Bridging biosafety and biosecurity gaps: DURC and ePPP policy insights from U.S. institutions
Data files
Sep 18, 2024 version files 239.23 KB
Abstract
Overview:
This study gathered empirical data on the knowledge and expertise of biosafety and biosecurity personnel, and researchers overseeing research with enhanced Potential Pandemic Pathogens (ePPPs) and Dual Use Research of Concern (DURC) across various U.S. sectors. The data aims to improve public health measures and oversight for DURC and ePPP, offering insights for future policies. A relationship was found between the size of biosafety/biosecurity teams and the likelihood of conducting ePPP research, with larger teams being more likely to engage in such research.
Methods:
A survey of 541 biosafety and biosecurity professionals was conducted between March 8 and April 10, 2024, with results analyzed using SAS at a significance level of 0.05. The study received approval from the Institutional Review Boards (IRBs) at Arizona State University and the University of Nevada, Reno.
Results:
Government institutions were found to be more likely to conduct DURC experiments compared to other Organizational Categories (i.e., Academic, Commercial, Consulting, Government, Other). Public institutions reviewed a higher number of experiments beyond the U.S. DURC Policy compared to Private for-Profit institutions. Institutions with larger biosafety/biosecurity teams were associated with increased research activities and more effective non-compliance reporting mechanisms (e.g., anonymous hotlines, anonymous reporting forms). Financial support and implementation challenges varied significantly across organizational categories.
Discussion:
The findings highlight the need for adequate staffing and resources for high-risk biosafety and biosecurity research activities. The survey results call for a tailored regulatory approach and equitable resource distribution for managing such research. Additionally, establishing effective non-compliance reporting mechanisms is essential for mitigating risks.
README: Bridging biosafety and biosecurity gaps: DURC and ePPP policy insights from U.S. institutions
https://doi.org/10.5061/dryad.1jwstqk4c
Description of the data and file structure
Overview
The dataset consists of 46 variables and 520 rows capturing various aspects of biosafety professionals' demographics, job characteristics, training, and research activities. Each row corresponds to an individual respondent, and each column captures a specific piece of information about the respondent or their professional experience.
*Dataset Format: .*csv
**Note: **the cell with “null” value represents that there is no answer recorded from respondent for that question
Demographic data were removed to protect respondent identities. Individual who are interested in obtaining the complete data set can contact the authors.
Columns and Descriptions
- PROGRESS: The progress or completion percentage of the survey by the respondent.
- DURATION: The total time taken by the respondent to complete the survey (in seconds).
- CHANNEL: The channel through which the respondent accessed the survey (e.g., email, anonymous).
- BIOSAFETY_JOB (Categorical): Position with biosafety responsibilities (Yes/No)
- NOTWORK (Categorical): Indicator if the respondent is currently a student, retiree or unemployed (Yes/No)
- BIOSAFETY_CONS (Categorical): Indicator if the respondent is a biosafety consultant (Yes/No)
- BSO (Categorical): Indicator if the respondent is a Biosafety Officer (BSO) (Yes/No)
- IBC (Categorical): Indicator if the respondent is a member of an Institutional Biosafety Committee (IBC) (Yes/No)
- IBC_OUTS (Categorical): Indicator if the IBC at their workplace is outsourced (Yes/No)
- EFFECTIVE (Categorical): Respondent's perception of their effectiveness to implement biosafety/biosecurity oversight at workplace (Yes/No)
- BIOSEC_JOB (Categorical): Job title or primary role of the respondent in biosecurity (Yes/No)
- TIME (Categorical): The percentage of time spent on biosafety and biosecurity
- USG_FUND (Categorical): Indicator if the respondent's work is funded by the US government (Yes/No)
- INSTITUTE_CAT (Categorical): Category of the respondent's institution (Academic, Government, Consulting…).
- INSTITUTE_CHA (Categorical): Characteristics of the respondent's institution (Public, Private For-Profit, Private Non-Profit)
- WORKFORCE (Categorical): Information about the biosafety professional’s team at workplace (1,2,…)
- DURC_EPPP_EFF (Categorical): Effectiveness of non-compliance reporting mechanisms to identify possible issues with Dual Use Research of Concern (DURC) and/or Enhanced Potential Pandemic Pathogen (ePPP) (Extremely Effective – Not at all)
- REPORT_PATHWAY (Categorical): Pathways for reporting DURC and ePPP activities (Yes/No)
- DURC_RESEARCH (Categorical): Indicator if the workplace conducts research that is subject to DURC (Yes/No)
- DURC_RESEARCH_OUTC (Categorical): Indicator if the workplace outsources research that is subject to DURC (Yes/No)
- DURC_RESEARCH_NOT (Categorical): Instances where DURC research was not conducted (Yes/No)
- IRE (Categorical): Indicator if the workplace has Institutional Review Entity information (Yes/No)
- DURC_TRAIN (Categorical): Indicator if the workplace trains researchers about risks associated with DURC (Yes/No)
- DURC_QUALITY (Categorical): Indicator of the quality of DURC training (Excellent to Poor)
- DURC_TRAIN_UPDATE (Categorical): Indicator of how well training is updated for DURC (Extremely well to Not well at all).
