Fall 2021 POLICY (10/05/2021)
Updated 10/5/2021 (Provost-Approved Policy)
Currently, consistent with Marching Forward and CDC recommendations for Albany County, all study participants and research team members who have in-person interactions must wear a mask, regardless of vaccination status. Exceptions for faculty/staff research protocols are as follows:
- Exception #1: Vaccinated participants may be unmasked for an essential study procedure if the procedure cannot be performed with a mask, but study staff must always be masked. Examples of essential study procedures: required eating or drinking, use of a vection drum to induce nausea, measurement of respiratory functions (e.g., use of a spirometer).
- Exception #2 (Applies to Off-Campus Research): Participants who:
· Are under the age of 2
· Have a medical condition, mental health condition, developmental or cognitive condition, or disability that makes it hard for them to wear a mask
· Are deaf and move their face and mouth to communicate
· Have trouble breathing, are unconscious, or are unable to remove a face covering without help
These are the minimal requirements. PIs may voluntarily choose to adopt additional safety measures.
All researchers will be expected to adhere to Siena’s IRB safety protocols when conducting research at off-campus locations. If the off-campus location has more stringent protocols in place, then those must be followed while at the location. Research that focuses on high-risk populations, such as prisoners, persons over 65, or those who are immunocompromised due to a health condition or use of immunosuppressive medications, may require additional safeguards. This will be determined during IRB review.
The PIs description of the safety plan and/or exemption request must be on file with and approved by the IRB before data collection begins. (A separate form is no longer being used.) This can be done as part of the initial application process on Processmaker or via email to firstname.lastname@example.org.
Previously Posted 9/14/2021
Currently, the IRB is approving in-person research for both student- and faculty/-staff-initiated applications. Minimally, protocols must adhere to Siena College's current Marching Forward plan and the NY Hero Act. Additional safety measures consistent with CDC recommendations (e.g., indoor masking for PIs and participants, regardless of vaccination status) may also be required.
As the situation is evolving, please contact email@example.com for specific guidance regarding safety protocols in effect at the time of your application and data collection.
SPRING 2021 Policy (2/16/21)
Currently all face-to-face, in-person research at Siena is paused. As part of our college’s re-opening plan during the COVID-19 pandemic, the Provost and IRB have began efforts in Fall 2020 to re-initiate in-person research activities.
For SPRING 2021, student-initiated research will remain online/remote (i.e., the in-person pause will remain in place).
Faculty and staff can resume in-person research contingent upon:
(a) Siena offering in-person classes on campus at the times of recruitment and data collection and
(b) IRB approval of a safety plan (click for form) that is consistent with CDC guidelines and Siena policy
This policy will remain in effect, minimally, until the end of the spring 2021 semester at which time it will be re-evaluated. Please contact IRB@siena.edu with questions.
PLEASE SEE FAQS, BELOW, FOR ADDITIONAL INFORMATION AND GUIDANCE
Q: I am interested in re-opening my approved study or applying for a new application. Do I need to change my consent form to include risks related to COVID?
No, you are not required to change the consent form. At your discretion, you may want to share information from Siena's Marching Forward plan.
Q: I understand no student-initiated research can use in-person procedures (on campus or in the community). I have students listed as co-PIs who function as research assistants. Can I still utilize students in this manner?
Students who are listed as co-PIs can participate in your in-person research under a few conditions. First, they need to be supervised (in your presence; actively observed) during all in-person interactions with participants. Second, they will need to be listed on the Siena IRB Safety Plan form that you submit for the project. Finally, their specific roles must not deviate from what is described in your safety plan.
Q: My students are doing community-engaged research and their site does not have the same restrictions as Siena. Should they follow the guidelines of the community site or Siena's IRB?
If students of Siena are engaged in research, regardless of the site, they need to adhere to Siena's IRB policies. This is the case even if an IRB Authorization Agreement (IAA) is in place with the partnering agency.
Q: I already have an approved protocol that involves in-person procedures. I would like to change some of the core procedures in light of COVID-19 that aren't covered in this safety plan. Can I do that?
Yes, but you need to file an Amendment for changes to approved procedures. The safety plan simply allows research, as it's currently described in the protocol, to re-open with additional safeguards.
Q: I am submitting a new proposal. Should I also submit a safety plan?
Yes, if you are submitting a new proposal that involves procedures that can't be carried out remotely, please complete the Safety Form and submit at the same time you submit your application.
Please contact IRB@siena.edu with questions.
Previously POSTED 3/20/20
In the context of rapidly evolving circumstances regarding COVID-19, and the college’s focus on social distancing and the health and well-being of the community, Siena College is placing temporary restrictions on human subjects research. Research studies involving face-to-face interaction and/or sharing of materials with participants must be halted, effective immediately. This pause will continue, minimally, until in-person classes resume on campus, at which time the policy will be re-evaluated.
In some cases, researchers may be able to utilize alternatives to face-to-face contact. The IRB is currently prioritizing amendments to active protocols to add study procedures to serve as alternatives to in-person recruitment and data collection (e.g., phone, Zoom conferencing, Qualtrics surveys, etc.)
Please see FAQs, below, for additional information and guidance
Q: Why Must In-Person Interaction With Study Participants Be Paused?
Given the current COVID-19 pandemic and the real risk of viral transmission, the risk/benefit ratio for in-person contact associated with research activities must be re-assessed. At this juncture, all research which involves face-to-face contact that has no direct subject benefit should be halted. Currently there are no active protocols at Siena College in which participants receive direct benefits.
Q: Are There Changes to Studies That Are Conducted Online, By Phone, or Via Videoconferencing?
No. Only studies in which there is physical interaction with participants are affected.
Q: What Do I Do If I Want to Change Procedures?
Researchers interested in continuing their research remotely should file an “Amendment” on the IRB website. You will be required to describe the changes and include a revised consent form. If your study currently requires signed informed consent, consider whether you can modify procedures by requesting a waiver of documentation of consent. (To be approved to waive documentation of consent, the study must present no more than minimal risk of harm to participants and involve no procedures for which written consent is required outside the research context, such as FERPA).
**IMPORTANT** Please do not include other changes to your study in amendment submissions beyond those required to conduct study procedures remotely.
Q: Can I Submit An Application For Future Research That Involves In-Person Contact With Participants?
No. At this time, and until the VPAA lifts the restriction for research that utilizes in-person procedures, this type of research will not be reviewed by the IRB. This is because the standard of minimal risk as “probability and magnitude of harm or discomfort....ordinarily encountered in daily life” is still evolving. The IRB needs to be able to apply this standard to its review in real-time.
Q: Who Can I Contact With Questions?
The IRB is still fully functioning. If you have questions or need assistance, please email IRB@siena.edu