F1000Research F1000Research 2046-1402 F1000 Research Limited London, UK 10.12688/f1000research.111082.1 Research Article Articles Effects of the COVID-19 pandemic on university-based research conduct and training: Exploring university-based researchers’ perspectives and experiences

[version 1; peer review: 1 approved with reservations]

 Ory Marcia G. Conceptualization Investigation Methodology Project Administration Resources Supervision Writing – Original Draft Preparation Writing – Review & Editing a 1 2 Lee Shinduk Conceptualization Data Curation Formal Analysis Investigation Methodology Project Administration Writing – Original Draft Preparation Writing – Review & Editing https://orcid.org/0000-0003-1336-819X 1 2 3 Radcliff Tiffany A. Conceptualization Investigation Writing – Original Draft Preparation Writing – Review & Editing 4 Jani Sagar Investigation Writing – Original Draft Preparation Writing – Review & Editing 2 Rice-Ficht Allison Conceptualization Investigation Writing – Original Draft Preparation Writing – Review & Editing 5 6 Waer Amy L. Investigation Writing – Original Draft Preparation Writing – Review & Editing https://orcid.org/0000-0003-1937-112X 7 Department of Environmental and Occupational Health, Texas A&M University, College Station, Texas, 77843, USA Center for Population Health and Aging, Texas A&M University, College Station, Texas, 77843, USA College of Nursing, University of Utah, Salt Lake City, Utah, 84112, USA Department of Health Policy and Management, Texas A&M University, College Station, Texas, 77843, USA Center for Microencapsulation and Drug Delivery, Texas A&M University, College Station, Texas, 77843, USA Health Science Research Center, Texas A&M Health Science Center, College Station, Texas, 77843, USA College of Medicine, Texas A&M University, College Station, Texas, 77843, USA mory@tamu.edu

Competing interests: A Rice-Ficht serves as managing partner, NanoRelease Technologies, LLC, San Antonio, TX. No other competing interests were disclosed.

 19 10 2022 2022 11 1195 24 6 2022 Copyright: © 2022 Ory MG et al. 2022 This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Background: The academic environment is critical for advancing knowledge through research and training of students who will serve as researchers, advocates, and leaders in the future, yet there is limited data on how the higher institution-based research enterprise is being impacted by the coronavirus disease 2019 (COVID-19) pandemic. The current study examines the perceived and expected impact of COVID-19 on engaging in a higher education institution setting, particularly focusing on student engagement in research and conduct of human subject research (HSR).

Method: The authors collected an online survey with faculty and staff in a large US university system focused on education, research, and service (6/8/2020-7/10/2020; N=709). The authors performed bivariate and multivariable logistic regression models to examine the differences in research impact by HSR.

Results: The majority of survey respondents (i.e., faculty and staff from a large US university system) perceived and expected at least some impact of COVID-19 on research and reported the impact to be negative. Researchers reported increased challenges in recruiting students for research activities and providing research-related learning opportunities for students. While COVID-19 impacted both HSR and non-HSR, HSR investigators have been disproportionately impacted by the pandemic.

Conclusions: Efforts are needed to further understand and overcome research challenges so that the university-based research environment can flourish for all researchers across disciplines and overcome the potentially lost learning opportunities for students. Lessons learned will help address future challenges to academic research activities and providing student research training.

 COVID-19 pandemic academic research research training human subject research The author(s) declared that no grants were involved in supporting this work. Introduction

The coronavirus disease 2019 (COVID-19) global pandemic has impacted most aspects of daily life. As of the time of the writing (June 2020), there were over 182 million confirmed COVID-19 cases and nearly four million mortality cases involving COVID-19 from around the globe ( CSSE, 2021). Alone in the United States, there were over 33.7 million confirmed COVID-19 cases and over 600,000 mortality cases involving COVID-19 ( CSSE, 2021). Mortality is only a part of the larger impact COVID-19 exerts on the social and political environment of people worldwide. The safety measures, such as social distancing, face coverings, travel restrictions, business closures, testing and quarantine, have impacted the daily activities and social norms and created a new normal of social and business interactions ( Bartik et al., 2020; Carel et al., 2020; Donthu and Gustafsson, 2020; Haleem and Mohd, 2020; UN, 2020). These changes are not only limited to the individuals but have also impacted whether and how organizations and institutions function ( Donthu and Gustafsson, 2020; Krishnamurthy, 2020; Soto-Acosta, 2020). Primarily led by a group of health science researchers, this study will focus on the impact of the pandemic on the university-based research enterprise.

