Clinical research undergoes constant changes with time as practices change. The profession has achieved best practices because of relationships among key players, their roles, and responsibilities. Some of the notable players in clinical trials include, research participants; research sponsors or Contract Research Organizations; government agencies and other affiliated institutions; regulators; the research team; and ethics committees (World Health Organization, 2002).
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It is important to note that several stakeholders may create complex challenges that could hinder teamwork approaches in clinical trials. However, it is the responsibility of all clinical trial stakeholders to share responsibilities and roles in order to ensure that they observe good clinical practices (GCPs). This article highlights roles and responsibilities of various stakeholders in clinical trials. It also explores research subjects’ roles and factors that might influence their decisions to take part in the study.
Clinical Research Trials Stakeholders
The Research Sponsor
The research sponsor is responsible for starting a clinical research study. Sponsors could be pharmaceutical or biotechnology firms that manufacture drugs or medical equipment. Sponsors could also be institutions of higher learning, governments, academics, and other institutions that deal with health issues.
Before these sponsors undertake any clinical trials or introduce new equipment and drugs, they must ensure that such new drugs and equipment are safe for human or animal consumption. Such drugs and equipment must demonstrate safety and efficacy when used. Hence, clinical investigation processes are necessary for such new drugs or equipment. However, research sponsors require other stakeholders in order to conduct these procedures and studies effectively.
The research team assists research sponsors with these roles and responsibilities. Study sponsors fund the research team to perform clinical research studies, but they must observe their roles during study processes. Some of these responsibilities and roles of the sponsor include the following:
- Developing clinical research protocols and guidelines
- Selecting appropriate and qualified investigators
- Providing research information related to benefits, risks, and selection criteria
- Ensuring that the study adheres to the study protocol
- Ensuring that the study adheres to all regulations and federal requirements
- The study must meet good research practices
A research team consists of several stakeholders, such as principal investigators (PIs); research coordinators; managers; laboratory technicians; analysts; research assistants; field recruiters and other stakeholders. However, the composition of the team depends on the type of study and expertise required.
The principal investigator is responsible for the entire research team and research processes. The PI must report to the sponsor on the study progress. One must recognize that every member in a team of researchers has specific roles and responsibilities. Overall, the research investigator must ensure that all elements of the study adhere to good clinical research practices. Some of the responsibilities of research team members include the following:
- The research team must ensure that the clinical research processes adhere to established protocol, regulations, and best practices in clinical research
- The team must obtain informed contests of all research participants. Participants can provide oral or written informed consents
- Researchers must protect rights of study participants and ensure safety and welfare of all research participants
- They must protect study materials
- The research team must observe and report any unexpected events to the research sponsor and ethics committees.
A research process is a collaborative process among all stakeholders. Researchers must work together with other bodies like IRB, sponsors, and the US Food and Drug Administration (FDA). All these stakeholders must collaborate in a study because of a common goal. All stakeholders require positive outcomes from the study.
The research team must collaborate with the IRB in order to ensure that the study remains ethical and protect rights, well-being, and safety of all research participants. Therefore, the research team must ensure that the research process is successful in order to get approval from relevant bodies. Regulatory bodies can never approve flawed study procedures and outcomes.
The FDA has the major role and responsibility of regulating all studies in order to protect research subjects. It protects the public by ensuring that “all drugs and medical equipment meet safety and efficiency standards” (Medpace Clinical Pharmacology, n.d). The agency must engage in a thorough evaluation of all study processes and outcomes in order to ensure safety and efficacy of drugs and medical equipment.
Research sponsors must submit all the necessary documents to the FDA for reviews. After a careful analysis of the study, the FDA may either approve or reject a study outcome. Apart from the review, the FDA must conduct a thorough audit process of all submitted projects.
Moreover, the process also involves inspection of the research process, including sponsors, IRB, and the research team. The FDA strives to ensure that all research stakeholders adhere to the best practices. Therefore, any malpractices or noncompliance may attract stiff penalties.
The Safety Team
The IRB has the responsibility of ensuring that clinical research studies meet established ethical standards. Hence, the major role of IRB is to protect human subjects in the study. Before any research begins, the IRB must ensure that the study meets and adheres to ethical standards and safety requirements.
The IRB must review the study protocol and guidelines in order to identify potential risks and benefits to research participants. Based on its findings, the board may approve or reject the study.
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In order to ensure absolute adherence to good practices, the IRB may perform several reviews at various points during the research process. If it notices any kind of noncompliance or unreasonable risks to research participants, then the body may order the research team and the sponsor to change their guidelines and protocols. In some cases, the IRB may terminate the study based on the level of violation detected.
The sponsor and the research team must note that any changes to the study protocol must get approval from the IRB. However, the team may only undertake such changes in cases of immediate potential risks to research participants. Even under such circumstances, the research investigator must inform the IRB about those changes in the study.
