*update: IN-PERSON HUMAN SUBJECTS RESEARCH (8/17/21)
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 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.
For additional information and guidance click here.
POLICY CHANGE working with individuals from vulnerable populations
Effective 10/1/19, all PIs (and their supervisors) who are recruiting individuals from vulnerable populations must provide verification of additional CITI training. Vulnerable populations (e.g., children, prisoners, individuals with impaired decision-making capacity, terminally ill patients, institutionalized individuals, people who are socially or economically disadvantaged) require additional considerations and protections. The guidelines are not thoroughly covered in the basic CITI training required for all PIs. More information can be found here as well as under "Online Certification Training."
CHANGES TO THE COMMON RULE (JAN 2019):
There were major changes to the Common Rule in January, 2019 which affect all researchers at Siena. Generally the changes involve reducing administrative burden, with less risky studies requiring less paperwork, and better protecting participants by making informed consent more meaningful.
- The number of exempt categories increased from 6 to 8, and several allow for minimal risk and collection of personally identifiable information. (Research that may have been categorized as expedited before break may now be exempt.)
- Most expedited research (in addition to exempt) no longer requires continuing review (renewal)
- You don't need a consent form for exempt studies that are no risk
- Expedited studies are automatically categorized as minimal risk
- Pregnant women are no longer considered "vulnerable" populations (!)
This doesn't affect research approved prior to January 21, 2019.
Before submitting your next application, you are encouraged to carefully review the "IRB Application Categories" and changes to the consent process. The online application has been updated to reflect the new federal policy. "Changes to the Common Rule" offers a more detailed explanation of what's new and different.
Please reach out to email@example.com with questions! A series of IRB trainings to assist you in the application process will be offered throughout the semester and announced on the Digest. If you are teaching a class in which several students will be submitting an application, the IRB welcomes the opportunity to come to your class.
THE IRB AND HUMAN SUBJECTS RESEARCH
Per federal regulations as prescribed in 45 CFR Part 46, any faculty, student and/or administrator/staff planning to engage in research involving human subjects must receive approval from the Siena College Institutional Review Board (IRB) prior to initiating any research activities, on or off campus.
What constitutes research or a research project? The US Office for Human Research Protections (OHRP) defines research as any “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
What is a human subject? It seems obvious but there is a OHRP definition for this as well. A human subject is a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) Identifiable private information.
ROLE OF THE SIENA COLLEGE IRB
The Siena College IRB provides oversight of OHRP guidelines. These guidelines help to assure that the wellbeing and dignity of individuals involved in research conducted at Siena College or by Siena College constituents are protected.
The IRB evaluates (1) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (2) appropriate guidelines for the selection of human subjects for participation in such research, and (3) nature and definition of informed consent in various research settings.
- Belmont Report (summary)
- Nuremberg Code
- WMA Declaration of Helsinki
- Human Experimentation: The Good, Bad & the Ugly (SciShow YouTube Video on historical perspective of above reports)
The IRB employs four (4) primary types of review depending on the degree of risk to human subject(s):
Exempt Review: Feedback sent 1-2 weeks after IRB application is submitted.
Exempt Limited Review: Feedback sent 2-3 weeks after IRB application is submitted.
Expedited Review: Feedback sent 2-3 weeks after IRB application is submitted.
Full Review: Full committee review conducted 1-3 months after IRB application is submitted.
REGULATIONS & RESOURCES
- Protection of Human Subjects, 45 CFR 46
- Family Educational Rights and Privacy Act (FERPA)
- Siena College Research Misconduct Policy