THE GEORGE WASHINGTON UNIVERSITY
Office of Human Research- Institutional Review Board
ohrirb@gwu.edu
Phone: 202-994-2715
humanresearch.gwu.edu
Student Investigator IRB Responsibilities Agreement (HRP-290)
IRB # (if already assigned, otherwise leave blank--will be assigned upon submission):
STUDY TITLE:
I understand that as the Student Investigator, in conjunction with the Principal Investigator and my site
preceptor (if applicable), I am responsible for all aspects of this research study. I understand that intentional or
involuntary violation of IRB policy is subject to appropriate penalties that could include further investigation
into the noncompliance, forfeiture of collected data, study expiration, and/or IRB-directed study termination. By
initialing the following statements I further agree that (initial below):
I will promptly respond to all requests for information or materials solicited by the IRB Office.
I will obtain and submit site permissions from any non-GWU location where I will be interacting with
participants, including recruiting, consenting, or data collection (if the site is withholding permission pending
IRB approval, this must be explicitly stated in the initial application).
I will abstain from enrolling any individual in a research study (i) until such study is approved by the IRB
and I have permission from the study PI and the site preceptor to begin study activities; (ii) during any period
when the IRB, sponsor, or principal investigator has suspended study activities; or (iii) following IRB or
sponsor/principal investigator-directed termination of the study.
If I am working with others on this study, I will ensure that all associates, colleagues, and other personnel
assisting in the conduct of the research study are appropriately informed of (i) the study procedures; (ii)
informed consent requirements; (iii) the potential adverse events associated with study participation; (iv)
adverse event reporting requirements; and (v) data collection and record-keeping criteria. In the event that I
have concerns about the study’s ethical conduct, I will alert the PI and the site preceptor immediately.
I will conduct the study in strict accordance with the current IRB-approved research protocol except
where a change may be necessary to eliminate an apparent immediate hazard to a given human research subject.
I will promptly report to the PI, site preceptor, and the IRB Office any deviations from the currently
approved research protocol (except for exempt studies, wherein the IRB should only be informed if the risks to
participants change, a new population is added, or there is a change in PI).
I will promptly report to the PI, site preceptor, and IRB (and, if applicable, to the sponsor and FDA) any
internal or external adverse event that is considered to be 1) unexpected; 2) serious) and 3) possibly or definitely
related to the study. This may include participant complaints or concerns.
I will request IRB approval of any proposed modification to the research protocol or to supporting
documents (such as consent, recruitment, data collection tools) prior to implementing such modifications.
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Student Responsibilities (HRP-290)
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THE GEORGE WASHINGTON UNIVERSITY
Office of Human Research- Institutional Review Board
ohrirb@gwu.edu
Phone: 202-994-2715
humanresearch.gwu.edu
Student Investigator IRB Responsibilities Agreement (HRP-290)
I will obtain and document informed consent prospectively and in accordance with the current IRBapproved informed consent documents (i.e., unless the IRB has granted a waiver of subjects’ consent).
I will maintain adequate, current, and accurate records of research data, outcomes, and adverse events to
permit an ongoing assessment of the risk/benefit ratio of study participation.
I will promptly report to the IRB any significant changes in the risk/benefit of study participation.
I will ensure that, in the event a research subject experiences a significant adverse event, every reasonable
effort is made to provide the subject with adequate care to correct or alleviate the consequences of the adverse
event to the greatest extent possible.
I will ensure that human research subjects are kept fully informed of any new information that may affect
their willingness to continue to participate in the research study.
I will maintain current training in Human Subjects Protections via the CITI training website
(CITIprogram.org) while the study is active. I understand that Human Subjects Protections training is valid for
two years then must be retaken. If my site preceptor has other training requirements I will ensure they are
updated and valid.
I will maintain current training on participant privacy/HIPAA (if PII or PHI is utilized in the research) via
the CITI training website (CITIprogram.org) or GW Skillport HIPAA modules while the study is active.
I will work with the PI and site preceptor ensure the submission of the research study for IRB continuing
review at least 30 days prior to study expiration.
I understand that if my research study expires before I am ready to close my study, I am required to
submit a new application, new supporting materials, and obtain new signatures. If the study is expired, study
activities must halt until re-approval is given.
I will notify the IRB, via the submission of a Study Closure Form, once all data collection and analysis of
identifiable information is complete.
Data and Confidentiality
I will never discuss participant information in the presence of any person outside of the program who is
not directly affiliated with the participant’s experience in the study, including but not limited to use of cell
phones outside of secure study-related environments.
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Student Responsibilities (HRP-290)
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THE GEORGE WASHINGTON UNIVERSITY
Office of Human Research- Institutional Review Board
ohrirb@gwu.edu
Phone: 202-994-2715
humanresearch.gwu.edu
Student Investigator IRB Responsibilities Agreement (HRP-290)
I will handle confidential data as discretely as possible and I will never leave confidential information in
view of others unrelated to the specific activity. I will keep all confidential information in a locked cabinet
when not in use. I will encrypt all computer files with personal identifiers when not in use. I will not use
portable media (e.g. USB drives) or laptops for data analysis unless the devices are fully encrypted and the data
have been de-identified. Identifiable data should never be kept on portable media. I will never use study data on
public computers.
I will maintain my computer protected by power on and screen saver passwords. I will not disclose my
computer passwords to unauthorized persons. No data will be maintained outside of sanctioned and secured and
encrypted devices.
I understand that I am responsible for preventing unauthorized access to or use of my keys, passwords,
and data codes.
I understand that I am bound by these policies, even upon resignation, termination, or completion of my
activities. Upon completion of my student project, my PI and site preceptor will advise me on handling of data,
materials, and any remaining follow up prior to my departure from the program.
I have received, read, and understood the above referenced guidelines. I agree to abide by
the Student Investigator Responsibilities Agreement.
___________________________________________________
Student’s Signature
____
Date
____________________________________________________________
Student’s Printed Name
___________________________________________________
Principal Investigator's Signature
_____
Date
___________________________________________________________
Principal Investigator's Printed Name
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