Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration [version 2; peer review: 2 approved]
Introduction: Controlled Human Infection Model (CHIM) studies provide a unique platform for studying the pathophysiology of infectious diseases and accelerated testing of vaccines and drugs in controlled settings. However, ethical issues shroud them as the disease-causing pathogen is intentionally i...
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| Language: | English |
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Wellcome
2023-02-01
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| Series: | Wellcome Open Research |
| Subjects: | |
| Online Access: | https://wellcomeopenresearch.org/articles/7-209/v2 |
| _version_ | 1797866144671989760 |
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| author | Vina Vaswani Medha Rajappa Samir Malhotra Shifalika Goenka Subitha Lakshminarayanan Rashmi Sangoram Jayanthi Mathaiyan Suganya Jayaram Prarthna Mukerjee Manjulika Vaz Khadeejath Farseena Amol Dongre Surinder Jaswal Nusrat Shafiq Olinda Timms Manmeet Kaur Rakesh Aggarwal Amrita Sekhar Sanjay Juvekar Gagandeep Kang Aditi Apte Abhishek Sharma |
| author_facet | Vina Vaswani Medha Rajappa Samir Malhotra Shifalika Goenka Subitha Lakshminarayanan Rashmi Sangoram Jayanthi Mathaiyan Suganya Jayaram Prarthna Mukerjee Manjulika Vaz Khadeejath Farseena Amol Dongre Surinder Jaswal Nusrat Shafiq Olinda Timms Manmeet Kaur Rakesh Aggarwal Amrita Sekhar Sanjay Juvekar Gagandeep Kang Aditi Apte Abhishek Sharma |
| author_sort | Vina Vaswani |
| collection | DOAJ |
| description | Introduction: Controlled Human Infection Model (CHIM) studies provide a unique platform for studying the pathophysiology of infectious diseases and accelerated testing of vaccines and drugs in controlled settings. However, ethical issues shroud them as the disease-causing pathogen is intentionally inoculated into healthy consenting volunteers, and effective treatment may or may not be available. We explored the perceptions of the members of institutional ethics committees (IECs) in India about CHIM studies. Methods: This qualitative exploratory study, conducted across seven sites in India, included 11 focused group discussions (FGD) and 31 in-depth interviews (IDI). A flexible approach was used with the aid of a topic guide. The data were thematically analyzed using grounded theory and an inductive approach. Emerging themes and sub-themes were analyzed, and major emergent themes were elucidated. Results: Seventy-two IEC members participated in the study including 21 basic medical scientists, 29 clinicians, 9 lay people, 6 legal experts and 7 social scientists. Three major themes emerged from this analysis—apprehensions about conduct of CHIM studies in India, a perceived need for CHIM studies in India and risk mitigation measures needed to protect research participants and minimize the associated risks. Conclusion: Development of a specific regulatory and ethical framework, training of research staff and ethics committee members, and ensuring specialized research infrastructure along with adequate community sensitization were considered essential before initiation of CHIM studies in India. |
| first_indexed | 2024-04-09T23:19:25Z |
| format | Article |
| id | doaj.art-2952692f60dd4a7f82d7f14db5f5b8cc |
| institution | Directory Open Access Journal |
| issn | 2398-502X |
| language | English |
| last_indexed | 2024-04-09T23:19:25Z |
| publishDate | 2023-02-01 |
| publisher | Wellcome |
| record_format | Article |
| series | Wellcome Open Research |
| spelling | doaj.art-2952692f60dd4a7f82d7f14db5f5b8cc2023-03-22T01:00:00ZengWellcomeWellcome Open Research2398-502X2023-02-01720878Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration [version 2; peer review: 2 approved]Vina Vaswani0Medha Rajappa1Samir Malhotra2Shifalika Goenka3Subitha Lakshminarayanan4Rashmi Sangoram5Jayanthi Mathaiyan6Suganya Jayaram7Prarthna Mukerjee8Manjulika Vaz9https://orcid.org/0000-0001-5867-1665Khadeejath Farseena10Amol Dongre11Surinder Jaswal12https://orcid.org/0000-0003-0161-5202Nusrat Shafiq13Olinda Timms14Manmeet Kaur15Rakesh Aggarwal16https://orcid.org/0000-0001-9689-494XAmrita Sekhar17Sanjay Juvekar18Gagandeep Kang19https://orcid.org/0000-0002-3656-564XAditi Apte20Abhishek Sharma21https://orcid.org/0000-0003-1250-8031Yenepoya University, Mangalore, Karnataka, 575018, IndiaJawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, Puducherry, 605006, IndiaPostgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, Chandigarh, 160014, IndiaCentre for Chronic Disease Control (CCDC), Delhi, Delhi, 