Read the Guide to Ramping Up RSCA and take a look at the plan template that navigates you through the information that is needed to develop a plan. Both documents can be found at: https://uncg.infoready4.com/#competitionDetail/1814161. A scrollable, html-version of the Guide to Ramping Up RSCA can also be found on the Keep Researching website.
One of the first steps is to determine the level of risk inherent in the activities that you will begin/resume. There are 3 categories of risk: Low, Moderate, and High. Examples of low, moderate, and high risk activities are described in the Guide to Ramping Up RSCA, detailed on the Keep Researching website. No matter what the risk profile, you will be asked to provide information about how you plan to mitigate risk. For human subjects research, there are example resources that can be used as models to develop your risk mitigation plans and other documentation such as the participant information form and participant COVID-19 and researcher COVID-19 screening forms. For lab, field, and community engaged research there are a series of leading questions found in the appropriate appendices, that when answered will manifest as the risk mitigation plan.
Ramp up plans for moderate and high risk human subjects research activities, both of which involve face to face/in person engagement with human subjects, must be vetted thoroughly. You should address every relevant issue/bullet in Appendix F. of the Guide to Ramping up Research, Scholarship and Creative Activity (RSCA) as is appropriate for the nature of the activities that you will begin/resume. Present risk mitigation activities in detail. You must also provide a copy of required documents, tailored to your study, such as the COVID-19 screening form and IRB participant information form. Examples of these documents are provided in Appendix F of the Guide to Ramping Up RSCA.
UNCG is using the InfoReady Review platform to manage the ramp up reentry plan submission process. The benefits of using this system are that it allows for electronic review and approval of plans, tracking and follow up; streamlining the process considerably.
The form that you need to complete and submit is listed under “Competition Files” on the right side of the Ramp Up Reentry Plan landing page and is named “Ramp Up Re-Entry Form.” The form is a word document that you can edit, save locally or to the cloud, and then upload when ready to submit the plan.
Once submitted, the plan will route through a series of reviewers: your Department Chair, Associate Dean for Research or Dean, and the Office of Research and Engagement. The Office of Research Integrity will review ramp-up plans when animals or human subjects are involved.
Many plans go through at least one revision owing to questions/concerns raised by the reviewers prior to approval; don’t be discouraged if your plan is not approved after the first round of reviews. The mitigation of risk associated with COVID-19 is new to all of us and every detail is important and could mean the difference between safety and infection. The revision process often necessitates meetings between investigators and key reviewers to discuss how to best address risks. This group approach results in plans that are more complete and risk mitigation activities that are more robust and that ensure safer environments for participants and researchers than what would have been the case otherwise. If you are uncertain about how to describe the mitigation of certain risks, please reach out to your Associate Dean for Research if available. Many have approved ramp up reentry plans in place and can share relevant examples and tips. In addition, for those Schools/Colleges who do not have an Associate Dean for Research or for other questions, Dr. Kim Littlefield (firstname.lastname@example.org) in ORE is also available for advice prior to submitting a plan or in the process of revising a plan.
A plan should be designated as "REVISED" when it is returned during the review process. Revised plans should include a cover page that details how reviewer comments have been addressed when the revised plan is resubmitted.
A plan should be designated as "MODIFIED" when previously approved risk mitigation activities are being modified to accommodate additional activities, personnel, space or instrumentation use. A modified plan originates from an approved "parent" ramp up reentry plan. Modified plans should highlight the proposed modifications within the context of the original plan (i.e., copy the original plan, insert and highlight the proposed modifications, submit for review and approval).
File naming conventions are presented in the Guide to Ramping Up Research, Scholarship and Creative Activity: https://uncg.infoready4.com/#competitionDetail/1814161.
Append “New” to the file name for a first-time submission, “Revised” is used when you are responding to a prior review; “Modified” is used when you are modifying an already approved plan.
You can check the status of your proposal by logging into InfoReady Review and clicking on “my submissions.” Depending on the volume and complexity of plans to be reviewed you can expect correspondence regarding your application within 3-5 days of submission. Notices will come from the following email address: Office of Research & Engagement InfoReady Review <email@example.com> and will likely have a subject line such as “Ramp Up Reentry Plan Approved.”
Before resuming RSCA activities all individuals must complete the UNCG COVID-19 training module. Please submit copies of the completion certificate to your department chair/head. Access to the training module can be found here: https://update.uncg.edu/work-on-campus/.
