Sex Workers as Vulnerable Subjects in Research

 TUSKEGEE AND GUATAMALA

November 16^th 1972 saw the hurried end and closure in Macon County, Alabama of a syphilis research program more famously known as The Tuskegee Experiment. Researchers had intentionally not treated 600 participants who had syphilis despite the fact that penicillin had been discovered as a cure and was available, withheld information about penicillin and prevented them from accessing syphilis treatments available for the purpose of monitoring and documenting the progression of syphilis in human subjects, all under the guise that they were receiving free health care from the national government. The experiments went on for 40 years before a leak to the media eventually caused its demise. This may be arguably the most infamous biomedical experiment in US history.

While researching the Tuskegee Experiment in 2005, Professor Susan Mokotoff found documents detailing yet another heinous experiment cloaked as research known as the Guatamala experiment. While the Tuskegee experiment followed and documented the progression of syphilis in the infected, this experiment involved intentionally infecting unknowing subjects with syphilis to test the effect of penicillin in curing syphilis. The records were incomplete but extrapolated data suggests that complete treatments were administered to only about 26% of the 1500 study subjects. Dr. John Cutler was involved in both these studies. The researchers paid prostitutes infected with syphilis to have sex with prisoners and some prison guards and some were directly injected with injections with the prisoners led to believe that it was medicine. The study appears to have ended in 1948 partly due to rumours of the experiment going round medical circle and the cost and scarcity of penicillin during the Second World War.

This was a dark era in medical research.

Both these experiments took advantage of vulnerable subjects for the ‘greater good of medical research and I took particular interest to sex workers as vulnerable subjects in research as shown by these two experiments, their vulnerability and the ethical considerations that should be taken when conducting research on sex workers.

VULNERABILITY

What is vulnerability and what constitutes vulnerability in subjects (commercial sex workers)?

It is a distinctive precariousness in the condition of the subject: a state of being laid open or especially exposed to something injurious or otherwise undesirable. A vulnerability is, so to speak, an avenue of attack and in this context, an avenue of attack through poorly thought out, planned or malicious research.

Kenneth Kipnis of the University of Hawaii seperates vulnerability into six general classes under which everything else would fall:

Cognitive: Does the subject have the capacity to deliberate about and decide whether or not to participate in the study? Capacity here can take many forms. There have been cases of commercial sex workers signing consent forms though they are illiterate or semi-illiterate  thus have no idea what they are consenting to. There are also those that are educated but not enough to understand the research, the risks and the benefits and so though literacy would be an advantage, he is still not fully capable of grasping the research concept.

Juridic: Is the subject liable to the authority of others who may have an independent interest in that participation? The authority in this case could be the sex worker’s madams, who would have a potential monetary benefit from the allowances given to the sex workers. The authority could also come with parental authorities or guardians for commercial sex workers who still live at home or are under the influence of their guardians.

Deferential: Is the subject given to patterns of deferential behavior that may mask an underlying unwillingness to participate? Deference to authority may not be an openly visible cultural diversification trait but in some communities for example, directness is looked down upon so the subject will not decline directly. There are communities that women see men as figures of authority to be obeyed and even out of their cultural context, still remain as they are and thus would never outrightly reveal their hesitance or unwillingness to participate.

Medical: Has the subject been selected, in part, because he or she has a serious health-related condition for which there are no satisfactory remedies? An example is the research team studying commercial sex workers’ immunity to HIV through possession of ‘T-Cells.’ They concluded that they could not use less vulnerable subjects to carry out the same research after looking at the alternatives as some of the subjects were infected with HIV which has no known cure.

Allocational: Is the subject seriously lacking in important social goods that will be provided as a consequence of his or her participation in research? Poverty makes people particularly vulnerable. Desperation caused by poverty could possibly make participants sign off without asking too many questions or sign off on research that they know will most probably harm them because they don’t feel like they have anything to lose.

Infrastructural: Does the political, organizational, economic, and social context of the research setting possess the integrity and resources needed to manage the study? Studies carried out on commercial sex workers operate within a context. Sex workers are in a particularly sensitive position seeing as the oldest trade in the world is also illegal. Sex workers face a hydra-headed composition of adversities in their day to day lives and thus the study needs to be socially and culturally welcoming and stable. Studies that are poorly funded and which are not well supervised or held responsible tend to be, by history, a disiaster in the making.

ETHICAL CONSIDERATIONS IN RESEARCH ON COMMERCIAL SEX WORKERS

 Sex workers are a highly researched community who have rarely been afforded the level of engagement or involvement in research necessary to ensure data collection and interpretation can be successful. Data integrity and the correct interpretation of data benefit substantially from the effective engagement of communities in the research process (Fawkes 2005b: 94).

Some common problems in research involving sex workers include:

     Misinterpretation or misuse of research data by the media, policy makers or the government which might lead to negative publicity for the sex workers or laws detrimental to their existence which would be an unintended effect of research.

   

     Some researchers with the likes of Mary Sullivan and Dr. Sheila Jeffereys may skew their research or structure it in such as a way as to support the criminalization and penalization of sex work which would punish the sex workers and make them more vulnerable than they already were.

