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Bioethics Commission Develops Ethical Framework—Guidance for National-Level Review of Higher Risk Pediatric Research Protocols

Written by Anne Pierson on April 16, 2013 — Leave a Comment

The central tenet of pediatric research ethics is that it should not pose greater than minimal risk (or the risks of daily life) to participants, and, when greater risk cannot be avoided in research, there must be a commensurate potential for direct benefit to pediatric participants or benefit to an identifiable class of children. Only in extraordinary circumstances can children and their parents be asked to take on greater risk with no prospect of direct benefit. Accordingly, the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) concluded that, in the context of pediatric medical countermeasure (MCM) research before a bioterrorism attack (i.e., “pre-event” MCM research), studies must generally pose no more than minimal risk. The Bioethics Commission concluded that pre-event pediatric MCM research posing greater than minimal risk can only proceed after national-level review and approval by the Secretary of Health and Human Services (the Secretary).

Although the regulatory provision for national-level review of pediatric research has been in place for more than 30 years, it has been used only 14 times, and experts convened to assist the Secretary in evaluating those protocols have consistently noted uncertainty in applying the regulatory criteria, which, in part, call for compliance with “sound ethical principles” without specifying what these are. The criteria for national-level review provide fundamental baseline protections for those children involved in approved protocols while permitting sufficient flexibility for the Secretary to exercise discretion in reviewing research, allowing her to tailor the review for a given context. This flexibility is important to ensure that essential research can go forward, but it leaves reviewers with few guidelines about what is otherwise a unique form of review.

Recognizing these difficulties, the Bioethics Commission developed a rigorous ethical framework to guide national-level review of pre-event pediatric MCM research. Of note, the Bioethics Commission found certain conditions in the context of pre-event pediatric MCM research merited stricter research limitations than otherwise permitted by the regulatory criteria for national-level review. For pre-event pediatric MCM research, the proposed framework requires that any approved protocol present no greater than a minor increase over minimal risk, despite the absence of a risk limitation for national-level review in other circumstances.

Other considerations outlined by the Bioethics Commission derive from the circumstances requiring national-level review more generally, rather than solely the considerations of MCM-related pediatric research. For instance, the Bioethics Commission concluded that, given that children in research meriting national-level review (i.e. greater than minimal risk with no prospect of direct benefit) participate primarily for the benefit of other children and society more broadly, justice requires that care and compensation be guaranteed for any research-related injury to a child participant. In addition, the Bioethics Commission concluded that equitable and appropriate access to any successfully tested intervention must also be guaranteed prior to the initiation of research.

The ethical framework, laid out below, provides additional specification of national-level review criteria, clarifying, specifying, and emphasizing the three regulatory criteria that govern national-level review. The Bioethics Commission clarified when a protocol offers a “reasonable opportunity” to address a “serious problem” affecting the health and welfare of children, stating that the research ”must present an opportunity to learn about a specific MCM candidate that might be useful in protecting or treating children exposed to a serious threat,” defined by consequences of exposure that are “life-threatening, permanently disabling, debilitating, or similarly grave” from an event that is “relatively likely, as opposed to remote.” The Bioethics Commission also specified a rigorous set of conditions to determine if research would be conducted in accordance with “sound ethical principles.” These conditions limit the degree of risk that may be posed by any protocol, account for essential concerns in research design, establish requirements for post-research distribution, treatment and compensation for research-related injury, and call for community engagement and transparency and accountability. Finally, the Bioethics Commission emphasized that researchers and persons independent of the research must communicate the heightened risks and uncertainties involved in MCM research so parents can provide informed permission and children can provide meaningful and developmentally appropriate assent.

Although the framework was developed to assess pediatric MCM research, it encompasses many of the considerations required for any national-level review. Expert panels might find that it presents useful guidance as they evaluate non-MCM pediatric protocols.

Posted in Medical Countermeasures, Uncategorized

What is anthrax vaccine adsorbed and what do we know about it?

Written by Rachel Bressler on April 12, 2013 — Leave a Comment

Anthrax is an infection of the skin, intestinal tract, or lungs caused by exposure to spores of the bacterium, Bacillus anthracis. Although several types of antibiotics are approved by the U.S. Food and Drug Administration (FDA) to prevent and treat anthrax, such antibiotics do not provide long-term protection against the persistence of dormant spores. Data from animals suggest that combining antibiotics with anthrax vaccine adsorbed (AVA) provides better protection against anthrax disease than treating with antibiotics alone.

