|Year : 2023 | Volume
| Issue : 4 | Page : 251-256
Overview of the National Ethics Committee Registry for Biomedical and Health Research in India: Stepping up to safeguard the ethical aspect of research involving human participants
Balu Venugopal1, Anu Nagar2, Yogesh Kumar1, Sujata Sinha1
1 National Ethics Committee Registry for Biomedical and Health Research, Department of Health Research, IRCS Building, Red Cross Road, New Delhi, India
2 Department of Health Research, 2nd Floor, IRCS Building, Red Cross Road, New Delhi, India
|Date of Submission||22-Mar-2022|
|Date of Decision||11-Aug-2023|
|Date of Acceptance||14-Aug-2023|
|Date of Web Publication||11-Sep-2023|
Room No. 113, Department of Health Research, National Ethics Committee Registry for Biomedical and Health Research, 2nd Floor, IRCS Building, Red Cross Road, New Delhi - 110 001
Source of Support: None, Conflict of Interest: None
As notified in the New Drugs and Clinical Trials Rules 2019, ethics committees (ECs), intending to review and oversee the conduct of Biomedical and Health Research (BHR) shall be required to register with the authority designated by the Central Government in the Ministry of Health and Family Welfare, Department of Health Research (DHR). The entire process of receiving and processing such applications is done online through the Naitik portal. Vide these rules, it has become mandatory for all institutions/entities whether publicly or privately conducting or intending to conduct BHR involving the human participants, to get their EC, registered with the DHR. A status report of the functioning of the National Ethics Registry and an analysis of ECs registered with the DHR are presented in this manuscript. A workflow of the processing involved in EC registration is given with sectorial segregation, and analysis of data on ECs across the country is made for the dissemination and information. This article elaborates on the registration requirements and process of the EC registry with the necessity of being registered with the DHR. 2100 login requests and more than 1560 applications for registration have been received; private hospitals and medical colleges have been the front-runner in getting their organization registered, and organizations in the commercial sector are faring better in terms of EC registration. Further dissemination and outreach efforts have to be made to draw the attention of various stakeholders regarding this requirement and thereby ensuring that all ECs in the country are registered with the DHR.
Keywords: Biomedical, ethics, Naitik, registry, research, standard operating procedures
|How to cite this article:|
Venugopal B, Nagar A, Kumar Y, Sinha S. Overview of the National Ethics Committee Registry for Biomedical and Health Research in India: Stepping up to safeguard the ethical aspect of research involving human participants. Indian J Pharmacol 2023;55:251-6
|How to cite this URL:|
Venugopal B, Nagar A, Kumar Y, Sinha S. Overview of the National Ethics Committee Registry for Biomedical and Health Research in India: Stepping up to safeguard the ethical aspect of research involving human participants. Indian J Pharmacol [serial online] 2023 [cited 2023 Oct 3];55:251-6. Available from: https://www.ijp-online.com/text.asp?2023/55/4/251/385495
| » Introduction|| |
Biomedical and Health Research (BHR) includes basic and applied studies and/or operational research designed primarily to enhance the knowledge about diseases and conditions (physical or socio-behavioral) scientifically, their causes, detection, and evolving strategies for health promotion, prevention, or amelioration of disease and rehabilitation, including clinical research. BHR studies are being conducted in large numbers across the country at research/medical/academic institutions, which involve the participation of patients or study participants, their biological samples, or data. Such studies are to be reviewed, monitored, and regulated at the institutional level through committees called Institutional Ethics Committees/Institutional Review Boards/Ethics Committees (ECs). These committees are entrusted with the responsibility of initial and continued review of proposals to ensure that the research participant's rights, safety, and well-beingness are protected. The Indian Council of Medical Research (ICMR) is India's most prominent body responsible for formulating, coordinating, and promoting biomedical research, and regularly publishes updated guidelines on ethical aspects of BHR to promote and facilitate ethical conduct of such research. However, with time as the number of BHR studies increased, ethical issues also started coming up. This gradual escalation led the scientists and legislatures to streamline the conduct of BHR studies and related ECs by bringing them under a regulatory framework. In continuation, when the New Drugs and Clinical Trials (NDCT-2019) rules were notified, it mandated that all BHR studies conducted should be reviewed and approved by ECs. Such ECs' constitution and function should be in accordance with the ICMR 2017 Ethical Guidelines for BHR involving Human Participants, 2017, which is currently the latest edition. Chapter IV of the ICMR 2017 Ethical Guideline details the EC composition and ethical review procedures.
