BIRAC: Indo-US Clinical Research Ethics Fellowship Program (India)

The present RFP for fellowship aims towards building a critical mass of trained scholars who will contribute actively to the international literature on clinical research ethics, and who will be able to advice clinical researchers, administrators and policy makers in India on emerging issues.

The Indo-US Clinical Research Ethics Fellowship Program has been jointly conceptualized by the Department of Bioethics, National Institutes of Health (NIH) and the Department of Biotechnology, GoI. The program has been designed to create leaders in the field of bioethics in India with the aim to specifically focus on capacity building in the area of clinical research ethics. After their training, and completion of the fellowship project, the fellows are expected to work towards capacity building in the area of clinical research ethics in India and establishment of centres of excellence in bioethics within research institutions. These centres of excellence are expected to serve as resource for research, training, guidance, and policy development, related to the ethics of clinical research in India.

Scope

• The program will support research projects in the field of clinical research ethics including, but not limited to, ethical aspects of:
  • Vaccine research and clinical trials
  • Research participant recruitment in clinical research
  • Informed consent for clinical research
  • Research with stored biological specimens
  • Return of unanticipated research results
  • Research on novel technologies such as stem cells, CAR-T treatment, and gene therapy
  • Controlled human infection models

• Research with specific vulnerable populations in interventional studies
• Research in new age technologies Artificial Intelligence/ Machine Learning (AI/ML), Data Sciences, Genomics) as applied in clinical Research.

Benefits

• The grant carries a fellowship honorarium of Rs.2.00 lakh per annum for candidates who have a permanent position in the host institute or are not availing any monthly fellowship; and of Rs.85000/- per month for temporary/contractual/adhoc position candidate hereinafter referred to as Fellowship Grant.
• Project Duration & Number Of Fellows:The projects will be supported for a period of 3 years (starting from signing of Agreement) extendable further based on performance review/evaluation of the project done by respective committee at BIRAC. The duration of the Fellowship will be for a period of up to three years. The number of fellows selected is subject to merit of the applications received and availability of joint funding.

Eligibility Criteria

• Any interested professional having the following eligibility can apply with the endorsement letter in the desired format from the Host Institute. Selection of the Host Institute shall be subject to qualifying the eligibility criteria provided.
• Fellow Applicant
• The applicant should be an Indian citizen.
• The upper age limit for this fellowship is 45 years at the time of the submission of application, age will be calculated by taking the date of closure of the call.
• This RFP will consider applications from the following three groups:
  • MBBS/BDS/Bachelors in Traditional Systems of Medicine /Masters level training in Nursing/Paramedical Disciplines or Masters in Life sciences/Pharmaceutical sciences/Social Sciences/Ethics/Health Law with two years of experience and demonstrated interest in ethics and/or regulatory aspects of clinical research
  • Clinician scientists with experience or training in ethics, working in institutions engaged in research who demonstrate an intent to take the learning from the fellowship forward for wider dissemination (preferably regionally or nationally).
  • M.D./M.S./M.D.S./PG Degree in Traditional Systems of Medicine (hereinafter to be referred as “M.D./M.S.” only)/ Ph.D. in Health Sciences/Life sciences/Pharmaceutical sciences/Social Sciences/Health Law or equivalent degree related to health from a recognized university in India. In case of Ph.D., the PhD thesis should be relevant for clinical research ethics.
• Note:
  • Those who have submitted their Ph.D. thesis and are awaiting award of degree are also eligible to apply, but their selection will be subject to the condition that they would have submitted thesis before the expiry of the validity of the award offer.
  • Those who are appearing in the final examinations of their M.D./M.S./M.D.S./ PG Degree (MD/MS) in Traditional Systems of Medicine and are waiting for their final result are also eligible to apply, but their selection will be subject to the condition that they should have their final result before the expiry of the validity of the award offer issued in this regard by BIRAC.
  • The fellows will NOT be allowed to work with their guide/co-guide and in the same department/institute from where they have earned their Ph.D./M.D./M.S./M.D.S. degree. The award will provide both a fellowship and a research grant.
  • Preference will be given to applicants who hold a permanent/tenured position in any Institution/University recognized in India complying with the eligibility.
  • It is desirable that the applicant should have an excellent track record (i.e., a track of peer reviewed publication or clinical research projects.
  • Applicant cannot have more than one fellowship at a given point of time.
  • Applicant should have a valid passport before execution of the “Award Letter” and be eligible for an appropriate U.S. visa.
• Host Institute:
  • Recognized Universities/ Institutes established under statutes/ Academic Research Institutes/ Research Foundation/ Medical, Dental or Traditional Medicine Colleges established as a legal entity under the relevant Laws of India having at least 51% Indian stakeholders (owners/partners/trustees/members/associates etc.) are eligible as a Host Institute (each one shall hereinafter be referred to as “Host Institute”). The Host Institute could be Public (Central/State)/Private, registered under or as a Trust, Society, Non-profit Organization or Corporations.
  • The Host Institute should have a department or active project-based engagement in Life Sciences or health related streams (Biotechnology/Biosciences/ Agriculture/ Horticulture/ Food technology streams/ Medical sciences/ Dental sciences/ Indian Systems of Medicine/ Law etc.) for technical support and expertise in bioethics field such as, but not limited to ethics, law, sociology, and public health.
  • The Host Institute should be at least 3 years or older.
  • Presence of supportive clinical trial infrastructure facilities, and a history of (clinical) research projects is a must.
  • It is desirous for the Host Institute to have Network of experts, collaborators who can provide technical/business mentorship to fellows.
  • Intent to provide a faculty post and /or set up a department focused on clinical research ethics.
  • The Host Institute should endorse a commitment of a minimum 40% of the time for 7 tenured candidates of institute i.e., the fellows and 100% of the time for adhoc/temporary/contractual candidate towards the fellowship.
  • Availability of IP, regulatory, business support to the fellows.

For more information, visit BIRAC.