Ethical Issues in Collaborative Research
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Ethical Issues in Collaborative Research – Module 6- DE Costea
Case study
You are part of a research team working on a collaborative project investigating the effectiveness of a new medical treatment for a rare tropical disease. The research involves multiple institutions, including academic researchers, pharmaceutical companies, and healthcare providers. Some team members have financial ties to the pharmaceutical companies involved in developing the new treatment.
What ethical dilemmas could you foresee will arise?
There are several ethical aspects to discuss here:
1. Conflict of Interest: Some team members have financial ties to the pharmaceutical companies involved in developing the new treatment. This raises concerns about potential conflicts of interest that could influence research design, data interpretation, and reporting of results.
2. Informed Consent: Participants in the research study are patients with the rare disease who may be desperate for treatment options. Ensuring that they fully understand the risks, benefits, and alternatives to participation in the study is critical. However, the complexity of the medical information and the urgency of the situation may pose challenges to obtaining truly informed consent.
3. Data Sharing and Transparency: The pharmaceutical companies involved in the research have proprietary interests in the new treatment. Balancing the need for transparency and data sharing with the companies’ intellectual property rights presents ethical dilemmas regarding how much data should be disclosed to the public and research community.
4. Equitable Partnerships: There are power imbalances among the collaborators, with academic researchers holding more influence and resources compared to community organizations or patient advocacy groups. Ensuring equitable partnerships and meaningful involvement of all stakeholders in decision-making processes is essential for the ethical conduct of the research.
5. Community Engagement: Engaging with patient communities and advocacy groups is crucial for the success of the research and the ethical integrity of the project. However, differing priorities, expectations, and levels of expertise among stakeholders may complicate efforts to effectively involve them in the research process.
*Please let your reflections/questions/comments related to the cases for discussion in the box bellow.
9 thoughts on “Module 6”
What ethical dilemmas could you foresee will arise?
there are many ethical issues such as conflicts of interest, including financial
interests ,professional affiliations that could influence the
research. all that require to establish procedures for reviewing and managing conflicts of interest, such as recusal
from decision-making processes or the appointment of independent reviewers.
to monitor and periodically reassess potential conflicts of interest throughout the research
project, especially in cases where circumstances may change over time.
Informed Consent: require Ensure that all team members receive training on obtaining informed consent and adhere
to ethical guidelines and regulatory requirements.
• Provide opportunities for participants to ask questions and seek clarification before
consenting to participate.
Data Sharing and Transparency: all team members should to establish data management plans outlining how data will be collected, stored, analyzed,
and shared within the research team.
• Implement secure data storage and transfer protocols to protect the confidentiality and
integrity of research data.
Equitable Partnerships: : collaborative research should be conducted in a manner that
promotes fairness and equity among all partners. This involves recognizing and valuing
the diverse expertise, perspectives, and contributions of each collaborator, regardless of
their status or affiliation.
Community Engagement: needs to prioritize active listening, dialogue, and collaboration with stakeholders to understand
their perspectives, needs, and priorities.
• Implement mechanisms for feedback, consultation, and co-creation of research
objectives, methodologies, and outcomes with stakeholders.
• Ensure equitable distribution of benefits and outcomes from the research to the
communities and stakeholders involved, including opportunities for capacity-building
and knowledge exchange.
we need more examples and cases
What ethical dilemmas could you foresee will arise?
there are many ethical issues such as conflicts of interest, including financial
interests ,professional affiliations that could influence the
research. all that require to establish procedures for reviewing and managing conflicts of interest, such as recusal
from decision-making processes or the appointment of independent reviewers.
to monitor and periodically reassess potential conflicts of interest throughout the research
project, especially in cases where circumstances may change over time.
we need more examples and cases
1- conflict of interest:
Collaborators should disclose any potential conflicts of interest that could influence the research process or outcomes. Transparent management of conflicts will ensure the integrity and credibility of the research findings.
2- Data Sharing and Ownership
Agreements regarding data sharing,
ownership, and intellectual property rights should be established early in the
collaboration. Clarity on these issues helps prevent disputes and ensures that
research data are used responsibly and for the benefit of society.
3- Ethical Review and Oversight by IRBs.
Measures done in conflict of interest
1- disclose potential conflicts of interest, including financial interests, personal relationships, or professional affiliations that could influence the research.
2- Establish procedures for reviewing and managing conflicts of interest, such as recusal
from decision-making processes or the appointment of independent reviewers.
3- Monitor and periodically reassess potential conflicts of interest throughout the research
project, especially in cases where circumstances may change over time.
Research Integrity and Misconduct
if there is a conflict of interest that was not disclosed could this be a misconduct act?
if so………
measures should be taken
1- Provide training and resources on research ethics, responsible conduct of research, and
good scientific practices to all team members.
2- Foster a culture of integrity, transparency, and accountability within the research team.
3- Establish procedures for reporting and investigating allegations of research
misconduct.
4- Encourage collaboration and peer review as mechanisms for ensuring the accuracy and
validity of research findings.
2. Informed Consent:
Ensuring that all team members obtain informed consent from research participants is essential, and ensuring that by:
1- Develop comprehensive informed consent documents that clearly explain the purpose, procedures, risks, and benefits of the research to participants.
2- Ensure that all team members receive training on obtaining informed consent and
adhere to ethical guidelines and regulatory requirements.
3- Provide opportunities for participants to ask questions and seek clarification before
consenting to participate.
4- Regularly review and update informed consent procedures to account for any changes
in the research protocol or participant population.
3. Data Sharing and Transparency
– Transparency and Accountability: Collaborators should be transparent about
their roles, responsibilities, and contributions to the research project. Clear
communication and documentation of agreements, protocols, and data-sharing
practices are essential to maintain accountability.
– Data Sharing and Ownership: Agreements regarding data sharing,
ownership, and intellectual property rights should be established early in the
collaboration. Clarity on these issues helps prevent disputes and ensures that
research data are used responsibly and for the benefit of society.
– Establish data management plans outlining how data will be collected, stored,
analyzed, and shared within the research team.
• Implement secure data storage and transfer protocols to protect the
confidentiality and integrity of research data.
4. Equitable Partnerships
Collaborative research should be conducted in a manner that promotes fairness and equity among all partners. This involves recognizing contributions of each collaborator, regardless of their status or affiliation.
5. Community Engagement:
Community Engagement and Stakeholder Involvement: Ethical considerations regarding
community engagement, stakeholder involvement, and benefit sharing should be integrated into team-based research. Ethical issues may arise if community perspectives, concerns, or priorities are marginalized or disregarded in the research process.
measurements to ensure that include:
1- Involve relevant stakeholders, including community members, policymakers, and
end users, in the research process from the outset through participatory approaches.
2- Prioritize active listening, dialogue, and collaboration with stakeholders to understand
their perspectives, needs, and priorities.
3- Implement mechanisms for feedback, consultation, and co-creation of research
objectives, methodologies, and outcomes with stakeholders.
4- Ensure equitable distribution of benefits and outcomes from the research to the
communities and stakeholders involved, including opportunities for capacity-building
and knowledge exchange.
Ethical dielmma here:
1conflict of interest due to the financial ties
2 transparency and disclosure it must to share foundation for transparency between team research member disclose financial ties and conflict of interest
3 research integrity: high ethical standards are demanded from researcher.
4 informed consent
5 regulatory compliance:to ensure ethical conduct through out the study