Key Concepts in Informed Consent for Clinical Research- week 7 reading

These flashcards cover critical vocabulary and concepts regarding informed consent in clinical research, highlighting participant understanding and ethical considerations.

Informed Consent

A process ensuring that potential participants understand the risks, benefits, procedures, and alternatives before agreeing to participate in research.

Research Contribution

The acknowledgment that enrolling in a study contributes to generalizable knowledge that benefits others in the future.

Research Relationship

The understanding that participants enter a relationship with investigators, who rely on their efforts to gather knowledge.

Research Impact

The extent to which participation in research will alter the participants' actions and experiences.

Therapeutic Misconception

The mistaken belief that the relationship with a researcher is equivalent to that with a clinician, potentially leading to misunderstandings about the nature of research.

ICH Guidelines

International regulations outlining essential elements needed for valid informed consent in clinical research.

CIOMS Guidelines

Ethical guidelines for biomedical research outlining 26 essential elements of informed consent.

Risks and Benefits

Information about potential negative outcomes (risks) and positive outcomes (benefits) associated with research participation.

Clinical Research

Systematic investigations aimed at improving health and well-being through studies addressing prevention, treatment, or cure of diseases.

Generalizable Knowledge

Knowledge derived from research findings that can be applied to a broader population beyond study participants.

Empirical Evaluation

The assessment of participants' understanding based on specific criteria related to their experience with research.