I. Principal Investigator (PI) Requirements
II. Co-Investigators, Other Study Team Members and Consent Designee
III. Participation of Post-Doctoral Fellows in Human Subject Research
IV. Medical Studies with Ph.D.s as Principal Investigator
V. Participant Complaints/Concerns
a. Must Be Faculty (including Emeritus) or Senior Staff Designated by the Organization as eligible to Serve as Principal Investigator.
The Organization requires the PI of a project to be either a member of the Faculty or a designated senior staff of one of the non-JHU entities covered under the Assurance. Faculty members are required to know and adhere to the policies of the SOM/SON/Institutions; therefore, they have the ultimate responsibility for conduct of human subjects research in accordance with those policies and the requirements and determinations of the JHM IRBs.
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 institution to the next. The PI and co-investigators must be sure to satisfy the credential requirements of each institution involved in the research. For example, credentials at JHH do not allow physicians to see patients at HCGH.
b. Must Originate and Sign All Study Related Correspondence with JHM IRBs.
Study related correspondence must be submitted to the JHM IRB by the principal investigator through the eIRB application. The JHM IRB will not accept or review correspondence, e-mails, faxes, or other documents that are submitted outside of the eIRB application.
Study related correspondence for paper studies submitted to the JHM IRB must be signed by the principal investigator. The JHM IRB will not accept or review correspondence, e-mails, faxes, or other documents that are submitted containing signatures of only a study coordinator, co-investigator, sub-investigator, research manager, student, fellow, or other individual not listed as the principal investigator.
Only in unusual circumstances when the principal investigator is not immediately available and when the matter is urgent or emergent should a co-investigator provide direct communication to the IRB. In this case the principal investigator should personally follow-up such communication as soon as possible.
c. Must Maintain a Protocol File of Human Research Project Documents.
The principal investigator must maintain a file of human subjects research project documents for each application on file with the IRB. The file must include, at a minimum, the following items:
- A copy of the original human subjects research application submitted to the JHM-IRB
- A copy of the sponsor's protocol (if applicable)
- A copy of the federal grant application (if applicable)
- A copy of the investigator's brochure for an investigational new drug (if applicable)
- A copy of the investigational device exemption information (if applicable)
- A copy of an investigator-initiated IND or IDE application (if applicable)
- A copy of the JHM IRB approved consent form.
- The original of each consent form signed by each participant enrolled in the research. For studies involving in-patients, the investigator 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, funding source, FDA, or others
- 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 (drugs, devices, biologics, assays, etc.) 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
d. Must Retain Records of Human Research Project to Comply With Federal and Institutional Time periods for Record Retention.
The principal investigator is required to retain records associated with a human subjects research project. The recordkeeping requirements vary. See (http://www.hopkinsmedicine.org/som/faculty/policies/facultypolicies/responsible_conduct.html#III) for the details of record retention requirements. For more information also see the guidance on Record Retention http://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/record_retention.html.
HIPAA: Under the HIPAA Privacy Rule, subjects have the right to ask Hopkins for an accounting of certain disclosures of their identifiable health information for a period dating six years from the date of the last covered disclosure. To ensure that Hopkins can meet this accounting requirement, the School of Medicine requires investigators to retain study records, along with records of all disclosures of study information, for the following time periods:
1) At least 7 years after the last subject has completed his or her participation in the study; or
2) The date of the last disclosure of identifiable health information from study records, if disclosures continue after all subjects have completed the study. (45 CFR 164.528)
This requirement to retain study records and to account for disclosures also applies to research that involves the secondary use of medical records or other identifiable health information.
For research involving children: The School of Medicine requires study records to be retained (at a minimum) until the child subject reaches the age of 23.
e. Data and Safety Monitoring
The principal investigator has the responsibility to ensure that a protocol has adequate data and safety monitoring. Applications submitted to the IRB must explain the primary DSMP. A range of options is available to the PI. Upon IRB approval of a DSMP, any proposed changes must be submitted to the IRB.
f. IND-IDE Requirements
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 a sponsor/investigator. Sponsor/investigator must adhere to the same 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.
Institutional Requirement for Sponsor-Investigators:
IND: All research studies for which an investigator holds an IND must comply with the Drug Use for Clinical Investigation (DUCI) policy. The IDS will monitor for compliance with sponsor-investigator requirements for drug recordkeeping. The PI will also need to comply with the sponsor/investigator responsibilities contained in FDA regulations 21 CFR 312.