Accordingly, as prescribed in NDCT-2019, an authority was designated, and a system was set up in the Department of Health Research (DHR) for the purpose of coordination and monitoring of EC registrations and activities related to thereof. This office, in the name of the National Ethics Committee Registry for BHR (NECRBHR), receives applications, reviews, and further processes it for registration of the ECs. The aim was to bring accountability and transparency and ensure a well-placed structure to regulate and oversee BHR in India. All ECs conducting review of BHR involving human participants/their samples/data may apply with documents and information as specified in the [Table 1] as given in the 3rd schedule of the NDCT 2019 for registration. The validity of provisional registration is for 2 years, and the final registration shall remain valid for 5 years from the issue date unless suspended/canceled by the designated authority in the DHR. The incumbent of the post of Joint Secretary, DHR, or as approved by the Competent Authority in the Ministry of Health and Family Welfare will be the Designated Authority. All ECs intending to perform BHR studies involving human participants/samples/data must get register with the NECRBHR. This will include (1) all medical, dental, pharmacy, nursing, and allied medical institutions, (2) all universities, colleges, and research institutions doing BHR, (3) hospitals/clinics, (4) AYUSH institutions and, (5) any other organizations intending to perform or review studies relating to BHR involving human participants.
|Table 1: A list of documents needs to be submitted in CT-01 format for the ethics committee registration application|
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| » Registration Process on Naitik Portal|| |
Any organization or institution planning to conduct BHR involving human participants, their data, or biological material must comply with the NDCT 2019 and have an EC to review and monitor the research as described in the National Ethical Guidelines 2017 published by the ICMR. These ECs are ought to be registered from the NECRBHR. The DHR has developed the Naitik portal for facilitating EC registrations and processing of their applications. The institute may create a login account by registering at the Naitik homepage. Further, once the login is approved, the user can apply and track the application status online through this portal. Naitik portal has been developed as an end-to-end digital portal to ensure paperless submission, processing, and issue of the registration certificate to ensure hassle-free processing with minimum time and effort. Once appropriate documents are submitted according to [Table 1] of the 3rd schedule and the completed application in the form certificate 1 (CT-01) as given in the NDCT 2019, the processing is done in 30 days as per the timeline given in the Citizens' Charter of the department. The portal provides all required information, including the ICMR Ethical Guidelines, NDCT rules 2019, and other submission requirements. It is a two-step process on the Naitik portal. The 1st step is to create a login account by providing applicant and organization details. In addition, identity proof for the applicant and address proof for the organization, under which EC is functioning, are to be provided with an undertaking in the prescribed format in the portal. It is always recommended that the Head of the Organization/Institute may be the applicant or any person authorized by him or her as the authority of the EC constituted. Once the login account is created, the EC registration application should be made in CT-01 form (portal generated), accompanied by other requisite information given in [Table 1] under schedule three of the NDCT 2019 [Table 1]. From October 2021, e-Hastakshar is implemented in the Naitik portal for a quick paperless login registration process and online user credentials verification.