- DURC_FINSUP (Categorical): Indicator of the amount of financial support for DURC activities (Excellent to Poor)
- DURC_DIFF (Categorical): Indicator of the perceived difficulties of managing DURC at the workplace (Extremely difficult to Extremely easy).
- DURC_IMPACT (Categorical): Impact of DURC on the respondent's work (Extremely Positive to Extremely Negative)
- ePPP_RESEARCH (Categorical): Indicator if the workplace conducts research that is subject to ePPP (Yes/No)
- ePPP_RESEARCH_OUTC (Categorical): Indicator if the workplace conducts research that may generate ePPP (Yes/No).
- ePPP_REVIEW_YN (Categorical): Indicator if research at the workplace has undergone a review under ePPP (Yes/No).
- ePPP_PREPARE (Categorical): Indicator of how prepared respondents are in understanding the risks associated with ePPP (Extremely Prepared to Not at all)
- ePPP_TRAIN (Categorical): Indicator if the workplace trains researchers about risks associated with ePPP (Yes/No)
- ePPP_TRAIN_QUALITY (Categorical): Indicator of the quality of ePPP training (Extremely Good to Extremely Bad)
- ePPP_TRAIN_UPDATE (Categorical): Indicator of how well training is updated for ePPP (Extremely well to Not well at all).
- ePPP_FINSUP (Categorical): Indicator of the amount of financial support for ePPP activities (Excellent to Poor)
- ePPP_DIFF (Categorical): Indicator of the perceived difficulties of managing ePPP at the workplace (Extremely difficult to Extremely easy).
- ePPP_IMPACT (Categorical): Impact of ePPP on the respondent's work (Extremely Positive to Extremely Negative).
- DURC_ePPP_SUBC (Categorical): Indicator if the workplace uses subcontractors or subawardees to conduct DURC/ePPP (Yes/No).
- FSAT (Categorical): Indicator if the workplace conducts research governed by the Federal Select Agent and Toxin (FSAT) regulations (Yes/No)
- RO_ARO (Categorical): Indicator if the respondent is the responsible official or alternate responsible official of FSAT (Yes/No)
- FSAT_FINSUP (Categorical): Indicator of the amount of financial support for FSAT activities (Excellent to Poor)
- FSAT_DIFF (Categorical): Indicator of the perceived difficulties of managing FSAT at the workplace (Extremely difficult to Extremely easy).
- FSAT_IMPACT (Categorical): Impact of FSAT on the respondent's work (Extremely Positive to Extremely Negative).
- DURC_RISKREDUCE (Categorical): Indicators of how effective DURC is at reducing risks (Extremely effective to Not effective at all).
- ePPP_RISKREDUCE (Categorical): Indicators of how effective ePPP is at reducing risks (Extremely effective to Not effective at all).
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Potential Use:
The dataset provides a rich source of information that can be leveraged by researchers, policymakers, public health officials, and organizational leaders to gain insights into biosafety practices, evaluate program effectiveness, and ensure compliance with safety regulations. By using this data, potential consumers can make informed decisions that enhance biosafety and public health outcomes.
Access information
Data was derived from the following sources:
- Data were collected through surveys administered to individuals affiliated with the American Biological Safety Association International (ABSA International) and those listed as Institutional Biosafety Committee contacts with the National Institutes of Health Office of Science Policy in 2024.
Methods
Data were collected through surveys administered to individuals affiliated with the American Biological Safety Association International (ABSA International) and those listed as Institutional Biosafety Committee contacts with the National Institutes of Health Office of Science Policy in 2024 in alignment with prior research of this profession (Fletcher et al., 2021; Gillum et al., 2013, 2014, 2016). 1096 individuals received the survey, and 541 respondents completed the survey in full or partial response, representing approximately 49.4% of the total recipients. Of these respondents, 21 were from countries outside of the United States and were eliminated from the study, as our grant was specific to only those located inside the United States. Participation in the survey was optional and voluntary. Because respondents were not required to complete every question, and respondents could skip or select “Prefer not to say” for certain questions, the total number of responses for each question varied.