Which of the following brought increased public attention to the problems with the IRB system?

Which of the following brought increased public attention to the problems with the IRB system?

Which of the following brought increased public attention to the problems with the IRB system?

A. HHS Inspector General Report of 1998.
B. 1983 Presidential Commission Report.
C. “Shut Downs” by OHRP.
D. Death of Jesse Gelsinger.

Correct Answer: D. Death of Jesse Gelsinger.

Understanding the IRB System

The IRB system, or Institutional Review Board system, is an important aspect of research ethics that is designed to protect human subjects who participate in research studies. The IRB is a committee of experts who review research proposals to ensure that they meet ethical standards and do not cause harm to participants.

IRB System Description
Common Rule The Common Rule is a set of regulations that applies to all federally-funded research involving human subjects in the United States. It outlines the basic ethical principles for protecting human subjects, including informed consent, risk minimization, and confidentiality. The Common Rule was revised in 2018 to enhance protections for research participants.
Expedited Review Expedited review is a process by which certain types of research can be reviewed and approved more quickly than the standard review process. This may include research that involves minimal risk to participants or research that involves the collection of data from existing sources.
Full Board Review Full board review is the most rigorous review process for research involving human subjects. It involves a review of the research proposal by a panel of experts, who assess the risks and benefits of the research and determine whether it meets ethical standards. Full board review is typically required for research that involves vulnerable populations, invasive procedures, or significant risks to participants.
Informed Consent Informed consent is the process by which participants in a research study are fully informed about the nature of the study, including the risks and benefits, and provide their voluntary agreement to participate. Informed consent is a fundamental ethical principle in research involving human subjects, and is required by law in many countries.
IRB Approval IRB approval is the process by which a research proposal is reviewed and approved by an institutional review board (IRB) before it can begin. The IRB is responsible for ensuring that the research meets ethical standards and that the risks to participants are minimized. IRB approval is typically required for all research involving human subjects, regardless of funding source or location.
Minimal Risk Minimal risk refers to the level of risk that is no greater than that encountered in daily life or routine medical procedures. Research that involves minimal risk may be eligible for expedited review or exemption from full board review.
Vulnerable Populations Vulnerable populations are groups of individuals who may be at increased risk of harm or exploitation in research due to their age, health status, socio-economic status, or other factors. Examples of vulnerable populations include children, pregnant women, prisoners, and individuals with mental disabilities. Research involving vulnerable populations typically requires full board review and additional safeguards to protect participants.


Role of the IRB

The primary role of the IRB is to protect the welfare and rights of human subjects who participate in research studies. The IRB reviews research proposals to ensure that the study design is ethical and that the potential risks to participants are minimized. The IRB also ensures that the informed consent process is properly conducted, and that the research subjects have a clear understanding of what the study entails and any potential risks or benefits.


Composition of the IRB

The IRB is composed of a diverse group of individuals who have expertise in various fields, such as medicine, law, ethics, and social sciences. The IRB also includes community members who are not affiliated with the research institution. The IRB members are trained to evaluate research proposals and ensure that they meet the ethical standards set forth by the government and the research institution.

Proposal Review Process

Before a research study can begin, the study team must submit a proposal to the IRB for review. The proposal should include details about the study design, the population to be studied, the potential risks and benefits, and the informed consent process. The IRB then reviews the proposal to determine whether the study meets ethical standards.

Approval and Rejection of Proposals

If the IRB determines that the study is ethical and meets the required standards, it will approve the study. However, if the IRB determines that the study does not meet ethical standards or poses too great a risk to participants, it may require changes to the study design or even reject the proposal altogether.


Treat lifethreatening and severelydebilitating illnesses

There are various life-threatening and severely debilitating illnesses that require different types of treatments. Some common examples of such illnesses include cancer, heart disease, stroke, HIV/AIDS, multiple sclerosis, and autoimmune diseases.

The treatment for each of these illnesses may involve a combination of medications, surgery, radiation therapy, chemotherapy, immunotherapy, and other specialized treatments. The goal of treatment is to improve the patient’s quality of life, manage symptoms, slow down the progression of the illness, and in some cases, cure the illness altogether.

In addition to medical treatments, there are also various lifestyle modifications and complementary therapies that can help manage the symptoms of these illnesses and improve overall well-being. Examples of such therapies include exercise, yoga, meditation, massage, acupuncture, and nutritional support.


Recordkeeping and record retention

Recordkeeping is the process of maintaining a systematic and organized record of data and information that is generated or received by an individual, organization or business. Recordkeeping is essential for the efficient functioning of an organization, as it ensures that important information is properly documented, stored and accessible for future reference and use.

Record retention refers to the practice of retaining records for a specific period of time in compliance with legal, regulatory and business requirements. It is important to establish a record retention policy that outlines how long specific types of records should be kept and the methods for securely disposing of them once their retention period has expired.

