Podcast
Questions and Answers
What is the principle of respect for persons primarily applied by?
What is the principle of respect for persons primarily applied by?
Requiring that all human subjects research participants provide voluntary informed consent to participate in research
Which of these are fundamental aspects of informed consent? (Select all that apply)
Which of these are fundamental aspects of informed consent? (Select all that apply)
What must researchers disclose to potential participants?
What must researchers disclose to potential participants?
The purpose of the study, any foreseeable risks, potential benefits, alternatives to the research, extent of confidentiality, compensation for injury, contact information, and conditions of participation.
Consent must be freely given or truly voluntary.
Consent must be freely given or truly voluntary.
Signup and view all the answers
Why is it not recommended to recruit participants from a population over which a researcher has authority?
Why is it not recommended to recruit participants from a population over which a researcher has authority?
Signup and view all the answers
Which consent document is recommended for use, based on completeness and ethical considerations?
Which consent document is recommended for use, based on completeness and ethical considerations?
Signup and view all the answers
What are the conditions under which IRBs can waive or alter informed consent requirements?
What are the conditions under which IRBs can waive or alter informed consent requirements?
Signup and view all the answers
Informed consent is designed to be a one-time act of signing a form.
Informed consent is designed to be a one-time act of signing a form.
Signup and view all the answers
Does the investigator need to obtain new informed consent from the participants for additional research analyses?
Does the investigator need to obtain new informed consent from the participants for additional research analyses?
Signup and view all the answers
The HHS regulations allow IRBs to waive the requirement for documented informed consent.
The HHS regulations allow IRBs to waive the requirement for documented informed consent.
Signup and view all the answers
What must be done if a participant regains the capacity to consent after the research has begun?
What must be done if a participant regains the capacity to consent after the research has begun?
Signup and view all the answers
What must be considered when studying pregnant women?
What must be considered when studying pregnant women?
Signup and view all the answers
Children are able to provide legally effective informed consent for themselves.
Children are able to provide legally effective informed consent for themselves.
Signup and view all the answers
Who provides permission for a child to participate in research?
Who provides permission for a child to participate in research?
Signup and view all the answers
What is required for prisoners involved in research?
What is required for prisoners involved in research?
Signup and view all the answers
Match the following terms related to informed consent:
Match the following terms related to informed consent:
Signup and view all the answers
What should be done if a child withdraws assent during a study?
What should be done if a child withdraws assent during a study?
Signup and view all the answers
Community consultation is not required when risks to a population are minimal.
Community consultation is not required when risks to a population are minimal.
Signup and view all the answers
Study Notes
Respect for Persons
- Two key considerations: individuals should be treated autonomously and individuals with diminished autonomy need additional protections
Informed Consent
- The principle of respect for persons is applied by requiring voluntary informed consent from research participants
- Key components of informed consent: voluntariness, comprehension, and disclosure
Voluntariness and Comprehension
- Decisions must be free of influence from researchers
- Individuals must have the capacity to understand and make informed decisions
Disclosure
- Research purpose
- Reasonably foreseeable risks
- Potential benefits to participant or others
- Alternatives to research
- Confidentiality protections
- Compensation if injury occurs
- Contact info for questions/participants rights/injuries
- Conditions of participation (right to refuse, withdraw without penalty)
Case Study: Sleeping Sickness Study
- The investigator should NOT recruit from students in classes or lab technicians (due to potential coercion)
- The investigator should recruit from the general campus population (students, faculty, staff) to avoid coercion
- Recruitment should not mention the study in classes or leverage authority
Informed Consent: An Ongoing Process
- Informed consent is not just a signed form, but an ongoing process that informs participants about the research
- Researchers should be confident participants comprehend all information and agree to procedures
- Investigators should use multiple methods to present information (oral presentations, educational materials, videos)
- Language should be readily understandable to the subject (adjust reading levels, translate)
Case Study: Consent Documents
- Consent Document 1 lacks essential elements for informed consent (risks, confidentiality protections, contact info, conditions of participation)
- Consent Document 2 includes all necessary elements, protecting against coercion by emphasizing voluntariness and withdrawal options
Waivers of Informed Consent
- Waivers of informed consent are permitted when certain conditions are met:
- Research is conducted by or for government officials and studies/evaluates public programs, or
- Research involves minimal risk, does not harm participants' rights/welfare, cannot be conducted without a waiver, and provides additional pertinent information post-participation
Practicability and Waivers of Informed Consent
- Decisions about waivers often focus on the issue of practicability
- Simply stating that consent is time consuming or costly is not sufficient for a waiver
- Waivers may be appropriate for medical record reviews or using existing data/specimens linked to identifiable individuals
- Specific decisions about practicability are made by the IRB
Case Study: New Analysis of Existing Data
- The investigator may need to obtain new informed consent from participants, unless:
- The criteria for a waiver are met and
- The IRB has approved a waiver of informed consent
Documentation of Informed Consent
- Informed consent should be documented using a written form that includes all required elements, or
- A short form that states all required elements have been presented orally
Informed Consent
- The requirement to obtain documented informed consent can be waived if the only record linking the participant to the research is the consent document and the main risk is a breach of confidentiality.
