Institutional Review Board

Overview

The Institutional Review Board is primarily responsible for evaluating, approving, and conducting reviews of any Gallaudet University research that involves human subjects. It is focused on protecting the rights and welfare of participants.

Regulated by the Federal Government, the Institutional Review Board is an important first stop for Gallaudet faculty, staff, and students planning to execute research on campus. Learn more about what needs IRB approval here.

If You Have Been A Research Participant

If you have been in a research study and want to provide feedback or report an adverse reaction, we want to hear from you.

IRB has office hours Friday mornings except when there are board meetings. The IRB chair Julie Hochgesang has virtual office hours and takes appointments via this Google Calendar link, where you can share your preference (e.g., Zoom meeting or text chat in Google Hangout). You can also email the IRB using the web form below.

Upcoming Meetings

Gallaudet IRB meetings usually take place every third Friday of the month during the academic year.

Support

Cayuse Account Request

Please complete the form below for access to Gallaudet Cayuse Human Ethics. You will receive an email with login instructions after you have been added to the system. Please allow 2-3 business days for account creation. You must be a student, staff, or faculty member...

How do I Submit to the IRB?

The following information will guide you through the IRB Process. If at any time you have questions, please email us at Contact here. You may also find answers on our FAQ page. All IRB protocol application forms are submitted via Gallaudet Cayuse Human Ethics. To...

IRB Determination Tool

If you are a student, faculty, or staff member of Gallaudet University in Washington, DC, please use the tool to help determine your research will require IRB review or not. Go to Tool

How to Delete a IRB Study

You can only delete a study in Cayuse Human Ethics if you have not submitted an initial submission for it. If a submission has already been submitted, you will need to submit a "Withdrawal" submission. Are any submissions associated with your study? If not, go...

IRB Application Process

Please submit applications at least one month before the projected start of research. All IRB applications are filed through Gallaudet Cayuse IRB, which is available to Gallaudet faculty, staff, and students. If you are a first-time user of the system, please submit a request to...

IRB Review Not Required

Most research conducted for classroom assignments does not meet the definition of human subjects research. It is the instructor's responsibility to ensure the ethical conduct of research. Classroom research involving collection or utilization of data on human subjects will not require a review from the...

CITI Program courses

Gallaudet University faculty, students, and staff involved in "human subjects research" are required to complete research ethics training, such as those listed below: Students in Research (Students) Conflicts of Interest (Faculty/Staff) Responsible Conduct of Research (if planning to film participants) The Gallaudet IRB recommends that...

Research Participants

To learn more about research participation, visit the page "About Research Participation" created by the Office for Human Research Protections. Report a Violation or Adverse Reaction:If you would like to report a violation or adverse reaction about any Gallaudet University IRB approved research study, then...

What Needs IRB Approval?

All Human Subjects Research conducted by students, faculty, or staff of Gallaudet University must be approved by the Gallaudet IRB. If your research meets the definitions of both research (Section L) and human subject (Section E), you must complete the IRB process. Learn more about...

Class Project

Please fill out the form below if you're doing a class project. Loading…

IRB Glossary

Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered...

IRB Resources

As an IRB Researcher, you can create a new study within Cayuse IRB from your Dashboard or the Studies page. Click in the upper right-hand corner of your Dashboard or the Studies page. Enter the title of your study. This can be up to 600...

IRB Sample Documents

All IRB applications are handled through Gallaudet Cayuse Human Ethics (https://gallaudet.cayuse424.com/irb). If you are a first-time user, please submit a request to have Gallaudet Cayuse Human Ethics account created. Please check IRB Process on how to complete your IRB Applications. Here is the list of...

IRB Membership

The following is a list of current IRB members: Name Title / Role Julie Hochgesang, chair Associate Professor, Linguistics Lori Lutz, vice chair Director of Monitoring, Evaluation, and Research, Clerc Center Kathy Arnos Non-voting Consultant Carolyn Corbett Professor, Clinical Psychology Teresa Crowe Professor, Social Work...

My research

Who do I contact if I have additional questions related to my study?

You can send your questions to the IRB at Contact here.

How do I distribute, collect, and store consent forms and other background information forms digitally?

There are several ways to make forms electronic by converting them into a PDF or creating digital versions (e.g., using Google forms). This means you can send your participant’s study forms via email and do not need to collect them in person. Be prepared to discuss any questions or concerns your participants have via email or their preferred video communication platforms like Zoom or Skype. Research teams should establish best practices for storing those forms in a secure password-protected storage device with back-ups. As a resource, University personnel has access to Adobe Sign through my.gallaudet.edu. Other online resources like Google forms can also be used if you describe how you keep information secure. If paper forms are required for whatever reason, handle them with care. Similarly, if you are creating digital resources but still handling them in person via tablet or laptop, sanitize your devices as recommended by health professionals.

