Ethics: July 2023 UPSC Current Affairs | Current Affairs & Hindu Analysis: Daily, Weekly & Monthly PDF Download

Controlled Human Infection Studies

Why in news?

Recently, Indian Council of Medical Research (ICMR) released a policy statement for the ethical conduct of Controlled Human Infection Studies (CHIS).

What is controlled human infection studies?

• It refers to the research methodology that involves intentionally exposing healthy human volunteers to a specific pathogen or infectious agent under controlled conditions.
• It is also called as human challenge studies in India which is different from human clinical trials.
• Aim- To understand disease pathophysiology & immune responses, develop vaccines, test treatment modalities and evaluate the safety and efficiency of potential new chemical entities.
  • Example: The yellow fever study in the early 1900s, for instance, established that mosquitoes transmitted the yellow fever virus.
• Types
  • Vaccine development trails
  • Treatment studies
  • Challenge studies

What are the benefits of CHIS?

• Better insights of disease: Conducting these studies in endemic settings can lead to outcomes relevant to the local population.
• Drugs in lesser time: Vaccine research uses data related to immune responses in early vaccine development and assess the minimum required dose for protection and immunization in shorter time frames.
• Better medical surveillance: Researchers can closely monitor the development and progression of an infectious disease from its earliest stages.
• Effective policy: CHIS can improve understanding of specific aspects of the transmission patterns this would contribute to the development of effective public health strategies and policies.
• Improve research capacity: Conducting CHIS can contribute towards building local research capacities, clinical facilities, laboratory diagnostics, experimental medicine and clinical governance on par with global initiatives.

What is the difference between human clinical trials and human challenge studies?

• Special safeguards- There has been a special safeguard in human challenge studies to prevent from SARS CoV 2 virus that causes COVID
  • To reduce harm to the participants, a weaker or less virulent form of the pathogen is used.
  • There should be a ‘rescue remedy’ to prevent the disease from progressing to its severe form.
    • Example: Remdesivir as rescue remedy for the participants in SARS-CoV-2 virus studies even when the substantial mortality benefit of remdesivir is unknown.

What are the guidelines in ICMR consensus policy statement?

• Allowed to participate- It is clearly mentioned that only healthy individuals in the 18-45 years age bracket are to be enrolled.
• Not allowed to participate-
  • Children and women who are pregnant, lactating or
  • Planning to conceive within the study period
  • Children will be included when “deemed appropriate”
  • Participants with pre-existing medical conditions.
• Medical Examination-A detailed medical examination of the participants is required before enrolment.
• Payment for participants- Information on payment should be mentioned in the consent form but the exact amount of payment for participation is to be revealed “only after the volunteer has consented to participate”.

What are the ethical issues with human challenge studies?

• Deliberate exposure: The human challenge trial are deliberately exposed to a disease-causing pathogen which makes it ethically more challenging.
• Payment issue: It is left to the investigators to not reveal the payment before the participant gives his or her informed consent.
• Assured payment even when the amount is not revealed may serve as an inducement.
• Need of effective rescue remedy: Infections like SARS-CoV-2 virus remains asymptomatic in some people while leading to death in others.
• The disease state in an individual cannot be 100% predicted even when a less infectious agent is used.
• Issue with informed consent: When the pathogen is studied in specific age groups such as children or disadvantaged groups.
  • Example: HPV vaccine trial in Andhra Pradesh in 2010, COVAXIN trial in Bhopal in 2020.

What lies ahead?

• Indian scientists should gain medical intervention expertise knowledge.
• There should be robust institutional structures and mechanisms in place to deal with the ethical challenges of human challenge studies.

