Research Ethics and Governance

Question 1

What does “normative ethics” refer to in the context of research?

Answer 1

Normative ethics refers to the classic consideration of “right vs. wrong” in research, and it suggests that not only researchers, but also members of society, publishers, taxpayers, and funding agencies should express concerns about research ethics.

Question 2

What does compliance refer to in the context of research ethics?

Answer 2

Compliance refers to adherence to specific guidelines, laws, and institutional policies, with different stakeholders like research institutions, regulatory bodies, and individual researchers expressing concerns in varying ways.

Question 3

What are the concerns of different stakeholders regarding compliance? (Research institutions, Regulatory bodies, Individual researchers)

Answer 3

Research institutions: Concerned about administrative burdens.
Regulatory bodies: Concerned about enforcing codes of conduct.
Individual researchers: Worried that compliance processes may slow down research.

Question 4

What is meant by rigor and reproducibility in research ethics?

Answer 4

Rigor and reproducibility refer to the quality of research that ensures it is scientifically sound, reproducible, and generalizable. (“Good science”). Everyone is a stakeholder because only rigorous and reproducible studies justify risks to participants.

Question 5

What does the social value dimension refer to in research ethics?

Answer 5

Social value refers to the importance of engaging multiple stakeholders, such as communities and funding bodies, to ensure that research questions align with societal priorities and offer real benefits to affected populations.

Question 6

Why is workplace relations considered a dimension of research ethics?

Answer 6

Workplace relations is important because poor work performance, staff turnover, or negative relationships between team members can undermine otherwise high-quality research.

Question 7

Flashcard 1: Voluntary Participation
Question (Hint: Participant’s freedom to choose)
What does voluntary participation mean in clinical research?

Answer 7

Voluntary participation means that participants must be informed that they are free to join or leave a research study at any time without any obligation. If incentives are offered, a research ethics committee (REC) must review them, and researchers cannot seek reimbursement if the participant decides to withdraw.

Question 8

Flashcard 2: Voluntary Participation - Incentives
Question (Hint: Leaving the study and incentives)
If a participant leaves the study early, can the researcher ask for reimbursement of the participation fee?

Answer 8

Answer:
No, researchers cannot pursue a participant for reimbursement of incentives if they choose to leave the study.

Question 9

Flashcard 3: Informed Consent
Question (Hint: Providing information)
What must participants be made aware of before giving informed consent in a study?

Answer 9

Answer:
Participants must be informed about the benefits, risks, outcomes, and any third-party interests involved in the study before agreeing to participate. Special attention is required for vulnerable individuals such as minors, pregnant women, or the mentally incapacitated.

Question 10

Flashcard 4: Vulnerable Persons and Informed Consent
Question (Hint: Special groups in consent process)
Who are considered vulnerable persons in clinical research requiring special considerations for informed consent?

Answer 10

Answer:
Vulnerable persons include pregnant women, terminally ill individuals, mentally incapacitated persons, minors, and prisoners.

Question 11

Flashcard 5: Confidentiality and Anonymity
Question (Hint: Protecting participant information)
What is the responsibility of researchers regarding confidentiality and anonymity?

Answer 11

Answer:
Researchers must ensure that participants’ data and personal health information (PHI) are either fully anonymized or kept confidential. If confidential, the data is accessible only to the researchers and anonymized for any third parties.

Question 12

Flashcard 6: Potential for Harm
Question (Hint: Types of harm to evaluate)
What kinds of harm must researchers evaluate in clinical trials?

Answer 12

Answer:
Researchers must evaluate both physical and psychological harm that participants might experience. Even in early-stage trials with limited safety data, the potential for harm must be minimized, and any adverse events must be reported immediately.

Question 13

Flashcard 7: Reporting Potential Harm
Question (Hint: Unexpected harm)
What should researchers do if unanticipated adverse events occur during a study?

Answer 13

Answer:
Researchers must immediately report any unanticipated adverse events to ensure the safety and well-being of the participants.

Question 14

Flashcard 8: Communicating Results
Question (Hint: Integrity in reporting)
What ethical considerations should researchers follow when communicating study results?

Answer 14

Answer:
Researchers must avoid plagiarism and misconduct, accurately report all results (even if they don’t support their hypothesis), and ensure that their findings are presented truthfully, regardless of the outcome.

Question 15

Flashcard 9: Results Unfavorable to Hypothesis
Question (Hint: Negative outcomes)
Should researchers report results that contradict their hypothesis or expectations?

Answer 15

Answer:
Yes, researchers have an ethical obligation to report results accurately, even if the outcomes are unfavorable to their original theory or hypothesis.

