Unspoken obligations: Perspectives on Post-Trial Responsibilities from a Tanzanian Research Ethics Committee and Researchers

doi:10.21203/rs.3.rs-4991638/v1

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Unspoken obligations: Perspectives on Post-Trial Responsibilities from a Tanzanian Research Ethics Committee and Researchers

https://doi.org/10.21203/rs.3.rs-4991638/v1

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Introduction: In the evolving landscape of medical research, ethical considerations extend beyond the duration of clinical trials, particularly concerning the post-trial care of participants. This study explores the perceived responsibilities of researchers and Research Ethics Committees (RECs), in ensuring participants’ well being after trials conclude.

Guided by ethical frameworks such as the Belmont Report and the Declaration of Helsinki, the research highlights the imperative to provide continued access to beneficial interventions, especially in resource-poor settings.

Methods: This qualitative phenomenographic case study, involved two primary data collection methods: Focus group discussions (FGD) and in-depth interviews. The FGD involved of REC members from three institutions with extensive experience in of externally funded clinical research in collaboration with international partners: (Kilimanjaro Christian Medical Centre [KCMC], Kilimanjaro Clinical Research Institute [KCRI] and Kilimanjaro Christian Medical University College [KCMUCO]. Additionally, in-depth interviews were conducted with researchers from these institutions. REC members and were eligible to participate in the FGD while researchers were selected purposively based on the principle of saturation. The interviews and FGD were transcribed and translated into English. NVIVO 12 software was used for data management and analysis, including familiarization with data, coding and theme identification.

Results: The analysis revealed key themes related to post-trial responsibilities, including challenges in implementing ethical principles and ensuring continued participant care. Significant gaps and inconsistencies in post-trial support, particularly in low resource settings were identified.

Conclusion: The findings highlight the urgent need to re-evaluate and improve post-trial participant care within clinical research. The study advocates for the development of strong support mechanisms, equitable distribution of research benefits, and enhanced ethical oversight to uphold participants' rights and welfare. These insights contribute to advancing bioethics and promoting a research environment that prioritizes ethical considerations and participant well-being.

post-trial participant care

ethical obligations

clinical research

equitable distribution of benefits

In the rapidly evolving field of medical research, ethical responsibilities extend beyond the active phase of clinical trials, encompassing the post-trial period where participants' continued care and rights must be considered. Research Ethics Committees (RECs) and researchers bear the ethical duty to protect participants, not just during the trial but also once it concludes. Ethical frameworks, including the Belmont Report (1979) and the Declaration of Helsinki (2013), emphasize the importance of maintaining ethical integrity throughout the research process, including post-trial obligations (World Medical Association, 2013).

The principles of beneficence and non-maleficence underscore the ethical challenges participants face, particularly in resource-limited settings where trial interventions, although effective, often become inaccessible post-trial, potentially leading to negative health outcomes (Millum, 2011). The principle of justice highlighting fairness and equitable treatment further stresses the need for researchers and sponsors to ensure participants benefit from their involvement, extending beyond the trial's completion (Beauchamp and Childress, 2013). Yet, applying these principles in practice remains a source of debate and inconsistency within the research community (Murray, 2007).

Existing literature highlights the importance of sustained support and post-trial care. However, significant gaps remain in how these ethical considerations are applied (Jansen and Hirst, 2018). Studies conducted by Haire and Jordens (2015), Mwangi et al, (2024), and Sofaer et al. (2014), reveal significant disparities in post-trial care, particularly in low- and middle-income countries (LMICs), where healthcare resources are often limited. This research seeks to explore the perspectives of RECs and researchers regarding post-trial obligations, contributing to a deeper understanding of ethical research practices and the potential for improving bioethical standards in clinical trials (Smith and Brown, 2019; Mastroleo, 2016).

By examining the intersection between ethical theory and research practice, this case study aims to provide new insights into the ethical complexities of post-trial participant care. It also proposes strategies to enhance post-trial responsibilities, thereby advancing ethical standards in medical research.

Research Design

This study employs a qualitative phenomenographic research design, to explore the complexities of ethical considerations surrounding post-trial obligations in clinical trials. This approach was selected for its capacity to illuminate the intricate roles of Research Ethics Committees (RECs) and researchers in safeguarding participant welfare after the trials conclude. Phenomenography is well suited to this study as it emphasizes understanding individuals’ lives and experiences (Smith et al., 2009), allowing for an in-depth exploration of the ethical dimensions that shape post-trial practices.