What is AVA?

AVA is a vaccine used to prevent anthrax disease. Currently, AVA is the only anthrax vaccine licensed by FDA.

First licensed in the United States in 1970, AVA is approved for use in persons 18 through 65 years of age who are at high risk of exposure to B. anthracis spores. The vaccine is approved for use before exposure has occurred, though FDA has authorized adminis¬tration of AVA to adults to prevent infection after exposure under certain emergency circumstances. AVA given before potential exposure to B. anthracis is administered in five doses over 18 months, followed by an annual booster.

What do we know about AVA?

Although few in the civilian population have received AVA, it has been widely distributed to members of the military. Since 1998, over 1.5 million military personnel have been vaccinated with AVA.

Evaluations of AVA indicate that its safety profile is comparable to other vaccines. Testing in both animals and human adults has revealed that the most common reactions to AVA include tenderness and redness near the injection site. Other mild reactions near the injection site—such as itching, development of a lump, and bruising—have also been reported, but they are less common. Even more rare are systemic events, such as fever, malaise, and myalgia.

The immunogenicity of AVA, that is, the ability of AVA to produce an immune response, has also been evaluated in both adult humans and animals, and data from these studies demonstrate AVA’s ability to produce a meaningful immune response to combat anthrax infection. However, although the mechanism of immunogenicity is understood, the precise level of antibody that confers protection against anthrax is unknown.

Although human challenge studies (research in which individuals are exposed to a disease or pathogen to test a drug or biologic’s ability to prevent infection) would be unethical in the case of anthrax, studies in animals suggest that AVA is effective, and that it is most effective when combined with antibiotics. Observational studies conducted when individuals are naturally exposed to B. anthracis also suggest that the vaccine is efficacious in adults. Data from a 1962 study evaluating an early anthrax vaccine (not AVA), indicated that the vaccine provided protection against the development of cutaneous anthrax disease.

What is left to learn about AVA?

Research on AVA is ongoing. The Centers for Disease Control and Prevention and the Institute of Medicine have stated that future research on AVA should include studies on long-term side effects, alternative dosing methods, and quantitative correlates of immunity in animal models.

Posted in Medical Countermeasures

Bioethics Commission Kicks Off Privacy and Progress Webinar Series

Written by Elizabeth Schaub on April 8, 2013 — Leave a Comment

The Presidential Commission for the Study of Bioethical Issues (The Bioethics Commission), along with the Genetic Alliance, recently kicked off a new yearlong webinar series. The series is based on The Bioethics Commission’s report, Privacy and Progress in Whole Genome Sequencing. The report concludes that “to realize the enormous promise that whole genome sequencing holds for advancing clinical care and the greater public good, individual interests in privacy must be respected and secured.”

The first webinar, which took place on February 12, featured Bioethics Commission Associate Director Kayte Spector-Bagdady who gave a broad overview of Privacy and Progress to more than 220 participants. Spector-Bagdady spoke for 30 minutes and offered a synopsis of Privacy and Progress along with a brief history of the Bioethics Commission. Spector-Bagdady said that the first webinar was designed to give a “high level overview of the Bioethical Commission’s report and its process before diving into the recommendations of the report.”

The second webinar in the series, offered on March 12, provided a more detailed analysis and explanation of the recommendations made in Privacy and Progress, and featured Bioethics Commission Senior Policy and Research Analyst Elizabeth Pike. More than 120 participants attended. “Spending time looking more closely at the recommendations allowed us to have a substantive discussion about consent, access, and data sharing. The question and answer portion of the webinar brought up further discussion on topics such as different state laws, protection for individuals, the need for consent, and what that entails,” Pike said. “All the webinars will have a 30 minute question and answer segments, which we hope will allow for thought provoking and engaging conversation,” Pike added.

Pike also previewed the webinars that will be coming up over the next few months; each recommendation in Privacy and Progress will be the focus of a webinar and will be led by various authorities on the issue.

The Genetic Alliance, a nonprofit health advocacy organization, is offering this series of monthly webinars on the second Tuesday of each month at noon. The series began in February and will end in December. All webinars are free and are archived for later viewing. 

The next installment, Strong Baseline Protections While Promoting Data Access and Sharing, will be held on April 9.