Question 16

Flashcard 1: The Nuremberg Code
Question (Hint: First ethical code)
What was the significance of the Nuremberg Code of 1947?

Answer 16

Answer:
The Nuremberg Code was the first set of standards for the ethical treatment of scientific research participants, developed in response to the inhuman treatment of prisoners in Nazi concentration camps. It emphasized that voluntary consent for participation “is absolutely essential.”

Question 17

Flashcard 2: Nuremberg Code - Voluntary Consent
Question (Hint: Participant choice)
What does the Nuremberg Code say about voluntary consent?

Answer 17

Answer:
The Nuremberg Code emphasizes that voluntary consent is “absolutely essential” for participation in scientific research.

Question 18

Flashcard 3: Nuremberg Code Impact
Question (Hint: Delayed effect)
Did the Nuremberg Code immediately influence the research community?

Answer 18

Answer:
No, the Nuremberg Code did not significantly impact the application of ethical principles until the 1960s and was even rejected by some in the research community at first.

Question 19

Flashcard 4: Declaration of Helsinki
Question (Hint: Ethical principles for clinical research)
What is the Declaration of Helsinki, and when was it first adopted?

Answer 19

Answer:
The Declaration of Helsinki is a set of ethical principles adopted by the World Medical Association (WMA) in 1964. It built upon the Nuremberg Code, introducing ethical standards specifically for clinical research.

Question 20

Flashcard 5: Declaration of Helsinki - Changes in Terminology
Question (Hint: Shift from “human experimentation”)
How did the Declaration of Helsinki differ from the Nuremberg Code in terms of terminology?

Answer 20

Answer:
The Declaration of Helsinki shifted from using the term “human experimentation” (used in the Nuremberg Code) to “clinical research,” reflecting a more modern and clinical approach to research ethics.

Question 21

Flashcard 6: Declaration of Helsinki - Consent Changes
Question (Hint: More flexible consent)
How did the Declaration of Helsinki change the approach to consent compared to the Nuremberg Code?

Answer 21

Answer:
The Declaration of Helsinki relaxed the strict “absolutely essential” requirement for consent in the Nuremberg Code, allowing for proxy consent from a parent or guardian when direct consent was not possible.

Question 22

Flashcard 8: Declaration of Helsinki - Legislative Status
Question (Hint: Moral obligation, not law)
Has the Declaration of Helsinki been adopted as law or regulation?

Answer 22

Answer:
No, the Declaration of Helsinki has not been adopted on a legislative or regulatory level. Instead, it serves as a moral obligation for physicians conducting clinical research.

Question 23

Question (Hint: Autonomy in decision-making)
What does the principle of “respect for persons” involve in bioethics?

Answer 23

Answer:
The principle of “respect for persons” involves treating individuals in a way that respects their autonomy in making medical decisions for themselves. It is commonly applied during the informed-consent process, where participants are given all necessary information to make an informed decision about their participation in a study.

Question 24

Question (Hint: Maximizing benefits)
What is the principle of “beneficence” in bioethics?

Answer 24

Answer:
“Beneficence” means that the practitioner should act with compassion and empathy, seeking to maximize the benefits and minimize the risks of harm. Researchers must consider both the short-term and long-term impact of their studies on participants, focusing on the overall well-being rather than just the advancement of knowledge.

Question 25

Question (Hint: Fair distribution of risks and benefits) What does the principle of "justice" advocate in research?

Answer 25

Answer: The principle of "justice" advocates for the fair distribution of risks and benefits in research. It prohibits the exploitation of vulnerable populations and requires impartial, unbiased recruitment of participants, ensuring that the study population is appropriate for the research.

Question 26

Question (Hint: Do no harm) How does "nonmaleficence" differ from "beneficence"?

Answer 26

Answer: While "beneficence" focuses on "doing good," "nonmaleficence" emphasizes "doing no harm." It means avoiding any actions that are unnecessary or unjustified in terms of the harm they may cause to patients or participants in a study.

Question 27

Question (Hint: US regulation for research with human participants) What is the Common Rule, and when was it issued?

Answer 27

Answer: The Common Rule was issued in 1981 in the US and governs biomedical and behavioral research involving human participants. It applies to all government-funded clinical research and outlines requirements for research institutions' compliance with ethical principles, informed consent processes, and the operations of institutional review boards (IRBs).

Question 28

Question (Hint: IRBs and informed consent) What are some key elements of the Common Rule?

Answer 28

Answer: Key elements of the Common Rule include ensuring research institutions' compliance with ethical principles, managing informed consent (obtaining, waiving, documenting), defining the roles and record-keeping of institutional review boards (IRBs), and protecting vulnerable research participants.

