Are Indian medical research systems prepared?

In 2022, I encountered three situations where my research expertise was challenged.

1.??????During routine medical care, a transgender person was identified as potentially eligible for a clinical trial. However, the study eligibility criteria stated male or female of 18 years or more. This led to confusion amongst the stakeholders, and the person was no longer interested when a consensus could be reached.

2.??????A researcher approached me for their social sciences research to assess access to gender-reaffirming medical care for teenage trans persons. I reached out to a few mental health practitioners but was met with silence.

3.??????In a Good Clinical Practices training session, a query was raised on the inclusion of transgender persons in Ethics Committees/ Institutional review boards. (EC/IRB). Current Indian regulations require gender representation in EC/IRB.

These instances made me ponder the involvement of transgender individuals in research and on the broader topic of research on health issues facing the transgender community. The transgender community is socially, culturally, and economically marginalized. They face umpteen challenges even for their basic life needs. When it comes to medical care, from my current understanding, the transgender community faces two significant challenges-

1.??????Access to health care is limited or difficult for a large proportion of the community members.

2.??????Resources and understanding of transgender medical issues and concerns are limited within the medical/healthcare professionals.

Hence, in the sphere of medical/clinical research, the question arises,

• Should research become another area where trans persons are denied access because of ignorance and prejudice?
• How to protect transgender participants from potential exploitation in research?

As a researcher or healthcare provider, one should remember-

a)??????Many health issues are specific to transgender people that require study to support evidence-based medical practice.

b)?????Transgender persons also face health issues like the binary male-female population. Principles of medical management for the general population cannot be blindly applied to them.

Like all research, a balancing act must be done between risks and benefits. However, in the case of transgender persons' involvement in research, a more careful and sensitive approach is needed. The transgender community should not be denied the benefits of research. (better understanding of their health issues, access to the latest medical innovations). At the same time, additional risks due to their vulnerability should be factored into research systems and processes.

A paper published in 2017 outlined nine principles to consider for Transgender Health Research.

(1) Whenever possible, research should be grounded, from inception to dissemination, in a meaningful collaboration with community stakeholders;

(2) language and framing of transgender health research should be non-stigmatizing;

(3) research should be disseminated back to the community;

?(4) the diversity of the transgender and gender diverse (TGGD) community should be accurately reflected and sensitively reflected;

(5) informed consent must be meaningful, without coercion or undue influence;

(6) the protection of participant confidentiality should be paramount;

(7) alternative consent procedures should be considered for TGGD minors;

(8) research should align with current professional standards that refute conversion, reorientation, or reparative therapy; and

(9) IRBs should guard against the temptation to avoid, limit, or delay research on this subject.

Current GCP and research guidelines (E.g., ICMR, 2017, India) have guidance for vulnerable populations. (not specific to the transgender community)

1.??????Every EC/IRB in India has a social worker representative to review research studies for risk to vulnerable populations.

2.??????EC/IRB can call for experts/ NGO members from vulnerable communities to provide expert advice on any research project involving vulnerable populations.

3.??????EC/IRB can enforce special consent provisions for vulnerable participants. These may include but are not limited to-

a.??????Have a representative from the transgender community be an impartial witness to the consent process.

b.??????Have the social worker of the EC/IRB witness the consent process.

c.??????Audio recording of the consent process. (Video recording only if the person is comfortable and agreeable)

These guidelines provide a basic framework for how to process research applications. However, due to factors pointed out earlier, research involving transgender persons needs a higher level of diligence.

What does EC/IRB need to consider while reviewing studies involving transgender people or individual transgender participants?