Posted in Whole Genome Sequencing

In Safeguarding Children, Commission provides guidance for application of section 407

Written by Michelle Spektor on April 4, 2013 — Leave a Comment

Most pediatric research can be approved by an institutional review board (IRB) if it poses only minimal risk, offers the prospect of direct benefit, or yields vitally important generalizable information about the participants’ condition. When a pediatric research proposal does not fit within these confines, to move forward, it must be elevated to national-level review under section 407 of 45 C.F.R. Part 46. Section 407 regulates pediatric research that poses higher risk to healthy children without the prospect of direct benefit.

Although some types of pediatric medical countermeasure (MCM) research might be approvable by an IRB as minimal risk, higher risk pediatric MCM research might require national-level review. In its report, Safeguarding Children: Pediatric Medical Countermeasure Research, the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) provides much needed guidance for national-level review in the MCM context.  

In order to be approved under section 407, the Secretary of Health and Human Services, in consultation with a national review panel, must find that the research (i) presents a reasonable opportunity to further the understanding, prevention or alleviation of a serious problem affecting the health or welfare of children; (ii) will be conducted in accordance with sound ethical principles; and (iii) makes adequate provisions for soliciting parental permission and meaningful child assent.

In formulating the recommendation that was adopted as section 407 three decades ago, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the National Commission) expressed the view in its report, Research Involving Children, that research presenting more than minimal risk to healthy children without the prospect of direct benefit could only be justified if the research is of major significance, if it addresses a grave and serious health problem, and if the expected benefit is significant.

The serious health problem the National Commission had in mind at the time was polio, and its members did not want their recommendations to be so restrictive that they would have prevented important pediatric research on polio vaccines (http://pediatrics.aappublications.org/content/113/6/1783.full). The National Commission also considered that there might be extraordinary situations in which the dangers of not involving children in more than minimal risk research are so great that it would be unethical to exclude them.

Critics of section 407 argue that its application has not conformed to the intent of the National Commission’s original recommendations.  Instead of reserving section 407 for exceptional situations, for example, IRBs might advance protocols for national-level review simply because they cannot be approved under other provisions that govern the majority of pediatric research. This has resulted in a situation where section 407 has sometimes been treated as a “catchall” for research that should be amended to conform to other approval mechanisms or possibly foregone.

Use of section 407 is further complicated by the fact that it fails to specify the “sound ethical principles” that should govern research under its purview and does not explain how to determine what constitutes a “serious problem.”  While this broad language lends national-level reviewers flexibility to take the particulars of each case into account, it has resulted in uncertainty among panels regarding the interpretation and application of these standards.

In order to successfully address ethical issues in pediatric MCM research, the Bioethics Commission needed to address the ambiguities of section 407 and clarify its guidelines. The recommendations in Safeguarding Children stipulate the circumstances in which a research protocol should proceed to national-level review under section 407, defines the terms and standards provided by section 407, and specifies ethical principles that should be used to assess research under section 407.

Posted in Medical Countermeasures

Community Engagement in Pediatric Medical Countermeasure Research

Written by Misti Ault Anderson on April 2, 2013 — Leave a Comment

The Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) recently published its report, Safeguarding Children: Pediatric Medical Countermeasure Research, in which it reviews the ethical considerations for conducting research on medical interventions that would be used to protect children in the event of a bioterror attack—also known as “medical countermeasures” (MCM). One important element of the ethical conduct of such research is community engagement.

Community engagement is a way for researchers to get feedback from the community that will be affected by the research in order to tailor the study to the community’s needs or concerns.  It also involves educating the public about the research, improving the community’s understanding of the study, and providing for more informed feedback and participation. Reaching out to marginalized communities, the general public, and other stakeholders helps to “ensure ethical study design, implementation, and access to benefits should the need arise.”

Involving the community in planning and conduct of research boosts public trust and increases the chance that individuals will recognize and take advantage of drugs or interventions that might be approved as a result of the research.  This is especially important in MCM research because the interventions under investigation are intended to mitigate harm after an emergency occurs, when time is of the essence.

The Bioethics Commission stressed that community engagement should be included in all pediatric MCM research. When research can be done before an emergency takes place (pre-event research), there is time for planning and researchers should consult the community and strive to design studies that account for the public’s concerns.

If an emergency, such as a bioterror attack, occurs before research has been completed, then medical interventions might be given to children in order to save lives, even if those interventions have only been tested in adults.  When this happens, it is important to study the safety and effectiveness of the intervention in children that receive it (post-event research). The Bioethics Commission stressed that community engagement is especially important in planning for post-event research, stating “[p]ost-event research planning should lay the groundwork for community engagement activities that can then be activated in the event of an attack.”