Effective recordkeeping and record retention are important for several reasons:

  1. Legal compliance: Many laws and regulations require organizations to keep certain records for a specified period of time. Failure to comply with these regulations can result in fines, legal penalties, or other legal consequences.
  2. Business continuity: Records can serve as important evidence in legal disputes or audits, and can also provide valuable insights into an organization’s history, operations, and performance.
  3. Accountability and transparency: Records can help establish and maintain transparency and accountability, and can be used to track and monitor organizational performance, decisions, and actions.
  4. Knowledge management: Records can help organizations capture and retain knowledge, expertise, and intellectual property, which can be used to inform future decision-making and improve organizational efficiency and effectiveness.


Investigational use in laboratory research animals or NOT?

Investigational use in laboratory research animals is a common practice in many fields of scientific research. This involves using animals as models to study biological processes, develop new treatments or therapies, and test the safety and efficacy of drugs and other medical products.

However, the use of animals in research is a controversial topic, and ethical considerations should always be taken into account. In most countries, regulations and guidelines have been established to ensure that animal research is conducted in an ethical and humane manner, and that animals are used only when there are no alternatives available.

Before conducting research on laboratory animals, researchers are required to obtain ethical approval from an animal ethics committee or institutional review board. This approval process involves demonstrating that the research is necessary and that the animals will be treated in a humane manner with minimal pain and distress.

Additionally, researchers are required to adhere to strict guidelines regarding the care, housing, and handling of laboratory animals. This includes providing appropriate nutrition and housing conditions, monitoring animal welfare, and minimizing pain and distress during experimental procedures.


Research Act

The National Research Act is a United States federal law that was passed in 1974. The law was created in response to public concerns about ethical issues in research involving human subjects, particularly in the aftermath of the unethical experiments conducted by the Nazis during World War II and the Tuskegee Syphilis Study in the United States.

The National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was tasked with studying the ethical issues involved in human subject research and developing guidelines for the protection of human subjects.

The most significant outcome of the National Research Act was the creation of the Belmont Report, which established the three ethical principles that should guide research involving human subjects: respect for persons, beneficence, and justice.

The principle of respect for persons requires that individuals be treated as autonomous agents and that their informed consent be obtained for participation in research. The principle of beneficence requires that research be conducted in a way that maximizes benefits and minimizes harm to participants. The principle of justice requires that the benefits and risks of research be distributed fairly among participants.

The National Research Act also led to the creation of institutional review boards (IRBs), which are responsible for reviewing and approving research proposals to ensure that they comply with ethical guidelines for the protection of human subjects.


Clinical research trial

A subject in a clinical research trial is an individual who participates in a research study that is designed to test the safety and efficacy of new treatments or interventions for a specific disease or medical condition.

Clinical research trials are conducted in several phases, and subjects may be recruited to participate at any stage of the trial. Prior to enrolling in a clinical research trial, potential subjects are given detailed information about the study and its procedures, and they must provide informed consent before participating.

During the course of the trial, subjects may be required to undergo various medical tests and procedures, such as blood draws, imaging scans, and physical examinations. They may also be required to take study medications or follow specific treatment protocols.

The primary goal of clinical research trials is to gather scientific evidence about the safety and effectiveness of new treatments or interventions. By participating in a clinical research trial, subjects are helping to advance medical knowledge and contribute to the development of new treatments and cures for a wide range of diseases and medical conditions.


45 cfr 46 raised to regulatory status

45 CFR 46 is a set of regulations that govern the ethical conduct of research involving human subjects in the United States. These regulations, also known as the Common Rule, were first issued in 1981 and were later revised in 1991.

In 2017, the U.S. Department of Health and Human Services (HHS) issued a final rule to revise and modernize the Common Rule. The revisions, which took effect on January 21, 2019, updated several aspects of the regulations to reflect changes in the research landscape and to improve the protection of human subjects.

The revised Common Rule includes several changes, including:

  1. The expansion of the definition of “research” to include the collection of identifiable private information or identifiable biospecimens, even if the information or biospecimens are not being used for research purposes.
  2. The requirement for informed consent to include a concise and focused presentation of the key information that is most likely to help a potential subject understand the reasons why they might or might not want to participate in the research.
  3. The establishment of a single institutional review board (IRB) review process for multi-site studies.
  4. The elimination of the requirement for continuing review of certain categories of minimal risk research.
  5. The requirement for institutions to provide broad consent for the storage, maintenance, and secondary research use of biospecimens.


IRB approval

amendments involving changes to IRB-approved protocols do not need prior IRB approval if: the changes are considered minor and do not affect the overall scientific validity, ethical acceptability, or risk-benefit profile of the study.

The determination of whether an amendment requires prior IRB approval depends on the specific policies and procedures of the institution and the type of changes being made to the protocol. Some common examples of changes that may be considered minor and do not require prior IRB approval include:

  • Administrative changes, such as changes to the study personnel or contact information.
  • Minor changes to the study procedures or data collection instruments that do not affect the risk-benefit profile of the study.
  • Changes to the study timeline or budget that do not affect the scientific validity, ethical acceptability, or risk-benefit profile of the study.

However, if the changes to the IRB-approved protocol are more significant and could potentially affect the risk-benefit profile of the study, then prior IRB approval would be required before implementing the changes. It is important for researchers to consult with their IRB and follow their institution’s policies and procedures regarding amendments to IRB-approved protocols.

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