The investigator must coordinate and collaborate with the IRB during research processes. Although the roles and responsibilities of these stakeholders differ, they must work together in clinical trials. For instance, the IRB’s interest is in protecting study participants while the research team’s main purpose is to conduct the study. In this case, the research coordinator must meet all the FDA’s standards, and the IRB’s safety and ethical requirements in order to proceed with the study.
Clinical Research Coordinators (CRCs)
The CRC has a critical role to play among the site team members. The CRC works alongside the principal investigator. These roles and responsibilities include the following:
Capacity building is a critical role of the CRC. He or she must ensure that the sponsor selects a team of investigators. In this regard, the CRC assesses and reviews labor, support required, infrastructure, and training needs of investigators. Experienced CRCs different areas are the best for training new recruits.
The CRC also has clinical trial-related roles and responsibilities. He or she should identify the most suitable study site. Such sites should meet all criteria of the study as stated in the protocol. Experienced CRCs can easily identify the best site for another clinical trial because of their experiences. Such CRCs understand study requirements and optimum site conditions. The CRC must also conduct a thorough in-depth study of new sites in order to determine their suitability for the clinical trials.
The CRC ensures that all relevant documents and information are available for the study. These include the participant list, financial disclosure and requirement documents, and informed consent forms among others.
In case a research participant is not a native speaker of a given language, the CRC must make sure that he or she translates the informed consent form to the local language for the research participant.
The CRC must recruit and make follow up for research patients. In this process, the CRC must ensure that all study participants are satisfied with the research processes. He or she must coordinate all visits of participants.
The CRC ensures that all study materials are safe. He or she must account for all supplies and usages of materials. In addition, the CRC ensures that the team labels and stores all relevant samples appropriately before transportation.
In cases of any amendment to the study protocol, the CRC must ensure that implementation of such amendments only takes place after the IRB approval.
After the clinical trial face is over, the CRC must engage in other post-trial roles and responsibilities. For instance, he or she must review all the case report forms (CRFs) and ensure that all documents are safe and secure.
One must recognize that the roles and responsibilities of CRC are many, and they may cut across several departments associated with the study. Further, CRCs must manage research processes, data, and ensure that the study meets regulatory standards.
Research participants take part in the study as volunteers. However, several reasons may influence volunteers to join the study. According to Medpace Clinical Pharmacology, it is important for volunteers to participate in the study freely (Medpace Clinical Pharmacology, n.d). The term volunteer refers to “choose to participate not participate without compensation” (Medpace Clinical Pharmacology, n.d). Therefore, some research participants get compensation for their time and roles in the study.
The organization notes that one may be “forced, coerced, or enticed into participating by the desire to please one’s doctor, excess money, or misleading promises of a cure of an illness” (Medpace Clinical Pharmacology, n.d). These are wrong practices in clinical trials, which do not define a research participant as a volunteer.
Research participants must interact with the principal investigator in the process of reviewing the informed consent form. The process is critical for participants because they must understand details about the study in order to make informed decisions about taking part in the study. Volunteers use this process to understand all details about the study, its benefits, and risks. Volunteers should only decide to take part after the informed consent process.
Volunteers also have the responsibility of ensuring that they satisfy all research entry criteria. This is the inclusion and exclusion criteria in clinical trials. It defines the research terms and provides characteristics of people who should or should not take part in the clinical trial. The criteria could include age, weight, disease states, medication, sex, socio-economic background, and allergy among other factors. These selection criteria improve safety of participants.
One must recognize that every clinical trial has different rules. However, stakeholders strive to include participants from different groups (gender, race, sex, socio-economic, and ethnic groups) who may benefit from the clinical trial.
Factors that might influence research participants to take part in the clinical trial
The Center for Information and Study on Clinical Research Participation (CISCRP) conducted original research and identified the following factors among research participants as the most influential in decision-making processes (CISCRP, 2009):
- Personal relationships with the research team or staff influenced the decisions to take part and complete the study
- Several volunteers want to “take control of their health in a structured environment” (CISCRP, 2009). Participants want to participate in health challenges, but they cannot do so in their environments or in local conditions. The study protocol, guidelines, informed consent, and research team provide the best environments for such trials.
- Many participants engage in the study because they understand the study protocol and guidelines.
- Post-trial follow-ups influence others to take part in subsequent studies, especially when they get information about the study progress and outcomes.
CISCRP. (2009). Research Participant Concerns: Factors That Most Inform and Educate Clinical Research Participants. Web.
Medpace Clinical Pharmacology. (n.d). Study Participant Information: Participating in Medical Research with Medpace Clinical Pharmacology. Cincinnati, Ohio: Medpace CPU.
World Health Organization. (2002). Handbook for good clinical research practice (GCP): Guidance for implementation. Geneva: WHO the Office of Publications.