Question:

Answer:

Questions About In-Person Research Visits

No. The final restrictions for conducting in-person research visits with participants were lifted on July 1, 2021.

There are no restrictions for in-person research activities when conducted in accordance with IRB approval, WSU's COVID-19 Policies, and all other applicable institutional and departmental policies. 

Vaccination of study personnel

Institutional vaccination mandates must be followed for all study personnel. Researchers affiliated with any of WSU's affiliate institutions must follow their institutional vaccination requirements.

The WSU vaccine mandate extends to all individuals visiting WSU campus with the exception of research participants.

Vaccination does not eliminate the requirement for the mitigation procedures that must be described below.

Vaccination of research participants:

You may include resources to help participants access the vaccine, however restricting enrollment to fully vaccinated individuals raises concerns that pertain to the equitable selection of subjects which is required by the Belmont Report described by the Ethical Principle of Justice. Therefore, requiring vaccines for research participants as a risk mitigation practice is not recommended.

Wayne State University's COVID-19 policies must always be followed. Additionally, investigators conducting in-person study visits at any site that is not on WSU campus must adhere to that institution's COVID-19 policies.

It is important to be familiar with the COVID-19 policies for your study site(s).

As the COVID-19 risk level changes, institutional policies and State and Federal health authorities modify their guidance, therefore it is best to go directly to these policies and guidance to answer this question.

CDC Guidance based on COVID-19 community level data:

https://www.cdc.gov/coronavirus/2019-ncov/your-health/covid-by-county.html

Investigators should consider the inability to verify an individual's vaccination status when developing a COVID-19 risk mitigation plan.

WSU Campus Screener for Faculty, Staff & Students:

Faculty, staff and students are required to complete the Campus Daily Screener each day before coming to campus.

Research Participants Visiting Campus:

All visitors including research participants must complete the WSU Guest Campus Screener on the day of the on-site visit and prior to arriving on campus to be permitted on campus.

Investigators may complete the guest campus screener on behalf of the research participant over the phone. When completing the campus screener on behalf of the participant, indicate this in the "purpose for campus visit" question on the screener along with any other pertinent details that should be documented.

Yes. On-site monitoring visits are important for monitoring the safety of research participants, and compliance with the approved study protocol. Visitors who come on site to monitor the study must complete the WSU Guest Campus Screener, and follow Wayne State University COVID-19 policy and guidance. WSU requires all visitors to be vaccinated before arriving on campus unless they are research participants visiting to partake in a research activity.

• https://wayne.edu/coronavirus
• https://research.wayne.edu/coronavirus/restartguidance 

7. What needs to be done before an investigator can begin seeing participants in-person?

Key considerations - It is important to be mindful that research participants are volunteers who must be afforded all reasonable protections to mitigate risk while participating in research.

Steps to take before beginning/resuming in-person research interactions with participants:

1. Review the research protocol to determine which study visits, interventions, or tests are essential to conduct in-person study visits so as to provide participant safety.
   1. Whenever possible, research should maintain remote study interventions/visits, as per IRB approval. All changes made to the research protocol and procedures to conduct study interventions/visits remotely must be submitted to the IRB in an amendment before those changes can be implemented.
2. Discuss with the Department chair the capacity to resume human participant research that requires in-person contact
3. Discuss options with the sponsor for alternatives to in-person study visits.
4. Consider whether the in-person study visit could coincide with a standard of care visit.
5. Develop comprehensive procedures to mitigate the risks of exposure to COVID-19. Such operational parameters may include but are not limited to the following:  

Masking, social distancing, screening, vaccination of study personnel interacting with participants, consideration of the duration of in-person contact with participants and staff, an established scheduling structure for coordinating participant visits and cleaning procedures between participant visits.

6. Develop a procedural checklist to ensure adherence to the mitigation procedures developed.

When research is conducted in the clinic/hospital setting, please follow that site's COVID-19 precautionary standard operating procedures. For research conducted at a WSU research facility, refer to the university's guidance: Information on restarting WSU research operations:

https://research.wayne.edu/coronavirus/restartguidance 

8. Do I need to submit Appendix N when planning to conduct in-person research visits?

As of December 1, 2022, the WSU IRB will no longer require the submission of Appendix N: Resumption of In Person Research and PI Attestation.

This form was a useful tool to help investigators describe COVID-19 precautions that the IRB reviewers needed to assess risk to participants during the height of the pandemic. With more widely available options for treatment, vaccines and testing, the IRB no longer requires the additional information that Appendix N provided to assess risks to participants.

9. What are the IRB submission requirements for a new study submission that involves in-person research activities?

New Study Submissions

Investigators must have an IRB approved plan to inform research participants of what to expect before the in-person research visit, such as procedures for completing the WSU Guest Campus Screener, and any masking guidelines based on the WSU policy and any other applicable institutional and departmental policies. This includes the following documents:

• Verbal scripts used to notify participants of what to expect before the in-person research visit and/or
• Information Sheet to notify participants of what to expect before the in-person research visit
• Procedural checklist to monitor adherence to COVID-19 risk mitigation plan.

Questions About IRB Submission Requirements and Submission Instructions

10. What should I do if I learn that a participant may have been exposed to COVID-19 or has tested positive for COVID-19 within 2 weeks of in-person study visit?

1. Contact WSU Campus Health Center: https://health.wayne.edu/contact/.
2. Follow WSU Campus Health Center's guidelines for testing and self-quarantining: https://health.wayne.edu/coronavirus/.

