July 2005
I. Principal Investigator
a. Must Be Faculty (including Emeritus) Or Senior Staff.b. Must Originate and Sign All Study Related Correspondence With JHM IRB.
c. Must Maintain a Protocol File of Human Research Project Documents.
d. Must Retain Records of Human Research Project to Comply With Federal and Institutional Time periods for Record Retention.
e. Data and Safety Monitoring
f. IND-IDE Requirements
II. Co-Investigators and Consent Designees.
a. Co-Investigator
b. Consent Designees III. Participation of Post-Doctoral Fellows in Human Subject Research
a. Conditions for Post-Doctoral Fellow Participation in Human Subject Research
b. Post-Doctoral Fellow “Competency Training”
c. Documentation of Post-Doctoral Fellow Competency Training IV. Medical Studies with Ph.D.s as Principal Investigator. V. Participant Complaints/Concerns
a. Must Be Faculty (including Emeritus) Or Senior Staff.
JHM IRB policy requires the principal investigator of a project to be a member of the Faculty or designated senior staff of one of the non-JHU entities covered under the Assurance. The reason for this requirement is that faculty are required to know the policies of the SOM/SON/Institutions and, thus, have the ultimate responsibility for conduct of human subjects research approved by the JHM IRBs. Note: For any study, whether the site is Hopkins or somewhere else, credentials to practice medicine for physicians and nurses are not transferable from one institution to the next. The 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. [back]
b. Must Originate and Sign All Study Related Correspondence With JHM IRB.
Study related correspondence submitted to one of the JHM IRBs must be signed by the principal investigator. The IRBs will not accept and 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. The principal investigator should personally follow-up such communication as soon as possible.
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c. Must Maintain a Protocol File of Human Research Project Documents.
The principal investigator must maintain a file of human subjects research project documents. The file must include, at a minimum, the following items: 1. | A copy of the original human subjects research application submitted to the JHM-IRB | 2. | A copy of the sponsor's protocol (if applicable) | 3. | A copy of the federal grant application (if applicable) | 4. | A copy of the investigator's brochure for an investigational new drug (if applicable) | 5. | A copy of the investigational device exemption information (if applicable) | 6. | A copy of an investigator-initiated IND or IDE application (if applicable) | 7. | A copy of the consent form stamped "Approved" by the JHM IRB. | 8. | 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 in the patient’s medical record. | 9. | A copy of all correspondence with the IRB, sponsor, funding source, FDA, or others | 10. | A copy of all data derived from the study (case report forms, computer data, adverse event reports, drug/device accountability records etc.) |
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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 depending on whether federal funding was provided for the project, whether there is funding from industry with contractual provisions governing data retention, or the protocol was conducted under FDA regulations. The data stored must be kept in a secure, protected manner in accordance with JHU SOM Data Retention Policy as set forth at: http://www.hopkinsmedicine.org/som/faculty/policies/facultypolicies/responsible_conduct.html#data Special Requirements for projects that involve FDA regulated articles (drugs, devices, biologics, assays, etc.): Records must be kept for periods required by FDA regulations based on whether the PI is a sponsor or only an investigator. (a) Sponsors must be made aware of their obligation to maintain adequate records showing the receipt, shipment, or other disposition of the investigational drugs. These records are required to include, as appropriate, the name of the investigator to whom the drug is shipped, and the date, quantity, and batch or code mark of each such shipment.
(b) Sponsors must be made aware of their obligation to retain the records and reports required by this part for 2 years after a marketing application is approved for the drug; or, if an application is not approved for the drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.
(c) An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects. If the investigation is terminated, suspended, discontinued, or completed, the investigator shall return the unused supplies of the drug to the sponsor, or otherwise provide for disposition of the unused supplies of the drug under 312.59.
(d) 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. Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual’s hospital chart(s), and the nurses’ notes. The case history for each individual shall document that informed consent was obtained prior to participation in the study.
e. Data and Safety Monitoring
The principal investigator has the responsibility to ensure that a protocol has adequate data and safety monitoring. The investigator should inform the IRB of the method of monitoring for the study. Examples include: 1. the PI will have the sole monitoring responsibility, 2. a group of designated JH faculty/staff, 3. an independent individual or group of non-JH individuals, 4. a designated medical monitor or group of monitors for commercially funded or not-for-profit sponsored studies, 5. the SKCCC CRO, 6. a formal Data Safety Monitoring Board (DSMB).
f. IND-IDE Requirements JHM investigators who submit protocols involving FDA test articles and for which they hold the IND or IDE will adhere to the same regulatory responsibilities as any other sponsor. The new application in such cases must include all supporting FDA documentation. Additionally, in cases where an IND product will be manufactured at Hopkins, the PI must submit documentation that the proposed drug 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. 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. Researchers 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 site visit investigators holding an IDE to determine compliance with FDA sponsor requirements in 21 CFR 812 before initiation of the research. Once an investigator has demonstrated compliance through an audit, the research may begin. The audit will be repeated at the time of continuing review. Investigational medical devices that involve electrical power and are not FDA approved or licensed for human use must be reviewed by JHH or JHBMC Departments of Clinical Engineering to determine that they are safe for use in or with human subjects. 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). Effective 1/31/05, investigator sponsors must complete the web based training on GCP. [back]
a. Co-Investigators
In addition to the Principal Investigator, co-investigators must represent to the JHM IRB that they:
1. Have read the protocol,
2. Have completed the following training: Human Subjects Research Compliance; Conflict of Interest; General Privacy Authorization and Privacy Issues Related to Research.
3. Have experience and/or training in the informed consent process, and
4. Are knowledgeable about the study and are capable of answering questions about the study posed by potential participants. By signing page 2 of the New Application, principal investigators and co-investigators document this commitment. When coinvestigators are added to the protocol after the initial review, the Primary Investigator must indicate the above, in writing, to the JHM IRB. The new coinvestigator must submit to the JHM IRB a signed letter accepting the responsibilities of serving as a coinvestigator. If the New Application is submitted by eIRB, the PI's submission of the application is evidence of the PI's commitment, and a co-investigator's completion of the "agree to participate" activity is evidence of the co-investigator's commitment. b. Consent Designees
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 form (or added to the study by amendment) may obtain consent only after the approval of the IRB for each designee. Each individual who interacts with potential research participants to obtain consent must submit, to the IRB, evidence of the following training: Human Subjects Research Compliance; Conflict of Interest; General Privacy Authorization and Privacy Issues Related to Research (http://secure.lwservers.net/default.cfm). The principal investigator must confirm that he/she has trained the individuals who will be getting consent, and each of these individuals must be knowledgeable about the study and capable of answering study-related questions posed by the potential participant.
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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://ohrp.osophs.dhhs.gov/humansubjects/guidance/expedited98.htm 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.
iii. Requests for exceptions to this policy should be addressed to the Associate Dean for Postdoctoral Programs (lwatkins@jhmi.edu) and the Vice Dean for Clinical Investigation ( dford@jhmi.edu).
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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.
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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.
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If the PI of an application submitted to a JHM IRB is a Ph.D., for purposes of subject safety, there must be a medical doctor listed as a co-investigator and he/she must be available during medical procedures. The name and telephone number of the M.D. must be provided on the consent form.
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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.
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