Given COVID-19 related health risks, higher education institutions have adopted additional safety protocols in response to the pandemic, with particular attention to social distancing, cleaning and disinfecting, and face covering ( ACHA, 2020; CDC, 2020). Similar to other disaster epochs, conducting human subject research amid the COVID-19 pandemic raises questions about ‘ethics’ ( Packenham et al., 2020; WHO, 2020). As such, some major higher education institutions in the United States have adopted regulations for academic researchers to get permission to conduct their research and others were required to enforce local government or state-wide restrictions, such as stay-at-home orders that prevented on-premise research altogether for a prescribed timeframe. These new guidelines are likely to impact the research environment in both intended and unintended ways. For example, mandated preventive measures, such as social distancing and wearing of protective equipment designed to provide safety to both investigators and study participants are also likely to impact how researchers operate a lab or implement interventions and experiments. In addition, researchers in academic hospital settings may face greater challenges due to greater health concerns, safety risks, and increased volume of vulnerable patients.

While the COVID-19 pandemic might offer opportunities for new research questions, new research approaches, and additional funding for some researchers, challenges in carrying out research have been reported from diverse health science fields ( Omary et al., 2020; Rhodus et al., 2020; Weiner et al., 2020; Yanow and Good, 2020). For example, Yanow and Good (2020) discussed potential challenges in conducting ‘non-essential’ research and potential harm of neglecting research that are related to diseases other than COVID-19. Nicol et al. (2020) and Weiner et al. (2020) discussed potential challenges and solutions in conducting geriatric research and pediatric research, respectively. Difficulty in conducting health science research can restrict medical and health science students’ research training and associated competency, which is critical for their research development, as well as their ability to review scientific evidence and ability to make evidence-based clinical decisions. Despite the foreseeable impact of COVID-19 on research entities, there has been limited data on the topic. The National Institutes of Health survey on COVID-19 was one of the few data-based discussion of the topic, and its preliminary findings showed increases in non-research burden, changes in productivity, and increases in research expenses ( Bernard and Lauer, 2020). Another gap in understanding of COVID-19 impact on academic research is COVID-19 impacts on training of future researchers and professionals. For example, medical and health science students’ research competency is critical for their research development, as well as, their ability to review scientific evidence and make evidence-based clinical decisions.

This paper attempts to address this gap by exploring researchers’ perspectives and early experiences of COVID-19 impact on their ability to conduct research. Given how diverse the research fields and methods are, each research entity can be uniquely impacted by COVID-19 ( Yanow and Good, 2020; Myers et al., 2020). As a primary objective, this study focuses on the differential experiences and expectation of researchers based on whether they engage in human subject research (HSR) or not. HSR refers to research involving a living individual about whom data are obtained through interaction or intervention or identifiable, private information are obtained or generated ( NIH, 2020). While COVID-19 has impacted both researchers working with and without human subjects, researchers working with human subjects are hypothesized to face unique challenges in recruiting and interacting with human subjects, as well as in providing needed research training and learning opportunities for students. This exploratory study adds to the current literature by examining the COVID-19 impact on human subject research versus non-human subject research and the research training of students. This timely cross-sectional study can provide valuable insights regarding the immediate pandemic impact perceived by the researchers in an academic setting and can better inform the future pandemic preparation.

 Methods Ethical approval and consent

The study was reviewed and approved by the Texas A&M Institutional Review Board (IRB2020-0622M). All included study participants provided electronic informed consent by reviewing the study information and checking “I agree to participate in this study.”.

 Study design and study respondents

A cross-sectional online survey was collected (June 2020 – July 2020) from 872 individuals in a large Research 1 university system focused on public state-wide educational, research, and service in the United States designated as a member of the American Association of Universities. Faculty and staff of the university system were sent recruitment emails through the university system email lists. Since multiple email lists were used, some individuals received multiple recruitment emails. The recruitment email contained a brief description of the study and a link to the online survey, and the survey began with detailed study information and consent section. 872 opened the online survey, and 863 (99.0%) provided informed consent to participate in the study. Among those who consented, 709 (82.2%) were eligible to participate in the study. A person was eligible to complete the survey if he/she was a current faculty or staff in the university system and engaged in any research activities. The final sample included in this study was 642 respondents who reported whether they engaged in HSR or not. Of 642 respondents included in this study, 238 self-reported engaging in HSR. Given the limited data availability, approximate response rate was calculated for a sub-group (principal investigators at the main campus location). This sub-group (n = 248) constituted over 82% of the respondents from the main campus location and 48% of the overall respondents who reported their principal investigator status. The sub-group had about 11% response rates (248 out of ~2300). As a recruitment incentive, at the end of the survey, respondents were invited to participate in a drawing for a chance to win $100 gift cards, and five of eligible researchers were randomly selected and awarded from the drawing. A copy of the survey can be found in the Extended data ( Ory, 2022).