110016, IndiaJawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, Puducherry, 605006, IndiaKEM Hospital Research Centre, Pune, Maharashtra, 411011, IndiaJawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, Puducherry, 605006, IndiaJawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, Puducherry, 605006, IndiaCentre for Chronic Disease Control (CCDC), Delhi, Delhi, 110016, IndiaSt John's Medical College, Bengaluru, Karnataka, 560034, IndiaYenepoya University, Mangalore, Karnataka, 575018, IndiaPramukhswami Medical College, Karamsad, Gujarat, 388325, IndiaTata Institute of Social Sciences, Mumbai, Maharashtra, 400088, IndiaPostgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, Chandigarh, 160014, IndiaSt John's Medical College, Bengaluru, Karnataka, 560034, IndiaPostgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, Chandigarh, 160014, IndiaJawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, Puducherry, 605006, IndiaTranslational Health Science and Technology Institute, Faridabad, Haryana, 101213, IndiaKEM Hospital Research Centre, Pune, Maharashtra, 411011, IndiaChristian Medical College, Vellore, Tamil Nadu, 632004, IndiaKEM Hospital Research Centre, Pune, Maharashtra, 411011, IndiaPostgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, Chandigarh, 160014, IndiaIntroduction: Controlled Human Infection Model (CHIM) studies provide a unique platform for studying the pathophysiology of infectious diseases and accelerated testing of vaccines and drugs in controlled settings. However, ethical issues shroud them as the disease-causing pathogen is intentionally inoculated into healthy consenting volunteers, and effective treatment may or may not be available. We explored the perceptions of the members of institutional ethics committees (IECs) in India about CHIM studies. Methods: This qualitative exploratory study, conducted across seven sites in India, included 11 focused group discussions (FGD) and 31 in-depth interviews (IDI). A flexible approach was used with the aid of a topic guide. The data were thematically analyzed using grounded theory and an inductive approach. Emerging themes and sub-themes were analyzed, and major emergent themes were elucidated. Results: Seventy-two IEC members participated in the study including 21 basic medical scientists, 29 clinicians, 9 lay people, 6 legal experts and 7 social scientists. Three major themes emerged from this analysis—apprehensions about conduct of CHIM studies in India, a perceived need for CHIM studies in India and risk mitigation measures needed to protect research participants and minimize the associated risks. Conclusion: Development of a specific regulatory and ethical framework, training of research staff and ethics committee members, and ensuring specialized research infrastructure along with adequate community sensitization were considered essential before initiation of CHIM studies in India.https://wellcomeopenresearch.org/articles/7-209/v2Risk benefits ethics viral strain vaccine development human challenge studieseng |
| spellingShingle | Vina Vaswani Medha Rajappa Samir Malhotra Shifalika Goenka Subitha Lakshminarayanan Rashmi Sangoram Jayanthi Mathaiyan Suganya Jayaram Prarthna Mukerjee Manjulika Vaz Khadeejath Farseena Amol Dongre Surinder Jaswal Nusrat Shafiq Olinda Timms Manmeet Kaur Rakesh Aggarwal Amrita Sekhar Sanjay Juvekar Gagandeep Kang Aditi Apte Abhishek Sharma Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration [version 2; peer review: 2 approved] Wellcome Open Research Risk benefits ethics viral strain vaccine development human challenge studies eng |
| title | Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration [version 2; peer review: 2 approved] |
| title_full | Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration [version 2; peer review: 2 approved] |
| title_fullStr | Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration [version 2; peer review: 2 approved] |
| title_full_unstemmed | Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration [version 2; peer review: 2 approved] |
| title_short | Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration [version 2; peer review: 2 approved] |
| title_sort | perceptions about controlled human infection model chim studies among members of ethics committees of indian medical institutions a qualitative exploration version 2 peer review 2 approved |
| topic | Risk benefits ethics viral strain vaccine development human challenge studies eng |
| url | https://wellcomeopenresearch.org/articles/7-209/v2 |
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