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I. Who May Serve as Principal Investigator (PI)
II. PIs Must Submit All Human Subjects Applications and Application Correspondence with JHM IRBs
III. PIs Must Maintain a Study File of Human Research Project Documents
IV. PIs Must Retain Records of Human Research Project to Comply with Federal and Institutional Time Periods for Record Retention
V. PI Must Provide and Adhere to a Data and Safety Monitoring Plan
VI. PIs must Follow Requirements for Conducting Research under and IND or IDE
VII. PIs Must Appoint and Train Study Team Members
VIII. PIs Must Address and Respond to Participant Complaints and Concerns
- Faculty members of The Johns Hopkins University*;
- Designated senior staff members of the Johns Hopkins Applied Physics Lab;
- Senior staff members designated by departmental authorities;
- Registered nurses in the Johns Hopkins Health System (JHHS) who meet the education, work and research experience, and additional requirements set forth by JHHS Department of Nursing; and,
- Properly credentialed clinicians at one of the JHM hospitals as designated by a local Research Review Committee (RRC) or the JHM ACH IRB.
(* Faculty ranks that may serve as a PI are: Professor, Associate Professor, Assistant Professor, Adjunct Professor, Professor Emeritus, Instructor, Research Associate, Lecturer, and Part-Time Faculty.)
PIs bear ultimate responsibility for the conduct of human subjects research (HSR) studies and for the safety of human subjects participating in them. PIs and their study teams must comply with federal, state, and local laws and regulations, Organization policies, and the determinations of the JHM IRBs
The PI may be a Ph.D. For purposes of subject safety, applications that involve medical procedures must include a study team member who is a medical doctor. This study team member must be available during medical procedures. The name and telephone number of the medical doctor must be provided on the consent form.
Note: For any study, whether the study site is Hopkins or elsewhere, credentials to practice medicine for physicians and nurses are not transferable from one Hopkins entity to the next. The PI and co-investigators must be sure to satisfy the credentialing requirements of each entity involved in the research. For example, credentials at the Johns Hopkins Hospital do not permit physicians to see patients or perform procedures at Sibley Memorial Hospital.
All human subjects research applications (including Changes in Research, Continuing Reviews, Protocol Events, and Termination Reports) must be submitted by the PI through the eIRB system. All formal correspondence with the IRB addressing the IRB’s questions and concerns must also be submitted by the PI through eIRB. (Co-investigators or other approved study personnel may assist in the preparation of applications and correspondence).
The PI must maintain a file of HSR project documents for each application on file with the IRB. The file must include, at a minimum, the following items (as applicable):
- For studies that originated as paper submissions, a copy of the original application submitted to the IRB.
- A copy of the sponsor's protocol.
- A copy of the federal grant application.
- A copy of the investigator's brochure for an investigational new drug (IND).
- A copy of the investigational device exemption information (IDE).
- A copy of an investigator-initiated IND or IDE application.
- A copy of the JHM IRB approved informed consent document(s).
- The original of each consent form signed by each participant enrolled in the research. For studies involving in-patients, the PI is responsible for ensuring that a copy of the consent form is added to the patient’s medical record.
- A copy of all correspondence with the IRB, sponsor, coordinating center, funding source, FDA, DSMB, or other parties essential to the conduct and oversight of the research.
- A copy of all data derived from the study (case report forms, computer data, adverse event reports, drug/device accountability records etc.). For research that involves FDA-regulated products, an investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation.
V. PI Must Provide and Adhere to a Data and Safety Monitoring Plan
The PI has the responsibility to ensure that a study has an adequate data and safety monitoring plan (DSMP) appropriate for the risk level of the study (see Organization Policy 103.6(c)). Either the eIRB application or the protocol submitted to the IRB must explain the DSMP to the IRB or indicate that no formal plan is required because the study presents minimal risk to subjects. Any proposed changes to an IRB-approved DSMP must be submitted to the IRB via a Further Study Action for Changes in Research.
JHM investigators who submit protocols involving FDA test articles and for which they hold the Investigational New Drug (IND) or Investigational Device Exemption (IDE) are considered by FDA to be sponsor-investigators. A sponsor-investigator, who may or may not be the PI on the protocol submitted to the IRB, must adhere to the same federal regulatory responsibilities as any other sponsor of an IND or IDE. The eIRB application in such cases must include all supporting FDA documentation. Additionally, in cases where an IND/IDE product will be manufactured at Hopkins, the PI must submit documentation that the proposed preparation meets standards for current Good Manufacturing Practice.
The Compliance Monitoring Specialists in the Office of Human Subjects Research will conduct pre-enrollment monitoring visits for studies for which a JHM investigator is a sponsor-investigator of an IND or IDE.
Institutional Requirements for Sponsor-Investigators:
IND: In addition to complying with the federal requirements under 21 CFR 312, all research studies for which an investigator holds an IND must comply with the Drug Use for Clinical Investigation (DUCI) policy. The Investigational Drug Service will monitor for compliance with sponsor-investigator requirements for drug record-keeping.
IDE: In addition to complying with the federal requirements under 21 CFR 812, certain devices uses in the research study must be reviewed by JHH or JHBMC Clinical Engineering Services or ACH Biomedical Engineering, as applicable, to determine that they are safe for use in or with human subjects. See Guidance on Clinical Engineering Services and Human Subjects Research Activities.
The PI is responsible for appointing study team members. All study team members must confirm for the JHM IRBs that they:
· Have read the protocol;
· Have completed the required training;
· Have experience and/or training in the informed consent process, and for individuals who will obtain consent, that they are knowledgeable about the study and are capable of answering questions about the study posed by potential participants.
Each study team member documents this commitment in eIRB when agreeing to serve on the study team.
Note: There are certain additional requirements for PIs to follow related to having post-doctoral fellows on study teams. Refer to the Guidance entitled Participation of Post-Doctoral Fellows in Human Subjects Research for these requirements.
Institutional Requirements for Obtaining Informed Consent
The PI must indicate in the eIRB application which investigators and other study team members are authorized to obtain informed consent from participants. The PI must confirm that he/she has trained the individuals who will obtain consent, and each of these individuals must be knowledgeable about the study and capable of answering study-related questions posed by the potential participant. Designations by the PI with respect to who may obtain informed consent must be made in compliance with Organization Policy 111.14.
The PI is responsible for providing contact information in a consent form to allow participants an opportunity to express complaints or concerns about study procedures or participation. The continuing review application is the mechanism by which PIs are to inform the IRB of complaints/concerns, though in certain circumstances PIs should inform the IRBs promptly. (PIs should consult with a Regulatory Affairs Specialist or other Senior Staff in the OHSR for advice on whether more prompt reporting of a complaint to the IRB should be made). If a participant contacts the OHSR directly, OHSR staff will contact the PI and request that he/she resolve the issue(s) raised and inform OHSR of the outcome. The PI is required to retain documentation in the protocol file of the resolution to any complaints/concerns.