CSTE IRB Workgroup

Document Workgroup Assessment Draft 11.25.19

View on OneDrive ↗

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.

Please use the below link review the assessment, do not provide actual data at this time as it will not save.
Qualtrics Preview: https://cste.co1.qualtrics.com/jfe/preview/SV_86pNHXfKzLxRsS9?Q_SurveyVersionID=current&Q_CHL=preview 

Comments & Events

Joni Koenig
Oops - I just responded. :) I did have a couple of points to clarify. Is it OK if I go back in?

Joni
Jessica Arrazola, Director of Educational Strategy at CSTE
Good morning, please provide comments on the workgroup assessment by Friday, December 13th.  Are there questions that can be removed? How can we refine the current response options to better mirror your experience? Any other questions to be added? Thank you!
Jessica Arrazola, Director of Educational Strategy at CSTE
Any comments about this draft assessment? Please be sure to post your comments/edits using this comment feature in basecamp.  Thank you!
Bernhard Kloppenburg
I do not have any at this time.
Henry Anderson
I do not have any additions

Andy
Kate Goodin, Surveillance Systems and Informatics Program Director
question 1, is it worth clarifying if they rely on an outside IRB if that is academic, another state agency, private, CDC...?  There have been issues with private ones in the past.  Do we care if they rely on an outside IRB if they have to pay for review?

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?
Henry Anderson
I don’t have any additions. Good start. Thanks

Andy
Alayna Nest
#5 & #6: May need to provide more specification here. We defer reviews & accept reviews on a case-by-case basis by putting Institutional Authorization Agreements in place for specific studies. Those IAA's have increased in numbers with the NIH sIRB policy and again will increase once the revised Common Rule single IRB regulations come into play. With that said though, our Board covers 2 institutions - the State Public Health Division and a local County Health Department. Both have FWA's filed and on those FWA's they list our IRB as the only IRB they rely on. Neither FWA lists external IRBs that the organization relies on though - b/c the Assurance filing specifically states: "NOTE: Institutions designating internal IRBs do not need to designate any of the external IRBs upon which it relies".
Alayna Nest
#8 I wasn't sure what this was asking here -- needs more specification. 

#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. 
Jon Meiman
#1: I think it's worth asking which type of outside IRB is utilized, as mentioned by Kate above. 

#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. 
Lou Gonsalves
This survey will be very helpful, as are the comments above. Thank you! I wonder if we can add a question asking whether the IRB charges a fee for reviews, and if so whether there is a different fee structure for different review types and/or different researcher applicant groups (e.g., academic/Federal/commercial/other)?
Paul Etkind
1. Would a local hospital be included in Option 3 ("human service agencies")? Personally, don't think of a hospital/clinical entity under that label, but that may be me.

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?"
Paul Etkind
As I think more about this from a local health department perspective, do we want to ask "If you don't have an institutional IRB, is it because you don't feel you need one? If so, can you describe the reason(s) why an IRB is not considered to be necessary?" 
Jessica Arrazola, Director of Educational Strategy at CSTE

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?
Paul Etkind
Jessica,

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
Robin Krause
Question #5 asks where your organization is located.  It incorrectly lists New York as being located in the MidAtlantic when it is actually located in the Northeast.   Question #12: How many new protocols were reviewed by your IRB each year for approval or determination (e.g. exempt research, non-human subjects research) in the last 12 months? needs to be clarified. 
 
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? 
Paul Etkind
12. I saw the disconnect in #12 ("reviewed each year ... in the last 12 months") but Robin Krause already reported that. 
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)? 
Henry Anderson
I too am retired. I did IRB for WIs DPH when I was state epi. We used the University IRB as we did not hae our own. I won’t fill out the questionnaire. But am interested in the survey that is being developed.

Andy

Henry A. Anderson, MD

Sent from Mail for Windows 10
Eleanor Low
I am not retired but i am no longer active with the University IRB . I wont fill out the questionnaire.  I am interested in the survey as it is being developed too.

