have you ever tried to find an old friend from school? Where did they move? Did they change their name? It is not always easy, is it? Well, imagine that you are trying to find a few hundred research subjects to get consent to use their pediatric data or tissue in a research study. Sure, their mom or dad said that it was fine to use this sample or this medical information for research, but that was decades ago when the subject was a child. Now that the child is an adult, perhaps the subject has their own ideas about whether or not researchers should be using these resources for science. Finding them, however, could be a problem. Who are they? Where are they? Do you really have to go through the trouble and expense to find them? What would these “donors” think if you just skipped that step?

To shed some light on some of these questions, the authors of a new article (Goldenberg AJ, Chandros Hull S, Botkin JR, Wilfond BS. Pediatric biobanks: approaching informed consent for continuing research after children grow up. J Pediatr. 2009 Jul 10. PMID: 19595370.) conducted a survey based on a hypothetical scenario:

“When you were an infant, your parents gave their permission for a blood sample of yours to be used in research on children’s health. Your doctor collected samples from hundreds of infants this way. Since then, your blood sample has been stored in a freezer along with a unique identification number and some background medical information about you. Several decades have passed and all of the infants whose blood samples were collected are adults. The researcher now wishes to continue to use your sample for research.”

The survey asks four questions to measure the level of concern about using this data in research. The final question asks: “Suppose that the researcher could not locate you. Would it be acceptable to you for the researcher to use your sample anyway?”

The survey of 1186 patients at 5 academic medical centers found that 54% of the respondents did not think that researchers should have to ask the adult for consent to continue using their pediatric samples. Of the 543 (46%) people responding that researchers should have to ask for consent, 228 found it “acceptable” for a researcher to use the samples if the subject could not be located. While these numbers might be encouraging to researchers using pediatric samples, one must remember that 310 people would NOT find it acceptable for the researchers to use the samples without consent. The survey also gathered valuable information about trust in researchers, attitudes regarding genetic research in general, and privacy about medical information.

In the discussion, the authors observe that contacting every subject “may not be feasible for those studies that lack the funding and administrative support to keep track of children years after the initial participation.” Therefore, the authors recommend increased public engagement. By using focus groups, community meetings, and other engagement methods, the authors suggest that the public might become more comfortable with the concept of ongoing use of pediatric samples without explicit consent from adults. Researchers would also be better equipped to identify communities and studies in which the subjects would absolutely expect to be contacted as adults for explicit consent for ongoing research with their pediatric samples. Further research, the authors suggest, could go beyond hypothetical scenarios and explore what actually patients enrolled in pediatric biobanks think (as children and later as adults) about these issues.

Reference:

Goldenberg AJ, Chandros Hull S, Botkin JR, Wilfond BS. Pediatric biobanks: approaching informed consent for continuing research after children grow up. J Pediatr. 2009 Jul 10. PMID: 19595370.

Related Articles:

Haas DM, Renbarger JL, Meslin EM, Drabiak K, Flockhart D. Patient attitudes toward genotyping in an urban women’s health clinic. Obstet Gynecol. 2008 Nov;112(5):1023-8. PMID: 18978101.

Hull SC, Sharp RR, Botkin JR, Brown M, Hughes M, Sugarman J, Schwinn D, Sankar P, Bolcic-Jankovic D, Clarridge BR, Wilfond BS. Patients’ views on identifiability of samples and informed consent for genetic research. Am J Bioeth. 2008 Oct;8(10):62-70. PMID: 19003716.

Neidich AB, Joseph JW, Ober C, Ross LF. Empirical data about women’s attitudes towards a hypothetical pediatric biobank. Am J Med Genet A. 2008 Feb 1;146(3):297-304. PMID: 18205141.

Tarini BA, Goldenberg A, Singer D, Clark SJ, Butchart A, Davis MM. Not without my permission: parents’ willingness to permit use of newborn screening samples for research. Public Health Genomics. 2009 Jul 11. PMID: 19602864.

Links:

For more on the ethics of pediatric biobanks, read about the Predictive Health Ethics Research (PredictER) program of the Indiana University Center for Bioethics or follow PredictER Blog.

Other Recent Research Ethics Articles (July 2009)

– J.O.