Informed Consent and Medical

¶ … statistics have on shaping healthcare policy and guiding evidence-based practice, it is critical that researchers understand how to present the results of their studies. It is also critical that healthcare workers develop strong skills in statistical literacy, so that the results of studies are not misconstrued. Not all research results are generalizable to a population outside of the sample. Even the most carefully constructed research designs need to be critically analyzed. Similarly, care must be taken when communicating statistical results to a general audience.

The American Statistical Association (1999) outlines eight main areas of ethical concern. Those areas of concern include the following:

• Professionalism

• Responsibilities to employers or funders

• Responsibilities in testimony or publications

• Responsibilities to research subjects

• Responsibilities to research team colleagues

• Responsibilities to other statisticians

• Responsibilities regarding allegations of misconduct

• Responsibilities of employers or clients to the integrity of research

In the healthcare setting, each of these ethical duties is relevant, but it is the latter that may be most relevant to daily work for practitioners who read, gather, disseminate, discuss, and interpret research findings and often implement those findings into evidence-based practice. It is therefore critical that statisticians be aware of the impact their work has on public health.

Statisticians are supportive of creating the "evidence-based society" and evidence-based organizational culture in healthcare (p. 5). However, statisticians are also in the unique position of having to offer warnings to healthcare practitioners, administrators, and pharmacists eager to deliver new products and services to the patient population. Statisticians deal with uncertainties and probabilities, whereas non-statisticians, even within the medical science arena, seek clear-cut, black-and-white answers.

When it comes to actual research methods and design, the role of statisticians is more immediately apparent. For example, statisticians have an ethical responsibility to honestly and objectively interpret raw data, regardless of the substantive content of a research hypothesis. A statistician with access to participant personal information has an ethical responsibility to preserve and safeguard privacy and confidentiality. The issues all researchers face when conducting experiments including informed consent, remain salient. Ascribing to statistical ethics generally promotes integrity, validity, and reliability in medical research overall.

The ethics of professionalism, responsibilities to employers, and the ethical responsibilities to research team colleagues require that statisticians and researchers ascribe to best practices in research design. Statisticians need to disclose the precise methods of data analysis used, including the software they use, and what data that needed to be excluded from the study and why. Research design should reflect the best interests of providing accurate results, not necessarily according to the desires and preferences of funders. Specific types of research designs and methodologies present unique ethical considerations. For example, cluster randomized trials have become increasingly common in healthcare and particularly in public health research. Cluster randomized trials help determine clustered effects of an intervention such as a vaccine.

The ethic of responsibility to research participants, as outlined by the ASA (1999) includes issues related to informed consent. Informed consent is different in cluster randomized trials versus other research designs. There are two basic types of cluster randomized trials: cluster-cluster, where the entire cluster is being measured, and individual cluster trials, where the individual participants are being measured. The type of design will vary depending on the research question and hypotheses. Informed consent protocol may differ depending on which of these cluster randomized trial methods is used. Of course, this simplistic classification ignores the plethora of other types of cluster randomized trials but general rules of thumb for informed consent create common sense guidelines for statisticians.

Regardless of type of cluster randomized trial, the primary areas of ethical concern include units of randomization, units of intervention, and units of observation ("Medical Ethics and Statistics," n.d.). Units of randomization imply different types or levels of consent. Individual consent alone may not be enough. Consent might need to be gleaned from community organizations and other group stakeholders like families or professional organizations. Care must be taken when presuming a leader of any organization speaks on behalf of the entire group or community, as this is not always the case. However, the use of proxies or gatekeepers will be inevitable in cluster randomized trials due to the complex nature of their design and the method of intervention administration. Consent must also be acquired at all levels of the trial, such as when an intervention is first administered and then when data is being collected. When cluster randomized trials are carried out in developing countries with problematic political institutions and inadequate legal or institutional safeguards to protect individuals, statisticians have a greater responsibility to ensure social justice. This is why consent must be gathered at multiple levels and at multiple stages in an intervention, as well as consulting with local officials ("Medical Ethics and Statistics," n.d.). Opting out of a trial presents its own unique ethical considerations, because a researcher cannot persuade a person to participate without appearing coercive.

Medical statistics ethical considerations extend throughout the world, raising important social justice and human rights concerns (Aynsley-Green, et al., 2012). When a funding organization seeks confirmation for a treatment intervention, it risks systematically excluding large numbers of people from receiving a potentially beneficial intervention. Alternatively, informed consent can be distorted as when potential participants overestimate instead of underestimate the risks of participation in a trial and lack access to appropriate information. Statisticians operating under the guidance of professional organizational codes of ethics like that of the ASA (1999) will understand their primary obligations are to their professional standards, to their colleagues, and their employers.

Cluster randomized trials sometimes threaten to undermine ethical responsibilities to research participants, as when an intervention is an airborne element affecting an entire community, or when a treatment intervention is available and desired but not being offered to non-participants. The latter scenario is politically problematic, given the potential for a treatment intervention to help people with terminal illnesses. Although the ASA (1999) does not mention social justice as an ethical responsibility of statisticians, social justice ethics are implied when well-endowed countries possessing rich medical services resources conduct experimental medicine trials on communities in developing countries. The recipient communities will frequently have large portions of the population suffering from diseases like HIV / AIDS, who do not wish to receive placebos in the trials. Yet without a control group, the research designs might suffer, causing an ethical conflict between the social justice responsibility to research participants and the responsibility to the professional duties of statisticians. Utilitarian excuses for the use of placebo controls need to be mitigated by commitments to redistributive justice ("Medical Ethics and Statistics," n.d.). Also, statisticians have a duty to promote ethical standards and professionalism in research; they are not singularly responsible for the root causes of social injustice. It is not right to sacrifice the integrity of research in the interests of appeasing public outcry.