Eleanor Low
Richard Danila
I have been the Chair or Co-Chair of the Minnesota Department of Health IRB since its inception in 1999 and would be happy to complete the survey. We are less active than we used to be, averaging about six new Full Board and 12 new expedited reviews annually. There is a half time administrator and clerical position as well, and the administrator and myself also conduct about 12 initial review proposals annually which we determine to be not research and not need further review.
Jessica Robbins
I would suggest that the question about role with the IRB include IRB Administrator and allow for multiple answers.
Diana Wong
I suggest that Question 29 include PII (identifiers not associated with health information). 

I recommend including a question or amending Question 30 to include an option for legal agreements such as data use and non-disclosure agreements.
Jerry Gibson
I'm retired from my state health departments so should not reply. I was chair of our university IRB earlier, which we used ordinarily along with out own DEpartmentd IRB.
Jon Meiman
At the Wisconsin Dept of Health Services we rely on the university for IRB review and oversight. Given that other health departments also rely on outside IRBs and will be responding to this survey, Q1 options may not apply. I recommend providing an additional option for Q1: either “other” or “Liaison to outside IRB”


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>
Craig Conover, Medical advisor, Chicago DPH, IRB Chair IL DPH
All the comments are most helpful. I've tried to incorporate the latest input into the following: 


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 
  • IRB vice chair 
  • IRB member 
  • IRB staff (administrative support) 
  • Other (eg liaison with outside IRB). Please provide your IRB title or describe your role:_________________________

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®) 
  • Certified Healthcare Research Compliance (CHRC) 
  • Certified in Healthcare Privacy Compliance (CHPC) 
  • Certified IRB Manager (CIM) 
  • Certified Research Administrator (CRA) 
  • Other (please specify): 

None 
  • 4. In what part of the United States is your IRB(s) located?




  • HHS Region 1 
    Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont
  • HHS Region 2
    New Jersey, New York, Puerto Rico, and the Virgin Islands
  • HHS Region 3
    Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, and West Virginia
  • HHS Region 4
    Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, and Tennessee
  • HHS Region 5
    Illinois, Indiana, Michigan, Minnesota, Ohio, and Wisconsin
  • HHS Region 6
    Arkansas, Louisiana, New Mexico, Oklahoma, and Texas
  • HHS Region 7
    Iowa, Kansas, Missouri, and Nebraska
  • HHS Region 8
    Colorado, Montana, North Dakota, South Dakota, Utah, and Wyoming
  • HHS Region 9
    Arizona, California, Hawaii, Nevada, American Samoa, Commonwealth of the Northern Mariana Islands, Federated States of Micronesia, Guam, Marshall Islands, and Republic of Palau
  • HHS Region 10
    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
  • We participate in an IRB formally established to serve multiple agencies (e.g. governmental public health and human service agencies have a joint IRB) 
  • We routinely rely on one or more an outside IRBs to review protocols  on behalf of the health department 


  • We occasionally encounter a situation where we need an IRB to review a protocol, and when this situation arises, we make the necessary arrangements for this to happen
  • To date, we have never needed an IRB to review a research protocol  
    (please explain):
  • Other (eg, 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)
  • Another state agency's IRB 
  • Commercial IRB(s)
  • CDC IRB 
  • Other (please specify): 

    If you  rely on  external IRBs,  are you charged a fee for reviews to be conducted?


  • Yes, we always pay a fee
  • Yes, we sometimes pay a fee
  • No, we never pay a fee
  • Other (please describe):______






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? 



  • Local health departments
  • Non-profit organizations
  • Other (please specify):


    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);
  • Yes, occasionally (provide details):
  • No
  • Other (please explain):


  • 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
  • In the process of receiving AAHRPP accreditation 
  • Other (please specify): 
  • None 

8. Do you have state (or county/city) regulations that define your IRB structure and functions, criteria for protocol approval, etc.? 

  • Yes 
  • No 

8a. Under what legal authority does your IRB operate, given that FWAs no longer cover non-federally funded/sponsored studies? 



  • IRB Policies and Procedures 
  • Other (please explain): 

9. Do you apply all IRB approval criteria defined in federal rules to: 

  • Federally funded/sponsored protocols only 
  • All protocols 

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)? 
00 1010 2020 3030 4040 5050 6060 7070 8080 9090 100 100 

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 
  • Somewhat above average 
  • Average 
  • Somewhat below average 
  • Far below average 
  • Other  (please explain):

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? 


