Ramp-up of Human Subjects Research
Yes, to the extent possible, studies should be re-designed to maximize remote interaction, generally by telephone. For example, consent forms and questionnaires can be administered remotely rather than in-person. The goal should be to minimize the time on-site for research participants and staff while maintaining the integrity of the research.
Additional guidance for communicating remotely with study participants is available in the COVID-19 Research FAQs.
No, if these are changes that are being implemented to avoid an imminent hazard to study participants. Federal regulations allow such changes without prospective IRB approval. At the time of the next submission to the IRB for the study, or when directed by the IRB, whichever occurs first, report the changes that have been made.
Yes, if the new location is appropriate for clinical research.
No, if these are changes that are being implemented to avoid an imminent hazard to study participants. Federal regulations allow such changes without prospective IRB approval.
At the time of the next submission to the IRB for the study, or when directed by the IRB, whichever occurs first, report the changes that have been made.
Participants should be called prior to their scheduled visit and screened for symptoms of COVID-19 on the phone. If positive screen, advised not to come in and contact provider/health facility. If negative, they are invited to come to the research site.
When a participant arrives at the research site, the research staff must conduct a COVID-19 screening in accordance with New York State and Columbia requirements at the entrance to the facility. The screening form must be retained for 21 days and then shredded.
If it is the day before the visit, the visit should be cancelled and the participant instructed to wear a face covering, self-isolate, and contact his or her health care provider for further instruction. Testing at a publicly accessible site should be recommended. If it is the day of the visit, the same procedure should be followed. Do not bring a participant who screens positive into the facility.
CUIMC currently has a no visitors policy, which will remain in place after resumption of clinical research. Research participants must be met in person by a research assistant with an ID badge clearly visible at the security desk of the building where they are scheduled to be seen and accompanied at all times while they are in the facility, including to (but not into) the restroom. CUIMC security will be made aware that when clinical research resumes, accompanied research participants may enter the facility.
Research participants should be instructed the day prior to the visit to wear their own face covering. If the participant does not have one when he or she arrives, the research staff should provide a surgical mask. Face covering is required at all times within CUIMC.
These procedures must be done in accordance with NYP policies and procedures for safety in the context of COVID-19. Please check to be sure that you remain current, as these procedures are periodically updated. As of this time, individuals performing these procedures must use appropriate PPE including N95 mask, surgical mask covering it, goggles or eye shield, gloves, and gown and have received appropriate training in donning and doffing PPE. Research staff using N95 masks must have a fit test performed prior to the re-start of the research procedures that require the N95 mask. Fit testing for clinical research coordinators and staff is available at Workforce Health and Safety or by appointment with Environmental Health and Safety.
In addition, the research participant must have a negative COVID-19 PCR test within the 5 days prior to the procedure. The test may be done here or alternatively written documentation of an outside test result may be provided (paper copy or through the patient portal in Epic) including date of the test, participant’s name and date of birth (second identifier required), type of test, and test result. The test must be a PCR test (not an antigen test) and obtained with nasopharyngeal swab. Keep in mind that turn-around time for outside testing may be inconsistent with the requirement that the test be done within 5 days of the procedure.
Yes, your department/School must also provide approval, in accordance with plans for internal prioritization and timing, so that requirements of New York State Phase II restart can be met, e.g., physical distancing, PPE, screening. Your department/School will receive notification when your study has been determined to be eligible for reactivation.
Yes. Documentation of each fit-test and training must be maintained in the research records in the Research Personnel Training and Qualifications section of the regulatory documents, including the dates of the fit-test and certificates of training.
No. The no visitor policy is applicable to study monitors for onsite monitoring visits. All monitoring visits should be conducted remotely. If you have any questions, contact the Clinical Trials Office at [email protected].