 Measures

This study used an online survey that was developed by the researchers and was sent to a number of university system researchers from various disciplines via email to evaluate its face validity. The questions used in this study was presented in Table 1. Main outcomes were specified to capture several possible aspects of COVID-19 impact on research: (1) overall impact on their research; (2) impact on specific research activities; (3) impact on student engagement; and (4) direct COVID-19 related changes (example: social distancing and wearing of personal protective equipment). Aspects of overall impact included: perceived severity of the impact, directionality of the impact, expected severity of the impact, and changes in research focus. Specific research activities included: data collection, data analyses, and dissemination of the study findings. Particularly for HSR, this study also examined participant recruitment, participant retention, and participant interaction. Because engaging students in research is considered an important aspect of research activities in large university systems, three different areas of student engagement in research were included: student recruitment, student financial support, and research-related learning opportunities for students. The direct changes in research due to COVID-19 included specific concerns and safety measures (e.g., social distancing and wearing of protective equipment) in relation to impacts on research activities. The questions that used 5-Likert point scale ranging from ‘very negative’ to ‘very positive,’ were dichotomized into ‘negative’ and ‘neither or positive.’ Dichotomization was performed because there were too few respondents reporting positive impacts. For example, for the question, ‘Taken all together, what has the impact of COVID-19 outbreak been on your research?,’ there were 4 (0.7%) respondents reporting ‘very positive’ and 18 (3.3%) reporting ‘somewhat positive.’

Key survey questions about researchers’ perceived and expected impact of coronavirus disease 2019 (COVID-19) on their research.
Categories/Question Response categories N
A. Research in general    
How much has the COVID-19 outbreak impacted your research? 5 categories (1 = Not at all, 5 = Severely) 547
Taken all together, what has the impact of COVID-19 outbreak been on your research? 2 categories (1 = Somewhat or very negative, 0 = Neither or somewhat or very positive) a 546
How much do you think the COVID-19 outbreak will impact your research in the future? 5 categories (1 = Not at all, 5 = Severely) b 514
Has the COVID-19 outbreak caused or needed you to change your research focus? 3 categories (1 = Not at all, 2 = Somewhat, 3 = A lot) 538
B. Research activities    
Please rate the impact of the COVID-19 outbreak has already had on the following aspects of your research: Data collection 2 categories (1 = Somewhat or very negative, 0 = Neither or somewhat or very positive) a , b 506
Please rate the impact of the COVID-19 outbreak has already had on the following aspects of your research: Data analyses 2 categories (1 = Somewhat or very negative, 0 = Neither or somewhat or very positive) a , b 502
Please rate the impact of the COVID-19 outbreak has already had on the following aspects of your research: Dissemination of the study findings 2 categories (1 = Somewhat or very negative, 0 = Neither or somewhat or very positive) a , b 497
C. Student engagement    
Please rate the impact of the COVID-19 outbreak has already had on the following aspects of your research: Recruitment of students for research activities 2 categories (1 = Somewhat or very negative, 0 = Neither or somewhat or very positive) a , b 465
Please rate the impact of the COVID-19 outbreak has already had on the following aspects of your research: Provision of financial support for students 2 categories (1 = Somewhat or very negative, 0 = Neither or somewhat or very positive) a , b 445
Please rate the impact of the COVID-19 outbreak has already had on the following aspects of your research: Provision of research-related learning opportunities for students 2 categories (1 = Somewhat or very negative, 0 = Neither or somewhat or very positive) a , b 474
D. Direct COVID-19 Outbreak-related changes    
How much will the following COVID-19 related concerns and changes affect your ability to conduct your research? (Needs for social distancing) 3 categories (1 = Not at all, 2 = Somewhat, 3 = A lot) b 529
How much will the following COVID-19 related concerns and changes affect your ability to conduct your research? (Needs for wearing personal protective equipment) 3 categories (1 = Not at all, 2 = Somewhat, 3 = A lot) b 519

N = total number of valid responses;

Originally 5 categories – merged because of skewed response distribution (i.e., only a small number of respondents responding ‘somewhat positive’ or ‘very positive’);

Respondents could respond ‘Not sure’ or ‘Not Applicable’ to these questions, and such responses were excluded from N and the rest of the analyses.

The primary independent variable was a dichotomous indicator, reflecting whether researchers engaged in HSR or not. This was determined based on respondents’ self-reported research types that they engaged in. Assessed covariates included principal investigator status (response categories: yes/no), number of years engaging in research, and use of experimentation or interventions. At the end of the survey, respondents reported their primary affiliation school/college, faculty status (response categories: faculty/staff/others) and sociodemographic characteristics (age, sex, race, and ethnicity). Primary affiliation was coded into multiple binary variables representing each school/college.

 Analyses

Sociodemographic characteristics of researchers and their research roles and experiences were described using frequency and percentage or mean and standard deviation and were compared based on engagement in HSR (e.g., Chi-square test for categorical variables and independent group t-test for interval variables). Each outcome variable was described using frequency and percentage, and bivariate analyses (i.e., bivariate logistic regression) were performed to examine the association between the outcome variables and engagement in HSR. For each outcome variable, multivariable logistic regression models were performed by adjusting for principal investigator status, number of years engaging in research, and use of experimentation or interventions. All statistical analyses were performed using SAS 9.4 (SAS Institute Inc., Cary, North Carolina).