Study Setting and Population

The research was conducted in Tanzania, a country with a rich history of clinical trials, particularly in HIV research. The study engaged a diverse group of stakeholders, including members of REC, and researchers. This context is characterized by over twenty years of hosting externally funded clinical research and numerous publications stemming from these studies.

Data Collection

Data were collected through in-depth interviews with researchers and through a focus group discussion (FGD) with REC members. In -depth interviews were conducted in person in a private location chosen by the participant, while the FGD was conducted in a private room at one of the institutions. All interviews and discussions were audio-recorded with participants' consent. The interview guide was developed based on existing literature on bioethics and post-trial responsibilities, and it was piloted with a small group of stakeholders to refine questions for clarity and relevance (Kvale and Brinkmann, 2009).

Data Analysis

All recorded interviews and FGD were transcribed verbatim, and translated into English where necessary.Thematic analysis was employed following Braun and Clarke’s (2006) six-step framework: familiarization with the data, coding, generating themes, reviewing themes, defining and naming themes, and writing up. This approach enabled the identification of recurrent patterns related to ethical considerations in post-trial care and the responsibilities of RECs and researchers. NVIVO 12 software was used to manage and code the data systematically, ensuring a rigorous and transparent analytical process (QSR International, 2020).

Ethical Considerations

Ethical approval for the study was obtained from College Research Ethics Review Committee (CRERC). All participants provided written consent prior to participation. The study adhered to the ethical principles outlined in the Declaration of Helsinki (World Medical Association, 2013), including respect for participants' autonomy, confidentiality, and the right to withdraw from the study at any time without penalty. Participants were assured that their responses, would remain confidential respecting the right not to disclose demographic details. Consequently, all information was anonymized to protect participants’ privacy.

Validation of findings

To enhance the credibility and validity of the findings, peer debriefing sessions and discussions with colleagues were conducted. These sessions provided an opportunity to gain diverse perspectives on the data analysis process, ensuring a more comprehensive interpretation of the findings. The collaborative approach also helped to identify potential biases and strengthen the overall validity of the results.

In general, both REC members and researchers admitted to never having contemplated the fate of participants beyond a trial, concurring that this oversight represents a neglected area warranting attention. Below are themes emerging from these discussions.

Global perspectives and interconnectedness of health issues

REC members provided insights into motivation and perspectives of the individuals driving clinical research. According to them, clinical research primarily focuses on drug development with a global outlook and a commitment to ethical principles including adherence to consent procedures and regulations. They noted a predominant emphasis on drug-related studies, especially in the context of global health crises.

Excerpt from a focus group discussion:

Interviewer: What are the reasons for conducting research?

RECM 3: “There are clinical reasons and mainly have been in relation to drugs. I haven’t seen much of vaccine”

RECM 4: “It is for clinical purposes not much on vaccine”

Another REC member expanded on this highlighting the importance of ethical considerations and responsible research conduct:

RECM 2: “I think research is all about protecting the end- users globally. While it’s a global endeavor adherence to ethical guidelines is crucial”

Funding sources and research priorities

REC members emphasize the diverse, funding landscape for research with significant contributions from external funders including pharmaceutical companies, foreign institutions and Non-governmental institutions (NGOs). They highlighted the reliance on government funding for oversight and support, particularly in the context of clinical trials.

The importance of government involvement was emphasized as essential to ensure ethical standards, protection of participants, and regulation of research practices.

Excerpt from a FGD

Interviewer: Who funds research?

RECM 1: There are a lot of funders… I think D is one of them

RECM 2: Most of them are external funders

RECM 6: Generally, it depends. it can be sponsored by a pharmaceutical company

RECM 4: Even donors from outside

RECM 7: Mainly funded from outside

RECM 5: Majority are funded by NGOs” (Non-governmental Organizations)

Interviewer: What about Government?

RECM 5: For clinal trials, the government are not experienced much

RECM 3 “I think the government…. (thinking).. I don’t think you can run a clinical trial without notifying the government because if anything goes wrong (silence) …anybody can come and do a clinical trial. Yes, the government is very crucial”

The role of the government was found to be crucial, particularly in terms of setting guidelines, ensuring ethical standards, and safeguarding the well-being of participants. Engaging in a clinical trial involving human participants to evaluate efficacy of medical interventions carries the risk of producing unfavorable outcomes, and in the event of such negative results, there is a need for protection mechanisms. A member REC member highlighted:

RECM 3 “A clinical trial can bring bad results so that if things go wrong, there will be protection and it must be accepted by the government. The government has very important arm”

Who benefits from research?

