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CSTE IRB Workgroup

Kevin Gibbs, IT Operations Manager at CSTEAmanda Masters, Director of Workforce Development at CSTEAl DemariaJennifer Lemmings, CSTEErica Runningdeer, ILJessica Arrazola, Director of Educational Strategy at CSTEJeff Engel, Senior Advisor for COVID-19 at CSTERita Altamore, EpidemiologistLesliann HelmusRachel StricofAmanda Payne, Senior Consultant at J Michael ConsultingKatie BrownAnne KjemtrupJen FiddnerJulius Tonzel, Epidemiologist at LA DOH, OPH, IDEPI +112 others
Ian Horste
Ian Horste •
Public Health Ethics Boards — Hello All, I apologize as this inquiry is only Institutional Review Board adjacent, but my hope is (given the "ethics" component) the audiences overlap. If this isn't the appropriate forum, feel free to let me know or ignore. Michigan is looking for good state/territory or local models for board... 		3
Robin Krause
Robin Krause •
HIPAA Waivers and ICF Waivers — Good morning Everyone,  I was wondering if any of your document in your approval letters the specific criteria for the HIPAA Waivers and/or ICF waivers?  If you do, could you provide an example of the  language? Thank you. 		3
Janice Hicks
Janice Hicks •
Untitled — This is a question from a department of Health policy staff member.  She has noted that there is a general lack of data on equity and it is of interest to many different parties.  Do any of you formally require/recommend that researchers include data on equity in their research?   		2
Craig Conover, Medical advisor, Chicago DPH, IRB Chair IL DPH
Craig Conover •
June 2021 OHRP Newsletter — Newsletter sign-up info:https://www.hhs.gov/ohrp/news/sign-up-for-announcements/index.html News from OHRP’s Division of Education and Development June 2021 Time is running out! Register now for this exciting event on June 15-16! OHRP’s upcoming Research Community Forum co-hosted by the Uni...
Craig Conover, Medical advisor, Chicago DPH, IRB Chair IL DPH
Craig Conover •
Data Use Agreements (DUAs) — Good morning,  Does your IRB require an executed DUA for IRB approval for a study that required health department data? For us, this approach would mean providing conditional approval and then  waiting weeks to months before providing final approval, during which lawyers from the state and  the ... 		11
Robin Krause
Robin Krause •
HIPAA — Good morning Everyone,  I came from a hospital setting and HIPAA was a huge part of research.  Is there ever a time when a HIPAA waiver is needed when performing research in a public health setting? I would appreciate any and all information on this, as there is no one left in the institution tha... 		22
Joni Koenig
Joni Koenig •
BRFSS — Hi all - I have a puzzle that I'm hoping you can help with.  This is a question for other states that receive cooperative group funding for the BRFSS - Behavioral Risk Factor Surveillance System.  At least until 2016, the CDC IRB determined the BRFSS to be Human Subjects Research Exempt (from com...
Joni Koenig
Joni Koenig •
Financial Conflict of Interest — I'd like to learn more about how other state public health departments have applied the financial conflict of interest (FCOI) requirements of 42 CFR 50 Subpart F for grants and cooperative agreements and 45 CFR 94 for contracts.  Do you have a separate policy for investigators who apply for/recei... 		2
Joni Koenig
Joni Koenig •
Office for Research Integrity Request — Request for Information The Office of Research Integrity (ORI) of the U.S. Department of Health and Human Services invites comments on activities that foster research integrity and promote the responsible conduct of research under 42 C.F.R. Part 93. In particular, ORI is interested in learning a...
Joni Koenig
Joni Koenig •
SACHRP Discussion on Public Health Surveillance Activities — The Secretary’s Advisory Committee on Human Research Protections (SACHRP) will meet virtually October 20, 2020, from 11:00- 4:30. The topics to be discussed include the Interpretation of Public Health Authority and Public Health Surveillance Activities at 45 CFR 46.102(k) and 46.102(l)(2), Justic...