     

     Inadequate funding and resources which are discovered only after research has started and thus they are unable to effectively carry out their research to completion and thus no benefits are acquired

Based on these problems and others faced, there are ethical considerations that should be taken when carrying out research to ensure the protection of the commercial sex workers from exploitation:

Benefits

This is perhaps the most visible and spoken of ethical factor that stands out when performing research. UNESCO’s Declaration on Bioethics and Human Rights notes that “Benefits should not constitute improper inducements to participate in research.”67 The Kenyan Guidelines on HIV vaccines research explicitly recognise this problem (paragraph 7.3) and clearly state that “monetary benefit could be an inducement for participation in a trial and thus would negate free consent.” Poverty can be a great factor in inhibiting voluntary consent. It has long been agreed that a reasonable monetary benefit is not payment for or an inducement to research but acts as compensation for the time, effort and comfort that the participant sacrifices to participate in research. On recognizing this comes the challenge of determining what the benefits will be, who can meaningfully share in the benefits, what motivates participants to take part in research and do monetary benefits play a role in their motivation and if so to what extent. Sex workers in Kenya and in other developing countries, are primarily in that position because of poverty or other extenuating circumstances and thus if their primary motivation is money, research on them would be unethical as they would be unable to make an  objective decision on their participation in research.

Legal environment and requirements

Researchers and the research sponsors should comply with the relevant national and international laws and regulation regarding research and if possible, specifically regarding HIV-AIDS research. Research involving human subjects is bound by the Declaration of Helsinki,28 and the CIOMS Guidelines.29 These do not have independent legal standing, but comprehensively touch on medical ethics, influencing the formulation of international, regional and national legislation.

UNESCO has issued a variety of Declarations relating to bioethics and human rights, which seem to be written with particular concern to developing countries where a lot of medical research has moved to because of less stringent research regulations. They provide guidelines in the formulation of relevant policies. The Human Genome Organisation (HUGO) Ethics Committee acknowledges benefit sharing as a research principle and apart from promoting benefits to the participating community, they also propose that benefits should not be limited to the communities that participated in the research. Kenya has also developed National Guidelines for Research and Development of HIV/AIDS Vaccines to provide a framework for evaluating and developing HIV/AIDS vaccines in the country.  The Guidelines provide a collaborative blueprint that enables government and non-governmental organizations to participate in research and development of the HIV vaccine.

 Ethical review approval and process

Ethical Review Boards (ERB) are necessary to ensure supervision of research to ensure that it is carried out within the set out bounds. The committees carry out approval of planned research, can review the research as it is going on and can intervene if ethical regulations are being flouted. For organizations carrying out international research, international guidelines dictate that approval should be sought from the ERB in the country where the researcher is based and the country where the research is going to take place. The ERB’S must clearly be identified by the researchers in their documentation and if approval will not be given by both boards then a satisfactory reason must be provided.

Informed consent / assent

Emerging economies have started to acknowledge the particular vulnerability that their citizens have due to their current economic or cultural position and thus have developed standards against which consent can be held to be valid or invalid. Standard procedures may be slightly modified to meet the social and cultural variations in the community but informed consent must be strictly adhered to in all this. The sex worker individual should not be put at risk by the requirements and should not face coercion into participation with the fear of detrimental consequences if they do not participate. The principles of informed consent- autonomy, justice and beneficience should be documented in written form and followed without exception for accountability. In the case of commercial sex workers, it should be clearly acknowledged and outlined that they are a vulnerable population and the necessary steps taken to ensure adherence to the principles of informed consent e.g. interviewing them to ascertain their motivation for participation in the research process. The potential benefits should be presented in a balanced and objective manner. The sex workers should be made aware of the actual and potential risks that they face, whether short-term or long-term. If the inducements/rewards/ benefits e.g. money or free healthcare  pose a challenge to obtaining informed consent then alternative avenues should be pursued. The sex workers should also be provided with alternatives in case they don’t want to participate in the research e.g. other research programs or other treatments that they could pursue.

Data protection

Data protection and privacy must be ensured, in compliance with national and international legislation. The research involves the use of sensitive data (personal and genetic) that deals with health, sexual lifestyle and partners, personal beliefs and thus the commercial sex workers need to be assured that their data will be confidential and handled in a professional manner that upholds their dignity and the law. The research must clearly outline who will hold the data, for how long the data will be held, how the data will be used, how it will be handled, stored and protected. The outlined uses must be strictly followed. The ownership of the samples and the genetic material obtained must be clearly outlined too. Material Transfer Agreements or Memoranda of Understanding exist in cases where data or genetic material will be carried across borders ensuring that the protection of the sex worker’s data is protected both locally and in the country where the data/ genetic material is transferred to.

Participation

Modern development communication theory which is also transferrable to research theory and practices has moved to the participatory model which takes subjects as active participants in solving their own problems and takes them on as equals. This has not pervasively taken place in research in developing countries, partly because of ignorance on the sex worker’s part and rigidness of current research methods but research is slowly moving in this direction for better results. Their opinion should be sought and all sex workers should be equally represented. The exclusion of certain groups from research can have dire long lasting effects on the research groups. The main issue when this happens is not maliciousness but in falsely assuming the homogeneity in research sample groups. Assuming that a certain segment will accurately represent the other sex workers as certain factors e.g. whether they are rural or urban, traditional or modern e.t.c create visible distinctions in their circumstances and even in the medical significance of data. The researchers may be unfamiliar with the community or for their own ease chose the most convenient subjects i.e. those located in urban areas, those who can speak English, those who already have ties to the NGO that the researcher is working with. When research is carried out to fit the limited budget allocation then methods like these may be employed to cut corners and the groups made invisible by the research may be devastatingly affected in policies and development programs.

Commercial sex work is an ethical discussion that reverberates internationally but the recognition of sex work as an occupation would help researchers carry out research in an ethical and responsible manner. The Hippocratic Oath would also help when facing conundrums- Do No Harm seems to succinctly sum up how to run biomedical research.