The discourse of research particularly within the context of bioethics, unveils a complex interplay of interests and priorities. The reservations voiced by REC members and researchers highlights a pressing concern: despite the financial support from external funders, the tangible advantages of research may not directly reach the local population involved in the trials. This skepticism becomes pronounced in cases where new drugs tested on a small population within Africa, prompting doubts about the adequacy of the sample in representing the diverse potential users. Notably, there exists skepticism regarding the direct benefits of research directly reaching to local population where trials are conducted. Both REC members and researchers have pointed out that, despite support from external funders, the ultimate beneficiaries may not necessarily be the individuals within the community.

Excerpt from a researcher:

Interviewer: Who do you believe benefits most from clinical research?

“I do not think we do benefit because at the end of the day they [external funders] will test the drugs on small population but at the end of the day the drug will not be used in Africa for nearly 10 years so the one who benefits more is the funder” (Researcher).

However, there were mixed reactions among the study groups with some feeling there are benefits for everyone. A researcher stated:

Researcher: “I think all benefit. For example, the participant will benefit by getting medicine. The government also benefits somehow”

The indispensable nature of research in navigating the complexities of medical treatment, facilitating the transition towards safer and more efficacious therapeutic strategies was observed. By nurturing a culture of continuous inquiry, and innovation, this REC member demonstrated how research not only identifies problems but also drives solutions, ultimately enhancing patient care and treatment outcomes.

RECM: “Research has many benefits, because research will enable us to discover new drugs but also to discover drugs that cause harm and many drugs have been removed from research. I remember when we entered chronic tuberculosis, the first approved drugs were injections, the injections were very harmful to the kidneys and were used for about two years and after the report from the research on the side effects that occur, the drugs have been removed, so now the drugs used are pills”

One key issue raised is the perceived delay or limited accessibility of the benefits of research for the local population where the trials are conducted. The sentiment is shared that the primary beneficially of the research seems to be the external funder rather than the community it aims to serves, raising fundamental questions about the equitable distribution of benefits and the genuine impact of research on the well-being of the local population.

“Research brings something new. Beneficially is both sides i.e. communities and participants and country at large. internationally, we are recognized as researchers” (Researcher)

Balancing the interest of researchers, funders and participants

A discrepancy in the negotiation of benefits was highlighted by both researchers and REC members. They suggested that researchers should negotiate for benefits, but they currently do not, emphasizing that if funders benefit for more than 15 years, the families of the participants should also have a way of benefitting.

“For me, I would recommend that the participants involved should also get economic benefits at the end of the day because the funders will benefit for 15 years to come, so the family should have a way of benefiting.” (Researcher)z

Who should negotiate?

The necessity of ensuring benefits for both funders and participants involved in the study indicates the importance of fairness and equity in resource distribution, recognizing the contributions of community members. Both REC members and researchers highlight a commitment to social justice and acknowledge the valuable role played by individuals beyond providing financial support

Both REC and researchers had a common responsory that indicated that although they should negotiate for the profits beyond the trials, they rarely did it. The words of this researcher appeared to sum up representing may others out there:

Researcher: For me I would recommend that the partcipants involved should also get economic benefits at the end of the day because the funders will benefit for 15 years to come so the family should have a way of benefits

Post-trial responsibility

According to both REC members and researchers, post-trial responsibility is a neglected area. Members lamented the pervasive influence of financial considerations, with experimental drugs raising worries about long-term-effects on individuals. REC members express a sense of powerlessness and frustration leading to a perceived lack of thorough evaluation and potential adverse consequences for participants in clinical trials.

Excerpt from a REC member:

Interviewer: What is the researcher‘s obligation after the trial has ended? Do you have any exit plans for participants after a clinical trial?

RECM: Let me be honest with the truth; after this discussion, I don’t know where this information is going. But in my personal experience this is an area that is neglected. I am the lead but I have never seen it….. If a drug is on trial and we said it is ok , and then 3 years down the line it affects participants! I feel bad about it but what can you do?

Post-trial participant support

There is lack of clear exit plans for participants after a clinical trial has been completed. However, while there may be progress reports provided to the REC, there are no formal or structured procedures in place for participants post-trial care or follow-up. As indicated in the response from different REC members, this lack of support contrasts with the focus on participant protection during the trial itself, highlighting a gap in the ethical oversight of clinical trials.

Excerpt from a focus group discussion

Interviewer: Do you have any exit plans for participants after a clinical trial?

1: No apart from progress report

5: No there isn’t. They just say that the study has completed the enrolment.

2: We are good in protection of participants during the trial but after that…nothing really….