| » Application Submission for Ethics Committees Registration|| |
Application mainly includes information regarding EC composition with member details and specific documents, including standard operating procedures (SOPs), as listed in the 3rd schedule of the NDCT 2019 [Table 1]. The latest self-attested biodata of the members with educational qualifications, relevant EC experiences (if any) designations, affiliations, and patient group representations (if applicable) should be submitted with the current contact details. A recent EC training certificate should be uploaded with biodata and may be updated from time to time. The 2019 NDCT Rules and the 2017 ICMR National Ethical Guidelines are among the regulations that EC members should be familiar with. They should also be trained in human research protection, EC-related activities, and SOPs. In case, a training certificate is not available, the applicant may request a maximum of 6 months for submission of the relevant training certificate for that EC member, a format on the same is available on the Naitik portal. Roles of EC members should be assigned according to the qualifications as prescribed in Chapter IV of the ICMR 2017 guidelines, and preferably 50% of EC members should be nonaffiliated. Chairperson and layperson shall not be affiliated with the host institute where EC has been set up. It should be ensured that the proposed EC should adequately represent age/gender and multidisciplinary and multisectoral in nature. At present, a set of documents (14 in number) needs to be uploaded for completing the application process on the Naitik portal. It includes a cover letter which is a formal letter requesting registration of EC with the NECRBHR and should be addressed to the designated authority, NECRBHR, DHR. The authority letter should be from the appellate authority/head of the institution authorizing the formation of the EC and may include the purpose and scope of the EC and other relevant information. However, in the case of independent ECs as per the ICMR Guidelines 2017, a statement on these points may be included in the authority letter. (1) The EC identity must be of a registered legal entity run by people who are not playing any role in the proposed EC and will monitor and oversee the independent functioning of the proposed EC; (2) the EC will not be accepting research proposals for review from such researchers/investigators whose institutions have EC unless there is a memorandum of understanding; and (3) the EC will be responsible and undertake site visits and continuously review the implemented projects till the end. Specific SOPs, to be uploaded with the application, are indicated in [Table 1]. Every EC reviewing BHR should have a clearly written SOP, which should be followed for EC operation and/or function. SOPs may be drafted referring to the ICMR ethical guidelines 2017 or as updated by the ICMR from time to time. Information regarding the inspection and audit of the EC by any regulatory authority or by a third party may be submitted. In the case of nonaudited EC, a justification may be submitted. The undertaking of the EC and the CT-01 form are autogenerated by the portal from information provided by the applicant, which must be uploaded after verification. The undertaking is autogenerated, and it should be uploaded after being signed by Chairperson and Member Secretary. It contains information (name, address, phone number, role in EC, affiliation, and qualification) about all the EC members and can be updated once there is a change in EC composition. CT-01 format should be as per the NDCT 2019 and is autogenerated on the basis of filled information initially and can be downloaded from the applicant account on the Naitik portal. Once all documents are uploaded, the application may be submitted for further processing. The entire process of login registration and application submission has been summarized in [Figure 1]. Applications received are verified for completeness, and any incomplete submissions are reverted to the applicant for modification and updating. On receiving the complete application, the designated authority issues a provisional certificate which is valid for 2 years. Before the expiry of the provisional certificate, a thorough review of applications is made, and a query is raised if required; following a satisfactory response to the query, the authority will grant the final registration, which will be valid for 5 years. If a registered EC desires to modify their EC composition or update any document, a provision is made to request change/update through the postsubmission section in the portal any time after issuance of the certificate.
|Figure 1: Application for ethics committees registration: Receiving and processing on the Naitik portal (Naitik.gov.in). EC = Ethics committee|
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| » Dissemination of Registry and Registration Requirements|| |
Before the NDCT 2019 came into force, ECs performing clinical trials had to mandatorily register with the Central Drugs Standard Control Organization (CDSCO), and ECs dealing only with research related to biomedical and health were voluntarily getting registered to the CDSCO. According to the NDCT 2019, the DHR has been mandated as the registration authority of ECs related to BHR involving human participants. Since the notification of NDCT rules 2019, all BHR studies and ECs that monitor and review such studies were brought under a regulatory framework to ensure transparency and accountability of the ethics review process in the country. As per this notification, all ECs reviewing the BHR studies involving human participants/biological material/data need to be registered with the NECRBHR, DHR irrespective of their registration status with the CDSCO. Various outreach measures have been taken to disseminate the information regarding the notification of the NDCT 2019 and the setting up of the NECRBHR at the DHR for the purpose of EC registration. Communications conveying the setting up of the registry and the need to enforce the NDCT rules 2019 regarding the registration of ECs were sent to various nodal agencies in the country associated with BHR. The Ministry of AYUSH, National Medical Commission, National Board of Examination, University Grant Commission, Pharmacy Council of India, Dental Council of India, Nursing Council of India, and all scientific research funding organizations – Department of Biotechnology, Department of Science and Technology, Council of Scientific and Industrial Research, and Health Secretaries of all States/union territories – were informed regarding the NDCT rules 2019 for further dissemination and needful action related to this requirement. In addition, official communications were also made individually to all medical/dental/pharmacy/nursing institutions across the country for their EC registration. The information was also shared through various conferences/seminars and programs related to BHR across the country by the DHR/ICMR.