Three weeks after your new or modified plan is approved a progress report, solicited from the InfoReady Review system, is due. If your plan is not working (too many people in the RSCA environment, people aren’t taking the daily self-health assessment seriously, etc.), let the Office of Research and Engagement know via this report. They will provide assistance to revise the plan in such a way as to address safety concerns while advancing the RSCA. The report involves answering simple questions via text fields online through the InfoReady Review platform and is not time intensive. No separate, formal, detailed document is required.
Yes. Because of the public health situation, it is recommended that research involving human participants be conducted remotely, if possible. However, situations will occur where remote engagement/data collection is not possible, face to face/in person data collection is necessary, participants must come to campus and/or human subject research participant engagement occurs in the community.
These situations are characterized as either moderate or high risk profile activities (see definitions and additional examples of moderate and high risk activities on the Keep Researching website). These situations will require the development of a detailed, thoroughly vetted ramp up reentry plan that describes the risk mitigation activities/measures that will be employed to help keep participants and researchers safe no matter how/where the research activities are conducted. Approval of moderate and high risk profile plans involving human subjects is granted on a case-by-case basis.
To date, no moderate or high risk plans have been barred from implementation. In several cases, faculty have been asked to delay implementation of a plan (based on poor public health indicators) or reduce the frequency of on-campus human subject participant engagement as a way to mitigate the risks associated with face to face engagement.
Yes. IRB (Internal Review Board, human subjects research) review focuses on the ethics, data collection and study methodology and population to be involved in the planned research. Likewise, IACUC (Institutional Animal Care and Use Committee) focuses on animal welfare and typical safety concerns, and IBC (Institutional Biosafety Committee) focuses on adhering to federal guidelines regarding safe and appropriate use of biological materials. The ramp up reentry plan focuses on and presents the risk mitigation activities that you will implement, in light of the COVID-19 pandemic, to protect participants/animals and the research personnel involved in the IRB/IACUC/IBC approved research activities.
Please note, IRB approval or an exempt designation is always required if you are conducting human subjects research. If you plan to conduct human subjects research on campus or in community settings, whether or not there will be direct contact with research participants and whether or not the research involves teams of people working together, you are required to submit a ramp up reentry plan. If your approved study involves no face to face contact with participants and among team members, and no activities will be conducted on campus or in the community, a ramp up reentry plan is not required.
An approved IRB modification is required to implement changes to human subjects research data collection methods.
A. If modified human subjects research data collection activities are implemented without direct contact with participants and/or among team members and off campus, a ramp up plan is not required.
B. If modified data collection activities are implemented with participants in a remote location(s) but you or your personnel intend to engage in these data collection activities on campus, a ramp up plan is required.
C. Reverting back to in-person or face to face human subject research data collection, whether on campus or in a community setting will require an approved IRB modification and either a new or a modified (see B. above) ramp up reentry plan.
Yes. Community engaged research and scholarship activities will very likely require a ramp up plan. Please see Q2 above for possible exceptions, and refer to guidance on risk mitigation for community engaged research on the Keep Researching website (Appendix G). If uncertain about whether a ramp up reentry plan is required for community engaged research activities please contact Dr. Kim Littlefield (firstname.lastname@example.org).
Yes. Community engaged research can occur on campus, at Controlled, Off-Campus sites - non-UNCG locations that have developed COVID-19 guidance for operations consistent with CDC guidance (e.g., educational institutions, health care clinics, etc.), and at Uncontrolled, Off-Campus sites - locations not subject to CDC operational guidelines (e.g., home visit sites, street corners, downtown gallery space, etc.). Risk mitigation activities must be tailored to the site/location at which the activities will occur. Detailed guidance can be found in Appendix G. of the Guide for Ramping Up RSCA.
Yes. Faculty who are engaged in grant or contract funded service delivery activities that bring community members to UNCG or UNCG personnel in contact with others in the community should complete a ramp up plan if for no other reason than to document what risk mitigation efforts that you will put in place to keep yourself, your personnel, and participating community members safe while on campus and/or to document the risk mitigation requirements of the off-campus site where you will be conducting your service delivery activities.
Yes. Field research warrants specialized risk mitigation considerations that are detailed in Appendix D. of the Guide for Ramping Up RSCA. Travel greater than 50 miles from the University, out of state, and international travel must be approved in advance by the Provost. The Office of Research and Engagement will notify you when the Provost approves the travel request.