4: ….and its not the way we should do things

Community engagement as an ethical obligation for post-trial support

The responses below echo sentiments that researchers have a duty to actively contribute to community betterment through the sharing of insights and the promotion of preventive measures. Some researchers articulated the viewpoint that researchers must not merely collect data and depart. Instead, they assert that researchers should provide feedback to the community and offer educational sessions focusing on preventive measures.

Reflecting on personal experiences, some researchers expressed a commitment to reflect this by prioritizing feedback to community in subsequent research endeavors. Others, in contrast acknowledged a lapse in community engagement observing a lack of substantial action beyond the presentation of research benefits:

Excerpt from the group discussion:

Interviewer: What do you think should happen on exit?

For me I think he or she [Researcher] should give report to community and provide education on how to prevent himself ..they should not just take their data and off they go (R6)

“From the study I did, I discovered later I was supposed to go to the community but I didn’t because I did not have finances but now, I will provide feedback from the community” (R2)

“I didn’t do anything. I just went there [to the community], told them the benefits then taking my data and off I went” (R7)

Follow up post-trial and transition back to standard care

Both researchers and REC members expressed uncertainty about follow-up process, indicating a potential neglect of this aspect in their personal experiences. They highlight a perceived issue of prioritizing financial gain over well-being, expressing concern about the consequences if a drug used in the trial negatively affects individuals later on. This is particularly in case of effectiveness and safety, where a participant after a trial is over has to shift back to their previous medication regime:

“The study has a duration that it has ended and they will be given medication similar to that of the study. They say that they will take them back to original medication” (R1)

Providing solution of post trial challenges: views from REC

REC members see the importance of establishing a dedicated team to address post-trial challenges. Ideally, the REC members feel this team should be formed immediately after a trial phase concludes and this should be outlined in the protocols failure to which would have detrimental consequences similar to a ‘gift of death’. Participating in discussions about post-trial challenges is seen as an eye opener for REC members, highlighting areas where improvement is necessary for more effective oversight. This is reflected in the response on how REC can deal with post-trial challenges.

Excerpt from FGD

1: There must be a team to sit right after research. I think that that REC should put it in the proposal

7: It is well clearly stated that the REC should follow up the entire process. If it is not indicated in the proposal, it could be like giving a gift of death

3: Sorry to wash my dirty linen in public but if it is to help the committee to improve. We must improve.

REC3: I can see how this discussion can be used to improve the RECs

REC 2: I think these are good things to talk. Some things are being put under the table so you must be able to look into it”

REC 4: It was an eye opener to be exposed to answer these questions without preparation”

REC 1 “When this study is done and finished, we shall benefit as a committee. It is self critique and will help us a lot to improve our house”

Post-trial Participant Care: Ethical obligations and practical challenges

Ethical responsibilities

Post-trial participant care is a critical aspect of ethical conduct in clinical research, yet it often remains insufficiently addressed (Miller & Joffe, 2016). This study, alongside existing literature, highlights the significant gap, between ethical guidelines and their practical implementation particularly in low resource settings (Levine et al., 2022; Taylor & Merritt, 2021; Mwangi et al., 2023) . Despite frameworks such as Belmont report and the declaration of Helsinki emphasizing the need tor post-trial care, real world applications frequently fall short, leaving participants vulnerable once trials conclude (Miller & Joffe, 2016, Emanuel & Menikoff, 2011). Our findings echo these concerns, highlighting the need for strong post-trial care protocols, especially in low resource settings.

Balancing interests of funders, researchers, and participants

The reliance on external funders, particularly pharmaceutical companies and international institutions, complicates the equitable distribution of research benefits. Although these trials may significantly benefit global health, the direct advantages to local populations, who often bear the research burden are minimal raising concerns about equity and fairness (Kim et al., 2023; Chalmers & Glasziou, 2009) This study along with recent literature highlights the need for more equitable distribution of research benefits ensuring that local participants who contribute to these trials receive tangible long-term advantages (King et al., 2004 2004; Moher et al., 2020).

Government oversight and participant protection

Effective government oversight is essential for maintaining ethical standards in clinical research. Recent research indicates that stronger regulatory frameworks and governmental support can enhance the ethical review process, ensuring that research practices comply with established guidelines (Larkin et al., 2021; World Health Organization, 2016). Our study suggests that in many low-income settings, the absence of strong government oversight contributes to the gaps in post-trial care, making the need for comprehensive regulatory frameworks more pressing (Institute of Medicine, 2003).

