Ch 7 - Ethical Issues in Clinical Research Flashcards
Nuremberg Code (1949)
KEY: Individuals should voluntarily consent to participate as a research subject.
Consent ONLY after having sufficient knowledge of the purposes, procedures, inconveniences, and potential hazards of the experiment
Declaration of Helsinki (1964)
Last modified in 2013
KEY: Make sure informed consent was obtained from subjects and studies received approval from a review board prior to initiating the research
What does the Declaration of Helsinki (1964) address?
The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods
National Research Act (1974)
Requires the development of a full research proposal that identifies the IMPORTANCE of the study, OBTAINING informed consent, and REVIEWED by an Institutional Review Board (IRB)
Belmont Report (1979)
KEY: Describes the guiding ethical principles for human research studies
Established the RULES and REGULATIONS that govern research efforts of the DHHS and FDA. OHPR is in charge of DHHS, responsible for implementing Belmont report guidelines
Practice vs Research
Practice: Routine intervention for the benefit of an individual that has reasonable expectation of success
Research: Activity designed to test a hypothesis, draw conclusions, and contribute to generalize knowledge, which may or may not benefit the individual being studied
The Common Rule (1991)
Revised 2 times (2011 and 2019)
Codifies regulations adopted by many federal departments and agencies, with a focus on institutional guidelines, informed consent, and review of proposals for the protection of participants.
The Health Insurance Portability and Accountability Act (HIPAA) (1996)
The process of protecting research subjects related specifically to the protection of private health information
Guiding Ethical Principles
Respect for Persons
Beneficence
Justice
Respect for Persons
~Autonomy~
Personal Autonomy: Self determination and capacity of individuals to make decisions affecting their lives and to act on those decisions
Can those with diminished autonomy participate in research?
Those with diminished autonomy must be protected.
IF an authorized surrogate decision-maker is available, and has the ability to make a reasoned decision, and committed to the well-being of the compromised individual
Beneficence
Obligation to attend to the well-being of individuals; all who engage in clinical research are bound to MAXIMIZE possible benefits and MINIMIZE possible harm
Justice
Fairness in the research process, or the equitable distribution of the benefits and burdens.
Subject selection appropriate for a study; most likely to benefit from its findings
Institutional Review Board (IRB)
Federal regulation
Reviews research proposals prior to implementation to ensure that the right of the subjects are protected
How many IRB members?
at least 5 with diverse backgrounds that facilitate complete and adequate reviews of the scientific and ethical details proposed research
1 member must be concerned with nonscientific issues such as lawyer, clergyman, or ethicist
IRB responsibilities
Review research proposals at convened meeting, considering the scientific MERIT of the project, the COMPETENCE of the investigators, the RISK to subjects, and the FEASIBILITY based on identified resources
T/F Proposals with noninvasive procedures or those where subjects can’t be identified do NOT need to go through an IRB review.
False, all proposals for studies involving human subjects must be submitted to the IRB
IRB will determine whether the project qualifies for full review, expedited review, or is exempt.
What do researchers need to report during an on-going study?
Any critical incidents associated with the project.
Any changes to the protocol, as they need to be submitted for approval.
Final notification when study is completed
Final notification to IRB
Includes information on subjects and study findings
Elements of Informed Consent
- Concise introductory summary
- Purpose of the research
- Procedures
- Potential risks and discomforts
- Potential benefits
- Information on study outcomes
- Alternatives to participation
- Confidentiality
- Compensation
- Contact Information
- Consent statement
- Signatures
Informed consent process
Starts with an invitation to participate
Statement of purpose of the study permits participants to decide whether they believe in or agree with the worth and importance of the research
The rest of the elements should be presented to them in a comprehendible short format
Control groups in an informed consent
Subjects should be aware if the study will have a control group and what that entitles
Disclosure -Informed C.
When risks are not great, exemption can be made to the informed consent to prevent bias.
Still have to let subjects know that some information is being withheld and will know at the end of the data collection
Potential Risk - Informed C
Steps to be taken to protect against risks and Tx available for potential side effects
Subjects should be notified of any new info. such as identifiable previous unknown risks
Potential Benefits -Informed C
researcher should explain the potential application of theoretical findings and how the findings will contribute to future research or patient care and if outcomes of the study will be shared with subjects
Subject Information Should Be Confidential and Anonymous
Research subjects should be told that steps are being taken to ensure confidentiality of all information, including descriptive and experimental data
The Informed Consent Form Must Be Written in Lay Language
Understanding what they are told or read
Language is clear and basic
Written in lowest educational level
The Researcher Must Offer to Answer Questions at Any Time
The subjects should have sufficient time to assimilate the details of the proposed project, prior to making their decision to participate. Question anything they are unsure
Consent Must be Voluntary
Subjects participate in own free will
Must be informed that there is no penalty if they refuse
Compensation for participation clear details
Subjects Must Be Free to Withdraw Consent at Any Time
Subjects free to discontinue participation at any time (before or during)
Research Misconduct
fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results
Fabrication
Making up data or results and recording or reporting them
Falsification
Manipulation research materials, equipment, or processes, or changing or omitting data or results such that the data are not accurately represented in the research record
Plagiarism
Appropriation of another person’s ideas, processes, results, or words w/out giving appropriate credit or attribution, and representing the work as one’s own
Conflicts of Interest (COI)
Set of conditions in which professional judgment concerning a primary interest (pts’ welfare) tends to be unduly influenced by a secondary interest (such as financial gain)
Purpose of peer reviewed
Provide feedback to an editor who will make decisions about whether a manuscript should be accepted, revised, or rejected
Retraction
the retraction of published studies that are found to be fraudulent or containing error
