- IRB Application For Initial Review and Approval
- Determination of Human Subject Research Form
- Application for Amendment
- Application for Exemption
- Application for Renewal
- Application for Approval to use Protected Health Information
- Report of Important Event
- Conclusion Report
- UNE Student Classroom Projects Application for Exclusion from IRB Oversight
- Case Study Registry
Due to the initial impact of the COVID-19 global pandemic, the University of New England suspended research activity involving in-person contact with human research participants. While the pandemic is ongoing, the University believes that it can begin to safely resume in-person contact with human research participants. The purpose of this policy is to guide researchers as they resume in-person research. The primary focus of these guidelines is the protection of human research participants. The University of New England has other policies and guidelines for protecting the general population in other contexts such as laboratory/animal research, employee return to campus, and teaching activities.
The University has established four (4) general risk categories for human subjects research:
- Research that does not require in-person interaction or intervention with a human research participant.
- Research that requires in-person interaction or intervention but does not involve physical contact or close contact. For the purposes of these guidelines, “close contact” means contact with any individual within 6 feet of that person for at least 15 minutes, which does not have to be continuous.
- Research that requires in-person interaction or intervention but does involve physical contact or close contact,
- Any in-person research in which:
- Researchers or participants are more than 65 years of age, or have certain underlying conditions that does or may place them at an increased risk for severe illness from COVID-19, as set forth in contemporary CDC guidance
- The research takes place off-campus
- Situations where the research involves an interaction or intervention in which there is a heightened risk of COVID-19 exposure, for example studies that include aerosolizing procedures (such as sputum induction or exercise tests) and studies that include research participant group activities (more than one (1) participant seen at one time).
Category 1 research was not paused, and all research activities that can be conducted remotely by utilizing online survey, video conferencing, telephone interviews, etc. should continue to be conducted remotely until further notice.
Category 2 and 3 in-person human subjects research may resume upon receiving the approvals set forth in Sections II and III below, and must adhere to the following guidelines regarding PPE and proper precautions. If there is any conflict between these guidelines and other applicable Federal, State, or University guidelines, the most protective measures shall take precedence.
Category 4 in-person human subjects research will be considered only on a case-by-case basis and requires an additional level of review by appropriate UNE personnel and the UNE Leadership team.
Guidelines for IRB Protocols
All new Applications for IRB review must address how the in-person human subjects research will conform to the COVID-19 specific guidelines. Prior to resumption of previously approved in-person human subjects research, the Principal Investigator must submit an IRB Amendment application that includes a plan addressing how COVID-19 related safety measures will be implemented, any revisions to IRB-approved procedures, and any updated protocol documents (consent forms, recruitment materials, etc.). At a minimum, the IRB Application or Amendment must include:
- A screening process, including but not limited to the completion and execution of the Screening Questionnaire and Research Attestation referenced below, consistent with these guidelines to determine if participants and staff are at a higher risk.
- Procedures for:
- maintaining physical distancing requirements to the maximum extent possible. Even for research in Category 3 above, all efforts should be made to physically distance whenever possible.
- use of PPE even when physical distancing is possible and planned, including research falling in Category 2 above, the type of PPE, and how it will be obtained.
- proper cleaning of materials, equipment, and commonly touched areas where the activities will take place.
- scheduling visits to avoid overlap in appointments, in conjunction with department practices (such as shared calendars) and Facilities management.
- A training plan for how all research personnel will be trained on proper use of PPE, proper sanitizing of PPE if it will be reused, proper sanitizing practices for furniture/study equipment, and disposal of PPE/sanitary supplies.
- The process for providing the University’s “Important Information about Research Visits During COVID-19 & Screening Questionnaire” document (as described more fully in Section III below) to participants and answering any questions or concerns they may have.
General Guidelines for all In-Person Human Subjects Research
- After receiving IRB approval consistent with Section II above, all Investigators must submit a Resuming Research Activity Plan to the Associate Provost for Research and Scholarship. This plan will undergo a 3-step review and approval process that includes approval by the Associate Provost for Research and Scholarship, the Human Resources Department, and Environmental Health and Safety which must be completed prior to resumption of in-person human subjects research.
- Researcher Participants must complete and document a symptom screen by a remote (phone/teleconference) screening within 24 hours before each study visit and when the participant arrives for their study visit (assuming they screen negative during the remote screening). The screening questionnaire is included in the “Important Information about Research Visits During COVID-19 and Screening Questionnaire” document. Please refer to Flow Chart 2 if research participants indicate a “YES” response to any question in the screening questionnaire.
- The remote screening must take place within 24 hours of the visit, but can occur anytime within that time period, including the day of the visit, so long as it is conducted prior to the participant entering a UNE campus.
- During the remote screening, research personnel should instruct participants to wear a mask or face covering to the study visit. If participants do not have a mask or face covering when they arrive for the study visit, research personnel may provide a mask or face covering. If these are not available, the in-person screening and study visit cannot proceed.
- At least 24 hours prior to a participant’s scheduled study visit, research personnel must provide the University’s “Important Information about Research Visits During COVID-19 and Screening Questionnaire” document to research participants, answer any questions they may have during the remote screening required above, and ask them to sign it.
- All researchers (faculty, staff and students) must complete the required attestation within 24 hours prior to each in-person human research participant visit. This provides an extra layer of safety for research participants. If the researcher cannot attest to all of the conditions on the Attestation Form, the researcher must not participate in that visit.