Posted in Medical Countermeasures

Revisiting Research Ethics

Written by Michelle Groman on March 28, 2013 — Leave a Comment

In its most recent report, Safeguarding Children: Pediatric Medical Countermeasure Research, the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) builds on its prior work concerning human subjects research protections. 

In November 2010, President Obama charged the Bioethics Commission to conduct a thorough review of current protections for research participants.  The Bioethics Commission completed its work in December 2011 and, in its report, Moral Science: Protecting Participants in Human Subjects Research, offered fourteen recommendations to improve the current system.  Less than one month later, HHS Secretary Kathleen Sebelius asked the Bioethics Commission “to conduct a thorough review of the ethical considerations of conducting clinical trials of medical countermeasures (MCMs) in children.”  In Safeguarding Children, the Bioethics Commission offered six recommendations in response.

Moral Science concerns human subjects research generally – focusing principally on research governed by the Common Rule (the federal policy that governs research supported by 18 federal departments and agencies), whereas Safeguarding Children concerns a very specific type of research – pediatric MCM research, that is, pediatric testing of FDA-regulated products and interventions used in response to chemical, biological, radiological, and nuclear attacks.  Pediatric MCM research is particularly complex: it involves pediatric research participants who are ethically and legally unable to consent to participate in research, and when conducted before an attack occurs (i.e., pre-event), it involves testing interventions with an unknown likelihood of ever being used.  Pediatric MCM research conducted after an attack (i.e., post-event) poses its own challenges because of the very stressful circumstances under which it would take place.

The Bioethics Commission echoed many of the themes that it initially raised in Moral Science in its consideration of the unique set of ethical concerns associated with pediatric MCM research.  In Safeguarding Children, the Bioethics Commission stressed once more the importance of compensation for research-related injury, community engagement, and transparency and accountability.  Given the particular ethical contours of pediatric MCM research and the need for heightened protections for research involving children, the Bioethics Commission’s Moral Science and Safeguarding Children recommendations in these areas are not identical; they are complementary.  

For example, in Moral Science, the Bioethics Commission’s central recommendation for transparency and accountability called for public access to basic data about federally supported research, specifically project title, investigator, location, and funding data.  In Safeguarding Children, the Bioethics Commission recommended public access of a different sort.  For pre-event pediatric MCM research that is greater than minimal risk, the Bioethics Commission called for, among other things, enhanced transparency by involving the public in the research review process, communicating the rationale for approving or rejecting a protocol, and providing periodic updates on the conduct of research.  As the Bioethics Commission explained, such enhanced transparency is necessary in this context because a group of individual children who do not stand to benefit directly from research will bear research risks for the potential benefit of children as a class.

The common themes in Moral Science and Safeguarding Children are grounded in the foundational principles of respect for persons, beneficence, justice, and democratic deliberation.  Applying these principles to difficult issues in research ethics, the Bioethics Commission continues to elucidate protections that should be in place to protect participants from undue risk in research.

Posted in Medical Countermeasures

Core Principles in Safeguarding Children

Written by Eleanor Gilmore-Szott on March 25, 2013 — Leave a Comment

In 1978 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the National Commission) published the Belmont Report, which established the three central principles of human subjects research protections—respect for persons, beneficence, and justice—and implicitly endorsed a fourth principle, democratic deliberation. These foundational principles guided the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) in responding to Secretary of Health and Human Services Kathleen Sebelius’s charge to examine the ethics of pediatric medical countermeasure (MCM) research – research that would inform the safety and proper dosing of pediatric interventions in the event of a public health emergency.

The principle of respect for persons requires research be conducted with regard for both autonomous individuals and those with diminished autonomy. Informed consent is the preferred process for assuring respect for autonomy and voluntary participation. However, within the context of pediatric research, informed consent, as an ethical and legal matter, is not possible due to the ongoing physical, mental, and moral development of adolescents and children. Respect for persons requires that pediatric research implement additional safeguards, ensuring that no child be treated merely as a means to pursue scientific or social progress. Three critical protections uphold the principle of respect for children:

  1. Parental Permission: The permission of legal guardians must be obtained, as they are responsible for acting in the best interests of the children in their care.
  2. Meaningful Child Assent: Children or adolescents must be included in the decision making process through age-appropriate agreement to research participation.
  3. Restrictions on Risk: The psychological and physical risks of research must be limited and low, in order to show respect for the current and future interests of children.

