single irb survey summary results

SINGLE IRB SURVEY SUMMARY RESULTSApril 17, 2018

NYU Clinical and Translational Science Institute (CTSI)NYU School of Medicine – Institutional Review Board

NYU School of Medicine – Institutional Review BoardNYU Clinical and Translational Science Institute

2

vSurvey Duration: 01/26/2018 – 02/28/2018

vSurvey Platform: REDCap

vTotal Number of Participants: 122q108 completed survey recordsq14 not completed survey records

General Information


3

Participating Institutions

vTotal of 105 Unique institutions participated in the survey

q15 Institutions are not affiliated with the CTSA

q59 CTSA Affiliated Institutions

q31 Not sure responses

No, 15

Not sure, 31Yes, 59

Is your institution affiliated with a CTSA?


4

Participating CTSA Institutions

v Albert Einstein (2)v Boston University (1)v Case Western Reserve University (1)v Columbia University (1)v Georgetown University (1)v Harvard University (1)v Indiana University Purdue University (1)v Johns Hopkins University (1)v Mayo Clinic (2)v Ohio State University (6)v Oregon Health & Science University (2)v Rockefeller University (1)v Stanford University (1)v University of California Davis (2)v University of California Irvine (1)v University of California Los Angeles (3)v University of California San Diego (1)v University of California San Francisco (2)

v University of Chicago (1)v University of Colorado (1)v University of Florida (2)v University of Illinois (3)v University of Massachusetts (1)v University of Miami (1)v University of Michigan (1)v University of North Carolina (1)v University of Rochester (1)v University of Southern California (1)v University of Texas Dallas (1)v University of Texas Houston (2)v University of Texas San Antonio (3)v University of Utah (3)v University of Washington (3)v Vanderbilt University (1)v Virginia Commonwealth University (2)v Wake Forest University (1)

(number of participants per institutions)


5

Section I. Administrative Information

Not sure, 3

Yes, 105

Does your institution have a Federal Wide Assurance?

No, 8 Not sure, 2

Yes, 98

Is your institution accredited by AAHRPP?

No, 2 Pending, 5

Yes, 101

Does your institute have an executed agreement with SMART IRB?

No, 2 Not sure, 2

Yes, 104

Does your IRB also act as the institutional privacy board?


6



7


If yes, which eIRB Platform?v Click/Huron (10)v iMedRIS (16)v InfoEd (12)v IRBManager (4)v IRBnet (35)v Key Solutions (8)v Other (9)

q Developed at UCI (1)q eProtocol (1)q home grown system (2)q home made 'BuckIRB’ (1)q HS FOX Database (1)q Kuali Coeus IRB (1)q Rascal (home-grown) (1)q homegrown IRB IS system (1)

No, 3Not sure,

11

Yes, 94

Does your institution use an electronic IRB system (eIRB)?

(number of participant responses)**All No or Not Sure responders indicated that they are willing to use an eIRB


8


No, 1 Not sure, 1

Yes, 92

For institutions using an eIRBplatform: Has your eIRB been

customized to the specific needs of your institution?

42

42

7

1

0 20 40

Basic modifications: customquestion fields, new question fields,etc.

Complex modifications: we can addwhole new submission forms, wholeadditional pages, integrate with oursingle sign-on system, etc.

Very simple modifications: logo, picklists

Other

describe how extensively your electronic IRB system ('eIRB') can be modified:

NYU School of Medicine – Institutional Review Board

NYU Clinical and Translational Science Institute9


No, 5

Not sure, 6

Yes, 82

Can your eIRB work with external systems (i.e. get live feed of your staff

lists from an HR system, receive updated training statuses from CITI, feed IRB approval status out to EPIC, etc.)?

No, 2 Not sure,

8

Yes, 72

Would you be interested using a public API

that allowed your eIRB to work with other

eIRBs to manage an NIH single IRB/multi-

site trial?



