Module 1 : Research Ethics

Participants must know all the potential benefits and harms of the study before it begins in order to give informed consent. This ensures that they are aware of the potential risks and benefits involved in participating and can make an informed decision about whether or not to take part. It is an important ethical requirement in research to ensure that participants are fully informed and have the necessary information to make a decision about their participation.

Research activities involving human subjects must be approved by an Institutional Review Board (IRB) before they can be conducted. The IRB ensures that the research is ethically conducted, protects the rights and welfare of the participants, and complies with relevant regulations and guidelines. This approval process is important to ensure that research involving human subjects is conducted in a responsible and ethical manner. Therefore, the statement "Research activity must be approved by Institutional Review Board (IRB) before any work can be performed" is true.

IRB stands for Institutional Review Board, which is responsible for reviewing and approving research studies involving human participants. This board ensures that the study is ethical and protects the rights and welfare of the participants. Therefore, it is necessary for all primary studies to be approved by the IRB before they can be conducted. CDC (Centers for Disease Control and Prevention) is a government agency that focuses on public health, NCBI (National Center for Biotechnology Information) is a database of biomedical and genomic information, and PROSPERO is an international database of prospectively registered systematic reviews. None of these entities are directly involved in the approval of primary studies.

Participants are not required to provide study staff with a good reason in order to withdraw from the study. It is their right to withdraw at any time for any reason, and they do not need to justify their decision. This is important to ensure participant autonomy and protect their rights in research studies. Therefore, the given statement is false.

The statement is true because conducting a clinical trial comparing two therapies when there is already clear evidence that one therapy is superior to the other would be unethical. It would be unethical because it would expose participants in the trial to unnecessary risks and potentially deny them access to the superior therapy. In such cases, it would be more appropriate to provide the therapy that has already been proven to be superior to all participants.

The principle of "maintaining autonomy for all potential and current study participants" aligns with the basic ethical principle of person respect. This principle emphasizes the importance of respecting the autonomy and dignity of individuals, ensuring that they have the right to make informed decisions about their participation in research. It promotes the idea that individuals should be treated as autonomous agents, capable of making their own choices and having their own values and preferences respected.

Individuals who have not shown improvement with existing treatment options for their condition are not required to enroll in a clinical trial. Clinical trials are voluntary and individuals can choose to participate if they meet the eligibility criteria and are interested in exploring new treatment options.

Giving a placebo should be prohibited if an effective treatment is existing because it is unethical to deceive patients and withhold a proven treatment. Placebos are typically used in clinical trials where there is no known effective treatment available. However, if there is an effective treatment already established, it would be considered unethical to give a patient a placebo instead of the known treatment. Patients have the right to receive the best available care and withholding an effective treatment would go against this principle.

Participants should not be required to give written permission to withdraw from a study. Informed consent is an ongoing process, and participants have the right to withdraw at any time without providing written permission. This is to ensure that participants have the freedom to make decisions about their involvement in the study and to protect their rights and well-being.

Investigators are not free to share study identifiable data with their collaborators. This is because study identifiable data contains sensitive information about the participants, and sharing it without proper consent or safeguards can violate privacy and confidentiality. Researchers must follow ethical guidelines and obtain appropriate permissions before sharing any identifiable data with collaborators.