Chapter 23 Flashcards
What 3 documents have influenced the research laws, policies, and regulations in countries across the globe?
1) Nuremburg Code (consent for experiment human trials)
2) Declaration of Helsinki (guidelines for human trials)
3) Belmont report (Common rule) (protection of human participants)
What are the 3 core principles of biomedical research ethics?
1) Respect for persons
2) Beneficence
2) Disributive justice
How can you minimize harm in a study?
1) Discontinuation of a study
2) Provide counseling services
True or false:
The principle of beneficence requires monetary compensation to be offered
False; the innate reward of contributing to science is a sufficient benefit.
Monetary benefits can be given under the principle of ___.
Nonmaleficence (participating shouod not he a burden; “Do no harm”)
What are the eight Central consideration and research ethics?
1) Contribution
2) Compensation
3) Consent
4) Confidentiality
5) Community
6) Conflicts of interest
7) Collaborators
8) Committees
When is the principle of voluntariness violated?
When an individual feels coerced into participation
Coercion includes:
Social pressure, requests from authority figures, or incentives that make it difficult for an individual not to agree to enroll in a study
How can we minimize the risk of coercion?
By being very transparent about what participants will gain and not gain from participation in a research study.
What are informed consent statements?
They provide essential information about research projects to potential research participants so that they can make a thoughtful decision about whether to enroll in a study
The informed consent statement must use:
Clear simple language to describe the study aims, procedures and expectations of participants, and the benefits and risks of participation.
The informed consent statement should emphasize that
Participation is voluntary and they can withdraw from the study at any time without penalty.
What are the key components of an informed consent statement?
1) Definition of research
2) Explanation of purpose
3) Why they were chosen as participants & how many
4) Description of the procedures and duration
5) Description of benefits
6) Description of risks
7) Description of steps taken to maintain confidentiality
8) Statement that participation is voluntary and participant may withdraw with no penalty
9) Description for the process of withdrawing from the study
10) Contact information for the researchers
11) Space for the participant’s signature
True or false:
The goal of the informed consent process is to acquire signatures from potential participants.
False; The goal is to ensure that participants truly understand the research process.
What are the steps of the informed consent process?
1) Reading the informed consent statement aloud to a potential participant or along the individual to read a copy of the statement
2) Allowing adequate time for the potential participant to consider whether he or she wants to participate
3) Answering any questions
4) Asking whether the individual wants to participate in the study and is willing to sign an informed consent form
True or false:
Acquiring a signature is the end of the informed consent process
False; the lines of communication must remain open during and after the data collection process.
What is the goal of the informed consent process?
Understood consent
When is consent not required?
In a limited number of observational studies, where participants have no reasonable expectation of privacy and will not interact with the researcher.
Anonymous questionnaires do not require an intensive informed consent process when:
1) The responses cannot be linked to individuals
2) The survey instrument does not ask sensitive questions
3) The researchers will not physically examine individuals or collect biological specimens
4) The questionnaire is so short that describing the study will take longer than completing the questionnaire
form
{Completion of the survey form can sometimes be considered adequate proof of willingness to participate.}
5) There are no foreseeable risks to participants
When is oral consent (verbal consent) an appropriate alternative to written consent?
When it is deemed inappropriate to ask people who cannot read a document to sign it. This must be witnessed by an independent third person and recorded.
What is privacy?
The assurance that individuals get to choose what information they reveal about themselves
What us confidentiality?
The protection of personal information provided to researchers
What kind of survey does not need any personally identifiable information?
Cross-sectional surveys.
When can a waiver of the need to document consent be requested? (ONLY written documentation)
When written documentation of consent is not acceptable because participants can be harmed by being linked to the study
What is a certificate of confidentiality?
Protects the identity of participants from being subject to court orders and other legal demands for information.
Who can faciliate communication between the community and the research team?
A local advisory board
True or false:
Both the legal representative’s consent and The potential participant should assent to participation.
True
Everyone who will be in direct contact with research participants and/or their personal data should complete ___.
Formal research ethics training
What are responsible conduct of research (RCR) training programs?
They spell out expectations and procedures for disclosing conflicts of interest, avoiding research misconduct, reporting research ethics or personnel violations, and otherwise exhibiting professionalism.