10

No, 4

Not sure, 17

Yes, 87

Has your institution ever acted as an sIRB in the

past, or currently

Not sure, 2

1-5 times,

34

11-15 times,

7

6-10 times,

16

21+ times,

15

16-20 times,

13

If yes, how many times has your institution acted as sIRB in past

5 years?

1-5 participating sites, 14

11-15 participating

sites, 1

16-20 participating

sites, 10

21+ participating

sites, 48

6-10 participating sites, 9

Not sure, 5

If yes, what was the largest number of participating sites in the past 5

years?


11

Section II. IRB Review Volume

No, 15

Yes, 93

Does your institution receive IRB applications sponsored by the NIH?



The goal of the following survey questions was to determine the amount of flexibility

requested/required for IRB study documents leading to the development of best

practices/standards for sIRB operations and efficient study startup.

Responses are:q Full sIRB Standardization - your site will accept sIRB standardized language/forms/processes

with no local IRB review (your local IRB will not review these instruments in order to adapt these

instruments to the local environment).

q Hybrid Approach - your site will be able to accept some sIRB standardized

language/forms/processes after local IRB review. (your local IRB will review these instruments

and may choose to modify some of these instruments for the local environment)

q Significant Local Modifications - your site requires review of all language/forms/processes and

would rarely approve a standardized (unmodified) study-wide instrument.

SECTION III – Assess Processes for Initial Evaluation of Protocol Documents and Protocol Modifications, and Tolerance for Process Standardization for sIRBParticipating Sites


13

SECTION III.A. Informed Consent Language

53%

55%

58%

65%

66%

66%

70%

72%

73%

79%

82%

92%

93%

44%

35%

42%

34%

33%

28%

29%

28%

26%

21%

18%

8%

7%

3%

10%

0%

1%

1%

6%

1%

0%

1%

0%

0%

0%

0%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Duration of participation

Risks or discomforts to the subject

Alternate procedures and courses of treatment

Purpose of research

Privacy Protection (HIPAA Authorization)

In case of injury explanation

Benefits to the subject

NIH Certificate of Confidentiality Statement

Research statement

Risks related to genetics research

Subject Remuneration (Subject Compensation)

Experimental procedures

Confidentiality of records

Full sIRB Standardization Hybrid Approach Significant Local Modifications


14

SECTION III.A.1. Informed Consent LanguageIf “hybrid” or “local”, who is responsible for local review (multiple choices allowed):

0 5 10 15 20 25 30 35 40 45 50

Research statement

Purpose of research












Reliance Coordinator Legal Counsel Conflict of Interest Committee Compliance Officer IRB Director



SECTION III.A.2. Informed Consent Language If “hybrid” or “local”, for any of the above, how many days are typically required for completion of institutional review/revision of study documents?

29%

22%

14%

7%

23%

30%

16%

17%

27%

24%

40%

50%

32%

57%

56%

65%

32%

18%

23%

47%

28%

25%

58%

23%

22%

21%

14%

22%

22%

43%

55%

43%

34%

47%

27%

12%

31%

25%

42%

0%

0…

0

18%

5%

3%

3%

8%

20%

6%

6%

3%

5%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Research statement

Purpose of research












1 - 7 day/s 8 - 14 days 15 - 21 days 22+ days


16

SECTION III.B. Other IRB documents/ definitions

33%

49%

56%

74%

79%

54%

38%

44%

26%

21%

13%

13%

0%

0%

0%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Review of Conflict of Interests (Financial Disclosures)

Education, training and certifications (i.e. Human subjectstraining, good clinical practice, CITI modules)

Definition/Description of vulnerable populations

Review of Recruitment Materials

Data Safety Monitoring Plan/ Charter



17

SECTION III.B.1. Other IRB documents/ definitionsIf “hybrid” or “local”, who is responsible for local review (multiple choices allowed):

0 5 10 15 20 25 30 35 40 45 50 55 60 65 70



Review of Conflict of Interests (FinancialDisclosures)

Education, training and certifications (i.e. Humansubjects training, good clinical practice, CITI

modules)




18

SECTION III.B.2. Other IRB documents/ definitionsIf “hybrid” or “local”, for any of the above, how many days are typically required for completion of institutional review/revision of study documents?