Lack of clear post-trial plans

Our study identified the lack of clear exit strategies and follow-up procedures for participants as a critical deficiency in post-trial care. This finding aligns with recent critiques that emphasize the necessity of a well-defined post-trial plans to prevent ethical lapses and exploitation (Emanuel et al., 2000; Buchanan & Keane, 2022). Enforcing strict adherence to these guidelines and developing specific strategies should be prioritized to safeguard participants well being.

Community engagement and feedback

The importance of community engagement in clinical research has gained increasing attention in recent years. Researchers have an ethical obligation to engage with communities not only during the trial but also after its conclusion, providing post-trial, providing feedback on outcomes and ensuring ongoing support (Folayan et al., 2015; Pratt et al., 2017). However, our findings consistent with other studies, reveal insufficient community engagement can undermine the ethical integrity of research, necessitating a greater focus on this area (McGowan et al., 2022).

Implications for future rsearch and practice

Our study suggests several recommendations for enhancing ethical practices in clinical research, echoing recent calls for reform. These include the need for improved regulatory frameworks, better governance structures and increased transparency in the negotiation of post-trial benefits (Kim et al., 2023; Larkin et al., 2021). Establishing dedicated teams to address post-trial challenges and ensuring equitable distribution of benefits among participants are crucial steps for advancing the integrity of clinical research (Miller & Brody, 2003; Council for International Organizations of Medical Sciences, 2016).

This study highlights the pressing need for a comprehensive re-evaluation of post-trial participant care in clinical research, particularly within the context where local populations and patients may be vulnerable to exploitation. Our findings reveal significant gaps in current practices, including the lack of clear exit strategies and post-trial support, inadequate negotiation of participant benefits, and limited government oversight. Addressing these issues is crucial for fostering a research environment that prioritizes participant welfare and upholds the highest ethical standards. Meaningful progress, requires collaboration among researchers, funders, and regulators to implement the recommendations outlined in this study. By doing so, clinical research can more effectively contribute to global health while ensuring that the rights and well-being of participants are protected and respected.

Study limitations

The findings may not be generalized to all other research ethics committees. Therefore, future research should incorporate broader range of perspectives and empirical data to inform ethical debates in these contexts.

Areas for future research

Future research should focus on examining the long-term impact of clinical trials on participants' health and well-being, ensuring equitable distribution of research benefits, and developing strong post-trial support mechanisms. Additionally, exploring effective community engagement strategies, assessing the ethical implications of various funding sources, and strengthening the oversight roles of research thics Committees and government bodies are essential areas that warrant further investigation. Addressing these issues will contribute to advancing ethical standards in clinical research and promoting greater health equity globally.

Clinical trial number: Not applicable

Ethical approval and consent to participate

The study was reviewed and approved by the College Research Ethics Review Committee (reference number: 2506).

Involvement of animals and human tissue: Not applicable

All processes in this study involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration.

Participants were fully informed about the purpose of the study, potential risks and benefits. Written consent was obtained prior to their participation. All data were anonymized to protect participants confidentiality

Consent for publication

Not applicable

Availability of data materials

The data generated and analyzed during the current study are not publicly available due to the sensitive nature of the data and the need to protect participant confidentiality in accordance with ethical guidelines. However, the raw data are available from the corresponding author on reasonable request, provided that the requester obtains the necessary ethical approvals and adheres to confidentiality agreements.

Any requests for data should be directed to Rose Mwangi, the corresponding author: [email protected] . Access will be granted following approval from the College Research Ethics Review Committee (CRERC) of the Kilimanjaro Christian Medical University College.

Ccompeting interests

The authors declare no competing interest

Funding This study was undertaken as part of self-sponsored PhD. Research, without any dedicated external funding

Authors’contributions

RM significantly contributed to the conceptualization and design of the study, the development of research tools, data acquisition, data analysis, and the composition of the manuscript.

SM played a crucial role in the thorough review and refinement of research tools, the analysis and interpretation of data, as well as revision the manuscript.

BM made substantial contributions to in methodological aspects of the study, and critical and revision of manuscript versions .

RNM provided comprehensive supervision and mentorship throughout the study, starting from its initial conception to the final manuscript.

Acknowledgments

I would like to express my deepest appreciation for the support of my mentors, co-authors, peer reviewers and colleagues for making this manuscript possible. I extend my thanks to Kilimanjaro Christian Medical University College for providing access to necessary research facilities and resources, which have greatly facilitated the progress of this study.

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No competing interests reported.

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Unspoken obligations: Perspectives on Post-Trial Responsibilities from a Tanzanian Research Ethics Committee and Researchers

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Ethical Considerations

Results

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