1. Is the research aligned with current medical practice guidelines for transgender health? E.g., WPATH Guidelines (World Professional Association for Transgender Health)
2. What type of consultation was held with the transgender community while developing the study protocol and procedures?
3. Have the participant-facing documents like consent or questionnaires been reviewed by members/ stakeholders from the community for language and sensitivity?
4. If the research is on minors (<18 yrs) or dependents, what procedures need to be in place to protect the individuals if they have not informed their gender identity to their family/caregivers?
5. Consider if there are additional vulnerabilities involved. E.g., lack of access to healthcare, health provider-participant relationship.
6. How will the information on gender identity be collected? This includes the terminology used in the context of the vernacular and local social practices.
7. Perform a careful review of patient-reported outcome instruments validated in the general population for questions that may be affected by gender identity.
8. What mechanisms are in place to refer for appropriate care or provide support to transgender individuals who may be diagnosed with health conditions or face social challenges during research? E.g., suicidal ideation, lack of housing and shelter.
9. What procedures are in place to protect participant privacy and confidentiality? Extra sensitivity and precaution are needed.
10. Consider the remuneration to be paid for participation. Many in the transgender community are not gainfully employed. A balance between compensation for their time and the potential for inducement has to be achieved.

11.??What mechanisms are in place to consult and inform community members on the research progress and results? Managing and mitigating any misuse or harm that may occur due to the interpretation/misinterpretation of study results is essential.

Before the EC/IRB reviews research proposals, the researcher, investigator, and study sponsor must ensure that the rights, safety, and well-being of the transgender person and community are protected.

What can researchers and study sponsors do?

1.??????Educate themselves on the appropriate language to be used when caring or undertaking research for transgender individuals, starting from their pronouns.

2.??????Educate themselves on the health issues and socio-cultural-economic intersectionality of marginalization in the transgender community.

3.??????Make efforts to engage and inform the transgender community and stakeholders involved with the community about medical/clinical research. This is essential as the community may have a higher level of apprehension because of socio-cultural legacies and practices.

4.??????For research involving issues specific to the transgender community, involve stakeholders and representatives from the community while developing study protocols, documents, and procedures.

5.??????Include gender-sensitive language in the eligibility criteria of study protocols.

6.??????Make provision for an option beyond Male and Female in study data collection forms.

7.??????Before screening any transgender person, consult the EC/IRB for guidance on consent procedures. (if not done at the time of the initial EC/IRB review of the research project)

8.??????Study sponsors should have policies to address situations where transgender persons are included in studies. These should be made in consultation with transgender community stakeholders and ethicists.

These are some markers I have placed for myself for any future research involving the transgender community. Have you or your organization ever been involved in research with transgender individuals? What were some of your challenges? What are some best practices for anyone planning to do such research?

If you are interested, I have included below a list of resources you may refer to.

1.??????Questions to ask when developing research studies for the transgender community.

a)??????CPATH Ethical Guidelines for Research Involving Transgender People & Communities. Canada: Canadian Professional Association for Transgender Health. Bauer, G., Devor, A., Heinz, m., Marshall, Z., Pullen Sansfa?on, A., Pyne, J, for the CPATH Research Committee. (2019). https://cpath.ca/wp-content/uploads/2019/08/CPATH-Ethical-Guidelines-EN.pdf

b)?????Correspondence; Brian Minalga et al; The Lancet; Volume 399, Issue 10325, P628, FEB 12, 2022 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02806-3/fulltext

2.??????Principles to apply for research with the transgender community.

Henrickson, M.; Giwa, S.; Hafford-Letchfield, T.; Cocker, C.; Mulé, N.J.; Schaub, J.; Baril, A. Research Ethics with Gender and Sexually Diverse Persons. Int. J. Environ. Res. Public Health 2020, 17, 6615. https://doi.org/10.3390/ijerph17186615

3.??????Considerations for IRB/EC.

Guidance and Ethical Considerations for Undertaking Transgender Health Research and Institutional Review Boards Adjudicating this Research. Noah Adams, Ruth Pearce, Jaimie Veale, Asa Radix, Danielle Castro, Amrita Sarkar, and Kai Cheng Thom, Transgender Health 2017 2:1, 165-175 https://www.liebertpub.com/doi/10.1089/trgh.2017.0012

4.??????WPATH standards of care for the health of transgender and gender diverse people- https://www.wpath.org/publications/soc

5.??????Consultation for Transgender health in India- https://www.athionline.com/