Table of Contents
Institutional Assurance and Commitments
Ethical Principles
Federal and State Regulations
Federalwide Assurance Responsibilities
HRPP Institutional Official
HRPP Executive Committee
CHR Co-Chairs
Principal Investigators
Human Research Protections Administrator
Office for Research Subjects
Research Regulations Specialist Institutional Review Boards
Committees on Human Research
Western IRB
Reciprocity Agreements
IRB of Record
Educational Support for Human Subjects Research
Human Subjects Training and Education Requirement What Needs Review by CHR
Does the Proposed Activity Require Review by CHR?
Is the Activity Public Health Research or Public Health Practice?
Review Requirements for Specific Research Activities
Research That Lacks Definite Plans to Involve Human Subjects
Training Grant Projects
Projects That Include a Planning Phase
Center Grants and Program Projects
Coordinating Centers and Statistical Centers
Grants and Contracts
Pilot Activities
Self-Experimentation
Oral History Studies
Student Research
Research Projects Transferred to JHSPH Preparing and Submitting New or Continuing Research Applications
and Amendment Requests Review and Monitoring of Research Projects
Review of New Applications (Categories of Review)
Exempt Review
Expedited Review
Full Committee Review
Sample Size Requirements
Other Review Committees
Pharmacy and Therapeutics
Ionizing Radiation
Biosafety Office and Institutional Biosafety Committee
Research That Uses Facilities of the General Clinical Research Center (GCRC)
Comprehensive Cancer Center/Clinical Research Office
Revisions
Amendments
Progress Reports and Continuing Review
Appeal of CHR Decision
Inactivation of Research or Withdrawal of CHR Approval
Recruiting Research Subjects
Direct Advertisements
Minorities and Women
JHSPH Students, Employees and Staff
Payments to Research Subjects
Informed Consent Process
Federal Regulations
Elements of Informed Consent
Two Types of Written Consent
Waivers or Alteration of the Required Elements
Waiver of Consent for Planned Research in Emergency Situations
Consent Obtained in a Language Other Than English
Secondary Subjects
Persons Unable to Give Consent
Consent for Clinical Procedures and other Services that Represent Standard of Care
Preparing a Written Consent Form or a Written Summary of What Will Be Said to Subjects
Tips for Developing Written Consent Forms
Consent for Research Done by Telephone
Review and Approval of Consent Forms
Tests of Understanding
Research Involving Vulnerable Populations
Children
Prisoners
Pregnant Women, Fetuses and Neonates
Decisionally Impaired Subjects
Ensuring Confidentiality
Certificates of Confidentiality
Storage of Biological Samples
Confidentiality of Drug and Alcohol Treatment Records
Unanticipated Problems and Adverse Events/Unanticipated Problems
Non-Compliance and Study Complaints
“Whistleblowers” Regulatory Issues
Reportable Diseases and Conditions
Other Topics
Conducting Research on the Internet
Human Embryonic Cells, Germ Cells and Stem Cell-derived Test Articles
Guidance for Investigators and Institutional Review Boards regarding research involving human embryonic cells, germ cells and stem cell-derived test articles (NOT-OD-02-044)
National Institutes of Health.
Audits and Monitoring
Conflict of Interest Policy and Conflict of Interest Form
IND Application - Investigator Inquiry Regarding Investigational New Drug
Disclosure of Test Results to Subjects Useful Links
FDA Published Guidelines on Good Clinical Practice (GCP)
FDA Regulations on Investigational New Drugs
This information was presented by Dr. David LePay at the December 10, 2001 FDA Training Seminar. | 