- Alternatively, the requirement can be waived if the research involves minimal risk and no procedures for which written consent is typically required outside of research.
- Individuals with diminished autonomy due to age, cognitive impairment, illness, or treatments require careful consideration of their capacity to consent.
- Decisional capacity should be assessed based on the individual's level of capacity and the complexity and risks of the study.
Legally Authorized Representatives
- Legally authorized representatives can provide informed consent for individuals with diminished capacity.
- Investigators should strive to obtain consent directly from participants to the extent possible.
- If a participant regains capacity after research begins, investigators should obtain their informed consent before continuing.
Pregnant Women in Research
- Research involving pregnant women requires preclinical studies and careful consideration of risks and benefits for both the woman and the fetus.
- Inducements to terminate pregnancy, participation in termination decisions, and determining neonate viability are prohibited.
- Investigators, IRBs, and funding agencies must comply with HHS regulations regarding pregnant women in research.
Children in Research
- Children are considered a vulnerable population without the capacity for legally effective informed consent.
- Children provide assent to participate in research to the extent they are able, while parents or guardians provide permission.
- IRB determines a child's capacity to assent based on their age, maturity, and psychological state.
- Assent and permission are required for research involving children.
Case Study: Lack of Assent from a Child
- If a child withdraws assent after enrollment, multiple factors should be considered:
- Child's age and ability to provide assent
- Strategies to gain cooperation
- Potential benefits for the child
- Severity of the child's fear and insistence to withdraw
- Options to alleviate fear or delay participation
- There may not be a clear-cut answer regarding withdrawing a child from the study.
- Researchers should utilize institutional resources like the IRB, Ethics Committee, a research participant's advocate, or the child's personal physician to make an informed decision.
Prisoners in Research
- Research involving prisoners requires approval from an IRB specifically constituted to address the concerns of this vulnerable population.
- Additional protections are needed because prisoners may be under constraints due to their incarceration.
- Advantages provided to prisoners through research participation must not outweigh their ability to freely decide.
- Assurances are needed that parole boards will not consider research participation in parole decisions.
Community Consultation
- In some cultures, community consent is needed as individual interests may be intertwined with the community's.
- Consultation is also appropriate when research involves risk to a discrete, identifiable population.
- Community consultation is required for emergency research where obtaining individual informed consent is not feasible.
Respect for Persons Summary
- The principle of respect for persons is applied through informed consent.
- Participants must consent freely and voluntarily, have the decisional capacity to understand the information, and receive complete information about the study to make an informed decision.
Respect for Persons Terminology
- Informed consent: Disclosure of information and voluntary agreement to participate in research.
- Waiver of informed consent: Situation where documented informed consent is not required.
- Informed decision: A decision made with adequate knowledge and understanding of the research.
- Undue influence: Pressure that unfairly influences a decision.
- Coercion: Use of force or threat to compel someone to participate in research.
- Diminished autonomy: Reduced ability to make independent decisions due to factors like age or illness.
- Legally authorized representative: Person authorized to make decisions for an individual with diminished capacity.
- Assent and permission: Assent is a child's agreement to participate, while permission is given by a parent or guardian.
- Community consent and consultation: Obtaining consent or seeking input from a community when the research involves the community's interests.
- Autonomous agent: Someone who can make independent choices.
- Voluntariness: Free will to participate in research without coercion or undue influence.
- Comprehension: Understanding the information presented during the consent process.
- Minimal risk: Research that poses risks no greater than those encountered in daily life.
- Practicability: Feasiblity of obtaining informed consent.
- Documentation of informed consent: Written record of the consent process.
- Identifiable population: A group of individuals easily recognized and potentially stigmatized.
- Emergency research: Research conducted in life-threatening situations where obtaining informed consent is not feasible.
- Emergency waiver: A waiver of informed consent for emergency research under specific conditions.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Related Documents
Description
This quiz explores the ethical principles of respect for persons in research, focusing on informed consent and the necessary protections for individuals with diminished autonomy. Examine key components, including voluntariness, comprehension, and the critical elements of disclosure. A case study on the Sleeping Sickness Study is also included to illustrate these principles in action.