Case Study 1

District Collector's Responsibility To Conduct Fair Elections

You are a District Collector of a city which is scheduled to go to polls in a week. The responsibility to conduct fair elections has been given to you. However, suddenly your mother suffers a heart attack and has to be admitted to a hospital in your home district, which is at a distance of 250 kms from the district of your posting. Doctor informs you that she needs to be shifted in Intensive Care Unit (ICU) and her chances of survival are bleak. You are the only child and want to be with her and your family at this moment. Your plea for an emergency leave has been rejected by the Election Commission. What would you do under such circumstances?
Solution: I have been presented with an ethical dilemma of choosing between personal and administrative responsibilities. Under the given circumstances, both of them demand my immediate personal attention. I will try to deal with the situation in the following manner:
I will visit my mother immediately after work and then try to come back the very same day. I will ask the doctor to keep me updated about my mother’s health. I shall communicate the same to my seniors in the government and request a medical attendant to my mother. Since the distance of the hospital is only 250 kms, I will try to pay a visit to my mother during the lean phases of electoral preparation by taking due permission from election commission. In my absence to ensure that the elections are conducted peacefully, I’ll take the following steps:
I will keep the election commission informed of my absence from city after office hours.
I will ensure that my subordinates and colleagues are aware of their duties and work so that even in my absence, polls preparation and execution does not suffer.
I will keep only selected colleagues informed of my absence from the city so that the general assumption keeps prevailing that the district collector is in the city.
I will always be in constant touch with all the concerned authorities and stakeholders.
While at work I will try to be in touch with my mother so as to make her feel comfortable. During the telephonic conversation will try to comfort her that she would be well soon and also assure her that after the elections I will spend more time with her. I will try to use technological tools like Skype for video chatting with her on Internet so that she feels better. I will also request the best doctors in the district to examine my mother’s case and ensure that she receives the best medical attention and care.

Case Study 2

Resident Welfare Association (RWA) vs Night Shelters For Labourers

You are the Station House Officer of a police station. Recently, there has been a spurt in theft incidents in your area. Some of these incidents have occurred even during daytime. The Resident Welfare Association (RWA) has blamed the labourers, residing in night shelters for the crimes.
The night shelters are the result of an initiative by the police to help the homeless people to seek refuge from the biting cold at night. You have taken great pain to get these night-shelters up and running. The record of all those who stay in these night shelters, for instance, their names and identity proofs, is with the police. But the police has no information if any one of them has a criminal record.
Even as an investigation regarding the thefts is going on, the RWA members are demanding that these night shelters be dismantled and the labourers be driven away from their homes.

• What are the options available to you?
• Evaluate each option and suggest the best course of action.

Solution: As the Station House Officer of a police station, which is also the custodian of the night shelter, the options available are:
(i) Dismantle the night shelters as per the demands of the Residents Welfare Association.
(ii) Persuade the members to wait for the investigation reports before taking any decisive action.
(iii) Provide additional security in the affected area to assuage their discontent.
(iv) Summon all the labourers and threaten them of eviction if they don't give the information they have of the thefts.
(v) Ignore the demands and continue with the investigation.
(vi) In the long run seek the cooperation of the welfare association to strengthen the security arrangement of the area and also suggest the local urban development office or municipality to install CCTV cameras.
Option (i) would provide immediate relief, but in absence of any conclusive evidence it will be injustice to the displaced. Also the entire community cannot be punished for the wrongs of a few (even if it is later proved that some of shelter inmates are involved).
Option (ii) is difficult to achieve in view of the opposition, but it is desirable and also legal.
Option (iii) is not legal, but permissible if any link exists of the involvement of some of the labourers in the recent theft. However, the threat should be exercised only on prime suspect and must be limited to investigation.
Option (iv) is legally correct but morally wrong for a Station House Officer, one's responsibility is also to address the genuine concerns of residents and keep the credibility of police intact.
Option (v) is applicable in the long run once the case is solved.
Since no conclusive evidence is available against the labourers, no legal action can be taken against them. One should begin an investigation immediately and till then take recourse to option (ii) i.e. talking with the association members and providing additional security to them. Once the case is solved the long run measures will be implemented.