Structure and Policies

June 14, 2021
Molloy College Policy regarding Human subject research in the time of Coronavirus (COVID-19)  

June 14, 2021 12:00 p.m.
Molloy College
Human subject research in the time of Coronavirus (COVID-19)
rev3

I. Molloy IRB Principles for conducting Research.

1. Protect the health and safety of researchers and human research subjects.
2. Resume research activities as public health conditions and campus resources permit.
3. Continue to ensure research compliance.


II. COVID-19 Guidance
All submissions will be reviewed on an individual basis for actual or potential risk vs. benefit to researcher and participant.

a. Follow the overall guidance of Molloy College Administration regarding COVID-19 : CORONAVIRUS INFORMATION AND STATUS AT MOLLOY COLLEGE
b. Additional Resource: New York State (NYS), and the Centers for Disease Control and Prevention
c. Primary Investigators / Co-Investigators will not submit or conduct any research or engage in activity that negates the COVID-19 guidelines set forth by Molloy College, or off campus site/institution policy.
d. Even with Molloy IRB Approval of a protocol Molloy College, NYS , CDC or off campus site /institution COVID-19 policies must still be followed.

Molloy College IRB can decide NOT to approve any human subjects research where a determination is made that the potential or actual risks outweigh the potential benefits to the participants.

Research: Regulations define Research as "a systematic investigation, including development, testing, and. evaluation, designed to develop or contribute to generalizable knowledge" (45CFR46.102(d)).

Minimal Risk: Common Rule (45 CFR 46.102):Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

COVID-19 update for Submitting protocols to Molloy Institutional Review Board

III. Human Subjects Research:

1. To resume face-to-face research with human participants at Molloy Campuses, all COVID-19 policies set forth by Molloy College Administration are to be followed.
2. To promote a safe environment when conducting face-to-face human participant research:

a. Assess the potential or actual Risk vs. Benefit to the researcher(s) and participant(s) of conducting in-person activities.
b. Consider if remote options: ZOOM, FACETIME, SURVEY MONKEY, GOOGLE FORMS
etc. are the best method(s) for achieving your goals given current conditions of the COVID-19 pandemic.
c. When conducting research/data collection/surveys off campus, researchers MUST follow those institutions /locations COVID-19 policy and take into account Molloy College, NYS and CDC recommendations.

IV. Recommended Best Practices: for the health and safety of those involved when conducting face-to-face human subject research.

a. Follow Site or Institution COVID -19 policy for face-to-face contact, PPE usage and take into account NYS and CDC recommendations.
b. Schedule one-on-one appointments only.
c. Schedule appointment times to avoid overlap/contact with other participants. Holding multiple participants in waiting areas should be avoided.
d. The PI must assess the status of both the research team members and the research participants with regard to COVID-19 (e.g., have not received a positive diagnosis in the past fourteen days, do not exhibit any symptoms, to the best of their knowledge, have not come in recent close contact with a person that may have COVID-19).


Any questions regarding Molly IRB and Human Subjects Research please contact:
Patricia A. Eckardt, PhD, RN, FAAN
Chair, Molloy College Institutional Review Board
Professor, Barbara H. Hagan School of Nursing
peckardt@molloy.edu

Molloy College Institutional Review Board Guidelines for Research Involving Human Subjects

IRB Manual (Doc)

Revised January 17, 2020; November 17, 2015; August 27, 2018; October 11, 2018