- Completed screening questionnaires and attestation forms must be kept in the same secure location where the researcher keeps other private IRB documents (e.g. participant consent forms) and must be maintained for a minimum of three (3) years.
- There may be a second growth of COVID-19 cases as Maine and U.S. economies restart, so please be prepared for potential setbacks and the possible need to reduce research on UNE campuses again in the future.
Guidelines for Physical Distancing, Sanitizing, and Face Covering / Personal Protective Equipment
- If possible, the research must be conducted in such a way to maximize physical distancing with at least six (6) feet of space between study participants and research personnel. Even for research in Category 3 above, all efforts should be made to physically distance whenever possible.
- If the research must be conducted in tight spaces, limiting occupancy in the room and remaining six (6) feet apart remain the default. When this is not possible, researchers and participants must add a face shield to a disposable mask. Researchers should consider and account for the potential need for additional PPE, such as protective clothing or gowns, beyond masks and face shields, depending on the amount of time researchers will be in close contact with human research participants. Researchers should understand that the more extensive the close contact the more they must consider additional protections.
- Restrict study visits to only those who are essential. Only the study team members necessary to carry out the research activities should be present.
- Schedule participants to avoid overlap and waiting time. A general guideline is to schedule study visits to allow at least one (1) hour between the end of one visit and the arrival of the next participant, but a longer period of time may be appropriate for some research protocols (such as those requiring extensive cleaning).
- All study equipment and furniture must be disinfected with a cleaner containing at least 70% ethanol before and after each in-person study session.
- Both researchers and participants should wash their hands before and after study sessions.
- Hand sanitizer must be available during the study sessions.
Face Covering/Personal Protective Equipment
- Both researchers and participants must wear an appropriate face covering at all times.
- Surgical or cloth face coverings that meet CDC safety guidelines may be used unless other measures are required by Environmental Health and Safety.
- If all parties cannot wear masks due to the nature of the research, then clear dividers or face shields must be used.
- Disposable face coverings and personal protective equipment should be used whenever possible.
- Surgical gowns and gloves must be worn for any in-person research involving a clinical intervention in which there is direct physical contact with the participant, aerosol producing procedures, research involving increased respiratory rates, or involving bodily fluids and human tissues.
Note: If a participant refuses to wear a mask or comply with these guidelines, then the study visit should either be rescheduled for a time when the participant agrees to comply or terminated if the participant states that they will not comply (in which case the participant should also be withdrawn from the study).
UNE REVIEW OF PLANS TO RESUME IN-PERSON HUMAN SUBJECTS RESEARCH
HANDLING A RESEARCH PARTICIPANT’S “YES” RESPONSES TO THE SCREENING QUESTIONNAIRE
Important Information and Screening Questionnaire for Participants
Important Information about Research Visits during COVID-1
The University of New England and its Institutional Review Board places the highest priority on the safety and protection of research participants. If you are considering whether to participate in an in-person study visit, it is important to understand that your study participation may include increased travel outside of your home and increased exposure to other members of the public, which may increase your risk of exposure to COVID-19. Because of this, the University is providing the following information to you regarding COVID-19 and what you may expect during your study visit.
General information about COVID-19
- COVID-19 is a respiratory virus spread mainly from person-to-person. It is also possible that a person can get COVID-19 by touching a surface or object that has the virus on it, and then touching their mouth, nose, or eyes.
- Current ways to minimize the risk of exposure to COVID-19 include physical distancing (maintaining at least 6 feet of space from other people), proper hand hygiene, and disinfecting surfaces that are frequently touched by other people.
- According the CDC, some people are more likely than others to become severely ill, which means that they may require hospitalization, intensive care, or a ventilator to help them breathe, or they may even die. People at increased risk for severe illness are adults over the age of 65 and people with certain underlying medical conditions, as set forth in contemporary CDC guidance. Please tell the research staff during your remote screening if any of these apply to you.
What you can expect during your research visit
You are encouraged to come to the study visit alone, if possible.
- Within 24 hours before your study visit, you will be screened for symptoms of COVID-19 and asked a few questions about recent contact with other people and any recent travel you may have done.
- When you arrive for your study visit:
- Please wear a cloth or surgical mask at all times upon leaving your vehicle unless otherwise instructed by the research staff. If you are not wearing a face mask, one will be provided to you.
- You will be screened for symptoms of COVID-19 again.
- All study visit areas will have University-approved hand sanitizer available in the area that you are encouraged to use frequently.
- The research staff will be wearing a face mask, and may be wearing other personal protective equipment (PPE) such as, gloves, face shield, and eye protection.
- The research staff will maintain at least 6 feet of physical distance from you whenever possible.
- Additionally, there may be a barrier (such as plexiglass) between you and the research staff.
- The University is following all current State and Federal guidelines for cleaning rooms and equipment between each study visit.
Symptom Screening Questionnaire
Attestation for Research Staff
All researchers (faculty, professional staff, and students) must complete the following attestation within 24 hours prior to each in-person human research participant visit.
All meetings begin at 2 p.m.
- March 29, 2021
- April 26, 2021
- May 31, 2021
If you are submitting a protocol to be reviewed at one of the above meeting dates, the complete submission MUST be received at least 14 days prior to the scheduled meeting date. Submissions arriving after the submission deadlines above will be reviewed at the next month's scheduled meeting.