1Day Sooner supports developing human challenge studies (or controlled human infection studies, CHIS) in nations where target diseases, like malaria, tuberculosis, or various diarrheal diseases, are endemic. This includes India, where CHIS have never before been conducted. We believe that CHIS there can be run safely and ethically, and are excited to see the release of the draft ICMR Consensus Policy Statement for the Ethical Conduct of Controlled Human Infection Studies (CHIS) in India.
While 1Day disagrees on a few specifics of the Statement, some of which are outlined below, we are nevertheless supportive of the ICMR Consensus Policy Statement as a whole and laud the effort the ICMR Bioethics Unit to devise it.
In response to ICMR’s public consultation request (which can be found here), 1Day Sooner submitted the following comments on the Statement on 1 August 2023 under the names of communications director Jake Eberts and advisory board member Dr. Sayantan Banerjee.
We are cognizant of the fact that our organization is primarily composed of staff from developing countries, and that each country, including India, has particular circumstance, histories, and challenges that must be accounted for. Our commentary below is focused narrowly on the experience, autonomy, and altruism of prospective volunteers, a core area of our mission as an organization.
Comments on the ICMR Statement
The contribution of all stakeholders involved in CHIS must be acknowledged and respected. (Page 7, Line 192)
Comment: 1Day Sooner believes it is important to highlight the indispensable role the volunteers play in any study, especially CHIS, and that volunteers themselves are also stakeholders in the research process, not mere passive participants.
Suggested change: Add “particularly volunteers.” Thus: “The contribution of all stakeholders involved in CHIS must be acknowledged and respected, particularly volunteers.”
To minimize harm, the study should be conducted for self-limiting infections and/or those which can be resolved with known medications and treatment protocols. (Page 9, lines 228–29 of the draft Statement)
Comment: We believe the protection of volunteers is important; equally as important is respect of volunteer altruism. 1Day Sooner received signups from over 1,400 Indians during 2020 and 2021, each expressing a willingness to potentially sign up for COVID-19 CHIS if they were useful to help accelerate the fight against the disease.
While ultimately not strictly necessary for the development of initial COVID-19 vaccines, we cannot discount the possibility of future pandemics that may benefit from a more unorthodox use of CHIS. Altruistic volunteers who are willing to take on higher risks for the greater good, in such circumstances, should be welcomed.
Suggested change: Add the following: “Exceptional circumstances, such as emerging pandemics, may warrant the careful use of CHIS for diseases that carry a higher degree of risks for volunteers.”
The researcher must evaluate the true nature of altruistic motives to participate and select only altruistic participants that meet the selection criteria of the study. (12, 342–43)
Comment: We believe that this criterion as currently written is not ideal for three reasons:
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The current wording may encourage researchers to exclude any volunteer they suspect of participating out of a desire for compensation, even if that is only a part of the volunteer’s motivation for joining a study. Altruism and a desire for compensation are not mutually exclusive. A charity worker can be considered someone who chose an altruistic career, but he or she is not un-altruistic for desiring fair pay as well.
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Assessing altruism is difficult, and it is easy for participants to lie about their motives. Over time, people may learn that CHIS requires “altruism” and alter their responses to researcher inquiries accordingly. Even if people are not aware of this requirement, they may still lie, for example, because of embarrassment to admit they need the money. We believe that the requirement as currently written might encourage misrepresentation and dishonesty by potential participants from the outset. Afraid of appearing too selfish, a participant might even be hesitant to ask legitimate questions about their own safety and the course of illness for a given study.
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Provided the volunteer is still able to properly consent to the study, understands the risks, and can abide by its requirements, it is not necessarily unethical if a major motive is compensation.
Suggested change: Strike these lines and replace with: “The researcher, whenever possible, should prefer to include participants who are at least in part motivated by a sense of altruism.”
The exact amount of payment for participation must be revealed only after the volunteer has consented to participate. Investigator should strive to reveal the payment only after the participant consents. (12, 352–54)
We understand the desire to avoid undue inducement, but we do not believe concealment of compensation information is advisable for two reasons:
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There is no way to prevent participants from discussing compensation with friends, family, or on social media; rumors and inaccurate information may easily arise. People may sign up for screening with mistaken beliefs that payment is higher than reality and thus agree in the informed consent process but then back out, or it could lead people to refuse to sign up for screening altogether after hearing a inaccurate, lower figure.
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We believe compensation information forms an important part of the informed consent process. For example, imagine a successful, self-employed computer programmer who wishes to join a study both to supplement her income and to help advance modern medicine. She knows she likely will not be able to work as many hours as she normally would because of the study, and estimates this lost work could be worth ₹1 lakh. To make a truly informed decision, she must know before she agrees if it will cause her financial loss. Thus, she has a right to know the amount of compensation before fully agreeing to the study.
Suggested change: Strike/remove these lines.
Regarding Section 7 of the Statement (“Advocacy, Public Engagement and Public Trust”):
We are strongly supportive of the recommendations made in this section. As an organization dedicated to elevating the voices of healthy medical volunteers, we believe it is both ethically imperative and strategically useful to make sure volunteers (or prospective volunteers) are included in public discussion and media coverage.
Regarding Annexure 2 (Informed Consent):
We believe that while it may be most productive to target recruitment among volunteers “from middle and upper socio-economic strata of the society,” we also believe that if there is a potential volunteer from the lower socioeconomic class who meets all other criteria — literacy, full understanding of the study and its risks, at least some altruistic motivation, etc. — he or she should not necessarily be excluded from participation based solely on their socioeconomic standing.