MCCCD Official Course Competencies:

HSE200  20034-20055

Legal and Regulatory Research Compliance

1.

Define a minimum of 50 regulatory terms, abbreviations and acronyms commonly used in research. (I)

2.

Explain the significance of the Common Rule, Federal Wide Assurances, and the Code of Federal Regulations (CFR) for research. (II)

3.

Describe the Food and Drug Administration (FDA) regulations as they apply to drugs/biologics and medical devices. (III)

4.

Complete Form 1572 and basic Investigational New Drug (IND) packet for a sample clinical trial. (III)

5.

List the 8 elements of an informed consent form (ICF). (IV)

6.

Complete a submission packet to an Institutional Review Board (IRB) for a sample clinical trial. (V)

7.

Recognize situations that may contribute to conflicts of interest. (VI)

8.

Describe strategies for resolving conflicts of interest. (VI)

9.

Describe potential risks associated with behavioral research. (VII)

10.

Describe when a Certificate of Confidentiality is required. (VII)

11.

Identify unique aspects of protecting vulnerable subjects with community-based qualitative research. (VIII)

12.

Compare and contrast Good Clinical Practice (GCP) and International Council on Harmonization (ICH) guidelines. (IX)

13.

Discuss the complexities of the terms "gene transfer" and "genetic research." (X)

14.

Identify special/vulnerable populations and related recruitment and retention strategies. (XI)

15.

Explain why different research team members including sponsors, investigators, and universities may have different publication expectations. (XII)

16.

Describe the impact of the Health Insurance Portability & Accountability Act (HIPAA) on the clinical trial research process. (XIII)

MCCCD Official Course Outline:

HSE200  20034-20055

Legal and Regulatory Research Compliance

I. Regulatory Definitions/Acronyms and Guidelines in Research

A. Terms

B. Abbreviations

C. Acronyms

D. Code of Federal Regulation Development/Sections for Research

E. Organizational Chart of Federal Research Regulation Development

F. Title 21

G. Food & Drug and Title 45 - Public Welfare

H. Federal Regulatory Statutes and Governing Agencies

II. Roles, Responsibilities & Functions of Regulatory & Research Entities

A. Regulatory and Research Entities

1. Department of Health and Human Services (DHHS)

2. Food and Drug Administration (FDA)

3. Office of Human Research Protection (OHRP)

B. Role of FDA verses OHRP

C. "Common Rule" or "Federal Policy"

D. Federal Wide Assurances

E. Institutional and Investigator Considerations

III. FDA-Regulated Research

A. Drugs/Biologics

B. Drug/Device Phases of Development

C. Medical Devices/Investigational Device Exemptions (IDEs)

D. IND Safety Reports

E. FDA Form 1572

F. Investigational New Drug Development Regulations

G. IND Submission Packet and Related Forms

H. Adverse Event/ Serious Adverse Event Reporting

IV. Informed Consent

A. Roles and Functions of Participants

1. Research Team

2. Institution

3. Sponsor

B. Consent as a Process

C. Required Elements

1. 8 mandatory components

2. Sample review

D. Vulnerable Subjects

V. Institutional Review Boards/Ethical Review

A. Office for Protection of Research Risks (OPRR) IRB Guide book

B. Differences between 21CFR 56 and 45CFR 46

C. Roles and responsibilities

D. IRB Sample Submission Packets

VI. Conflicts of Interest

A. Types of Financial Conflicts

B. Current issues

1. Financial

2. Incentives

3. Data

4. Publication

C. Case Studies

VII. Behavioral Research Issues

A. Psychological/Social Risks

B. Vulnerable Populations

C. Privacy/Confidentiality

D. Certificates of Confidentiality

1. When required

2. Federal exceptions

VIII. Qualitative Research and Process Improvement

A. Community Based Qualitative Research

B. Process Improvement: Research or Not?

C. Disenfranchised Populations

D. Tissue Studies

E. Record Reviews

IX. Practice Guidelines

A. GCP-Standard Operating Procedures for Clinical Researchers

B. ICH Guidelines

C. GCP verses ICH Guidelines

D. Sample Standard Operating Procedures (SOPs)

1. Academic sites

2. Private sites

3. Governmental sites

X. Special Ethical Concerns in Clinical/Genetic Research

A. Placebo

1. Uses

2. GCP verses ICH guidelines

B. Data Monitoring Committees

C. Genetic Testing

1. Consents

2. Gene transfer

D. Protected Health Information Data Bases and HIPPA

XI. Participant Recruitment and Retention in Clinical Trials

A. Technology: Electronic Data Bases and HIPPA

B. Recruitment of Special Populations

C. Education of Potential Subjects

D. Retention Strategies

XII. Publication of Study Results

A. Peer Reviewed Journal Publication Standards

B. Withholding data

C. Non-IRB Approved Research

XIII. HIPAA Privacy Considerations

A. Protected Health Information

B. Implementation of HIPAA

C. Electronic and Database Considerations

D. Recruitment and Multinational Ramifications