9%

13%

13%

32%

33%

9%

11%

31%

15%

30%

64%

44%

44%

40%

22%

18%

31%

11%

13%

15%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%





modules)
















SECTION IV – Assess Processes for Reportable Events and Subject Complaints, and Tolerance for Process Standardization for sIRB Participating Sites


20

SECTION IV. Reportable Events and Subject Complaints

33%

33%

57%

65%

63%

63%

39%

32%

4%

4%

4%

3%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Reporting Time Frame for subject complaints

Subject Complaint procedures

Reporting Time Frame for Reportable events

Defining IRB Reportable events



21

SECTION IV.1. Reportable Events and Subject ComplaintsIf “hybrid” or “local”, who is responsible for local review (multiple choices allowed):

0 5 10 15 20 25 30 35 40 45 50 55 60 65 70







22

SECTION IV.2. Reportable Events and Subject ComplaintsIf “hybrid” or “local”, for any of the above, how many days are typically required for completion of institutional review/revision of study documents?

19%

16%

23%

20%

27%

16%

29%

26%

41%

49%

41%

36%

14%

20%

7%

19%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%



















SECTION V – Assess Processes for Evaluation of Protocol Documents by Ancillary Committees and Tolerance for Process Standardization for sIRB Participating Sites


24

SECTION V. Evaluation of Protocol Documents by Ancillary Committees

55%

57%

62%

33%

31%

26%

13%

13%

13%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Outcomes of ancillary review(s) and process for re-review(s)

Timing of ancillary reviews

Defining ancillary reviews (i.e., confidentiality, risk mgmt., IBC,PRMC)



25

SECTION V.1. Evaluation of Protocol Documents by Ancillary CommitteesIf “hybrid” or “local”, who is responsible for local review (multiple choices allowed):

0 5 10 15 20 25 30 35 40 45 50 55 60 65 70

Defining ancillary reviews (i.e., confidentiality,risk mgmt., IBC, PRMC)


Outcomes of ancillary review(s) and process forre-review(s)



26

SECTION V.2. Evaluation of Protocol Documents by Ancillary Committees If “hybrid” or “local”, for any of the above, how many days are typically required for completion of institutional review/revision of study documents?

28%

16%

19%

23%

27%

21%

45%

47%

45%

5%

11%

15%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Defining ancillary reviews (i.e., confidentiality, riskmgmt., IBC, PRMC)


Outcomes of ancillary review(s) and process forre-review(s)



27

SECTION VI. Acceptance of Reliance Agreement for sIRB Participating Sites

No, 1 Not sure, 5

Yes, 100

Would your institution be willing to engage in a Reliance agreement with a sIRB?


29


55%

55%

41%

37%

4%

8%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Indemnification Statement

Distribution of responsibilities


*Verification of human subjects training,review and management of conflicts ofinterest, management of changes in studypersonnel.

*Historically this has probably been themost difficult issue to address universally.In the past, issues where the ReviewingIRB has an indemnification agreement withlanguage inconsistent with the participatingsite's institutional requirements


30

SECTION VI.1. Acceptance of Reliance Agreement for sIRB Participating SitesIf “hybrid” or “local”, who is responsible for local review (multiple choices allowed):

0 5 10 15 20 25 30 35 40 45 50 55 60 65 70







31

SECTION VI.2. Acceptance of Reliance Agreement for sIRB Participating SitesIf “hybrid” or “local”, for any of the above, how many days are typically required for completion of institutional review/revision of study documents?

