FAQs

PRIOR TO STUDY SUBMISSION:

1. How do I know if I need to submit my human subjects research for review and IRB approval?

Go to the IRB submissions page, and download and complete the “Human Subject Research Determination Worksheet”. This is a self- evaluation tool provided so that YOU can make your own determination if your study needs to be submitted for IRB review. If after completion you are still unsure, you may email the completed form to ohrirb@gwumc.edu, and request that your worksheet be reviewed for a decision. We will email back with the determination.

Generally, class requirements, CEs, oral histories, case studies, secondary (publicly available) data analysis, with no intent to publish or present outside of local context, would not be considered Human Subjects Research and not require IRB review.

2. How can I request assistance with the forms, IRB process or my study submission?

We welcome your calls or emails at any point during your research process to answer any questions you may have. The staff of OHR are available to meet with you during the hours of 9am and 4pm, to discuss your project or in-process paperwork.

To discuss your project in more detail, please request a ½ hour appointment in our office between 9am and 4pm. We request that you bring all forms and study materials with you at that time. Send your request to the Education Outreach Coordinator ohrirb@gwumc.edu.

3. How much time should I allow for an IRB approval of my research?

We request that your Exempt or Expedited application and study materials be submitted to this office for review at a minimum of 4 weeks prior to your anticipated research start date. Our review process generally can take approximately two to three weeks from time of submission; however, we cannot guarantee that we can accommodate your deadlines if you allow less time for IRB review. This approval timeframe assumes that all CITI training is complete, and all proper and completed paperwork has been submitted with the application. Missing information will delay the approval process.

For full board (high risk) studies, please refer to the Full Committee meeting deadlines and dates webpage at: http://www.gwumc.edu/research/human/meetings.html.

AFTER STUDY APPROVAL:

1. What I want to make changes to my study after I have IRB approval?

All changes to IRB approved Expedited and Full Board studies require modification approval prior to implementing any unapproved changes. Please submit a Modification Form, indicating the change(s) you are making, and the justification. Changes to the protocol would include additions of staff, changes to procedures, or even additions/deletions/changes to a survey or questionnaire. Exempt studies require modification approval only when changes may increase the risk to subjects, or when you want to start collecting identifiers.

2. When do study team changes require a change to the protocol and/or IRB notification?

According to the GW HRPP Policy on Modifications to Ongoing Studies, investigators must submit a protocol modification to the Office of Human Research (OHR) for the addition or removal of key study personnel*. Key study personnel is defined as anyone who is responsible for the day-to-day protocol decision-making related to the study conduct and/or will interact with research participants for the purposes of recruitment, consenting, collection of data, or have access to sensitive, identifiable research data. Sensitive information are those data that, if disclosed outside the research, could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. Examples include, but are not limited to, HIV status, psychiatric diagnosis, participation in illegal activities, etc. Investigators should maintain a listing of all personnel who assist with the research in the study file.

Investigators working with students or residents, who anticipate changes in the key study personnel on a rotating basis, should submit a memo listing the personnel at the beginning of the semester (or rotation). The memo should indicate the individual's name, his/her roles and responsibilities, and the anticipated time frame that s/he will be assisting the investigator. Should the time frame change (i.e., the time frame is extended), then an updated listing should be submitted to the OHR, otherwise, no additional notification is needed until the next semester or beginning of the next rotation. 

*Please note, changes in study personnel for exempt studies do not require IRB notification. Additionally, if collaborating with someone outside of the GW Research Community, the PI must obtain the necessary IRB approval/determination before that individual may assist with the research. Please contact the OHR for further information on working with non-GW affiliated collaborators.

3. When can I close my study with the OHR?

An IRB approved study can be closed in the OHR when all data collection and subject interaction has been completed, all private identifiable information has been stored, de-indentified, or destroyed in accordance with IRB approved protocol. This is applicable to all Expedited and Full Board studies. Please submit the Closure Form when these criteria have been met. (not applicable for Exempt studies).