 Results Study respondents

The majority of respondents were ages 35–64 years old (n = 362, 78.8%), male (n = 269, 56.6%), white (n = 394, 90.8%), not Hispanic (n = 424, 91.0%), faculty (n = 415, 78.3%), and currently serving as a principal investigator (n = 420, 81.6%). The respondents were from various fields of study including agriculture and life sciences (n = 78, 15.2%), health sciences (n = 60, 11.7%), liberal arts (n = 56, 10.9%), engineering (n = 55, 10.7%), sciences (biology, chemistry, mathematics, physics & astronomy, and statistics) (n = 51, 9.9%), education and human development (n = 46, 8.9%), and other fields (n = 168, 32.7%). On average, the respondents have engaged in research for over 19 years.

Compared to the respondents who did not engage in HSR, those who engaged in HSR were significantly more likely to be females (n = 106, 61.3% vs. n = 100, 33.1%, p < .001) and faculty (n = 163, 84.9% vs. n = 252, 74.6%, p = .02). Compared to those who did not engage in HSR, a greater percentage of respondents engaging in HSR were in education and human development (n = 44, 24.0% vs. n = 2, 0.6%, p < .001) and less percentage in agriculture and life sciences (n = 17, 9.3% vs. n = 61, 18.4%, p = .006), engineering (n = 6, 3.3% vs. n = 49, 14.8%, p < .001), or science (n = 4, 2.2% vs. n = 47, 14.2%, p < .001). While a greater percentage of respondents engaging in HSR were in health sciences (n = 28, 15.3% vs. n = 32, 9.7%), the statistical significance was marginal (p = 0.06). The respondents who engaged in HSR were also less likely to report using experimentation or interventions (n = 122, 51.3% vs. n = 252, 63.8%, p = .002) and had fewer years of experience engaged in research (16.0 vs. 20.8 years, p < .001).

 Impact on research in academic setting

The majority perceived (n = 504, 92.1%) and expected (n = 494, 96.1%) at least some impact of COVID-19 on research, reported the impact to be negative (n = 430, 78.8%), and made changes in their research focus because of COVID-19 (n = 245, 45.5% somewhat and n = 64, 11.9% a lot) ( Table 2). Compared to the respondents not engaging in HSR, the respondents engaging in HSR had significantly higher odds of perceiving (Odds Ratio (OR)  =  2.25, 95% Confidence Interval (CI) = [1.07, 4.74], p = .03) and expecting (OR = 4.86, 95% CI = [1.50, 15.79], p = .009) severe impacts of COVID-19 on research. Compared to the respondents not engaging in HSR, the respondents engaging in HSR were 2.28 times more likely to make some changes to their research focus and 3.73 times more likely to make a lot of changes to their research focus because of COVID-19. Adjusted associations between the perceived and expected impacts and engagement in HSR were comparable to the observed bivariate associations.

Bivariate and multivariable logistic regression models predicting impact of coronavirus disease 2019 (COVID-19) on research.
Impact of COVID-19 on research (magnitude) Impact of COVID-19 on research (direction) Expected impact of COVID-19 on research in the future Impact of COVID-19 on research focus
Response categories 5 categories (1 = Not at all, 5 = Severely) 2 categories (0 = not negative, 1 = negative) 5 categories (1 = Not at all, 5 = Severely) 3 categories (1 = Not at all, 2 = Somewhat, 3 = A lot)
Total number of responses 547 546 514 538
Frequency (%) Not at all: 43 (7.9%) Not negative: 116 (21.2%) Not at all: 20 (3.9%) Not at all: 229 (42.6%)
Slightly: 129 (23.6%) Negative: 430 (78.8%) Slightly: 145 (28.2%) Somewhat: 245 (45.5%)
Moderately: 123 (22.5%)   Moderately: 156 (30.4%) A lot: 64 (11.9%)
Extensively: 161 (29.4%)   Extensively: 156 (30.4%)  
Severely: 91 (16.6%)   Severely: 37 (7.2%)  
Bivariate        
Engaging in human subject research Not at all (ref) vs. Slightly (OR = 0.68, 95% CI = [0.33, 1.40], p = 0.296) Not negative (ref) vs. Negative (OR = 0.89, 95% CI = [0.58, 1.36], p = 0.586) Not at all (ref) vs. Slightly (OR = 0.80, 95% CI = [0.29, 2.23], p = 0.669) Not at all (ref) vs. Somewhat (OR = 2.28, 95% CI = [1.54, 3.38], p < 0.001 **)
Not at all (ref) vs. Moderately (OR = 0.88, 95% CI = [0.43, 1.80], p = 0.717)   Not at all (ref) vs. Moderately (OR = 1.07, 95% CI = [0.39, 2.95], p = 0.898) Not at all (ref) vs. A lot (OR = 3.73, 95% CI = [2.09, 6.64], p < 0.001 **)
Not at all (ref) vs. Extensively (OR = 0.83, 95% CI = [0.41, 1.67], p = 0.598)   Not at all (ref) vs. Extensively (OR = 1.76, 95% CI = [0.64, 4.81], p = 0.273)  
Not at all (ref) vs. Severely (OR = 2.25, 95% CI = [1.07, 4.74], p = 0.033) *   Not at all (ref) vs. Severely (OR = 4.86, 95% CI = [1.50, 15.79], p = 0.009) *  
Multivariable a        
Engaging in human subject research Not at all (ref) vs. Slightly (aOR = 0.76, 95% CI = [0.33, 1.73], p = 0.511) Not negative (ref) vs. Negative (aOR = 1.07, 95% CI = [0.67, 1.70], p = 0.785) Not at all (ref) vs. Slightly (aOR = 0.995, 95% CI = [0.30, 3.36], p = 0.993) Not at all (ref) vs. Somewhat (aOR = 2.46, 95% CI = [1.61, 3.78], p < 0.001 **)
Not at all (ref) vs. Moderately (aOR = 1.03, 95% CI = [0.45, 2.37], p = 0.941)   Not at all (ref) vs. Moderately (aOR = 1.62, 95% CI = [0.48, 5.43], p = 0.435) Not at all (ref) vs. A lot (aOR = 4.26, 95% CI = [2.26, 8.02], p < 0.001 **)
Not at all (ref) vs. Extensively (aOR = 1.04, 95% CI = [0.47, 2.34], p = 0.920)   Not at all (ref) vs. Extensively (aOR = 2.54, 95% CI = [0.76, 8.43], p = 0.129)  
Not at all (ref) vs. Severely (aOR = 2.74, 95% CI = [1.15, 6.51], p = 0.023) *   Not at all (ref) vs. Severely (aOR = 5.64, 95% CI = [1.42, 22.44], p = 0.014) *  