2%

29%

30%

22%

43%

33%

25%

16%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%







32

v We recognize that each survey participant’s responses to the survey questions may vary depending on whether their institution is joining a multisite study as the Participating Site or acting as the sIRB Primary Site of record for a multisite study. Therefore, we asked survey participants to provide their responses to the same series of questions as the sIRB Primary site of record for a multisite study. q Out of 108 survey participants who completed the survey

o 73 survey participants opted not to respond o 17 survey participants did respond to the question (missing response)o 18 survey participants provided their responses as the sIRB Primary site

Survey for sIRB Primary Sites

No, 73

Yes, 18

Missing response, 17


33

The goal of these survey questions is to determine the amount of flexibility requested/required for IRB study documents leading to the development of best practices/standards for sIRB operations and efficient study startup.Responses are:

q Full sIRB Standardization – as a primary site you would prefer participating sites to accept all sIRB standardized language/forms/processes with no local IRB review (the participating site’s local IRB will not review these instruments in order to adapt these instruments to the local environment).

q Hybrid Approach – as a primary site you would accept local review of sIRB standardized language/forms/processes and would allow modifications to some of these instruments. (the participating site’s local IRB will review these instruments and may choose to modify some of these instruments for the local environment)

q Significant Local Modifications – as a primary site you would allow the participating site’s local IRB to review all language/forms/processes in order to adapt all instruments to the local environment.

SECTION III (Primary Site) – Assess Processes for Initial Evaluation of Protocol Documents and Protocol Modifications, and Tolerance for Process Standardization for sIRB Primary


34

SECTION III (Primary Site).A. Informed Consent Language

7%

14%

36%

43%

64%

71%

79%

79%

79%

79%

86%

86%

86%

64%

57%

50%

43%

29%

21%

14%

14%

14%

14%

7%

7%

7%

29%

29%

14%

14%

7%

7%

7%

7%

7%

7%

7%

7%

7%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%











Research statement

Purpose of research




35

SECTION III (Primary Site).A.1. Informed Consent LanguageIf “hybrid” or “local”, who is responsible for local review (multiple choices allowed):

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Research statement

Purpose of research















SECTION III (Primary Site).A.2. Informed Consent LanguageIf “hybrid” or “local”, for any of the above, how many days are typically required for completion of institutional review/revision of study documents?

0%

0%

33%

0%

0%

33%

33%

20%

29%

50%

25%

45%

25%

0%

0%

0%

0%

0%

0

0%

20%

29%

13%

42%

27%

0%

100%

100%

67%

100%

100%

67%

67%

60%

43%

38%

25%

27%

75%

0%

0…

0

0%

0%

0%

0%

0%

0%

0%

8%

0%

0%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Research statement

Purpose of research














37

SECTION III (Primary Site).B. Other IRB documents/ definitions

23%

31%

54%

62%

83%

38%

15%

38%

38%

8%

38%

54%

8%

0%

8%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Review of Conflict of Interests (Financial Disclosures)

Education, training and certifications (i.e. Human subjectstraining, good clinical practice, CITI modules)






38

SECTION III (Primary Site).B.1. Other IRB documents/ definitionsIf “hybrid” or “local”, who is responsible for local review (multiple choices allowed):

0 1 2 3 4 5 6 7 8 9 10





modules)




39

SECTION III (Primary Site).B.2. Other IRB documents/ definitionsIf “hybrid” or “local”, for any of the above, how many days are typically required for completion of institutional review/revision of study documents?

0%

60%

20%

56%

33%

0%

0%

40%

11%

17%

100%

40%

30%

33%

50%

0%

0…

10%

0%

0%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%





modules)




40

The goal of these survey questions is to determine the amount of flexibility requested/required for IRB study documents leading to the development of best practices/standards for sIRB operations and efficient study startup.

Responses are:q Full sIRB Standardization – as a primary site you would prefer participating sites to accept all

sIRB standardized language/forms/processes with no local IRB review (the participating site’s local IRB will not review these instruments in order to adapt these instruments to the local environment).



