Marshall University

Huntington, WV

  

SUBJECT:  Investigator Responsibilities for Submitting IRB Documents

 

PURPOSE:  To establish guidelines for submitting the required documents to the Institutional Review Board (IRB) for research activities which involve human subjects.

 

POLICY:  To delineate the specific protocol, informed consent, protocol application, assessment checklist, educational certificates, and other related documents that must be submitted to the IRB for review. 

 

SCOPE:  This policy covers all research activities that involve the IRB review process (e.g., full convened, expedited, continuing, training, protocol or informed consent changes, SAE/AEs, closures).

 

RESPONSIBILITY:

The Principal Investigator (PI) is responsible for ensuring the well-being and safety of the study subjects.  The PI must ensure the proper conduct of the study; adherence to the study protocol; and compliance with all applicable regulations, guidelines, and policies. The PI is responsible for submitting complete and accurate documents to the IRB in a timely manner.

 

DEFINITIONS:

(a)    An “Investigator” is an individual who conducts a research study and under whose immediate direction the investigation is administered.  When a team of individuals conducts an investigation, the responsibility leader of the team is the PI.

(b)   A “Protocol” is a document that states the background, rationale, and objectives of a clinical trial and describes in detail the design, methodology, and organization of a trial as well as the statistical methods and the situations likely encountered during the trial and their possible remedies.

　

RESPONSIBILITIES OF PRINCIPAL INVESTIGATORS: Principal Investigators are responsible for:

a.  Acquiring the required training for PI and research staff before beginning any human subjects research

b.  Requesting approval for planned research

c.  Obtaining and documenting informed consent from all subjects

d.  Requesting prior IRB approval for all changes in the research protocol or consent form

e.  Notifying sponsoring agency of IRB actions

f.   Submitting periodic reports to the IRB

g.  Promptly reporting serious adverse events, complications, and complaints.  Also informing subjects of study related injuries.

 h. Notifying the IRB of study closure

 i.  Permit FDA, Sponsor representatives, ORI/IRB representatives, and other Regulatory Officials to survey and inspect study records and information.

j.  Maintaining records

k.  Keeping well informed about principles and procedures of human subjects protection

 

I.  Taking Required Training before beginning any human subjects research:  Each person engaged in human subjects research has an obligation to acquire and apply an in-depth knowledge of the ethical principals (as in the Belmont Report) and good clinical practice that govern such research.  To ensure that all principal investigators, co-investigators and research staff have a clear understanding of their responsibilities and obligations, the Marshall University Office of Research Integrity (ORI)/Institutional Review Board has implemented an educational program.  The educational requirements are listed on the ORI/IRB website and included in the Protocol Application Form.

 

All individuals engaged in conducting research involving human subjects will be required to complete a training program.  This includes all principal investigators, co-investigators, study coordinators, study nurses, and all individuals that will be listed on a Protocol Application Form.  This training MUST be completed and the education module certificates submitted to ORI BEFORE any protocol may be submitted to the IRB for review and approval.

 

II.  Requesting Approval For Planned Research:  A principal investigator planning a new research project must complete and submit the following documents for IRB review and approval.  These documents must be submitted to the ORI/IRB Office no later than 30 Days in advance of the date of the meeting in which they desire the protocol reviewed:

a.  Completed Protocol Application (Must include CVs, Current License and Board Certification information of PI, Co-PI and all Research Staff, Training documentation of all research personnel, and completed Attachment D forms for all staff)

b.  Copy of Protocol and all associated documents relevant to the study

c.  Informed Consent, Assent, or Requests for Waivers

d.  Protocol Assessment Form

e.  Any relevant grant applications

f.  The investigator's brochure (when one exists)

g.  The DHHS-approved sample informed consent document (when one exists)

h.  The complete DHHS-approved protocol (when one exists)

 

All documents and detailed instructions for the completion of the ORI/IRB Protocol Application are provided on the ORI/IRB website at www.marshall.edu/research/ori or if you have additional questions, please contact Trula Stanley, IRB Coordinator at (304) 696-7320 or email her at stanley@marshall.edu.

 

NO HUMAN SUBJECTS MAY BE INVOLVED IN ANY RESEARCH PROJECT UNTIL IT HAS BEEN REVIEWED AND FULLY APPROVED BY THE IRB. 

  

III.  Obtaining And Documenting Informed Consent From All Subjects:  It is unethical to conduct research without freely given consent or to take advantage of a subject’s situation as a patient or client to induce participation in research without consent on the basis of complete information.  The process of Informed Consent involves several essential features that are described in detail in the Informed Consent and Assent Standard Operating Procedures.  The IRB must approve all consent forms that will be used for enrolling research subjects.  The consent form is valid for no more than one year; it carries an expiration date and bears an official IRB color stamp.

 

1.  If your study does not require the use of consent, a request for Waiver of Informed Consent must be submitted for approval.  A template of this request can be located in the Informed Consent and Assent Standard Operating Procedure.