IDE: The Organization requires a monitoring process for receipt, dispensing, and record keeping concerning devices that are studied using an IDE granted by FDA. The monitoring process shall be performed by the Compliance Monitoring Specialists of the OHSR.
PIs or co-investigators who serve as a sponsor/investigator for an IDE research project are required by the Organization to follow FDA regulations 21 CFR 812 Subpart C applicable to sponsor responsibilities. Compliance monitoring specialists of the OHSR must conduct a site visit with investigators holding an IDE to determine the PI’s understanding of the requirements for sponsors in 21 CFR 812 before initiation of the research. Once an investigator has demonstrated compliance through a site visit, the research may begin. The site visit will be repeated at the time of continuing review.
Institutional Requirements for Device Review: Certain devices, either approved for marketing or not approved, are part of the research study and must be reviewed by JHH or JHBMC Departments of Clinical Engineering to determine that they are safe for use in or with human subjects. See guidance on “Clinical Engineering Services and Human Subjects Research Activities”.
Record Keeping and Reporting: Investigator/sponsors must comply with the record-keeping requirements provided in 21 CFR 312.57 for INDs, and in 21 CFR 812.140(b) for IDEs. An investigator/sponsor holding an IND must also satisfy the requirement to ensure that the FDA “and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug.” (21 CFR 312.50) Similarly, an investigator/sponsor holding an IDE must report to the FDA and all reviewing IRBs and participating investigators any evaluation of an unanticipated device effect within ten (10) working days of first receiving notice of the effect. (21 CFR 812.150 (b)(1))
The Principal Investigator is responsible for appointing study team members. All study team members must represent to the JHM IRB that they:
1. Have read the protocol,
2. Have completed the required training: Human Subjects Research Compliance; Conflict of Interest; and Privacy Issues Related to Research (http://training.jhu.edu/ComplianceTraining/ (for users with JHED ID) or http://training.jhu.edu/ComplianceTraining/noJHED/ (for non-JHED users).
3. 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.
For eIRB applications, each study team member documents this commitment when electronically agreeing to serve on the study team. When study team members are added to the protocol after the initial reviews, the Principal Investigator must indicate the above to the JHM IRB. For old paper studies, the new co-investigator must submit to the JHM IRB a signed letter accepting the responsibilities of serving as a co-investigator.
a. Consent Designee
The principal investigator does not have to obtain the consent personally. The study team may include consent designees who are authorized to obtain consent. Consent designees listed on the IRB application (or added to the study by a change in research request) may obtain consent only after the approval of the IRB for each designee. Each individual who will interact with potential research participants to obtain consent must complete the required training: Human Subjects Research Compliance; Conflict of Interest; and Privacy Issues Related to Research (http://training.jhu.edu/ComplianceTraining/ (for users with JHED ID) or http://training.jhu.edu/ComplianceTraining/noJHED/ (for non-JHED users). The principal investigator 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.
a. Conditions for Post-Doctoral Fellow Participation in Human Subject Research
Post-doctoral fellows may participate in human subjects research only under the following conditions:
i. they are credentialed by a Johns Hopkins Health System entity as clinical fellows or
ii. they have a University appointment as a research fellow and:
- do not administer any medication or drug
- do not represent themselves as a physician or other caregiver
- engage only in minimal risk research activities, as determined by the JHM IRBs. (See http://www.hhs.gov/ohrp/policy/index.html#expedited for examples.)
- are given the same training to perform the techniques and research procedures as set forth in the job descriptions of personnel who perform the same duties. For example, a research fellow who is to perform phlebotomy would have to complete the same training as required for Johns Hopkins Medicine personnel performing phlebotomy and would need to be certified to do so, and
- if they are not a U.S. citizen or permanent resident, obtain written authorization to engage in incidental patient contact from the Johns Hopkins Office of International Services.
b. Post-Doctoral Fellow “Competency Training”
It is the Principal Investigator’s responsibility to assure that post-doctoral fellows who participate in human subjects research are trained in the data collection techniques and research procedures that they will perform as part of the research protocol. These include any technique or procedure involving incidental patient contact. Training for these techniques and procedures is referred to as “competency training” and such training should be documented.
c. Documentation of Post-Doctoral Fellow Competency Training
When submitting a protocol to the JHM IRBs for review, the Principal Investigator must
i. identify any post-doctoral fellows who are to participate in the protocol and,
ii. certify the competency training in writing of each post-doctoral fellow participating in the protocol.
IV. Medical Studies with Ph.D.s as Principal Investigator.
The PI of an application submitted to a JHM IRB 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 M.D. must be provided on the consent form in section 17, paragraph C.
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. 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.