11. Do I need to submit an amendment to the IRB if I had to pause enrollment due to the university's restrictions to in-person research activities?

If study accrual/enrollment is paused/suspended or put on hold due to a public health crisis/pandemic such as the COVID-19 (but not due to research-related risks or safety concerns) by the Principal Investigator or Sponsor, then notification to the IRB can be submitted to the IRB at the next routine amendment and also indicated at the next annual renewal.

If study accrual/enrollment is paused/suspended or put on hold by the Principal Investigator or Sponsor due to research-related risks or safety the pause or suspension in accrual/enrollment must be reported to the IRB as an amendment in a timely manner. An Unanticipated Problems Report & Event Reporting form may be required, if applicable.

12. The COVID-19 research restrictions required me to pause enrollment and research activities. My study is approaching the IRB expiration date and I am preparing to submit a continuing review. Should I include information about the pause in my continuing review?

Yes. You can include this information in the Study Status section of the continuation submission form.

13. Do I need to include the screening procedures required by the facility in where in-person research activities will take place in my IRB submission?

No. Screening procedures required by the facility where research activities will take place do not require an amendment to the IRB application unless that screening data is going to be used for research.

Questions About Protecting Research Participants and Staff from Exposure to Coronavirus

14. Can research staff continue to handle research data when working from home?

Yes. WSU human resources policies must be followed with all work from home arrangements. See WSU HR Return to Campus Website for more information. Work with your department's IT group to set up access to the secure server that the research data is being stored on. It is important that research data is not being saved on personal computers. If the data storage and/or protection plans will be changing from what was previously reported and approved by the IRB, then you will need to submit an expedited amendment to notify the IRB of these changes.

15. What can I do if I am aware of an investigator that is not complying with WSU's Human Research Protection Policies and have concerns for the safety of research participants?

If you are concerned about the rights, welfare, and safety of a research participant, please promptly notify the IRB. Complaints can be sent to the Wayne State Research Subject Advocate by emailing irbquestions@wayne.edu, or calling 313-577-1628.

You can also send an anonymous tip to:

WSU Office of Internal Audit (OIA) anonymous hotline:

• (313) 577-5138

OIA also has a website where concerns can be reported anonymously:

https://internalaudit.wayne.edu/report

Questions About Study Modifications

16. I would like to obtain consent electronically. What platform can I use to obtain electronic consent?

You can use any electronic signature platform as long as it meets the requirements described in our policy: 9-1 Requirements of Informed Consent. This policy is available on our HRPP Policies and Procedures webpage.

1. Legally valid - needs to verify signer's identity (must be equivalent to a handwritten signature executed on paper).
2. Must be presented to the participant/LAR in a language they can understand.
3. Allow users to move forward and backward through the consent document. 
4. Allow users to save progress and go back to the consent form at a later time.
5. Provide the participant a copy of the consent form (either electronic or paper).

The process for the electronic presentation and documentation of the consent form must be described in detail in the IRB application.

An IRB On-Demand Training video about electronic consent is available in the On-Demand Training Library on the IRB Education website.

FDA has made their own Electronic Consent Platform Available for qualifying clinical trials for Free

The U.S. Food and Drug Administration is making its previously developed FDA MyStudies app available to investigators to securely present and document informed consent electronically for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 control measures.

FDA MyStudies is now referred to as COVID MyStudies in the Apple App and Google Play stores. The display name that appears underneath its icon after it has been downloaded is COVID19.

17. May we conduct home visits for studies with no potential direct benefit?

Yes. There are no restrictions for home visits that are done in accordance with IRB appoval and university policies.

The IRB strongly recommends home visits to be conducted by research personnel who are fully vaccinated.

Masking & social distancing during the home visit are encouraged.

18. Can I switch my in-person on-site follow up procedure to a telephone follow-up?

Yes. If you are able to gather the same information needed through a telephone call, or other remote method, we encourage investigators to modify the protocol accordingly.

A telephone script for this participant interaction must be included in the IRB submission for approval.

Other Questions

19. My clinical trial is listed on clinicaltrials.gov. Do I need to post any COVID-19 related modifications made to my study on clinicaltrials.gov?

Some studies registered at the federal site clinicaltrials.gov are modifying their research procedures to include testing for SARS-CoV-2 and/or assessment of COVID-19 symptoms. The ClinicalTrials.gov information for the study should be updated to include these new procedures, if they are done for research purposes. If they are being added as public health surveillance activities in coordination with public health authorities, the registration information does not need to be modified. The federal requirement about modifications is that any research-related changes that are communicated to the subjects (past, ongoing, future) must be added to the study's ClinicalTrials.gov registration with 30 days after IRB approval of the modification.

20. I would like to collect data to help us better understand the outbreak, signals, outcomes and trends. Does this require IRB approval?

The revised Common Rule carved out a pathway to conduct Public Health Surveillance Activity without requiring IRB approval to help improve the response to global health emergencies.

Activities that are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). The collection and testing of information or bio-specimens conducted, supported, requested, ordered, required, or authorized by a public health authority is permitted only under these limitations. Public health surveillance activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters)

We ask that you complete our Human Participant Research Determination Tool and submit to the IRB following the instructions on the form to obtain a formal IRB determination and documentation before proceeding with any Public Health Surveillance activities.

An IRB On-Demand Training video about Human Participant Research determinations is available in the On-Demand Training Library located on the IRB Education website.