SD = standard deviation; ref = reference; OR = odds ratio; CI = confidence interval; aOR = adjusted odds ratio;

p < 0.05;

p < 0.001.

Multivariable model after adjusting for principal investigator status, number of years engaging in research, and use of experimentation or interventions.

 Impact on research activities

The majority of the study respondents reported negative impact of COVID-19 on data collection (n = 387, 76.5%), and over 41% reported negative impact on data analyses (n = 209) and dissemination of the study findings (n = 206) ( Table 3). Compared to the respondents who did not engage in HSR, those who engaged in HSR were significantly more likely to report negative impact of COVID-19 on data collection (OR = 2.16, 95% CI = [1.36, 3.45], p = .001). There was not any statistically significant association observed between engagement in HSR and impact of COVID-19 on data analyses (OR = 0.94, 95% CI = [0.65, 1.36], p = .74) or dissemination (OR = 1.35, 95% CI = [0.93, 1.95], p = .11). After adjusting for principal investigator status, number of years engaging in research, and use of experimentation or interventions, the odds of the respondents who engaged in HSR to report negative impact on data collection remained higher than the odds of the respondents who did not engage in HSR (Adjusted Odds Ratio (aOR)  =  2.74, 95% CI = [1.63, 4.62], p < .001). The associations between engagement in HSR and impact of COVID-19 on data analyses (aOR = 0.92, 95% CI = [0.61, 1.37], p = .67) and dissemination (aOR = 1.28, 95% CI = [0.86, 1.92], p = .23) remained statistically insignificant after adjusting for principal investigator status, number of years engaging in research, and use of experimentation or interventions.

Bivariate and multivariable logistic regression models predicting impact of coronavirus disease 2019 (COVID-19) on research activities.
Impact of COVID-19 on: Data collection Impact of COVID-19 on: Data analyses Impact of COVID-19 on: Dissemination
Response categories 2 categories (1 = negative, 0 = not negative) 2 categories (1 = negative, 0 = not negative) 2 categories (1 = negative, 0 = not negative)
Total number of responses 506 502 497
Frequency (%)      
Negative 387 (76.5%) 209 (41.6%) 206 (41.4%)
Not negative 119 (23.5%) 293 (58.4%) 291 (58.6%)
Bivariate      
Engaging in human subject research Not negative (ref) vs. Negative (OR = 2.16, 95% CI = [1.36, 3.45], p = 0.001) * Not negative (ref) vs. Negative (OR = 0.94, 95% CI = [0.65, 1.36], p = 0.739) Not negative (ref) vs. Negative (OR = 1.35, 95% CI = [0.93, 1.95], p = 0.112)
Multivariable      
Engaging in human subject research Not negative (ref) vs. Negative (aOR = 2.74, 95% CI = [1.63, 4.62], p < 0.001) ** Not negative (ref) vs. Negative (aOR = 0.92, 95% CI = [0.61, 1.37], p = 0.670) Not negative (ref) vs. Negative (aOR = 1.28, 95% CI = [0.86, 1.92], p = 0.226)

SD = standard deviation; ref = reference; OR = odds ratio; CI = confidence interval; aOR = adjusted odds ratio;

p < 0.05;

p < 0.001.

Multivariable model after adjusting for principal investigator status, number of years engaging in research, and use of experimentation or interventions.