19. When a protocol is submitted to your IRB that is ready for full board 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 
  • About right 
  • Too much 

21. Do you use IRB software to manage IRB submissions? 

  • Yes 
  • No

    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 
  • No
  • Other
  • Not Applicable 

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? 



  • We plan always rely on the single IRB identified  for the study 
  • We have a statute or rule that prohibits health department reliance on the single IRB
  • We are considering implementing a statute or rule that prohibits reliance on the single IRB
  • If we identify a compelling reason, we will attempt to not be required to rely on the single IRB 
  • Other (please explain):








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 
28. How many of the following members does your IRB have, not including any alternate members? 

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?
Information that relates specifically to an individual. HIPAA designates the following as direct identifiers: names; postal address information other than town or city, state, and zip code; phone numbers; fax numbers; email addresses; social security numbers; medical record numbers; health plan beneficiary numbers; account numbers; certificate/license numbers; vehicle identifiers and serial numbers including license plate numbers; device identifiers and serial numbers; URLs; IP addresses; biometric identifiers; and full face photographic images and any comparable images.
What is an Indirect Identifier?
Information that can be combined with other information to potentially identify a specific individual. HIPAA designates the following as indirect identifiers: city, state, and zip codes; elements of dates; and other numbers, characteristics, or codes not HIPAA-designated as direct identifiers.

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): 

New question: 


Does your health department (or multi agency)IRB review  DUAs prior to execution and/or after execution (check all that apply): 
  • We review all DUAs prior to execution
  • We review all DUAs after execution
  • We do not routinely review  DUAs as part of our our IRB review and approval process
  • Other: 




32. What topics would you like to be addressed through the CSTE IRB workgroup? 









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. 

Please click the blue arrow below to submit your responses. 

Powered by Qualtrics 
Navina Forsythe
Sorry I'm kind of late to this and I miss the meetings as they actually overlap with our regular IRB meeting. I'm trying to understand the purpose of the survey and what actions or decisions some of these questions will inform. If I was a recipient of the survey I would start it then probably stop because the purpose of the survey and questions would be unclear to me. And as an IRB chair most of these questions would not provide useful information to me, only a few of them. I am a strong advocate that collection of information should be to inform some decision and be actionable and not to collect a bunch of info just because it may be interesting if it is not going to be used beyond that. Could you help me understand the purpose and use more and then I might be able to provide more targeted feedback.

thanks,
Navina
Pam Isom
I have missed the deadline for the comments.   My apologies I have been out of the office for a while.   I did have a few comments/questions.

  • Is there already some data or could we collect some information regarding the departments such as are they Centralized; Independent per county or jurisdiction; are the HIPPA covered or hybrid entities.
  • At various places in document it states in "the last 12 months".  Would it be better to define a specific time period with date to date.  Based on the time the survey is completed there could be some significant difference in the time frame.  If it was from Date to Date the data would be consistent and easier to compare. 
  • Question 5 section option "We have our own IRB at the health department"   Could this include  at the county/jurisdiction health department and then another option for at the state health department.
  • Question 7 response "None"  Could a text box be added to capture the reason as to in accreditation status (probably will be the cost).
  • Question 8, I am interested in why the have the state/county/cit regulations and how they work with the federal regulations.  I am not sure how to capture that here.  
  • Question 18,   Many times the protocol is submitted; however, it is returned to the PI for additional information or corrections.   Depending on the PI response time this could skew  the time and appear the IRB was much slower with processing.  It would be cleaner to ask what the time is once the protocol packet is 100% complete.
  • Question 22 may be better located after #6 if the clarifications to note to #6 are accepted.
  • Question #28  Full Members, Community Members & Non-Scientific Members I think this would be clearer to determine Full Members who are internal and external to the institution.  Also, capturing those with a scientific title would be helpful.
Thanks!   Pam
Alayna Nest
In the latest version of the survey, Q4, Region 10 should reference Washington State, not Hawaii.
Craig Conover, Medical advisor, Chicago DPH, IRB Chair IL DPH
Here are my suggestions for question edits based on input. For info on health department organizational type, I think we can use info that ASTHO has collected for state health depts? (eg see https://astho.org/Research/Data-and-Analysis/State-and-Local-Governance-Classification-Tree/)
 
suggested edits: 

Under initial respondent information section, add 
Is your agency
a covered entity
a hybrid entity
Other: ______
  • 4. In what part of the United States is your IRB located?




