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Chapter 10: Problem 9

y Who reviews? Government regulations requre that institutional review boards consist of at least five people, including at least one scientist, one nonscientist, and one person from outside the institution. Most boards are larger, but many contain just one outsider. (a) Why should review boards contain people who are not scientists? (b) Do you think that one outside member is enough? How would you choose that member? (For example, would you prefer a medical doctor? A member of the clergy? An activist for patients' rights?)

Short Answer

Expert verified
Non-scientists ensure ethical perspective. One outsider is minimal, more may enhance diversity and ethics. Outsider choice depends on research type.

Step by step solution

01

Understanding the Purpose

Institutional review boards (IRBs) are established to review research proposals to ensure ethical standards are met. Scientists may be experts in their field, but they may not always consider ethical implications as thoroughly. Having non-scientists, including outsiders, ensures diverse perspectives and encourages broader ethical considerations.
02

Why Include Non-scientists

Non-scientists provide a different viewpoint that helps in considering the societal and ethical impacts of research. Scientists might focus on research validity and methodology, while non-scientists emphasize human impact, ethics, and moral implications, ensuring a balanced review that protects research subjects and aligns with public interests.
03

Evaluating One Outsider's Sufficiency

While regulations require at least one outsider, the sufficiency of just one depends on the research context. One outsider can bring a new perspective, but with a diverse array of projects, more than one outsider might ensure that biases are minimized and the review process is more comprehensive.
04

Choosing the Right Outsider

Selecting the appropriate outsider depends on the context of the research. A medical doctor might be ideal for research involving medical ethics, while a member of the clergy could provide insight into moral or spiritual concerns. An activist for patients' rights would be important if the research involves vulnerable populations. The choice should align with the potential ethical issues in the research being reviewed.

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Key Concepts

These are the key concepts you need to understand to accurately answer the question.

Ethical Standards
Institutional Review Boards (IRBs) play a crucial role in upholding ethical standards for research involving human subjects. These standards are essential for ensuring that research is conducted responsibly and respects the rights and well-being of participants. When the IRBs review research proposals, they ensure that researchers adhere to key ethical principles, such as informed consent, confidentiality, and minimizing harm.
  • Informed Consent: Participants should be fully aware of the research's purpose, procedures, risks, and benefits before agreeing to take part.
  • Confidentiality: Protecting participants' privacy and personal information is vital.
  • Minimizing Harm: Researchers must take steps to prevent harm to participants and weigh the risks against the potential benefits of the research.
By upholding these standards, IRBs help maintain public trust in research practices and ensure that studies are conducted with integrity. Ethical standards prevent the exploitation of participants and ensure that the research contributes positively to society.
Non-Scientists in IRBs
Including non-scientists in Institutional Review Boards (IRBs) is essential to gain diverse viewpoints and an increased focus on the ethical and societal implications of research. Scientists, while experts in their fields, might prioritize scientific milestones over broader ethical and societal concerns. Non-scientists bring unique perspectives that emphasize the human aspect of research.
  • Diverse Perspectives: Non-scientists often consider the potential impact of research findings on society and individuals, facilitating a more rounded evaluation of ethical issues.
  • Public Interests: Non-scientists are likely to represent community views and public interests, ensuring that research aligns with societal values.
  • Balanced Discussions: Their involvement leads to discussions that balance scientific advancement with ethical responsibilities.
By incorporating non-scientists, IRBs aim to create checks and balances that enrich the ethical review process, providing a well-rounded assessment of research proposals.
Research Proposals
Understanding the process of reviewing research proposals is vital for ensuring the ethical conduct of studies involving human subjects. An effective proposal review by an Institutional Review Board (IRB) involves multiple steps to ensure that the research meets ethical standards. Firstly, a proposal should clearly outline the research objectives, methodology, participant recruitment processes, and data collection techniques. Next, the IRB examines whether the research is in compliance with ethical principles, such as minimizing harm and ensuring informed consent. This step also involves evaluating the qualifications of the researchers and resources to conduct the study safely. When selecting an outsider for the IRB, it's important that their expertise aligns with the potential ethical issues raised by the research. For example, for clinical trials, an outsider with experience in patient rights may provide valuable insights to protect participants. On the other hand, in social research, someone familiar with community concerns might better address societal impacts. Thus, the thorough evaluation of research proposals by the IRB not only ensures adherence to ethical standards but also fortifies the integrity of the research process, ensuring beneficial outcomes for society.

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Most popular questions from this chapter

Charging for data? Data produced by the government are often available free or at low cost to private users. For example, satellite weather data produced by the U.S. National Weather Service are available free to TV stations for their weather reports and to anyone on the web. Opinion 1: Government data should be available to everyone at minimal cost. European governments, on the other hand, charge TV stations for weather data. Opinion 2: The satellites are. expensive, and the TV stations are making a profit from their weather services, so they should share the cost. Which opinion do you support, and why?

The Willowbrook hepatitis studies. In the 1960 s, children entering the Willowbrook State School, an institution for the intellectually disabled, were deliberately infected with hepatitis. The researchers argued that almost all children in the institution quickly became infected anyway. The studies showed for the first time that two strains of hepatitis existed. This finding contributed to the development of effective vaccines. Despite these valuable results, the Willowbrook studies are now considered an example of unethical research. Explain why, according to current ethical standards, useful results are not enough to allow a study.

Coercion? U.S. Department of Health and Human Services regulations \({ }^{7}\) for informed consent state that, "An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence." Coercion occurs when an overt or implicit threat of harm is intentionally presented by one person to another in order to obtain compliance. Which of the following circumstances do you believe constitutes coercion? Discuss. (a) A researcher has developed a vaccine against a new virus. The researcher is recruiting healthy adult volunteers from an inner city to determine if the vaccine is safe in humans. Volunteers will be paid for their participation. One participant tells one of the research nurses that he would not have enrolled in the study, but he recently lost his job and needs the money. He claims that he feels as though he has no alternative but to participate. (b) A research nurse is asked to consent and provide samples for three minimal risk studies during her first week on the job. She is told "everyone working here is enrolled in these studies."

Studying your blood. Long ago, doctors drew a blood specimen from you as part of treating minor anemia. Unknown to you, the sample was stored. Now researchers plan to use stored samples from you and many other people to look for genetic factors that may influence anemia. It is no longer possible to ask your consent. Modem technology can read your entire genetic makeup from the blood sample. (a) Do you think it violates the principle of informed consent to use your blood sample if your name is on it but you were not told that it might be saved and studied later? (b) Suppose that your identity is not attached. The blood sample is known only to come from (say) "a 20-year-old white female being treated for anemia." Is it now okay to use the sample for research? (c) Perhaps we should use biological materials such as blood samples only from patients who have agreed to allow the material to be stored for later use in research. It isn't possable to say in advance what kind of research, so this falls short of the usual standard for informed consent. Is it nonetheless acceptable, given complete confidentialiry and the fact that using the sample can't physically harm the patient?

Sunshine Laws. All states in the United States have open records laws, sometimes known as " Sunshine Laws," that give citizens access to government meetings and records." This includes, for example, reports of crimes and recordings of 911 calls. A crime report will include the name of anyone accused of the crime. Suppose a 10-year-old juvenile is accused of committing a crime. A reporter from the local newspaper asks for a copy of the crime report. The sheriff refuses to provide the report because the accused is a juvenile and he believes the name of the accused should be confidential. Is this an issue of confidentiality? Discuss.
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