Regulatory Science Symposium: “Keys to a Clinical Trial: Management and Operations” Session 7 - Protecting the Rights of Research Participants: Ethical Considerations & Informed Consent Processes (2024)

Competencies: Ethical Considerations, Vulnerable Populations, Regulatory and Quality Sciences, Human Research Protection Program, Education, Program Improvement, Policy and Procedures, Institutional Review Board (IRB), Clinical Trial Workforce

Course Syllabus/Topics:

1. Human Research Protection Program (HRPP)
1. Formerly the Office for Protection of Research Subjects
2. Shift from participants being called “subjects”
3. Responsible for:
1. Education
2. Policy related to engaging participants in research
3. Policy that addresses how participants are enrolled
4. Program improvement within Institutional Review Boards (IRBs) within HRPP, and within institution (USC sites and affiliated hospitals)
4. IRBs
1. 3 biomedical, 1 social behavioral
2. What is Human Research?
1. Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
2. Human subject(s) - a living individual about whom an investigator conducting research obtains:
1. Information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens
2. OR
3. Uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
3. IRBs
1. Oversight body including standing committees that is charged with reviewing research involving human participants
1. Functions as a surrogate for human participants
2. Members are faculty, staff, or students of the institution and local community members
3. Research involving humans must be approved by the IRB before research begins
4. IRB Committees Structure
5. HRPP structure
6. IRB Process
1. Ensure alignment with the Belmont Principles
1. Respect for person
2. Beneficence
3. Justice
2. Ensure compliance with the Federal, State, and Local Regulations and Laws (Common Rule, FDA, etc.)
3. Review and approve research (exempt and expedited)
4. Supports Full Board Committee
7. Study Design
1. Ethical considerations for study design
1. Sampling and recruitment – how are you generating your sample and who is the audience? How are your recruitment methods aligned with that?
2. Cultural competence/humility
2. What does it mean to be culturally competent or demonstrate cultural humility?
3. Instrumentation
4. Risks
1. What are the potential risks to your participants?
5. Benefits
1. Who will ultimately benefit from your research?
8. Consent
1. Ethical considerations for consent
1. Voluntary
2. Fully informed
3. Ability to stop participating
4. No coercion, undue influence
5. Awareness of power dynamics
6. Attend to cultural context
7. Ensure consent is a process
9. IRB Submission
1. Full Board: greater than minimal risk (e.g., drug study/domestic violence study), reviewed by a full committee
2. Expedited: minimal risk (e.g., blood draw /alcoholism), IRB Chair/designee reviews
3. Exempt: not greater than minimal risk; e.g., educational tests, interviews, surveys, IRB Chair /designee/staff reviews
10. The way you become certified for human subjects research is through CITI Process
11. IRB Submission
1. Categories of research reviewed
1. Full Board: Greater than minimal risk; Expedited: Minimal risk; Exempt: No greater than minimal risk
12. IStar: Platform used to submit an IRB application
1. Used prior to data collection
2. Difficult to obtain approval after data collection
13. Caution
1. Data collected with no IRB approval cannot be used
2. IRB must be informed about changes to a study that increase risk.
3. Ask questions before acting
4. Use the HRPP and IRB website and resources for support at https://hrpp.usc.edu
14. Questions?
    
    

Acknowledgements
Accompanying text created by:
Roxy Terteryan, RKS Project Administrator, SC CTSI (atertery@usc.edu)
Rushaanaaz Sokeechand, Student Worker