How do I protect against the loss of video data during a recording?

Test your recording materials, and make sure that your video data is being recorded onto a device that has sufficient storage. Please be aware that many video conferencing software record only audio. You can make screen recordings using QuickTime or similar software, and you can back-up your data using a camera that is also filming your screen.

Some video conferencing software like Zoom allow for recording. You can directly store these in the cloud through your Zoom professional account for example and if linked to your ECHO360 account, the recording will show up there as well. If stored directly to your local computer, Gallaudet grants 1TB space size to faculty using Google Drive and Microsoft OneDrive to store your information. You may need to drag and move your important files and documents from your office computer. It is recommended that you consider multiple backups of your data (both online using cloud storage and offline using external hard drives).

What does “enrollment” mean? I don’t think I’m enrolling any participants.

Enrollment is just a way of saying how many people are involved in your study. It’s inherited from the federal regulations.

Do researchers need to keep hard copies of consent forms, or can they be scanned and saved electronically? If paper copies are needed, how long must they be stored?

It’s up to the researcher(s) which format they’d like to use for consent and other forms. Whichever format they use, they must be stored for up to three years after the completion of the project. If electronic versions are used, researchers must describe how they’re keeping them secure in the consent forms.

COVID-19 Impact

What if a subject reported possible COVID-19 exposure or symptoms during a prior study visit?

Please follow institutional policy, see “seeking medical care”.

Regarding temporary halt to study enrollment, what do I do?

UNLESS the study hold is initiated at the request of an external funding agency or the study’s Data and Safety Monitoring group (if there is one). You have the option to renew your study through Cayuse Human Ethics if your approval has expired. If your prior study was not submitted through Cayuse Human Ethics and you wish to renew that, please complete this form to request the transfer of your project to Cayuse Human Ethics for renewal and modification if necessary.

How should I screen participants for COVID-19?

We recommend all in-person contact be suspended. If you need to meet with someone, send an email to ask if there is potential for exposure to the novel coronavirus (COVID-19) or symptoms of illness before any study-related visits and in-person interactions and plan accordingly. The CDC (or whoever) recommends that research participants with possible exposure or symptoms of illness should not participate in in-person interactions until after the time recommended by the current public health recommendations. might include the following, which could be modified to fit your participant population and the location of in-person interactions. Any YES answer should be considered sufficient reason to postpone in-person visits. Decisions about in-person visits should be especially conservative for people at higher risk per public health recommendations: 1.) Have you had any of the following symptoms in the past two weeks, even if they were mild? Fever New cough Runny nose New shortness of breath Muscle aches 2.) Have you had close contact* with a person who is under investigation for possible COVID-19? 3.) In the past three weeks, have you visited a country or facility with sustained (ongoing) occurrence of COVID-19, such as the following (and any other locations consider Level 3 by the CDC): China Iran Most of Europe Japan South Korea Long-term care facilities in the area. *Close contact is defined by the CDC as (a) being within approximately 6 feet (2 meters) of a COVID-19 case for a prolonged period of time. Close contact can occur while caring for, living with, visiting, or sharing a health care waiting area or room with a COVID-19 case OR (b) having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on).

As a PI of my research, what should I be doing now?

First, consider the safety of your study team and participants. If any in-person interactions can be postponed, please do so. Immediately communicate your plan with all relevant parties. Make sure communication is accessible – consider everyone’s communication preferences and needs. Encourage your study personnel and participants to follow all precautions recommended by health professionals (e.g., District of Columbia Department of Health and CDC, also see resources at Gallaudet’s site for novel coronavirus (COVID-19). Establish remote access for your work. Consider this checklist developed by University of Washington, Office of Research. Checklist:

Identify emergency personnel and ensure they know what to do in the event of suspended operations
Remind lab personnel of your communication plan or create one if not in place
Identify priorities in case of restricted access
Ensure remote access to files, data, servers, etc.
Prioritize experiments
Plan for remote proposal submission
Check travel restrictions before making travel plans.

What if I’m not sure if I should keep doing my research?

Consider prioritization of tasks within your research project. Depending upon the nature of your research, you might consider prioritizing work that can only be carried out in your research facility, and work that could be done by remote support, such as data analysis. You may want to postpone work that requires in-person interaction until conditions are less risky for all. Stockpiling results and data now that could be analyzed remotely in the future is a potential option that might create future flexibility. (adapted from: https://www.washington.edu/research/announcements/mitigating-impacts-to-research-activities-due-to-covid-19/)

Do I need to modify my consent form or my study to include the risks of COVID-19 if there will be in-person interactions?

