Protecting Human Research Participants: Select Quiz Questions

For research involving pregnant women, it is essential to consider the risks and potential benefits for both the fetus and the pregnant woman. This is because any research intervention or procedure may have potential implications for the health and well-being of both the mother and the developing fetus. Therefore, it is crucial to thoroughly evaluate the potential risks and benefits before involving pregnant women in research studies to ensure their safety and well-being.

The term "systematic investigation designed to develop or contribute to generalizable knowledge" refers to a process that follows a structured approach to gather information and generate new knowledge. Evaluation involves assessing the effectiveness or value of something, while research development focuses on creating new knowledge or improving existing knowledge. Testing involves conducting experiments or trials to gather data and validate hypotheses. Therefore, all of these activities contribute to the goal of developing or contributing to generalizable knowledge.

An individual may have diminished autonomy if they are a neonate, incarcerated or involuntarily confined, or unconscious. Neonates are not capable of making autonomous decisions due to their age and lack of cognitive abilities. Individuals who are incarcerated or involuntarily confined have their autonomy restricted by external factors such as legal constraints or confinement. Unconscious individuals are unable to exercise their autonomy as they are not conscious or aware of their surroundings. Therefore, all of the mentioned reasons can contribute to diminished autonomy in an individual.

The correct answer is "All of the above." The National Institutes of Health (NIH) has specific policies addressing the inclusion of children, women, and minorities in research. They also have policies regarding the treatment of research subjects in HIV/AIDS antiretroviral studies after completing trials in developing countries. These policies aim to ensure that research is conducted ethically and that diverse populations are included and treated appropriately in clinical studies.

All of the above options are appropriate methods for maintaining confidentiality of private information obtained from human subjects. Keeping data in a password-protected database ensures that only authorized individuals can access the information. Storing images in a secured cabinet adds an extra layer of physical security. Coding data or specimens and keeping the key to the code in a separate, locked drawer ensures that even if the data is accessed, it cannot be easily deciphered without the key. Therefore, all of these methods contribute to maintaining confidentiality effectively.

In research studies, it is important to have an authority other than the investigator determine if the proposed studies are exempt from regulatory requirements. This helps ensure unbiased decision-making and adherence to ethical standards. By having an institutionally designated authority involved in the process, there is an added layer of oversight and accountability. Therefore, the statement that an institutionally designated authority should determine if proposed studies are exempt from regulatory requirements is true.

The most influential event that led to the HHS Policy for Protection of Human Research Subjects was the Syphilis Study at Tuskegee. This study, conducted by the U.S. Public Health Service from 1932 to 1972, involved withholding treatment from African American men with syphilis, even after a cure became available. The study raised ethical concerns and led to public outrage when it was exposed in the media. As a result, the study prompted significant changes in research ethics and the establishment of guidelines to protect human subjects in research.

An "autonomous person" is someone who understands the risks and benefits of their participation in a study and is capable of making a voluntary decision if they are provided with adequate information. This means that they have the mental capacity to comprehend the potential risks and benefits, and they have the freedom to make their own choice without any external coercion or influence. It is important for individuals to be autonomous in research studies to ensure that their participation is truly voluntary and based on informed consent.

When informed consent information is presented orally, it is necessary to document it using a short form that affirms that all the required elements were presented verbally. This documentation ensures that there is a record of the consent process and that all the necessary information was provided to the individual. By documenting the use of a short form, it confirms that the oral presentation of the informed consent information took place and acknowledges that the individual had the opportunity to ask questions and understand the details before giving their consent. Therefore, the statement is true.

The correct answer is False. Even if a researcher determines that their study poses no more than minimal risk, it is still necessary for the protocol to undergo IRB review and approval. This is because ethical guidelines and regulations require all research involving human subjects to be reviewed by an IRB to ensure the protection of participants' rights and welfare. The determination of minimal risk by the researcher does not exempt the study from this requirement.

Children are required to provide assent in order to participate in research, unless the Institutional Review Board (IRB) determines that they are too young. Assent is the child's affirmative agreement to participate in the research, indicating their understanding of the study and willingness to take part. However, the IRB may decide that children of a certain age or cognitive ability are not capable of providing meaningful assent, in which case their participation would require alternative measures or be excluded altogether.

The regulations do not require that the informed consent process be delivered in a language that is understandable to the subject.

The statement is false because it is not ethical to use deceptive methods in research, even if the scientific goals can be achieved by non-deceptive methods. Deceptive methods involve misleading participants or providing false information, which violates the principles of informed consent and honesty in research. Researchers are expected to prioritize ethical considerations and ensure the well-being and rights of participants throughout the research process.

The Belmont Report is significant because it articulated ethical principles that formed the basis for the HHS Human Subjects Regulations. This means that the report provided a framework and guidelines for the protection of human subjects in research, ensuring that their rights and welfare are respected. It played a crucial role in shaping the ethical standards and regulations that researchers and institutions must adhere to when conducting research involving human subjects.

In this scenario, the correct answer states that individual informed consent is required in addition to the cultural norm. This means that even though community consent may be the norm in the localities, it is not enough for conducting research. The individual's explicit and informed consent is necessary to ensure that they fully understand the research study and voluntarily agree to participate. This requirement is in line with ethical principles and protects the rights and autonomy of each individual involved in the research.

The correct answer is Voluntariness, Comprehension, Disclosure. Informed consent requires that individuals voluntarily agree to participate in a study without any coercion or pressure. They should also have a clear understanding of the study's purpose, procedures, risks, and potential benefits. This comprehension ensures that participants can make an informed decision. Lastly, disclosure refers to the researcher's responsibility to provide all necessary information to the participant, allowing them to make an informed choice about participating.

The expedited IRB review process is not less stringent than review by the full IRB. In fact, the expedited review process is used for minimal risk research, which means that the level of scrutiny and oversight is still high, but the review process is faster compared to full IRB review. Therefore, the correct answer is False.

When reviewing research in a different geographical location and/or cultural context, IRBs have a responsibility to obtain knowledge of the local context. This can be done by talking to individuals who have traveled to the region and have direct knowledge of the local research context. Alternatively, the IRB can defer to another IRB that is situated within the local research context or ask specialists with direct knowledge of the local research context to participate in IRB discussions. Therefore, the correct answer is either option B or option C.

The statement is false because while 45 CFR 46 does require Federal Departments and Agencies to rely on IRBs to evaluate risks, protection, and potential benefits of research, it does not require them to rely solely on IRBs. Other considerations and evaluations may also be taken into account in the decision-making process.

Clinical equipoise refers to the state of scientific uncertainty where researchers are unsure which study intervention is superior to another. It means that there is genuine doubt or disagreement among the medical community regarding the comparative effectiveness of the interventions being studied. This concept is important in ethical research as it ensures that participants are not being exposed to unnecessary risks or harm when there is no clear evidence of one intervention being better than the other.

The statement is false because therapeutic misconception refers to the tendency of research participants to misunderstand the distinction between research and clinical care. It is not the investigators who mislead the participants about the research purpose, procedures, or benefits, but rather the participants themselves who mistakenly believe that they are receiving individualized therapeutic benefits from participating in the research.