BIRAC Indo-US Clinical Research Ethics Fellowship Announced - Applications Invited

BIRAC Indo-US Clinical Research Ethics Fellowship Announced

The Indo-US Clinical Research Ethics Fellowship Program has been jointly conceptualized by
Department of Bioethics, National Institutes of Health (NIH) and Department of Biotechnology, GoI. The program has been designed to create leaders in the field of bioethics with the aim to create capacity in the area of clinical research ethics. After completing the project, the fellows are expected to work towards capacity building in the area of clinical research ethics in India and establishing centres of excellence. Centre of excellence is expected to serve as a resource for guidance and policy related to the ethics of clinical research in India.

Program Overview:

Industry-Academia Collaborative Mission for Accelerating Discovery Research to Early
Development for Biopharmaceuticals – “Innovate in India (i3) Empowering biotech entrepreneurs & accelerating inclusive innovation”, also referred to as National BioPharma Mission (NBM).

OBJECTIVE:

The objective of the program is to support motivated individuals with strong scientific background with interest in the field of bioethics. 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.

SCOPE:

The program will support research projects in the field of clinical research ethics including, but not limited to, ethical aspects of:

• Ethical aspects of vaccine research and clinical trial

• Research subject recruitment in clinical research

• Informed consent taken during the 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 vulnerable populations such as prisoners, children, or the socioeconomically

WHO CAN APPLY:

Any interested fellow person 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 below.

ELIGIBILITY:

A. Fellow Applicant –

• The applicant should be an Indian citizen. This fellowship is open to Persons of Indian
Origin (PIO) and Overseas Citizen of India (OCI).

• 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.

• The applicant must have obtained PhD in any area of Life sciences/Medical
sciences/Pharmaceutical sciences or M.D./M.S./M.D.S or equivalent degree from a
recognized university in India. 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.

• The fellows will NOT be allowed to work with their Ph.D. 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.

• The applicant should have an excellent track record (i.e., peer-reviewed publications or
equivalent)

• Applicant cannot have more than one fellowship at a given point of time.

• Applicant should have a valid passport and be eligible for an appropriate U.S. visa.

Host Institute:

• Recognized Universities/ Institutes established under statutes/ Academic Research
Institutes/ Research Foundation/ Medical 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 in Life Sciences or related streams
(Biotechnology/Biosciences/Agriculture/Horticulture/Food technology streams etc.)
for technical support and expertise in the bioethics field such as but not limited to ethics,
law, sociology, and public health.

• Age of the Host Institute should be at least 3 years or more.

• Presence of a supportive clinical trial infrastructure facility is a must.

• It is desirous for the Host Institute to have a Network of experts who can provide
technical/business mentorship to fellows.

• Plan to establish a permanent position in clinical research ethics in due course, subject
to meet statutory requirements.

• The Host Institute should endorse a commitment of 40% of the time for tenured
candidates of the institute and 100% of the time for Adhoc/temporary/contractual candidate
towards the fellowship.

• Host Institute to provide endorsement letter(s) to the Fellow Applicants.

• Availability of IP, regulatory, and business support to the fellows.

NATURE OF SUPPORT AND FUNDING BY BIRAC:

• The research projects will be funded at recognized academic institutions, national
laboratories and other recognized R&D institutions carrying out clinical research
and/or has clinical trial infrastructure qualifying the eligibility criteria as provided in
eligibility section above. No funding shall be provided to the selected fellow candidates
directly by BIRAC.

• BIRAC shall not be responsible for any delay in disbursement of grant caused by the
selected fellow applicant and host institute in submitting the required documents sought
by BIRAC from time to time.

• The grant carries a fellowship of Rs.2.00 lakh per annum for candidates who have a
permanent position in the host institute or is not availing the monthly fellowship and
of Rs.85000/- per month for those candidates working on temporary/contractual/Adhoc position (refer Table 1 below) hereinafter referred to as Fellowship Grant. The selected fellows on temporary/contractual/adhoc positions to avail only one salary either from the fellowship or the place of employment

PROJECT DURATION & NUMBER OF FELLOWS:

The projects will be supported for a period of 3 years (starting from signing of the Agreement) extendable further based on performance review/evaluation of the project done by the respective committee at BIRAC. The duration of the fellowship will be for a period of up to three years and up to 2 fellows for this call will be awarded.