At this time, the IRB does not believe it is necessary for most studies. We recommend that study personnel do not bring participants to a facility in which there has been a positive or presumptive-positive case of COVID-19. If your protocols have changed to accommodate the ongoing situation to ensure everyone’s safety, IRB approval is not required. Please do submit any changes via email or through Cayuse Human Ethics to document your changes. This can be done by uploading the new forms or a short memo describing the changes. If you have any questions about this, you may reach out to us via email at Contact here.

Can I still interact with my research subjects?

Consider the study population and the location before. Assuming that populations and locations with few reported cases are free of novel coronavirus (COVID-19), you should consider the possible impact of the study on care providers, their institutions, and their patients/consumers who will likely be dealing with a significant increase in workload. Also if you are doing research at external research sites, it may be possible they are prohibiting visitors or closed altogether. If there is a compelling reason you cannot postpone in-person interactions, you should: Consider remote meetings (e.g., Zoom) as an option. This adjustment in your project proposal does not require an IRB amendment. Screen all participants for possible exposure to the novel coronavirus or symptoms of exposure to respiratory illness before scheduling any in-person interactions. Participants with possible exposure or symptoms of illness should not participate in person. This screening procedure does not require IRB approval or a submission of modification. Ensure that hand sanitizer, hand washing facilities and/or cleaning wipes are readily available for participants and study personnel, when in-person interactions will occur. Abide by all recommendations and actions of the appropriate public health authorities (e.g., District of Columbia Department of Health and Gallaudet and CDC) such as social distancing. Ensure every day that study personnel who will interact with participants are symptom-free and have not had possible exposure to COVID-19.

Cayuse Human Ethics

How do I submit my paper-based minutes?

As has already been in effect, we are not accepting paper-based applications for any new research. You can submit your study for IRB review through Gallaudet Cayuse Human Ethics. Please refer to How Do I Submit to learn how to submit electronically via Cayuse Human Ethics. If you are a student or a new or short-term staff/faculty member, please request a Cayuse Human Ethics account.

My files are too big to attach in Cayuse IRB. What should I do?

Upload the files to your Google Drive or OneDrive to a single folder and share that folder with us as a link. Please keep that folder active as long as your project is active.

Why do I keep getting expiration reminders after completing a Renewal submission?

The Cayuse system is set to send notices of IRB approval expiration starting 60 days in advance of expiration, and once every two weeks thereafter. Those reminders continue going out even after a renewal submission has been created. Their behavior is tied directly to the expiration date of the study and so those notifications will continue to go out until the review on the renewal is complete.

How can I delete a study in Cayuse Human Ethics? I have duplicate studies and how do I delete those duplicates?

You can only delete a study on Cayuse Human Ethics if you have not submitted an initial submission for it. If a submission has already been submitted, you will need to submit a “Withdrawal” submission. Please see our guide on how to delete a study in Cayuse Human Ethics.

I am a faculty sponsor, the student has asked me to certify however some changes need to be made before submitting. How do I send the submission back to the student?

There is a “RETURN TO INVESTIGATORS” button you can hit to send the application back to the student, and reopen it. This can be found on the submission details page. You or the student could then make changes. (Unfortunately, you can’t make comments in the application for the student.)

Why can’t I see CITI results for myself or another researcher in Cayuse IRB?

Your email address is likely different on CITI, please ensure you set your Gallaudet email address as a PRIMARY email address on CITI. Once it is set to your Gallaudet email, Cayuse Human Ethics will pick it up.

How long does it take to review a Cayuse IRB submission?

If you submit a complete application (all details are complete and clear), an exempt review can take about two weeks. Applications that involve more than minimal risk or vulnerable groups can take longer since it may require discussion with the reviewer(s), modifications of your protocols, attending a convened IRB meeting, and so forth. Be sure to plan ahead. We recommend two months or more before you need to start collecting data. Also, if your submission is incomplete, this can hold up the process.

I’m a student at Gallaudet submitting an application. How do I add my faculty sponsor to my application?

To add a faculty as your sponsor, please select co-principal investigator/sponsor and use people finder to find a faculty who is sponsoring you. The faculty sponsor is required to approve/certify your research.

Can external researchers get a Cayuse account?

No – they have to get a Gallaudet Sponsor and the sponsor has to submit for them. External researchers can be listed as unaffiliated key personnel in your Cayuse Human Ethics submission. They will not be able to access Gallaudet Cayuse Human Ethics directly but you can save a copy of the PDF and share that with them.

What is my username and password?

Cayuse Human Ethics is accessible through single-sign-on with your Gallaudet credentials. If you are a student and using the system for the first time. staff, or new faculty member please request an account. Existing faculty have been pre-loaded into the Cayuse Human Ethics system.

How do I log in?

Gallaudet Cayuse Human Ethics is available to Gallaudet faculty, staff, and students.

Other FAQs