 

IV.  Requesting PRIOR IRB approval for all changes in the research protocol or consent form:  All desired or contemplated changes in the research protocol or the consent form must immediately be reported in writing to the IRB.  These changes may include any changes or new information that may affect the risk/benefit assessment of the study or any significant new findings that may affect, or relate to a subject’s willingness to continue their participation in the research.

 

V.  Notifying sponsoring agency of IRB actions:  It is the responsibility of the Principal Investigator to notify the Research Sponsor of all IRB actions.

 

 VI.  Submitting periodic reports to the IRB: All protocols receiving either IRB Expedited or Full Board approval must be periodically reviewed.  The IRB makes the determination of the frequency for continuing review for each protocol after the initial approval.  The continuing review process will take place for the duration of the protocol.  It is the responsibility of the Principal Investigator to comply with the continuing review requirements and must submit the required documentation in a timely manner in order to insure that there will be no interruption in the research process.  The Principal Investigator must ensure that their protocol does not exceed the expiration date that has been initially approved.  The following completed documents must be completed and submitted to the ORI/IRB Office 30 days in advance of the next IRB meeting date that does not exceed the expiration of the protocol:

 

a.  Continuing Review Protocol Assessment Form

b.  List of all active study subjects and addresses

c.  Any consent updates that the investigator now desires to make

 

In the event that the protocol does not receive continuing review by the required date, the study will be closed and must be submitted as a new protocol.  Every effort will be made by the ORI/IRB Office to ensure that the Principal Investigator is aware of the expiration date ahead of time, but the Principal Investigator will have the total responsibility for the timely submission of their protocol information.  All Continuing Review documents may be found on the ORI/IRB website or if you have additional questions, please contact Trula Stanley, IRB Coordinator at (304) 696-7320 or email her at stanley@marshall.edu.

(In the event that a study will be ending or closed just before the continuing review date, please contact the ORI/IRB Office for specific instructions.) 

 

VII.  Promptly Reporting Serious Adverse Events, Adverse Events, Complications, and Complaints:  Principal Investigators must promptly report serious adverse events, adverse events, complications, and complaints to the IRB to ensure the protection of research subjects and to comply with federal and other regulations.

 

1.  Serious Adverse Events, Adverse Events, and Complications:  For information on the reporting of all AEs and SAEs refer to the Adverse Event/Serious Adverse Event Standard Operating Procedures located on the ORI/IRB website.

 

2.  Complaints:  All complaints received from study subjects to the Principal Investigator must be submitted to the ORI/IRB Office.  Please refer to the Complaints, Non-Compliance, and Regulatory Improprieties Standard Operating Procedures located on the ORI/IRB website.

 

VIII.  Notifying The IRB Of Study Closure:  The Principal Investigator must notify the ORI/IRB in writing of study closure within 10 business days and must request that the study be formally closed by the IRB.  As part of the request for closure, the PI must include a final report, which should include any findings as a result of the study.  The study will be closed by the IRB coordinator and documented in the agenda of the next IRB meeting.

 

XI.  Permit FDA, Sponsor representatives, ORI/IRB representatives, and other Regulatory Officials to survey and inspect study records and information:  Periodically, there will be a requirement to review IRB approved research study information.  The Principal Investigator must comply and cooperate with request for an audit from any of regulatory officials listed previously.  There are different types of audits that may take place such as: Subject surveys, consent process observation, random protocol file audits, random subject study file audits, research data review, interviews with PIs, Co-PI, and research staff, and many other methods may be introduced.  These audits are very important and must be conducted to ensure the safety of human subjects is maintained at all times.

 

X.  Maintaining Records: The Principal Investigator must protect and maintain all research-related documentation in a secure location.  The PI must maintain adequate and accurate documentation of case histories for each subject that records all observations and data gathered during the study subjects participation and research visits.  In addition, the investigator must maintain accurate and complete records of the receipt, dispensing, and return of all clinical supplies including study drugs.  All such discrepancies must be noted and explained. All study documentation must be maintained and secured for 3 years after final closure of the study.  Please note that study sponsors may have additional requirements for maintaining study documentation.  Study Sponsor requirements must be acknowledged in addition to the ORI/IRB regulations.

 

XI.  Keeping Well Informed About Principles and Procedures of Human Subjects Protection:  It is the responsibility of the Principal Investigator to keep up-to-date on new information and regulations concerning the protection of human subjects involved in research.  The ORI/IRB website will be maintained with the most up-to-date information involving research.  All Standard Operating Procedures will be continuously updated to reflect new regulations as they are released.  The PI must make every effort to read all Standard Operating Procedures and any other information that is available concerning human research.  The PI must comply with annual training requirements and can inquire about additional training that is available with the ORI/IRB Office.

 

FOLLOW-UP RESPONSIBILITY:  Director, Office of Research Integrity

 

REFERENCES:  45 CFR 46

                             38 CFR 16.107

                       

　

 

Revised 5-1-2007