This guidance is superseded by guidance dated April 9, 2020
March 26, 2020: Guidance for Researchers Conducting Human Subject Research during Covid-19
In response to the COVID-19 outbreak, the Office of Research Compliance is providing guidance for research activities that involve in-person interaction with study participants, effective March 26, 2020 and continuing until further notice.
Effective March 26, 2020, the Office of Research Compliance is categorizing all human subject research into areas according to risk and benefit in order to better inform Stony Brook University researchers in conducting studies. This guidance applies to all ongoing and new research studies (including exempt research) as well as activities that have been/will be deemed Not Human Subjects Research conducted by Stony Brook University personnel that involve in-person interactions with participants.
Studies that Involve COVID-19
COVID-19 applications - The Stony Brook University Institutional Review Board will be prioritizing review of COVID-19 applications that involve a direct intervention and potential for a direct benefit to subjects or implications for the benefit to future patients.If you are submitting a COVID 19 study to the Stony Brook IRB, it will be processed in the usual fashion. We are making every effort to hold additional meetings, as needed, to make it as easy as possible for investigators to get appropriate studies reviewed and approved. While recognizing the intense interest and scientific benefit of studying COVID-19 patients, the Stony Brook IRB is concerned about the cumulative burden of multiple research projects on these seriously-ill patients and patients with similar symptoms or disorders who may be cognitively and emotionally strained.We are relying upon the clinical facilities to manage this issue through coordination so as to minimize the number of separate consent processes, in-person visits, procedures, and specimen collection. It is essential that Principal Investigators obtain permission from the appropriate clinical facility for access to patients.
Studies that do not involve COVID-19
Direct Benefit to Research Subjects – On-going and newly submitted studies in which there is likelihood of direct benefit to the research subject, and/or serious or immediate harm could be caused to the subject if the research were stopped, should continue, with appropriate safeguards. Direct and meaningful benefit means that participation in the study has a good probability of a direct and positive impact on the serious medical or serious psychological condition of individual subjects for one or more of the study groups.
- Potential cure of a serious disease
- Significant reduction of serious disease burden
- Treatment or stabilization of a serious medical or psychological condition that is having a significant negative impact on the participant (this could include treatment of substance abuse).
- Diagnosis of a serious condition that is treatable and that would otherwise not be known to the participant
Examples that do not meet this criterion, unless they are focused on COVID-19 or SARS-CoV-2, include:
- Most Phase 1 trials of investigational drugs
- First-in-human studies of an investigational drug or device
Newly submitted research protocols can be approved and on-going research can continue if the Principal Investigator determines the research can be conducted in a safe manner that protects subjects, researchers and research staff, and the community. These considerations include:
- Alternatives to having the participant be on-site for study visits; and the potential impact on research staff (illness and absences) if face-to-face visits are required
- Drug availability and/or the ability of the drug shipped to the subject and used by the subject in the home
- Contact of subjects prior to each in-person visit to conduct a COVID-19 exposure screening questionnaire
- Use of Personal Protective Equipment during the delivery of research interventions or monitoring of subjects.
The Principal Investigator will determine that the study be allowed to enroll subjects in newly approved research or continue enrollment in on-going research.
Moderate Direct Benefit to Research Subjects - On-going and newly submitted studies in which continued participation by enrolled participants may result in a direct benefit and would, if stopped, pose some risk to the research participant.
- Research protocols evaluating treatments for chronic conditions (e.g., asthma, hypertension, depression, etc.)
- Research protocols involving assessment of the safety or efficacy of an intervention which, if stopped, could significantly and adversely impact the potential societal benefit of the science.
- Pharmacologic or non-pharmacologic self-management for diabetes or cancer symptoms
The Principal Investigator should determine if the research can be conducted in a safe manner that minimizes individual contact. These considerations include:
- Remote assessment if possible and the potential impact on research staff (illness and absences)
- Use of personal protective equipment (PPE) and extensive precautions (if visits must be conducted in-person) that protect subjects, researchers and the community.
- Contacting subjects prior to each in-person visit to conduct a COVID-19 exposure screening questionnaire
Newly submitted research can be approved and on-going research can continue if the Principal Investigator determines the research can be conducted in a safe manner that protects subjects, researchers and research staff, and the community.
Low/No Direct Benefit to Research Subjects - On-going and newly submitted studies in which continued participation by enrolled participants would not result in a direct benefit and which poses little or no known risk to the research subject.
- Cohort and natural history studies where delays in data collection have limited impact on objectives
- Research in which placing a hold on the research does not substantively impact research objectives
These studies must not enroll new subjects where there is face-to-face interaction or continue to conduct face-to-face visits. On-line visits or data collection that does not require direct (face-to-face) participant interaction may continue. If the research cannot be conducted remotely, the research must stop during this time.
On-going and newly submitted studies determined by the IRB to be Exempt or activities that will be or may have been deemed Not Human Subjects Research - must stop all direct participant interaction(s) and stop enrollment of new participants unless the activity cannot be conducted remotely.