 The principle of beneficence has two parts: first, it requires that research seeks to secure the well-being of individuals and communities; second, it includes the corollary principle of non-maleficence, the obligation to “do no harm.” In pediatric MCM research, beneficence and non-maleficence entail both an obligation to minimize harm to children participating in research—to the extent that is ethically and practically possible—and the duty to safeguard children as a class against potential attacks.

The principle of justice requires fair treatment of participants and the equitable distribution of the benefits and burdens of research. In pediatric MCM research especially, the principle of justice reinforces the obligation to avoid exploiting children, who are members of a vulnerable population. Research may include children only when the knowledge sought requires including pediatric participants and cannot be acquired using animal studies or computer models. Furthermore, children must never be used for research when the same information could be obtained through voluntary adult participation.

Democratic deliberation, the final principle, is implicit in the Belmont Report and the National Commission’s other work. Since its first project, democratic deliberation has been the approach of this Bioethics Commission. This principle provides for an inclusive and respectful process of collaborative decision making, achieved by involving stakeholders such as parents, community members, and other interested parties, or their representatives. For MCM research, the most ethically complex cases must undergo a case-by-case national-level review. As acknowledged by the National Commission, this process ensures careful and open consideration of the ethical principles discussed, especially in circumstances during which “any debate about their application should be held at the most public level of discourse.”[1]

Through the reaffirmation of these four principles, the Bioethics Commission has made clear the firm ethical requirements that must be met in order to proceed with any pediatric MCM research protocol. As expressed by the National Commission, “[u]nless research can be designed which reflects all [these principles], it cannot be called ethical.”[2] MCM research with children does not involve balancing competing principles; rather, joint consideration of all four is necessary to establish the highest ethical standards, ensuring all children are protected from both unethical research and the tragedy of attacks.

[1] The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1977). Research Involving Children (DHEW Publication OS 77-0004). Washington, DC: Department of Health, Education, and Welfare, p. 141. Retrieved from http://bioethics.georgetown.edu/pcbe/reports/past_commissions/Research_involving_children.pdf.

[2] Ibid, p. 136.

Posted in Medical Countermeasures

What Is “Minimal Risk” For Research with Children?

Written by Nicolle Strand on March 21, 2013 — Leave a Comment

Conducting clinical research with children is necessary to ensure that children are prescribed safe and effective medications.  However, children are legally prohibited and ethically unable to consent to clinical research.  As a result, clinical research with children requires more careful ethical analysis and oversight.

According to federal regulation, clinical research with children is generally acceptable if it involves only minimal risk, and satisfies certain other ethical criteria.  Research that subjects children to greater than minimal risk may only be approved under certain specified circumstances, such as when the research offers the prospect of direct benefit to the participant.

So the question is – how do we define minimal risk? 

Federal regulation of human subject research protections defines minimal risk as no greater than the degree or likelihood of harm a child would face during everyday life or during a routine physical or psychological exam. 

However, the regulations do not specify the circumstances of the child who serves as a comparator in the definition.  What kind of neighborhood does the child live in?  Does the child have a chronic health problem, like severe allergies, that requires frequent tests and exams?  It is easy to see how, depending on the circumstances of the child referred to in the regulation, the procedures that qualify as minimal risk could vary dramatically. 

Several national committees, including the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1977, the National Human Research Protections Advisory Committee in 2001, and the Secretary’s Advisory Committee on Human Research Protections in 2005, have added more specificity to the interpretation of “minimal risk.” 

According to these national commissions’ interpretation, minimal risk should be no greater than the risk a healthy child, living in a safe environment encounters daily or during a routine medical exam.  This interpretation brings more clarity to what qualifies as minimal risk.  The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) accepted this interpretation in its recent report, Safeguarding Children: Pediatric Medical Countermeasure Research.

Blood draws are generally considered minimal risk.  The most common side effect from a blood draw is pain from the needle stick; other effects are rare, and even the discomfort is short-lived and mild.  However, research that involves many blood draws over a short period, and might deplete blood volume, might be more than minimal risk.

Another way to determine whether a procedure is minimal risk is to assess what conditions might result.  For example, conditions such as redness or moderate soreness at an injection sight are minor and considered minimal risk.  However, fever or malaise that results in missed days of school is greater than minimal risk. 