 Impact on student engagement

The majority of the study respondents reported negative impact of COVID-19 on recruiting students for research activities (n = 327, 70.3%) and providing research-related learning opportunities for students (n = 328, 69.2%), and 43.1% (n = 192) reported negative impact on providing financial support for students. There was not any statistically significant difference observed in impact of COVID-19 on recruiting students for research activities (OR = 1.13, 95% CI = [0.75, 1.71], p = .56), providing financial support for students (OR = 0.98, 95% CI = [0.66, 1.45], p = .93), and providing research-related learning opportunities for students (OR = 0.999, 95% CI = [0.67, 1.50], p = .997) based on engagement in HSR. The association between engagement in HSR and impact of COVID-19 on student engagements remained statistically insignificant after adjusting for principal investigator status, number of years engaging in research, and use of experimentation or interventions.

 Impact from social distancing and protective equipment

The majority reported at least some impact of the needs for social distancing (n = 465, 87.9%) or the needs for wearing personal protective equipment (n = 368, 70.9%) on conducting research ( Table 4). Compared to the respondents who did not engage in HSR, those who engaged in HSR were significantly more likely to experience a lot of impact of the needs for social distancing (OR = 1.83, 95% CI = [1.02, 3.31], p = .045) or personal protective equipment (OR = 2.37, 95% CI = [1.42, 3.94], p < .001) on their research. After adjusting for principal investigator status, number of years engaging in research, and use of experimentation or interventions, the respondents who engaged in HSR remained significantly more likely to experience a lot of impact from the needs for social distancing (aOR = 2.82, 95% CI = [1.46, 5.45], p = .002) or personal protective equipment (aOR = 2.98, 95% CI = [1.69, 5.24], p < .001) than those who did not engage in HSR.

Bivariate and multivariable logistic regression models predicting perceived impact of the coronavirus disease 2019 (COVID-19) safety regulations on research.
Impact of the needs for social distancing on research Impact of the needs for wearing personal protective equipment on research
Response categories 3 categories (1 = Not at all, 2 = Somewhat, 3 = A lot) 3 categories (1 = Not at all, 2 = Somewhat, 3 = A lot)
Total number of responses 529 519
Frequency (%)    
Not at all 64 (12.1%) 151 (29.1%)
Somewhat 245 (46.3%) 258 (49.7%)
A lot 220 (41.6%) 110 (21.2%)
Bivariate    
Engaging in human subject research Not at all (ref) vs. Somewhat (OR = 0.97, 95% CI = [0.54, 1.76], p = 0.922) Not at all (ref) vs. Somewhat (OR = 1.14, 95% CI = [0.74, 1.76], p = 0.549)
Not at all (ref) vs. A lot (OR = 1.83, 95% CI = [1.02, 3.31], p = 0.045) * Not at all (ref) vs. A lot (OR = 2.37, 95% CI = [1.42, 3.94], p < 0.001) **
Multivariable    
Engaging in human subject research Not at all (ref) vs. Somewhat (aOR = 1.42, 95% CI = [0.74, 2.75], p = 0.293) Not at all (ref) vs. Somewhat (aOR = 1.51, 95% CI = [0.93, 2.43], p = 0.095)
Not at all (ref) vs. A lot (aOR = 2.82, 95% CI = [1.46, 5.45], p = 0.002) * Not at all (ref) vs. A lot (aOR = 2.98, 95% CI = [1.69, 5.24], p < 0.001) **

SD = standard deviation; ref = reference; OR = odds ratio; CI = confidence interval; aOR = adjusted odds ratio;

p < 0.05;

p < 0.001.

Multivariable model after adjusting for principal investigator status, number of years engaging in research, and use of experimentation or interventions.

 Discussion and conclusions

This study examined the university-based researchers’ perceived and expected impact of COVID-19 on conducting HSR and non-HSR. Consistent with other studies ( Omary et al., 2020; Rhodus et al., 2020; Weiner et al., 2020; Yanow and Good, 2020), the current study found that both researchers engaging in HSR and non-HSR perceived that their research was impacted negatively by COVID-19. As predicted, the perceived and expected impact tend to be more severe for HSR than in non-HSR. This study showed greater likelihoods of changing research focus, experiencing negative impacts on data collection, and experiencing negative impacts from the needs for social distancing or wearing of personal protective equipment among the researchers conducting HSR versus those not conducting HSR.

Both researchers engaging and not engaging in HSR reported increased challenges in recruiting students for research activities and providing research-related learning opportunities for students. This finding can be particularly relevant for health science students who were pulled from direct patient contact in their clinical clerkships in mid-March 2020. The students returning to their clerkship rotations are likely to face unprecedented learning and training environments ( Weiner, 2020). Our medical students in particular where allowed to return to direct patient contact in June 2020 with the exception of limited access to COVID-19 positive patients or patients under investigation for COVID-19. This alone created the need for complex algorithms as it pertains to different medical specialties (e.g. Intensive Care Units) and required significant faculty and student instruction/education to navigate. This observation aligns with Yanow and Good (2020)’s discussion of the uncertainty in day-to-day operation and productivity students and trainees are faced. According to the National Opinion Research Center (NORC)’s January 2021 report on the COVID-19 impact on graduate school, only 24% of institutions agreed consistent graduate advising was received by students during the pandemic ( Stewart et al., 2021).