Question 29

Question (Hint: WHO and global ethics guidelines) What is the purpose of the CIOMS guidelines, and when were they issued?

Answer 29

Answer: The CIOMS (Council for International Organizations of Medical Sciences), in association with the WHO, issued guidelines in 1982 to provide universal ethical principles for health-related research involving humans globally. These guidelines offer commentary on ethical principles, particularly for vulnerable persons and research in low-resource settings.

Question 30

Question (Hint: Special considerations for certain groups) What does the CIOMS guidelines focus on regarding vulnerable populations?

Answer 30

Answer: The CIOMS guidelines provide specific guidelines on "women as research participants" and pay special attention to research conducted in low-resource settings, ensuring that vulnerable populations are ethically treated.

Question 31

Question (Hint: Harmonizing global clinical research standards) What is ICH-GCP, and what was its purpose?

Answer 31

Answer: ICH-GCP (International Council for Harmonisation - Good Clinical Practice) was issued in 1996 to create a harmonized set of guidelines for clinical research. Its purpose was to unify quality standards for clinical trials globally, incorporating existing GCP regulations from the EU, Japan, Australia, North America, and WHO.

Question 32

Question (Hint: Global effort for consistency in clinical trials) When was the ICH-GCP guideline issued, and who was involved in its development?

Answer 32

Answer: The ICH-GCP guideline was issued in 1996 after conferences in the early 1990s. It was developed by the International Council for Harmonisation (ICH), which included representatives from regulatory agencies and industry associations in Europe, Japan, and the US.

Question 33

Question (Hint: Ethical foundation for clinical trials) What ethical principles should clinical trials follow according to ICH-GCP?

Answer 33

Answer: Clinical trials should be conducted in accordance with ethical principles that originate from the Declaration of Helsinki and are consistent with Good Clinical Practice (GCP) and applicable regulations.

Question 34

Question (Hint: Product information) What type of information must be available about the investigational product before starting a trial?

Answer 34

Answer: Adequate nonclinical and clinical information on the investigational product must be available to support the proposed clinical trial.

Question 35

Question (Hint: Trial design) What is required regarding the design of clinical trials?

Answer 35

Answer: Clinical trials must be scientifically sound and described in a clear, detailed protocol.

Question 36

Question (Hint: Following the protocol) How must a clinical trial be conducted?

Answer 36

Answer: A clinical trial must be conducted in compliance with a protocol that has received prior approval from an institutional review board (IRB) or independent ethics committee (IEC).

Question 37

Question (Hint: Medical responsibility) Who is responsible for medical care and decisions during a clinical trial?

Answer 37

Answer: The medical care and decisions during a clinical trial should always be the responsibility of a qualified physician or, when appropriate, a qualified dentist.

Question 38

Question (Hint: Qualifications of research staff) What is required of individuals conducting a clinical trial?

Answer 38

Answer: Each individual involved in conducting a trial must be qualified by education, training, and experience to perform their respective tasks.

Question 39

Question (Hint: Consent requirement) What must be obtained from every subject before participation in a clinical trial?

Answer 39

Answer: Freely given informed consent must be obtained from every subject prior to their participation in the clinical trial.

Question 40

Question (Hint: Risks vs. benefits) What should be considered before initiating and continuing a clinical trial?

Answer 40

Answer: Foreseeable risks and inconveniences must be weighed against the anticipated benefits for both the individual trial subject and society, and the trial should only continue if the benefits justify the risks.

Question 41

Question (Hint: Prioritizing participants) What takes priority over scientific and societal interests in a clinical trial?

Answer 41

Answer: The safety and well-being of trial subjects are the most important considerations and should prevail over scientific and societal interests.

Question 42

Question (Hint: Investigational product handling) How should investigational products be managed?

Answer 42

Answer: Investigational products should be manufactured, handled, and stored in accordance with applicable Good Manufacturing Practice (GMP) and used according to the approved protocol.

Question 43

Question (Hint: Ensuring quality) What systems should be implemented in a clinical trial?

Answer 43

Answer: Systems and procedures must be implemented to assure the quality of every aspect of the trial, with a focus on protecting human subjects and ensuring reliable results.

Question 44

Question (Hint: Trial data management) How should clinical trial information be handled?

Answer 44

Answer: All clinical trial information should be recorded, handled, and stored in a way that ensures accurate reporting, interpretation, and verification.

Question 45

Question (Hint: Protecting participant privacy) How should the confidentiality of subject records be handled?

Answer 45

Answer: The confidentiality of records that could identify subjects must be protected, in compliance with privacy and confidentiality rules according to applicable regulatory requirements.