Procedures that might have severe and lasting effects are not generally considered minimal risk.  Some examples include skin biopsies, bronchoscopies, and lumbar punctures.

The more specific definition of minimal risk can help to clarify federal human subject research protection regulations.  Using the refined consensus interpretation of minimal risk, established by several national committees and accepted by the Bioethics Commission, is central to reviewing and approving ethical pediatric research.

Posted in Medical Countermeasures

What are Medical Countermeasures?

Written by Olivia Nevitt on March 20, 2013 — Leave a Comment

The Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) recently published a report, Safeguarding Children: Pediatric Medical Countermeasure Research, addressing the ethical considerations in conducting clinical trials of medical countermeasures (MCMs) with children. The Bioethics Commission received its charge for this report from the U.S. Department of Health and Human Services Secretary, Kathleen Sebelius, whose offices is “responsible for developing and stockpiling safe and effective [MCMs] to protect the nation from bioterror attacks.”

What are MCMs?

In its report, the Bioethics Commission considered MCMs to encompass “U.S. Food and Drug Administration (FDA)-regulated products and interventions used to combat the effects of chemical, biological, radiological, or nuclear (CBRN) events,” one of several varied definitions of MCMs.  Because MCMs can include protections for and responses to many different types of events (e.g., disease, outbreaks, natural disasters, terrorist attacks), various government agencies, policy centers, and legislators have specified the term to reflect the focus of their work.

Some organizations define MCMs very broadly, encompassing a variety of causes of harm, including natural disasters and infectious disease outbreaks such as the 2009 H5N1 influenza virus and the SARS outbreak of 2003.  Others broaden the definition in terms of types of responses to harm.  The White House Office of Science and Technology Policy, for example, employs a broad definition of MCMs, which includes “both biologic and pharmaceutical medical countermeasures (e.g. vaccines, antimicrobials, and antibody preparations), non-pharmaceutical medical countermeasures (e.g. ventilators, devices, personal protective equipment such as face masks and gloves), and public health interventions (e.g. contact and transmission interventions, social distancing, and community shielding) to prevent and mitigate the health effects of biological agents,” some of which are FDA-regulated and some of which are not.

Alternatively, the definition can be narrowed, for example, by specifying the type of response used to prevent and mitigate harm (e.g., pharmaceuticals or public health strategies) or limiting the type of events that might cause the harm in question (e.g., natural events or acts of terrorism).  The Bioethics Commission employed its narrow definition in response to Secretary Sebelius’s charge. The Secretary tasked the Bioethics Commission with conducting “a thorough review of the ethical considerations of conducting clinical trials of medical countermeasures in children” including “the ethical considerations in conducting a pre- and post-event study of AVA PEP [anthrax vaccine absorbed post exposure prophylaxis] in children”—an MCM designed to respond to a terrorism attack. Moreover, Secretary Sebelius specifically referenced “bioterror attacks” in her charge.

The Bioethics Commission adopts a narrow definition for the purposes of this report. The Bioethics Commission’s guidance, however, might be applicable to a wider range of pediatric research.

Posted in Medical Countermeasures

Multiple steps must be taken before ethical pediatric anthrax vaccine trials can be considered

Written by Hillary Viers on March 19, 2013 — Leave a Comment

Today the Presidential Commission for the Study of Bioethical Issues concluded that the federal government would have to take multiple steps, including additional research in adults, before anthrax vaccine trials with children could be ethically considered by the U.S. government. 

In its report released today, Safeguarding Children: Pediatric Medical Countermeasure Research, the Bioethics Commission responded to a request from Health and Human Services Secretary Kathleen Sebelius.   Last year the Secretary asked the members to study the question of anthrax vaccine trials with children after receiving a recommendation from another federal committee that such research be initiated, pending ethical review.

Bioethics Commission Chair, Amy Gutmann, Ph.D., authored a Perspective about the report released today in the New England Journal of Medicine.  In the piece Gutmann concludes, “Sound science must always respect our ethical obligations to protect children from unnecessary risks. Medical countermeasure research warrants an ongoing national conversation to ensure an unwavering commitment to safeguard all children both from unacceptable risks in research and through research promoting their health and well-being.”

Read the Bioethics Commission’s report.

Read the Perspective in NEJM.

Posted in Human Subjects Protection, Medical Countermeasures
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