Clark University’s Institutional Review Board (IRB) is responsible for ensuring that all research conducted by faculty, staff, and students, protects the rights and welfare of human subjects. All human subjects research at Clark must be reviewed by the IRB.
Application forms and instructions may be found on the Mentor IRB Website. Exempt and expedited reviews are generally considered on a rolling basis. For other types of research, submission deadlines for monthly IRB meetings are listed on the sidebar. Apart from situations in which urgent review is required due to extenuating circumstances, the IRB does not review applications during the summer.
Turnaround time for proposal review is normally 1-3 weeks after submission (for exempt or expedited reviews) or 1-2 weeks after the meeting date (for full board reviews). An additional week is sometimes needed for special circumstances. Note that there are submission deadline dates for each scheduled IRB meeting. The point of contact for IRB matters is Linda Cote, Grant and IRB Coordinator, at firstname.lastname@example.org.
NOTE: Some committee determinations may require review of a revised proposal at a subsequent meeting of the full committee. It is strongly urged that research planned for summer be submitted for review NO LATER THAN APRIL to allow time for resubmission if required. Proposals submitted for the final (May) meeting of the academic year are rarely approved in time for research to take place over the summer.
Update (May 24, 2021): In-Person Research Pause
UPDATE (May 24, 2021): Subject to public health and vaccination data, the IRB anticipates that the current pause on in-person due to Covid-19 risk will be lifted as of June 1, 2021 for most research involving human subjects conducted in the United States. The pause will be lifted for all domestic in-person research involving individual subjects. In-person research activity involving human subjects outside the United States remains paused. Furthermore, studies that include research subject group activities (e.g., focus groups) in indoor settings remain paused until further notice. For research activity that remains paused, researchers may continue to apply for waivers of the pause following the IRB policy statement issued on August 5, 2020 (see https://www.clarku.edu/offices/sponsored-programs-and-research/irb-human-subjects/).
Researchers must comply with all other restrictions imposed by the Clark Reopening Committee (CRC). For example, because Clark University does not currently allow external visitors on the campus grounds, it is not permissible to conduct human subjects research that requires outside visitors to the campus. Due to this university restriction on outside visitors to campus, on-campus human subjects research with external participants (i.e., those not already permitted to be on campus as Clark faculty/student/staff/etc.) remains de facto paused until this university policy is changed.
All permitted in-person research interactions are expected follow relevant health and safety protocols applicable to the setting (e.g., social distancing, masking), consistent with Clark University, CDC, state/site guidelines. If complying with these guidelines will require changes in your approved study procedures, then an amendment must be filed with the IRB for approval prior to the commencement of in-person research activities.
Full information on this IRB policy update, including information on amendment requests related to health and safety protocols, may be found here: IRB COVID19 Update May 24 2021_FINAL.
Any questions regarding this policy should be directed to the IRB (email@example.com).
Update (August 5, 2020): In-Person Research Pause
UPDATE (August 5, 2020): The pause on in-person research due to Covid-19 risk remains in place. However, the IRB recognizes the possibility that some types of in-person human subjects research, in some locations, might be conducted in such a way as to maintain the minimal-risk standard. The bar is quite high in meeting this minimal risk standard (face-to-face meetings with masks and social distancing would not be sufficient). Nevertheless, the IRB will consider case-by-case waivers to the research pause for a limited set of circumstances.
Waivers of this type will only be approved if researchers can demonstrate that: (1) the research will provide direct social benefit, (2) there is overriding or urgent justification to conduct the requested in-person research at the current time, and (3) the research will be conducted in such a way that the risk of Covid-19 infection is minimal.
Regarding condition (2), completion of a degree requirement is not considered to be an overriding or urgent justification. Advisors and departments are encouraged to alter requirements and projects to enable degrees to be completed using research methods that are not subject to the research pause. Regarding condition (3), the burden will be on the researchers to demonstrate that the minimal risk standard applies. This implies that the risk is no more than the subjects would encounter regularly as part of their day-to-day lives.
As an illustration, IRB might consider a waiver for research where all in-person interaction occurs concurrent with interactions at the facility that will already be taking place, regardless of the research project. An example would be an observation of already-ongoing classroom activities at Clark, with students who are already present in the classroom, such that no additional in-person interactions are required beyond those already taking place. Interactions of this type would have to occur under all relevant safety guidelines appropriate to the setting. As before, waivers will continue to be considered for cases where the benefits of continued in-person interactions outweigh the risk due to COVID-19 (see original statement below).
Researchers who wish to apply for such a waiver for an already-approved protocol do so using the waiver application on the Mentor website. The waiver application is found under the Amendments tab, with the title “COVID-19 Request Waiver of Pause.”
For research that has not been previously approved by the IRB (and hence does not have a protocol number), you must first submit a new application for approval through the Mentor website, with an explanatory note that you will be requesting a waiver. Once the application is provisionally approved, you must then proceed to request an Amendment in Mentor for “COVID-19 Request Waiver of Pause.” For additional instructions, please contact firstname.lastname@example.org.
Changes to In-Person Research Due to COVID-19
Due to new and unforeseen risks of COVID-19 exposure, Clark University’s Institutional Review Board (IRB) has temporarily paused all human subjects research at Clark University involving additional in-person interactions. “Additional in-person interactions” implies that participating in the research will cause people to come into additional personal contact with other people — including researchers, subjects or others.
This pause applies to all research conducted under Clark IRB approval that fits the above description, regardless of location (i.e., on or off campus). This includes multi-institutional (collaborative) research projects operating under Clark IRB approval. That is, if the project fits the above description and is operating under the oversight of Clark’s IRB, it is subject to this temporary suspension of activities.
If you are in doubt as to whether this pause applies to your project, please assume that it does apply unless instructed otherwise by the IRB.
For details about these changes, visit the University’s COVID-19 Information page or download the IRB Policy on Human Subjects Research Under COVID-19.
Beginning with the January 1, 2019, deadline, all individuals submitting proposals to the IRB must have completed CITI training. Training must be renewed every three years. Mentor will automatically flag your submission if your training has expired. CITI training must include the “RCR Basic Curriculum + Human Subjects” modules.