Comprehension of informed consent and voluntary participation in registration cohorts for phase IIb HIV vaccine trial in Dar Es Salaam, Tanzania: a qualitative descriptive study
Abstract Background Informed consent as stipulated in regulatory human research guidelines requires volunteers to be well-informed about what will happen to them in a trial. However, researchers may be faced with the challenge of how to ensure that a volunteer agreeing to take part in a clinical tri...
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| Format: | Article |
| Language: | English |
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BMC
2024-03-01
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| Series: | BMC Medical Ethics |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12910-024-01033-z |
| _version_ | 1797259000184569856 |
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| author | Masunga K. Iseselo Edith A. M. Tarimo |
| author_facet | Masunga K. Iseselo Edith A. M. Tarimo |
| author_sort | Masunga K. Iseselo |
| collection | DOAJ |
| description | Abstract Background Informed consent as stipulated in regulatory human research guidelines requires volunteers to be well-informed about what will happen to them in a trial. However, researchers may be faced with the challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. This study aimed to find out volunteers’ comprehension of informed consent and voluntary participation in Human Immunodeficiency Virus (HIV) clinical trials during the registration cohort. Methods We conducted a qualitative study among volunteers who were enrolled in the registration cohort of HIV clinical trials in Dar es Salaam, Tanzania. A purposive sampling strategy was used to obtain twenty study participants. The data were collected between June and September 2020 using a semi-structured interview guide. In-depth interviews were used to collect the data to obtain deep insights of the individual study participants on the comprehension of informed consent and participation in the clinical trial. A thematic analysis approach was used to analyze the data. Themes and subthemes were supported by the quotes from the participants. Results Volunteers described comprehension of informed consent from different perspectives. They reported that various components of the informed consent such as study procedure, confidentiality, risk and benefits were grasped during engagement meetings. Furthermore, the volunteers’ decision to participate in the registration cohort was voluntary. However, trial aspects such as health insurance, free condoms, and medical checkups could have indirectly influenced their reluctance to withdraw from the study. Conclusion Engagement meetings may increase the comprehension of informed consent among potential participants for HIV clinical trials. However, trial incentives may influence participation, and thus future research should focus on the challenges of giving incentives in the study. This will ensure comprehension and voluntary participation in the context of HIV clinical trials. |
| first_indexed | 2024-04-24T23:02:28Z |
| format | Article |
| id | doaj.art-44258f5d53c9407c89496111223f2cfe |
| institution | Directory Open Access Journal |
| issn | 1472-6939 |
| language | English |
| last_indexed | 2024-04-24T23:02:28Z |
| publishDate | 2024-03-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Ethics |
| spelling | doaj.art-44258f5d53c9407c89496111223f2cfe2024-03-17T12:37:34ZengBMCBMC Medical Ethics1472-69392024-03-0125111310.1186/s12910-024-01033-zComprehension of informed consent and voluntary participation in registration cohorts for phase IIb HIV vaccine trial in Dar Es Salaam, Tanzania: a qualitative descriptive studyMasunga K. Iseselo0Edith A. M. Tarimo1Department of Clinical Nursing, Muhimbili University of Health and Allied SciencesDepartment of Nursing Management, Muhimbili University of Health and Allied SciencesAbstract Background Informed consent as stipulated in regulatory human research guidelines requires volunteers to be well-informed about what will happen to them in a trial. However, researchers may be faced with the challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. This study aimed to find out volunteers’ comprehension of informed consent and voluntary participation in Human Immunodeficiency Virus (HIV) clinical trials during the registration cohort. Methods We conducted a qualitative study among volunteers who were enrolled in the registration cohort of HIV clinical trials in Dar es Salaam, Tanzania. A purposive sampling strategy was used to obtain twenty study participants. The data were collected between June and September 2020 using a semi-structured interview guide. In-depth interviews were used to collect the data to obtain deep insights of the individual study participants on the comprehension of informed consent and participation in the clinical trial. A thematic analysis approach was used to analyze the data. Themes and subthemes were supported by the quotes from the participants. Results Volunteers described comprehension of informed consent from different perspectives. They reported that various components of the informed consent such as study procedure, confidentiality, risk and benefits were grasped during engagement meetings. Furthermore, the volunteers’ decision to participate in the registration cohort was voluntary. However, trial aspects such as health insurance, free condoms, and medical checkups could have indirectly influenced their reluctance to withdraw from the study. Conclusion Engagement meetings may increase the comprehension of informed consent among potential participants for HIV clinical trials. However, trial incentives may influence participation, and thus future research should focus on the challenges of giving incentives in the study. This will ensure comprehension and voluntary participation in the context of HIV clinical trials.https://doi.org/10.1186/s12910-024-01033-zInformed consentClinical trialsVolunteersHIV clinical trials |
| spellingShingle | Masunga K. Iseselo Edith A. M. Tarimo Comprehension of informed consent and voluntary participation in registration cohorts for phase IIb HIV vaccine trial in Dar Es Salaam, Tanzania: a qualitative descriptive study BMC Medical Ethics Informed consent Clinical trials Volunteers HIV clinical trials |
| title | Comprehension of informed consent and voluntary participation in registration cohorts for phase IIb HIV vaccine trial in Dar Es Salaam, Tanzania: a qualitative descriptive study |
| title_full | Comprehension of informed consent and voluntary participation in registration cohorts for phase IIb HIV vaccine trial in Dar Es Salaam, Tanzania: a qualitative descriptive study |
| title_fullStr | Comprehension of informed consent and voluntary participation in registration cohorts for phase IIb HIV vaccine trial in Dar Es Salaam, Tanzania: a qualitative descriptive study |
| title_full_unstemmed | Comprehension of informed consent and voluntary participation in registration cohorts for phase IIb HIV vaccine trial in Dar Es Salaam, Tanzania: a qualitative descriptive study |
| title_short | Comprehension of informed consent and voluntary participation in registration cohorts for phase IIb HIV vaccine trial in Dar Es Salaam, Tanzania: a qualitative descriptive study |
| title_sort | comprehension of informed consent and voluntary participation in registration cohorts for phase iib hiv vaccine trial in dar es salaam tanzania a qualitative descriptive study |
| topic | Informed consent Clinical trials Volunteers HIV clinical trials |
| url | https://doi.org/10.1186/s12910-024-01033-z |
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