| » Status of Ethics Committees Registration|| |
The status of EC registration with the NECRBHR since its inception (from September 2019) to July 2023 was assessed and reviewed further. Based on existing numbers of medical, dental, pharmacy, nursing institutions, hospitals, and academic/research institutions registered/associated with respective authorities, it was expected that at least around 4000 ECs should have been registered with the NECRBHR within the aforementioned time period.
However, only approximately ~50% of ECs have created a login account on the Naitik portal, and ~30% of ECs have submitted applications. Currently, around 2100 ECs have created login accounts in the Naitik portal, of which 20% are government organizations and 80% belong to the nongovernment/private category. On the basis of type of organization, approximately 30% of the total registered ECs belong to hospital/clinic, while 25% and 10% belong to medical and dental colleges, respectively, and 14% belonged to academic/research organizations [Figure 2]. A very small percentage of AYUSH organizations, as well as independent ECs, are registered along with allied medical institutions such as physiotherapy, pharmacy, and nursing. A few pathological laboratories and clinical research organizations from the industry sector are also registered. Considering the total number of medical/allied medical institutions in the country, it may be seen that ~40% of the total number of medical/dental colleges are still not registered [Figure 3], and a miniscule number of pharmacy and nursing colleges are registered on the Naitik portal. It may also be noted that 5% of ECs failed to complete the process for final certification after the expiry of the provisional certificate due to nonresponsiveness from their part.
|Figure 2: Types of organizations registered with the National Ethics Committee Registry for Biomedical and Health Research on the basis of their primary activities, others include all organizations which do not fall into these mentioned categories|
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|Figure 3: Comparison of the number of medical, dental, nursing, and pharmacy colleges registered with NECRBHR Vs total number in the country. NECRBHR = National Ethics Committee Registry for Biomedical and Health Research|
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| » Discussion and Conclusion|| |
The NECRBHR has been accepting applications since October 2019; however, it is still below the expected/anticipated number of ECs that would have been registered with the DHR. It is a matter of concern that a large number of medical colleges, dental colleges, pharmacy, and nursing colleges are still unregistered with the NECRBHR when compared with the total number present in the country. It is to reiterate that academic studies, including research and thesis submissions where human participants, their tissues, or data are involved; such studies should be reviewed and approved by an EC registered with the NECRBHR.
Primarily, the lack of numbers of registered ECs can be attributed to the lack of awareness about the NDCT rules 2019 and the need for registering their ECs with this regulatory authority, i.e., DHR. This also indicates that BHR studies may still have been conducted and reviewed by ECs that do not comply with the NDCT rules and ICMR guidelines. A huge gap between registered ECs versus the total number of institutions in the case of pharmacy and nursing colleges may be because associated medical/dental colleges review the academic studies in these institutes. It may also depend on whether or not BHR studies are involved in their academic curriculum and course design. However, it is advisable that nursing/pharmacy colleges may also set up their own ECs if they are receiving a substantial number of academic review proposals as part of the curriculum/otherwise for quality subject-specific review. Any institution can constitute multiple ECs in case of a large number of research proposals are received for review. It is expected that organizations/institutions under the AYUSH category doing BHR also register with NECRBHR, DHR. Hopefully, with increasing outreach measures like region-wise meetings with ECs, using platforms like trainings, workshops, conferences some of these have already been initiated will create more awareness among ECs in the coming days. It is expected that through these measures, all related ECs will register with the NECRBHR, and this trend will continue in the future.
Support from the ICMR in all forms is highly acknowledged.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| » References|| |
Mathur R, Swaminathan S. National ethical guidelines for biomedical & health research involving human participants, 2017: A commentary. Indian J Med Res 2018;148:279-83.
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[Figure 1], [Figure 2], [Figure 3]