Workgroup Assessment Draft 11.25.19
Please take a look at this draft of the workgroup assessment. What questions need to be clarified? Any new questions to propose? We will discuss on our December call, but feel free to note your suggestions in the comments.
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Please use the below link review the assessment, do not provide actual data at this time as it will not save.
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Joni
Andy
question 2, are you asking if there are any additional regulations other than the federal? like state or local regulations/rules/laws?
question 4, should we ask last year or on average? I think it would be easier to get a concrete number for what happened in 2019, then as a follow up question if this was more or less than average for the last 5 years. Could we get an answer for each of the categories separately?
question 5 and 6 also change to 2019.
question 13, do we want to explicitly state that these categories are not mutually exclusive?
Can we ask a question about whether they routinely allow local health departments to submit to the IRB and under what conditions?
Andy
#16: I'd suggest adding in the word "approximate" as we do not track amendment requests so I'd just have to give you a ball-park number.
#19: I'd specify with whom there is a "communications breakdown" -- either researchers or among IRB staff. e.g. we have breakdowns with researchers that prolong our reviews and add greatly to our workload. However, there are never breakdowns among the IRB as I am the only staff member.
I'd also specify who the unrealistic deadlines are coming from -- for us, it is the research teams (they expect their emergency to be the Boards priority). How this question reads, people could also be implying unrealistic deadlines from their Board itself/a supervisor/Chair/whomever.
#14: In the answer options, I assume "agency IRB" refers to the public health authority? We rely on the researcher's IRB approval in most cases. This could be an additional option to answer this question.
11a. I would suggest being more specific in your wording and ask "What percent FTE is your IRB chair paid to perform this function?"
12b. Same wording as 11a.
Would you consider adding "If your agency does not have an IRB, what are the barrier(s) to establishing one?"
Here is an updated version that incorporate your comments. We will discuss this version on an upcoming call. What other suggestions do you have to improve the assessment? Any questions that should remove?
Since I am retired and am not working for a public health jurisdiction, I cannot respond to the IRB survey. I just want to explain my non-response.
Paul
12. How many new protocols were reviewed by your IRB for approval or determination (e.g. exempt research, non-human subjects research) in the last 12 months?
Should be clarified:
25. How many paid FTEs staff your IRB (to perform administrative functions, e.g. IRB coordinator), not including the Chair, Vice-chair, and other IRB members?
25. How many paid FTEs does your IRB have on staff to perform administrative functions, e.g. IRB coordinator, not including the Chair, Vice-chair, and other IRB members?
I did not note the question but asking about barriers to an IRB implies to me that all jurisdictions should have one or have access to one. Will we catch those jurisdictions who feel they do not need one, and if they don't, why do they believe that to be so (small health department, does not conduct research as defined, perhaps other reasons)?
Andy
Henry A. Anderson, MD
Sent from Mail for Windows 10
Eleanor Low
I recommend including a question or amending Question 30 to include an option for legal agreements such as data use and non-disclosure agreements.
Jon Meiman, MD
Chief Medical Officer and State Epidemiologist for Occupational and Environmental Health
Wisconsin Department of Health Services
1 West Wilson St – Room 150
PO Box 2659
Madison, WI 53701
Phone: 608-266-1253
jonathan.meiman@dhs.wisconsin.gov<mailto:jonathan.meiman@dhs.wisconsin.gov>
CSTE IRB Workgroup Assessment
Thank you for your interest in CSTE’s IRB workgroup. The data you provide will inform the workgroup’s activities. Please coordinate with your colleagues to ensure only one assessment is completed per jurisdiction. Please direct any questions to Jessica Arrazola at JArrazola@cste.org
Please enter your contact and agency information.
Name
Title
Agency
Email
1. What is your IRB role?
IRB chair
2. Approximately how many years have you been involved with IRBs (including years as an IRB member)?
3. What certifications do you hold that are relevant to your IRB work? Please select all that apply.
Certified IRB Professional (CIP®)
None
Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont
New Jersey, New York, Puerto Rico, and the Virgin Islands
Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, and West Virginia
Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, and Tennessee
Illinois, Indiana, Michigan, Minnesota, Ohio, and Wisconsin
Arkansas, Louisiana, New Mexico, Oklahoma, and Texas
Iowa, Kansas, Missouri, and Nebraska
Colorado, Montana, North Dakota, South Dakota, Utah, and Wyoming
Arizona, California, Hawaii, Nevada, American Samoa, Commonwealth of the Northern Mariana Islands, Federated States of Micronesia, Guam, Marshall Islands, and Republic of Palau
Alaska, Idaho, Oregon, and Hawaii
5. Who serves as the principal IRB (or equivalent) for your agency?
We have our own IRB at the health department
(please explain):
5a. For approximately
what % of protocols do you rely on external IRBs?
0 10 20 30 40 50 60 70 80 90 100
If answer is not “0”...
What type(s) of external IRBs do you primarily rely on? (check all that apply)
Academic or hospital IRB(s)
Academic or hospital IRB(s)
If you rely on external IRBs, are you charged a fee for reviews to be conducted?
5c. If your agency does not have an IRB, what are the barriers to establishing one, if any?
6. Does your organization external organizations have IRB authorization agreements in place with any of the following categories of external organizations?
The next 2 questions were moved from farther on to this part of the survey
22. If your IRB is a state health department IRB, does your IRB routinely allow local health departments to submit protocols to your IRB for review and approval ?
Yes, routinely (provide details);
22a. Under what conditions do you allow local health departments to submit to your IRB?