Robin Krause
Robin Krause •
Board Members Conflict of Interest Attestations — How often do you have your IRB Members sign a conflict of interest attestation?  Do they only sign once and it is good for the duration of their service or do you have them sign annually? 		2
Craig Conover, Medical advisor, Chicago DPH, IRB Chair IL DPH
Craig Conover •
Untitled — Does your IRB track human subjects research training (via requiring submission of certificates) for outside PIs and their study staff during continuing review? Is so, at what interval do you require training to take place?  		7
Craig Conover, Medical advisor, Chicago DPH, IRB Chair IL DPH
Craig Conover •
Updated Decision Charts for the Revised Common Rule — From OHRP: UPDATED Decision Charts for the Revised Common Rule are Here! OHRP updated its Decision Charts to reflect the revised Common Rule requirements.  These graphic charts are designed to help you decide if an activity is research involving human subjects that must be reviewed by an insti... 		2
Larissa Singletary
Larissa Singletary •
Question about engagement in HSR during COVID-19 — Hello! I work for a local health department that is performing COVID-19 testing in our community. We send our specimens to a clinical diagnostic lab affiliated with an academic institution. Researchers at the academic institution would like to use the leftover specimens for COVID-19 research (spe... 		2
Alysia Kwon, Vice Chair and Administrator
Alysia Kwon •
Informed consent forms - expedited studies — Hi all - What date(s) do you use for informed consent forms for expedited studies that have been transitioned under the Revised Common Rule?  Do you still use an expiration date?  		2
Robin Krause
Robin Krause •
Research Staff listed on a protocol application — Does anyone have a clearly defined policy on who should be included on a protocol as research staff? 		3
Craig Conover, Medical advisor, Chicago DPH, IRB Chair IL DPH
Craig Conover •
Reviewer checklists — Does anyone use reviewer checklists to facilitate/document IRB review of protocols? If so, would you be willing to post in the resources section of basecamp? Thanks!     		2
Alysia Kwon, Vice Chair and Administrator
Alysia Kwon •
Retroactive IRB approval — I asked this at the last meeting but wanted to get feedback from others in the group.  I’m wondering if any of you grant retroactive IRB approval, for example, if an exempt project that never received (or requested) IRB approval prior to implementation needs approval after the fact because a publ... 		9
Joni Koenig
Joni Koenig •
No longer HSR — A project was designated as "human subjects research" under the Pre-2018 Requirements (aka Old Rule), but was transitioned to comply with the 2018 Requirements and now does not meet the definition of "human subjects research". It more accurately meets the definition of "public health surveillance... 		7
Jessica Arrazola, Director of Educational Strategy at CSTE
Jessica Arrazola •
Human Subjects Research Training Requirements — •What training does your agency use for internal researchers?  • CITI ($) • Association of Clinical Research Professionals (free if no continuing education credits): https://acrpnet.org/courses/ethics-human-subject-protection/ • FHI 360 (free, long): https://www.fhi360.org/sites/all/libraries/web... 		10
Craig Conover, Medical advisor, Chicago DPH, IRB Chair IL DPH
Craig Conover •
Consent form for release of hospital discharge data — Our IRB has received several applications from investigators performing clinical trials related to social determinants of health (eg provision of housing), where subjects will consent (or not) to release of administrative data from public health  (eg hospital discharge data)  and other state agen...
Jessica Arrazola, Director of Educational Strategy at CSTE
Jessica Arrazola •
Single IRB criteria — (1)  Has your IRB established criteria for Single IRB to determine which IRB will be the Single IRB (e.g., risk assessment, entity receiving grant funding, etc.)?  (2)  If you are not the Single IRB, is your IRB still responsible for tracking human subjects protection training and evaluating in t...
Robin Krause
Robin Krause •
"For Cause" Audit Review Template — Does anyone have a "For Cause" Audit Review Template they are willing to share? I am finding our PAM Review form is falling short for a "For Cause" Audit Review.
Jessica Robbins
Jessica Robbins •
Exempt from review letters — We have several form letters for exempt from review determinations, which I've posted in the Templates section.  I will note that these are more detailed than those I have seen from other institutions.  I wanted to be sure that we had a record of the basis on which we deemed the study to be exemp...