In the short-term, the limited ability to recruit and engage students in research activities can result in an inadequate workforce to meet current research needs. This can also reduce the opportunities for students to learn about the cutting-edge knowledge in the field and gain applicable research skills. In the long-term, this can potentially impact the quantity and quality of the future research workforce. This finding implies the importance of dedicated efforts to enable higher education institutions to continue to engage students in research activities and to provide quality research-related learning opportunities in the context of the pandemic. While the NORC report provides valuable insights regarding the innovations emerged in graduate schools during the pandemic ( Stewart et al., 2021), the report did not discuss about the research training for students. Monitoring of future research pipeline and especially impact on academic medicine should be an area for future research.

Compared to the researchers not engaging in HSR, those engaging in HSR can potentially face greater challenges in maintaining their research focus and data collection because of the short- and long-term changes generated by COVID-19 on individual attitudes, behaviors, lifestyle, and social norms ( Bartik et al., 2020; Carel et al., 2020; UN, 2020). Some HSR investigators could be influenced directly by COVID-19 and inevitably need to adapt their research as illustrated in the following examples. Research focusing on efficacy of diabetes education programs in community or clinical settings might inevitably be put on a hold until the appropriate safety measures were built into its research protocol. A major revision might include shift to an online education platform. While such shift to digital tools can create an opportunity for some researchers, the opportunity may not be appreciated by all researchers in the field and the changes can directly impact any ongoing research projects. For instance, in an evaluation research focusing on opioid overdose and naloxone administration training for health science students shifted the program delivery from in-person format to an online format. Shift to the online course format could limit the comprehensiveness of naloxone administration training. Furthermore, shift to the digital tools can restrict diversity of the training and research program reach. Another example is the delays or pause of clinical trials due to the government restrictions on travel to administer the proposed intervention. While executive orders restricting travel are perceived as a necessary or inevitable safety measures, such safety initiative negatively influences the progress of research and limits the opportunity to train students, who are likely to have limited time in a school, in research conduct.

HSR could also be indirectly influenced. Previous studies showed that demographic characteristics and appearance of researchers and social interaction between human subjects and researchers can influence the data collected from the human subjects ( Campbell et al., 2019; Bittmann, 2020). The needs for social distancing and wearing of personal protective equipment could influence both appearance of researchers and social interaction with human subjects. For example, a medical student commented about facial masks impeding verbal communication with her patients ( Weiner, 2020). In addition, COVID-19 can directly impact human subjects’ experiences with interpersonal interaction ( Carel et al., 2020; Ghosh et al., 2020), as well as their safety concern about participating in a research study. Depending on their locations, medical and health science students returning to their clerkship rotations might need to work with a greater volume of patients with lower health care capacity.

The long- and short-term impacts of COVID-19 on both University budgets and household financial situations can also affect the provision of and meaning of research stipends to human subjects. Furthermore, the comparability of the study findings before, during, and after COVID-19 presents challenges for HSR, especially if the outcome variable of interest is impacted independently of any intervention efforts (e.g., lifestyle behaviors such as physical activity or substance abuse behaviors).

Limitations

The current study findings are based on self-reported perceptions rather than objective measures, such as research productivity. While the questionnaires used in this study was face-validated by researchers from various disciplines, the questionnaires did not go through a vigorous validation and reliability assessments. Further limitations of the current study include the sample representativeness and study generalizability. While the overall response rate could not be estimated, the response rates among the principal investigators at the main campus location was about 11%. In terms of demographics, the faculty respondents consisted of a higher proportion of White (85%) and a smaller proportion of female (43%), as observed in the institutional and national faculty demographics. The latest institutional diversity data available showed 63% non-Hispanic White and 36% female ( Office of Diversity, 2021). Nationwide full-time faculty in degree-granting postsecondary institutions data showed less than 70% White and 44% female ( NCES, 2018). There were some over-representation of White faculty members in this study, which may be related to the selection bias or related to the differences in the target population (i.e., faculty engaging in research or teaching vs. faculty engaging in research and teaching).

This study utilized the data collected from a large public Research 1 university system at a single point in time, and hence the study finding may not be generalizable to other types of universities or settings. However, given the common themes in COVID-19 associated changes (examples: social distancing, sanitation, and personal protective equipment), it can be assumed that the observed impact of COVID-19 on research is comparable in academic medicine and other settings and will continue to be a challenge as the pandemic timeline is uncertain. More studies from diverse research settings could help illuminate the impact of pandemics and other prolonged global emergencies on the research enterprise. Another limitation is that the sample had incomplete representation of researchers from diverse fields. While the study team attempted to make the survey relevant to all existing research fields by consulting about the survey questions and wording with researchers from various backgrounds, not all fields use common language and research methods. The study team received some questions from the respondents about the survey language (e.g., ‘secondary data’) and post-survey comments regarding relevancy of some questions (e.g., a question about participant interaction) in the survey to their fields. Therefore, this study focused on the general questions that were likely to be relevant in most fields. In addition, the survey questions are shared ( Table 1) for the readers’ information.

