• Investigator Responsibilities
  Principal Investigators, Co-Investigators and Consent Designees, Post-Doctoral Fellows, and Ph.D.s
• Research Protocol Management System
  Web access to IRB application status

Certificates of Confidentiality

• Certificates of Confidentiality
  Purpose of Certificate, application, expiration, transfer, protocol changes

Change to approved research

• Changes in Research Guidance
• Changes in Research Form
  For paper studies only, not for eIRB

• IRB Review of Research: Project Closed to Accrual, in Data Analysis Only, or Terminated

• Organization Policy on Registration of Clinical Trials
  Definition of clinical trial and what needs to be registered.
• Registration of Clinical Trials
  Guidance on registering clinical trials research

Complaints or concerns

• Expressing Concerns or Complaints about Research
• Organization Policy on Complaints from Research Participants, Investigators and Research Staff, the Community, etc.

Compliance Training

• School of Medicine Research Compliance Training Course Requirements
  Description of the courses and access to the online training.
• Training Requirements for Human Subjects Research
  For the PI and other Study Team Members, including non-Hopkins co-investigators.
• Course on Research Ethics (C.O.R.E.)

• Continuing Review of JHM IRB Approved Studies
• Continuing Review Form
  For paper studies only, not for eIRB

• Coordinating Center Functions and Multi-Site Studies

• Data Gathering, Storage and Retention
• Record Retention

• Departmental Pre-Review

Federal Wide Assurance (FWA)

• Federal Wide Assurance Numbers

• Application of GCP to the Conduct of Clinical Research

GCRC Data Safety Review

Please Note: The Institute for Clinical Translational Research (ICTR) has several Clinical Research Units (CRUs). They are the East Baltimore Clinical Research Units (EBCRUs) and Bayview Clinical Research Units(BCRUs) and were formerly known as the General Clinical Research Units. Information about the ICTR CRUs may be found at the ICTR website: http://ictr.johnshopkins.edu

• Investigators as Study Participants (Self-Experimentation)

• Plans for Detecting and Managing Incidental Findings Associated with Research Imaging Procedures

• Kennedy Krieger Institute's Human Subjects Review Policy

Maintaining Study Records

• Data Gathering, Storage and Retention
  For Data Retention Requirements for the FDA, HIPAA, and the institutions.
• Record Retention

• School of Nursing requirements
• Johns Hopkins Hospital requirements
• School of Nursing Policy on Departmental Signature for New IRB Submissions

• Oncology Research Guidance

• JHM Pathology Tissue/Specimen Use Committee Guidance

• Reciprocity Overview
• Baltimore City Health Department (BCHD) Agreement
• Baltimore City Health Department (BCHD) Guidance for researchers
• Bloomberg School of Public Health (BSPH)
• Howard County General Hospital (HCGH)
• JHM IRB CIRB/PedCIRB Facilitated Review Procedures
• JHU Homewood Agreement
• Johns Hopkins Healthcare Data Sharing Committee
• Kennedy Krieger Institute
• Medstar
• National Institute on Aging (NIA)
• National Institution on Drug Abuse (NIDA)
• National Cancer Institute Central IRB– NCI CIRB (adult)
• National Cancer Institute Pediatric Central IRB – NCI PedCIRB
• SON, KKI, Johns Hopkins Bayview, Johns Hopkins Applied Physics Lab (APL), Johns Hopkins Community Physicians (JHCP) 

• Patient Recruitment and Referral
• Recruiting Study Subjects and Reasonable Payment (Remuneration)
  Advertising, Paying subjects
• Students and Employees
• Self-Experimentation
• Providing information about departmental studies open to enrollment

Renewing your IRB approved study

• Continuing Review of JHM IRB Approved Studies
  For continuing review applications, and information about what happens if approval expires
• Expired Protocols & Consent Forms

• Organization Policy on Reports of Unanticipated Problems Involving Risks to Participants or Others (Policy No. 103.6(b))
  All adverse events, adverse device effects, and unanticipated problems, including major protocol deviations not approved by the IRB.
• Unanticipated Events Flowchart
• Submission of Sponsor IND Safety Reports
• IND Safety Reports Flowchart
• Reporting Protocol Deviations
• Deviations Flowchart
• How and When a Principal Investigator Should Report Death of a JHM Research Participant
• Organization Policy on Reporting Death of a JHM Research Participant (Policy No. 103.6(b)(i))

• Research Protocol Management System (RPMS)
• Web Access to IRB Application Status

Research Records

• Participants’ Access to Study Records
• Monitoring Visits
• Compliance Monitor Informational Sessions - Spring 2006, Fall 2006
• Data Retention Policy
  University ownership of data, Length of time data should be retained, Recommendations about format of study records
• Record Retention

• Sedation Guidelines for Research Protocols Involving Diagnostic, Operative and Invasive Procedures

Studies using Johns Hopkins HealthCare Data

• JHHC Data Sharing

Study Team members

• Participation of Post-Doctoral FellowsIn Human Subjects Research
• JHH Nursing Research Approval

• WIRB Review of JHM Studies
• Fees for JHM IRB and WIRB Review of Research Protocols