  • HHS Region 1 
    Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont
  • HHS Region 2
    New Jersey, New York, Puerto Rico, and the Virgin Islands
  • HHS Region 3
    Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, and West Virginia
  • HHS Region 4
    Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, and Tennessee
  • HHS Region 5
    Illinois, Indiana, Michigan, Minnesota, Ohio, and Wisconsin
  • HHS Region 6
    Arkansas, Louisiana, New Mexico, Oklahoma, and Texas
  • HHS Region 7
    Iowa, Kansas, Missouri, and Nebraska
  • HHS Region 8
    Colorado, Montana, North Dakota, South Dakota, Utah, and Wyoming
  • HHS Region 9
    Arizona, California, Hawaii, Nevada, American Samoa, Commonwealth of the Northern Mariana Islands, Federated States of Micronesia, Guam, Marshall Islands, and Republic of Palau
  • HHS Region 10
    Alaska, Idaho, Oregon, and Washington
7. Please indicate your IRB accreditation status: 

  • Association for the Accreditation of Human Research Protection Programs (AAHRPP)  accreditation
  • In the process of receiving AAHRPP accreditation 
  • Other (please specify): 
  • None 
7a. (If answer  is other or none,  is the reason for not pursuing AAHRPP accreditation lack of resources (eg funding/staff)? 
Yes
No

You may provide any additional comments regarding IRB accreditation  here: 
  



18. When an application submitted to your IRB is complete and ready for expedited review, what is the estimated average time it takes for the review to be completed? 


19. When an application that is submitted to your IRB is complete and ready for full board review, what is the estimated average time it takes for the review to be completed? 


additional questions for end of survey:


--How does your IRB classify the collection of Pregnancy Risk Assessment Monitoring System (PRAMS) data? 

Human subjects research
Surveillance
N/A, our IRB does not review the PRAMS data collection protocol  
Other (please describe): 

How does the IRB classify the collection of Medical Monitoring Project (MMP) data?  
Human subjects research
Surveillance
N/A, our IRB does not review the MMP data collection protocol 
Other (please describe):




Have you discontinued, or do you plan to discontinue conducting IRB continuing review for minimal risk research?


Yes
No
We have implemented, or will implement a less burdensome process than continuing review for most or all  minimal risk  (eg requiring submission of a brief status report to be reviewed by the IRB   
Other:
 


Would you like the opportunity to provide comments to CSTE to incorporate into feedback to CDC/HHS  regarding   HHS's Nov 2018 draft guidance document: 

Activities Deemed Not to Be Research: Public Health Surveillance 2018 Requirements

Craig Conover, Medical advisor, Chicago DPH, IRB Chair IL DPH
The IRB membership question could be rephrased as follows: 
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)
Non-scientific committee members (including alternates)
Non-Affiliated (Community) Committee Members (including alternates):
Alternate committee members:
Julia Hood
I suggest adding a question on type of agency (e.g. state health department, local health dept, tribal health agency, other).  Some of the questions may not be relevant to non-state health departments -- should there be a N/A option and/or skip patterns?
Henry Anderson
I assume that all states/counties have an IRB review mechanism. However I wonder if they are satisfied with how it works. I think some states have had to cobble things together to meet the requirements for some grants. Is CSTE interested in exploring establishing an IRB as part of their CDC cooperative agreement? If so then I would ask if states would be interested in using such a centralized service? I think most states probably don't have sufficient demand to warrant the considerable cost of maintaining their own IRB and might welcome a "public health specific" IRB under CSTE auspices  if CSTE  could get the resources to establish one.

Just a thought.
Jessica Arrazola, Director of Educational Strategy at CSTE
Thank you for your additional comments and suggestions. Please send any other edits by Friday, January 17th to be included in the final version.  The most recent draft is January 8th (attached).