Research Ethics Flashcards
Importance of Guidelines/IRB
- Give defined structure to follow
- Investigators have many priorities; the IRB (an independent review) minimizes any potential conflicts created by the distorted view of a well intended researcher
- Social Accountability, assuring members of the public and enrollees of the study of ethical trials and a favorable risk-benefit ratio.
rights of patients afforded by the Helsinki Declaration
a. nature/purpose/risk of trial must be explained by the doctor.
b. patient’s freely given consent
c. conducted only by qualified persons& under the supervision of a qualified medical personnel.
d. risk/benefit favorable
e. At any time during the subject/guardian is be free to withdraw permission for research
f. Investigator must respect the right of each individual to safeguard his personal integrity, especially if the subject is in a dependent relationship to the investigator.
7 requirements for determining if research is ethical
a. Social/Scientific Value: treatment, intervention or therapy being evaluated will improve health/wellbeing or increase knowledge
b. Scientific Validity: Use of accepted scientific principles and methods, including statistical techniques to produce reliable and valid data
c. Fair subject selection: selection of individuals so that the stigmatized and vulnerable individuals are not targeted for risky research and the rich and socially powerful are not favored for potentially beneficial research
d. Favorable risk/benefit ratio: Minimization of risks; enhancement of potential benefit. Risks proportional to benefit to subject/society
e. Independent Review: review of the design of the research trial, its proposed subject population and the risk/benefit ratio by a committee unaffiliated with the organization
f. Informed consent: Provision of information to subjects about the purpose of the research, its procedures, potential risks, benefits and alternatives. This way the individual can make a voluntary and informed decision about whether to participate in the study
g. Respect for potential and enrolled subjects:
i. Permitting withdrawal from the research
ii. Protecting privacy through confidentiality
iii. Informing subjects of newly discovered risks/benefits
iv. Informing subjects of results of clinical research
v. Maintaining welfare of subjects
a. Placebos are ethical in randomized clinical trials (RCTs) if
i. the placebo is in additional to the standard of care
ii. there is no known effective standard of care for the symptoms studied
iii. subjects are given access to rescue treatment
**Subjects receiving placebos should be no more likely to suffer than those receiving active treatment.
Informed consent
Informed consent: permission granted in the knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with full knowledge of the possible risks and benefits.
Institutional review board
Institutional review board: a committee formally designated to approve, monitor, and review biomedical and behavioral research involving humans and charged with protecting the rights and welfare of people involved in research.
Helsinki Declaration
Helsinki Declaration: Cornerstone of human research ethics. a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA).
Belmont Report
Belmont Report: summarizes ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice
Risk / Benefit
Risk / Benefit: the comparison of the risk of a situation to its related benefits.
Conflict of interest
Conflict of interest: a situation in which an individual’s decisions are influenced by their personal interests
Placebo
Placebo: a harmless pill, medicine, or procedure prescribed more for the psychological benefit to the patient than for anything physiological