APPLICATION PROCESS AND INSTRUCTIONS:

1. Application guideline and process:

The proposals can be submitted online by the Fellow Applicants as per the format. The website will provide a detailed user guide to facilitate the online proposal submission. Prior to application, applicant should prepare the following:

• A cover letter describing his/her interest in the program, including a description of
current position and bioethics research conducted; plans for pursuing a career in
bioethics; how participation in the NIH mentored bioethics research program might
help to advance his/ her current bioethics research and the preferred time period for
your visit at the NIH.

• A research proposal clearly defining the work to be undertaken in the host institute and
at Department of Bioethics, NIH, USA. The proposal must describe how the project
fits within current bioethics research projects in the Department of Bioethics, NIH and
the proposed research proposal in India. Proposal should mention NIH faculties who
might be able to mentor the project; and whether there has been any prior discussion of
the proposed bioethics research with a faculty member.

• An endorsement letter from the Host Institution, duly forwarded by the Competent
Authority in favour of the fellow applicant. If employed, a certificate from his/her
employer to accept the fellowship should be submitted. The endorsement should
include a statement describing current involvement in bioethics research; how the
fellow will be involved in bioethics research activities after the NIH mentored bioethics
research program; and how participation in the NIH mentored bioethics research
program will enhance your involvement in these bioethics research activities. The
endorsement letter should be written on an official letterhead and provide a clear
indication of the letter writer’s position.

• Curriculum vitae of the applicant

• Description of available clinical trial infrastructure and clinical trials, or active
collaboration with institutions that support clinical trials at the host institution.

• Availability of host institutional expertise in relevant fields, such as ethics, law,
sociology and public health.

• A description of how the position in clinical research ethics is integrated in the
infrastructure for clinical trials at the institution.
The process of submitting the proposal online is detailed below:

• Go to BIRAC’s website https://www.birac.nic.in

• Click on the Call for Proposal and then-current call tab in order to view the call detailed
description.

• Click on the active call against Indo-US Clinical Research Ethics Fellowship.

• If you are already a registered user, then kindly enter your login credential at the below
link in order to submit proposal: https://birac.nic.in/login.php

• If you are a new user then you need to register by clicking on link:
https://birac.nic.in/birac_registration_page.php

• Once you register the account will be activated, login by using login credentials then
kindly click on “Indo-US Clinical Research Ethics Fellowship” on the dashboard to
submit the proposal.

• Applicants are advised to fill‐up and submit their applications early without waiting for
the last date in order to avoid any last-minute contingencies. The system stops
accepting applications automatically after 5:30 PM of the last date of submission.

• Applicants are advised to provide sufficient details in their applications to allow for an
informed and fair evaluation/review.

• Applicants are advised to provide self‐contained proposals with essential supporting
materials provided as uploads.

• Requests for changes in the proposal, once submitted will not be entertained.

• Please read through the proposal in its entirety and ensure that your technical details,
budget, and organization details comply with the eligibility criteria provided.
The Applicants should read the guidelines for clear instructions and other details for
comprehensive proposal preparation. Proposals for projects that do not meet the
eligibility criteria and/or do not directly respond to the call area will not be reviewed,
regardless other parameters.

• The proposed budget shall be made INCLUSIVE of all applicable taxes and shall be
considered accordingly. The applicant’s commitment to putting in its resources as part
of the Project will be specified distinctly.

Selection process for DBT Indo-US Clinical fellowhsip

Proposals will be selected based on a three-tier selection process:

• Primary eligibility check by BIRAC.

• Peer review and shortlisting of proposals by Evaluation Committee.

• Presentation of research proposal before the Evaluation Committee and final selection.

• Fellows will be selected based on evaluation of their individual qualifications and the
institutional commitment and other ancillary documents submitted by the Applicant
Institute.

• BIRAC reserves the right to accept or reject any application for this fellowship without
assigning any reason.

• Successful submission of an application form does not guarantee admission to this
fellowship program.

APPLICATION TIMELINES: KEY DATES

  • RFP Publication 01st July 2022 till 29th August 2022 (05:30 pm)
  • Closing of Application 8 weeks (60 days) from date of publication of RFP.

Click Here To Apply Online

View Main Notification

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