HSC 201 - Ethics & IRB

Ethics, Clinical Trials,

Clinical Trial

a structured treatment program designed to identify risks and benefits of new (experimental) treatment options as compared to the standard of care

From the patient perspective, what makes participating in a clinical trial different (more or less promising) than participating in an observational study?

• Benefits:

  • try a new treatment method - access to options that aren’t available to others outside the trial

  • contribute to the development of alternative treatments - help others

  • find a cure that is currently not available - may be the first to benefit

  • closer clinical observation

• Risks:

  • first human testing

  • unknown side effects

  • treatment may be ineffective

  • may receive a placebo

Placebo

substance thought to have no therapeutic effect; helps to tell if the response is real

*added to the standard of care

Control Arm

patients that receive only the standard of care; serve as a control group

Blinding

method that occurs when patients and/or researchers do not know if participants are receiving the placebo or study drug

Phases of Clinical Trials: Pre-Clinical

phase of a clinical trial in which only lab and animal testing occurs (no humans)

Phases of Clinical Trials: Phase 1

phase of a clinical trial in which safety is the primary focus; involves 20-80 people

Phases of Clinical Trials: Phase 2

phase of a clinical trial in which safety, identifying side effects, and measuring effectiveness are the primary focuses; involves 100-300 people

Phases of Clinical Trials: Phase 3

phase of a clinical trial in which measuring effectiveness and monitoring side effects are the primary focus; involves 1,000-3,000 people

Phases of Clinical Trials: Phase 4

phase of a clinical trial in which monitoring long-term side effects is the primary focus

Pros & Cons of Pre-Clinical Trial

Pros & Cons of Phase 1 Trial

Pros & Cons of Phase 2 Trial

Pros & Cons of Phase 3 Trial

Pros & Cons of Phase 4 Trial

Where can details about benefits and risks of clinical trials be found?

details can be found in the Informed Consent Document

Composition of an IRB

made up of at least 5 members

• diverse backgrounds — scientists, non-scientists, lay people, etc.

Functions of an IRB

• review new and revised research protocols

• approve or disapprove of protocols

• ensure that informed consent is documented (if required)

• conduct continual review of long-term research projects

• ensure protection of human subjects participating in research

• protect researchers by preventing potentially harmful activities

• legally protect research institutions from liabilities resulting from activities

Types of IRB Review: Exempt

IRB review level common for educational, pedagogy, surveys, interviews, and analyses of existing data - type studies

Types of IRB Review: Expedited

IRB review level common for routine clinical practices and individual or group characteristics

Types of IRB Review: Full Review

IRB review level for studies that involves more than minimal risk

• involves a full IRB board meeting

• requires approval from majority of IRB members

Minimal Risk (associated with using human subjects in research)

the probability and magnitude of harm/discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests

Coercion

• involving “an overt threat or harm … to obtain compliance, and offer of excessive, unwanted, inappropriate reward”

• occurs when an overt or implicit threat of harm is intentionally presented by one person to another in order to obtain compliance

Example of Coercion in Human Subjects Research

• researchers threaten to harm patients if they don’t participate in the study

• researchers offer excessive, inappropriate rewards for participation

Beneficence

research should have the welfare of the research participant as the goal of any clinical trial

Protected Health Information (PHI)

any information, including demographic data, in any form that relates to:

• individual’s past, present, or future physical or mental health condition

• provision of healthcare to the individual

• past, present, or future payment for the provision of healthcare to the individual

Examples (x2) of Protected Health Information (PHI)

1. past/present/future physical or mental health conditions

2. past/present/future payment for provision of healthcare to individuals

Golden Rule of PHI

“don’t share anything without authorization about a patient’s personal information that you wouldn’t feel completely comfortable sharing about yourself or if you can’t be 100% sure that they would feel comfortable with you sharing it”

*** get authorization from the patient first!

HIPAA Privacy Rule

rule that protects a patient’s individually identifiable health information

Requirements for Using PHI

consent from the patient