SECTION IV (Primary Site) – Assess Processes for Reportable Events and Subject Complaints, and Tolerance for Process Standardization for sIRB Primary Sites


41

SECTION IV (Primary Site). Reportable Events and Subject Complaints

54%

62%

85%

85%

46%

38%

15%

15%

0%

0%

0%

0%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%







42

SECTION IV (Primary Site).1. Reportable Events and Subject ComplaintsIf “hybrid” or “local”, who is responsible for local review (multiple choices allowed):

0 1 2 3 4 5 6 7 8 9 10







43

SECTION IV (Primary Site).2. Reportable Events and Subject ComplaintsIf “hybrid” or “local”, for any of the above, how many days are typically required for completion of institutional review/revision of study documents?

0%

0%

33%

40%

50%

50%

33%

40%

50%

50%

33%

20%

0%

0%

0%

0%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%







44

The goal of these survey questions is to determine the amount of flexibility requested/required for IRB study documents leading to the development of best practices/standards for sIRB operations and efficient study startup.Responses are:

q Full sIRB Standardization – as a primary site you would prefer participating sites to accept all sIRB standardized language/forms/processes with no local IRB review (the participating site’s local IRB will not review these instruments in order to adapt these instruments to the local environment).



SECTION V (Primary Site) – Assess Processes for Evaluation of Protocol Documents by Ancillary Committees and Tolerance for Process Standardization for sIRB Primary Sites



SECTION V (Primary Site). Evaluation of Protocol Documents by Ancillary Committees

23%

23%

23%

23%

23%

31%

54%

54%

46%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Defining ancillary reviews (i.e., confidentiality, risk mgmt., IBC,

PRMC)


Outcomes of ancillary review(s) and process for re-review(s)



46

SECTION V (Primary Site).1. Evaluation of Protocol Documents by Ancillary CommitteesIf “hybrid” or “local”, who is responsible for local review (multiple choices allowed):

0 1 2 3 4 5 6 7 8 9 10







NYU Clinical and Translational Science Institute

47

SECTION V (Primary Site).2. Evaluation of Protocol Documents by Ancillary Committees If “hybrid” or “local”, for any of the above, how many days are typically required for completion of institutional review/revision of study documents?

40%

30%

40%

30%

30%

30%

30%

30%

30%

0%

10%

0%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Defining ancillary reviews (i.e., confidentiality, risk

mgmt., IBC, PRMC)


Outcomes of ancillary review(s) and process for

re-review(s)



48

SECTION VI (Primary Site). Acceptance of Reliance Agreement for sIRB Primary Sites

Not sure, 1

Yes, 15

Would your institution be willing to engage in a Reliance agreement with other participating sites?


49

The goal of these survey questions is to determine the amount of flexibility requested/required for IRB study documents leading to the development of best practices/standards for sIRB operations and efficient study startup.

Responses are:q Full sIRB Standardization – as a primary site you would prefer participating sites to accept all

sIRB standardized language/forms/processes with no local IRB review (the participating site’s local IRB will not review these instruments in order to adapt these instruments to the local environment).



SECTION VI (Primary Site). Acceptance of Reliance Agreement for sIRB Primary Sites


50

SECTION (Primary Site). Acceptance of Reliance Agreement for sIRB Primary Sites

8%

15%

69%

46%

23%

38%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%







51

SECTION VI (Primary Site).1. Acceptance of Reliance Agreement for sIRBPrimary SitesIf “hybrid” or “local”, who is responsible for local review (multiple choices allowed):

0 1 2 3 4 5 6 7 8 9 10







52

SECTION VI (Primary Site).2. Acceptance of Reliance Agreement for sIRBPrimary SitesIf “hybrid” or “local”, for any of the above, how many days are typically required for completion of institutional review/revision of study documents?

0%

45%

58%

27%

33%

27%

8%

0%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%