Several brief reports and perspectives have anecdotally discussed the impact of COVID-19 on research and scientists ( Omary et al., 2020; Yanow and Good, 2020; Wigginton et al., 2020). Despite the limitations, this study adds to the growing body of research based on primary data collected from researchers. First, this study provides important insights regarding the potentially lost learning opportunities for students to be addressed in higher education institutions, with specific focus on research training. Bridging from the lessons learned from the current pandemic, higher education institutions should develop the emergency standards of operation for faculty, staff, and students to enable continued learning and training opportunities. Further qualitative or mixed-methods evaluation of phenomenon can benefit the development of such emergency standards of operation. Lessons learned from this process will make us better equipped to deal with future challenges and the potential negative consequences to our ongoing academic research activities.

Second, the empirical findings in this study showed that researchers engaging in HSR have been disproportionately impacted by COVID-19 and that efforts are needed to further understand and overcome their challenges. For example, the needs for social distancing and wearing personal protective equipment generated additional hurdles for researchers engaging in HSR. Potential solutions might be to consider pandemic or emergency preparation budget as a part of the grant budget or higher education institutions develop emergency fund for research in academic settings.

While such efforts may already be underway in response to the swiftly changing circumstances, a natural progression of the current work would be to identify and examine the existing efforts and provide insights into ways that researchers, research institutions, and sponsoring agencies can adapt their research. These findings have strong implications for the academic medicine community, whether primarily lab-based studies or involving clinical or community-based research involving human subjects.

Next steps include continuing to analyze the ongoing impact of COVID-19, as well as its vaccine deployment, on both our HSR and non-HSR throughout our institution and utilizing our findings to try and find creative ways to mitigate the negative effects of the pandemic we are currently still facing or other challenges that we will face in the future. It is critical to move beyond a simplistic view of negative research impacts to a better understanding of how academic research and associated training can be enriched by meeting challenges of the past year.

 Data availability Underlying data

The data supporting the findings of the study are not made publicly available due to the data use restrictions stated in the informed consent form (approved by TAMU IRB) and considerations that their containing information that could compromise the privacy of research participants. Given that the data were collected from staff and faculty from a university system there are concerns that a combination of several key demographic characteristics, research fields, and research types can potentially identify an individual. For researchers with specific research/study questions relating to the data, the anonymized data can be available on request from the lead author [MO]. Upon reasonable request, with TAMU IRB approval, we can share whether participants engaged in any human subject research (yes/no) and key outcome data (i.e., COVID-19 impact on research) without any demographic characteristics, research fields, and research type data that can potentially identify an individual.

 Extended data

Texas Data Repository: Effects of the COVID-19 pandemic on university-based research conduct and training. https://doi.org/10.18738/T8/W6IGCE ( Ory, 2022).

This project contains the following extended data:

COV19Res_Online Survey_TDR_220411.pdf (A copy of the online questionnaire)

Data are available under the terms of the Creative Commons Zero “No rights reserved” data waiver (CC0 1.0 Public domain dedication).

 Acknowledgements

We thank Jason Moats, PhD, Texas A&M Engineering Extension Service and core member of the Texas Emergency Management Advisory Group for his helpful insights on research impacts. Also, the authors wish to thank all respondents who volunteered to participate in this study and our colleagues who supported the study by providing insight and expertise and assisting with recruitment.

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Competing interests: No competing interests were disclosed.

 30 11 2023 Copyright: © 2023 Hermawan D 2023 This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The author(s) is/are employees of the US Government and therefore domestic copyright protection in USA does not apply to this work. The work may be protected under the copyright laws of other jurisdictions when used in those jurisdictions. recommendation approve-with-reservations

1. This paper give an overview of university-based researchers’ perspectives and experiences, focusing on student engagement in research and conduct of human subject research (HSR), however "experiences" in this context is not yet clearly defined and quite few discuss in this paper.

2. Several parts of this paper still lack of references.

3. Elaborate human subject research (HSR) from a large US university system's overview in Introduction.

4. Several Table, i.e. Table 1. need to discuss more, since quite unclear.

5. Explain the reason to choose bivariate and multivariable logistic regression models in this research.

6. Title can be revised to be more concise.

7. Give implication of this research if Covid-19 situation or similar occur again in the future.

Is the work clearly and accurately presented and does it cite the current literature?

Yes

If applicable, is the statistical analysis and its interpretation appropriate?

I cannot comment. A qualified statistician is required.

Are all the source data underlying the results available to ensure full reproducibility?

Yes

Is the study design appropriate and is the work technically sound?

Yes

Are the conclusions drawn adequately supported by the results?

Partly

Are sufficient details of methods and analysis provided to allow replication by others?

Partly

Reviewer Expertise:

Marketing, communication, innovation

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.