GW OFFICE OF HUMAN RESEARCH IRB FORUM JULY 2015 NEW FORMS AND POLICIES

UPDATED DOCUMENTS

IRB APPLICATION (HRP-200) Merges the previous Exempt from IRB Review Request and Human Subjects Research Synopsis form; This form now captures all information required by the IRB to appropriately review studies; If an investigator feels their study may be reviewed as Exempt, only sections in orange are required to be completed; If the IRB makes a determination of Expedited, the remainder of the document will be requested to be completed by the investigator.

HIPAA WAIVERS Full HIPAA Waiver Request (HRP-280) Partial HIPAA Waiver Request (HRP-281) As a reminder, HIPAA waivers are not granted by the IRB, but rather the privacy officer of the covered entity from which you will be accessing PHI.

IRB OF RECORD REQUESTS When GW will be serving as the IRB of Record, please complete Form HRP-573; When another institution will be serving as the IRB of Record, please complete Form HRP-574; Please also review the revised procedures before submitting an IRB of Record request to OHR.

OTHER FORMS FOR SUBMISSION Changes have been made to the following documents: Continuing Review Request (HRP-202) Modification Request (HRP-203) Closure Form (HRP-206) Please be sure to always use the most recent versions of documents. Outdated versions will not be accepted for review.

NEW FORMS

RESEARCH PERSONNEL FORM (HRP-201) This form is to be used to track the research team through the study lifecycle; It is to be submitted at initial and continuing review and whenever a change in the team occurs. A modification request document is not required for changes in team members. It is the responsibility of the investigator, NOT THE IRB to maintain CITI and other pertinent trainings of the research team: Training certificates are not maintained by the Office of Human Research.

CONSENT AND ASSENT Consent template for Biomedical Research with HIPAA Authorization (HRP-500) Consent template for Social/Behavioral Research (HRP-501). If HIPAA is required for S&B research, please use the biomedical template and modify the document accordingly. Assent template for children ages 7-12 (HRP-506) and (HRP-507) are now available.

WAIVER OR ALTERATION OF CONSENT Submit the Waiver or Alteration of Consent Supplement (HRP-294) with the IRB Application form (HRP-200) when requesting a waiver of consent, waiver of documentation of consent, or an alteration of consent; This form provides the IRB with additional information to determine if a waiver is appropriate.

PROBLEMS WITH RESEARCH This has been updated to the Promptly Reportable New Information Form (HRP-572); This new form accompanies the new policy, “Prompt Reporting Requirements HRP-801”; For additional information on this form and when to use it, please check our website for the IRB Forum from April 2015 titled, “Promptly Reportable Information & Events. When to Report Unanticipated Problems & Protocol Violations”.

STUDENT INVESTIGATORS Student Investigator Responsibilities (HRP-290) should be submitted for all student-initiated research including undergraduate, graduate, doctoral, law, and medical student research; One form for student group projects is sufficient, but all students should sign the document before submitting.

FUNDED PROJECTS Submit the Funding Source Supplement(HRP-220) for funded projects; This document should be used regardless of the funding source; If a funding source changes, please update the document.

PRISONERS Submit the Prisoner Certification Supplement (HRP-291) when conducting research with prisoner populations; This should be submitted at initial review or anytime this population is targeted for recruitment; Prisoner means any individual involuntarily confined or detained in a penal institution; The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing (45CFR (c)).

CHILDREN Submit the Children Supplement Checklist (HRP-292) when conducting research with persons who have yet to reach age of majority; This should be submitted at initial review or anytime this population is targeted for recruitment.

NON-ENGLISH SPEAKERS Submit the International/Non-English Speakers Supplement (HRP-293) when conducting international research or research with persons who cannot speak or understand English; This should be submitted at initial review or anytime this population is targeted for recruitment.

POLICIES

NEW POLICIES GW Policy on Principal Investigator Responsibilities (HRP-004); GW Policy on Classroom Research (HRP-081); GW Policy on Adults Lacking Capacity to Consent (HRP-082);

UPCOMING EVENTS August: No IRB Forum but OHR will hold open house September: OHR will be hosting a “Fall IRB Days” symposium. Topics include consent writing workshop, international research discussion panel, IRB process with breakout sessions for PIs and students, and GCP training for study coordinators. October: IRB Forum will focus on vulnerable Populations November: IRB Forum will discuss chart reviews

QUESTIONS? Office of Human Research Humanresearch.gwu.edu