6a. What percentage of your total number of protocols does this encompass?
0 10 20 30 40 50 60 70 80 90 100
7. Please indicate your IRB accreditation status:
Association for the Accreditation of Human Research Protection Programs (AAHRPP) accreditation
8. Do you have state (or county/city) regulations that define your IRB structure and functions, criteria for protocol approval, etc.?
Yes
8a. Under what legal authority does your IRB operate, given that FWAs no longer cover non-federally funded/sponsored studies?
IRB Policies and Procedures
9. Do you apply all IRB approval criteria defined in federal rules to:
Federally funded/sponsored protocols only
10. How many full board IRB review meetings did you hold in 2019 the last 12 months?
11. Approximately what percent of protocols are reviewed by the full IRB (convened meeting)?
12. How many new protocols were reviewed by your IRB each year for approval or determination as exempt research, non-human subjects research, etc. in 2019the last 12 months?
13. What was the approximate number of initial full board reviews of new studies conducted in 2019 the last 12 months? Please do not include amendments, adverse events, and continuing reviews.
14. What was the approximate number of initial expedited reviews of new studies conducted in 2019 the last 12 months? Please do not include amendments, adverse events, and continuing reviews.
15. Approximately how many continuing reviews did your IRB perform in 2019 the last 12 months?
16. Approximately how many amendments/modifications to existing protocols did your IRB review in 2019 the last 12 months?
17. Were the numbers of all review types performed by your IRB in 2019 the last 12 months higher or lower than the average for the past 5 years?
Far above average
18. When a protocol is submitted to your IRB that is ready for expedited review, what is the estimated average time it takes for the review to be completed?
20. Currently, how would you assess your IRB-related workload in relation to your staffing?
Too little
21. Do you use IRB software to manage IRB submissions?
Yes
21a. What software do you use to manage IRB submissions?
Consider moving next 2 questions to after question 6.
22. If your IRB is a state health department IRB, does your IRB routinely allow local health departments to submit to your IRB?
Yes
22a. Under what conditions do you allow local health departments to submit to your IRB?
23. Does your IRB charge a fee for reviews?
Yes
No
Sometimes
23a. Please explain whether there are different fee structures for different review types and/or applicant groups.
24. To what extent have you implemented revised/new policies and procedures as a result of new federal (OHRP) Common Rule regulations (the Revised Common Rule)?
New question: Do you plan to require federally funded/supported cooperative studies using a single IRB to also submit an application for study approval to your IRB, when the study involves health department participation or release of identifiable health department data?
25. How many paid FTEs staff your IRB (to perform administrative functions, e.g. IRB coordinator), not including the Chair, Vice-chair, and other IRB members?
26. Is your IRB chair paid to perform this function?
Yes
No
26a. What percentage FTE is your IRB chair paid to perform this function?
0 10 20 30 40 50 60 70 80 90 100
27. Does your IRB have a vice-chair?
Yes
No27a. Is your IRB vice-chair paid to perform this function?
Yes
No
27b. What percentage FTE is your IRB vice-chair paid to perform this function?
0 10 20 30 40 50 60 70 80 90 100
Note: These categories are not mutually exclusive.
Full members (including chairs):
Community members:
Non-scientific members:
Prisoner representatives:
29. Does your agency allow release of identifiable data from at least some programs to outside researchers?
We do not release any line level data with HIPAA identifiers to outside researchers
After health department IRB approval, we release line level data from some or all programs to outside researchers, but only limited data sets (no HIPAA direct identifiers)
After health department IRB approval, we release line level data from some or all programs with direct and indirect HIPAA identifiers to outside researchers
Other (please explain):
Definitions:
What is a Direct Identifier?
30. Does your IRB specifically require verification of any of the following security controls as a condition of release of identifiable data to outside researchers?
Operating systems and applications that are supported and updated
Anti-Malware installed and set to auto update and scan
Auto screen lock to password/code •
Disk encryption
File encryption
No use of memory sticks/thumb drives for identifiable data storage
No use of laptops for identifiable data storage
Other (please specify):
31. If any of these security controls are required, who do you have verify they are in place?
Investigator
IT official at investigator’s institution
Other (please specify):
Does your health department (or multi agency)IRB review DUAs prior to execution and/or after execution (check all that apply):
33. Are there topics you would like to present on to the group or share about your experience?
Thank you for providing input for the CSTE IRB workgroup.
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thanks,
Navina
suggested edits:
Under initial respondent information section, add
Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont
New Jersey, New York, Puerto Rico, and the Virgin Islands
Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, and West Virginia
Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, and Tennessee
Illinois, Indiana, Michigan, Minnesota, Ohio, and Wisconsin
Arkansas, Louisiana, New Mexico, Oklahoma, and Texas
Iowa, Kansas, Missouri, and Nebraska
Colorado, Montana, North Dakota, South Dakota, Utah, and Wyoming
Arizona, California, Hawaii, Nevada, American Samoa, Commonwealth of the Northern Mariana Islands, Federated States of Micronesia, Guam, Marshall Islands, and Republic of Palau
Alaska, Idaho, Oregon, and Washington
Association for the Accreditation of Human Research Protection Programs (AAHRPP) accreditation
Yes
You may provide any additional comments regarding IRB accreditation here:
Other (please describe):
N/A, our IRB does not review the MMP data collection protocol
Activities Deemed Not to Be Research: Public Health Surveillance 2018 Requirements
Including the chair(s)and vice chair(s), how many of the members in each of the following categories does your IRB have?
Scientific committee members (including alternates)
Alternate committee members:
Just a thought.