The university manages human subjects research integrity/ethical/compliance matters and the IRB. The human subjects module of GW iRIS initiates and tracks the status of IRB applications.
Commercial IRBs are independent pay-for-service IRBs that provide regulatory and ethical review services for academic and non-academic institutions to conduct reviews of research involving human subjects.
(Please see Commercial IRBs (WCG, Advarra) for more information)
Currently, all industry-sponsored trials are sent to WCG IRB for review. All other studies (federal and non-federal) should be sent to GWIRB for review. If you have questions, please contact the office at firstname.lastname@example.org
The Office of Clinical Research helps to make sure trials conducted at GW follow not only study protocols, but all applicable laws and regulations. We are continually assessing our systems to streamline clinical trials and ensure compliance.
What IRB should I use?
|Study Type||WCG IRB||iRIS|
If you are using a commercial IRB, like Advarra, for a new study, a reliance agreement (attach reliance form for Advarra) must be completed and approved by the IRB.
If you are unsure when to use a reliance agreement, please reach out to the OCR and we will help guide you.
Need Privacy Officer Approval?
Are you conducing a retrospective chart review OR do you need access to charts for screening? Then you will need privacy approval!
Please send an email to email@example.com with the following documents attached:
- IRB Outcome letter
- HIPAA waiver reviewed by the IRB
- Protocol or application
- List of relevant data points
Turn-around is approximately one week. Do NOT send the email directly to Scott Intner.
If you have additional questions, please email the OCR at: firstname.lastname@example.org.
Common Regulatory Documents and the Regulatory Binder
It is vital to the integrity of the study that regulatory binders are kept organized and up to date with all relevant trial materials.
- Common Regulatory Documents
- FDA 1572 (when applicable) - this document MUST be printed on both sides of the paper and updated any time there is a change in location, labs, or PI/Sub-Is
- Protocol Signature Page (PSP) - Signed by the local site PI
- Study Protocol
- Investigator Brochure (when applicable)
- Designation of Authority (DOA) Log
- Training Logs and Certificates
- Site Visit Log - To be completed by study monitors
- CV - All staff on the DOA log must have a signed CV, dated within the last 2 years
- GCP training - CITI GCP training for all staff on the DOA Log (expires every 3 years)
- Financial Disclosure Forms (FDF) - Competed by the PI and all Sub-Is
- Conflict of Interest (COI) - Completed by the PI and all Sub-Is
- Medical License - For PI, Sub-Is, and Pharmacists
- Informed Consent (ICF) - All versions of the ICF
- All IRB Submissions and Approval Documents
- Note to File (NTF)
- All study related correspondences
- Study Updates and Newsletters
- Subject Screening/Enrollment Log
- Drug Accountability Log - if applicable
Promptly Reportable Information
Investigators must report certain events that occur during the conduct of their research to the IRB. Events that may impact subject safety, confidentiality, information security, or privacy, or conduct of human subjects research without IRB approval require prompt reporting, while other less serious issues may require reporting to the IRB at the next continuing review or study closure.
NOTE: Prompt reporting requirements may vary across IRBs; so, be sure to check with the IRB of record for your protocol to determine what must be reported.
The following events must be reported to the IRB within five (5) business days of the study team becoming aware of the event:
- Conduct of human subjects research without IRB approval, including:
- Conduct of research without submitting study for IRB review.
- Conduct of research prior to receiving IRB notification of final approval.
- Initiation of substantive changes (i.e., changes that would affect the subjects' willingness to participate, such as changes to study procedures, risks and/or benefits) to the research protocol without prior IRB approval, including changes necessary to eliminate apparent immediate hazards to the subject.
- Inclusion of vulnerable subject populations without specific IRB approval.
- Conduct of research when IRB approval has expired or been closed, suspended, or terminated.
- Subject interactions or review of identifiable research data by individuals who have not completed appropriate investigator requirements (e.g., COI disclosure and CITI training).
- Major protocol deviations that placed subjects at greater risk of harm (including physical, psychological, economic, or social harm), caused actual harm to subjects or others, OR for greater than minimal risk research, compromised the integrity of the study data such that the subject’s data can no longer be used in analysis of study outcomes. This may include:
- Dosing errors.
- Enrolling a subject who does not meet eligibility criteria.
- For greater than minimal risk research, enrollment of more subjects study-wide than approved by the IRB
- Study visits outside of the protocol-specified timeframe or missed study visits.
NOTE: Study visit deviations that do not meet any criteria above should be reported with the next renewal submission, if applicable, or study closure.
- Consent, assent, and/or authorization issues, including:
- Failure to obtain consent, assent, and/or authorization from subjects, including obtaining consent or authorization from someone who cannot legally act on behalf of the subject.
- Conduct of research after subject decides not to participate, dissents, or withdraws from the research
- For subjects originally enrolled as minors with parental permission, failure to obtain consent prior to direct interaction after a subject turns eighteen years of age
- For subjects originally enrolled via consent of a legally authorized representative, failure to obtain consent prior to direct interaction after a subject gains consent capacity
- Following use of a short form consent, failure to re-consent the subject on a translated consent form unless an exception applies
- For greater than minimal risk research, failure to obtain the subject's signature on the informed consent.
- When use of a witness is required, failure to document the involvement of a witness in the consent process
- Enrolling subjects or continuation of subject participation using an inaccurate consent that could affect the subject’s willingness to participate (such as omission of study procedures, risks, and/or benefits).
- Disclosure or release of identifiable subject data outside the research team, which:
- May place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, educational advancement, or reputation, and/or
- Is determined by the appropriate covered entity’s HIPAA Privacy Officer, after review, to be a breach as such term is defined in the HIPAA Privacy Rule.
- Events that are reportable due to being determined to be a HIPAA breach must be reported to the IRB within five (5) business days of the Privacy Officer notifying the study team that the event has been determined to be a breach.
- Failure to report required information to the IRB at the time of renewal. Specifically:
- Systemic failure to report minor protocol deviations and/or minor noncompliance at time of renewal
- For multi-site research where GWU is serving as the IRB of record for external sites, failure to report information related to external sites at time of renewal
- IRB or HRPP noncompliance, including:
- Failure to provide the required level of IRB review
- Failure to assign an appropriate expiration date to research which results in IRB review being conducted less frequently than required
- Failure to communicate to the study team in a timely manner a study suspension or termination
- Any other error that may significantly compromise the rights or welfare of subjects
- Other Events
- Adverse event, either on-site or at an external research location, assessed by the PI as (1) unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the study-related documents, and (b) the characteristics of the subject population being studied, (2) related or possibly related to study participation, AND (3) suggests that the research places subject(s) or others at greater risk of harm than was previously known.
- Unanticipated adverse device effects.
- Complaints about the conduct of the research
- Study suspensions or holds related to risk, safety or compliance issues
- Local audit reports with any findings which meet prompt reporting criteria (e.g., Internal GWU for-cause and routine audits).
- Failure to submit amendments which update risks, benefits, or procedures within 60 days of receipt.
- Failure to promptly report events when required per HRPP Policies
NOTE: Receipt of an external auditing/monitoring report, such as an FDA Form 483, in itself does not require prompt reporting. However, the study team must evaluate each finding in any such report and assess whether the event(s) meet prompt reporting criteria.
We have identified an eRegulatory Binder solution! We will be launching Florence in the second half of 2023.
We also plan on launching eConsent platform through Florence portal. Please visit this page again to receive updates!