J Clin Med Res

Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc

Journal website http://www.jocmr.org

Original Article

Volume 5, Number 3, June 2013, pages 185-193

Characteristics and Causes for Non-Accrued Clinical Research (NACR) at an Academic Medical Institution

**Table 1.** IRB Level of Review and Sponsorship Category for Both NACR and ACR, Northwestern University, 2010 - 2011
	NACR			ACR			Total
Sponsored Studies
Industry-funded	60	6	54	212	35	177	272 (32.0%)
Federally-funded	30	9	21	140	63	77	170 (20.0%)
Foundation-funded	13	8	5	55	36	19	68 (8.0%)
Total Sponsored Studies	103	23	80	407	134	273	510 (60.0%)

Non-Sponsored Studies
Total Non-Sponsored Studies	41	27	14	297	239	58	338 (40.0%)

Total	144	50	94	704	373	331	848 (100.0%)

Table 1. IRB Level of Review and Sponsorship Category for Both NACR and ACR, Northwestern University, 2010 - 2011

NACR

ACR

Total

Sponsorship

NACR

Expedited Review

Full Panel Review

ACR

Expedited Review

Full Panel Review

NACR & ACR (% of Total)

Sponsored Studies

Industry-funded

212

177

272 (32.0%)

Federally-funded

140

170 (20.0%)

Foundation-funded

68 (8.0%)

Total Sponsored Studies

103

407

134

273

510 (60.0%)

Non-Sponsored Studies

Total Non-Sponsored Studies

297

239

338 (40.0%)

Total

144

704

373

331

848 (100.0%)

**Table 2.** Summary of IRB Study Closures According to Reporting Entity, Northwestern University, 2010 - 2011
Reporting Entity	No NACR	≤ 1 NACR	Only NACR	Total
Principal Investigator	224 (68.3%)	71 (21.7%)	33 (10.0%)	328
Department/ Division	31 (42.3%)	34 (48.6)	5 (7.1%)	70

Table 2. Summary of IRB Study Closures According to Reporting Entity, Northwestern University, 2010 - 2011

Reporting Entity

No NACR

≤ 1 NACR

Only NACR

Total

Principal Investigator

224 (68.3%)

71 (21.7%)

33 (10.0%)

328

Department/ Division

31 (42.3%)

34 (48.6)

5 (7.1%)

**Table 3.** Total Number of Full Panel Reviews for 94 NACR Studies According to Submission Type and Sponsorship, Northwestern University, 2010 - 2011
	Submission Type (# of deferred submissions)
This includes studies that require written or verbal consent as well as projects that have waived consent.
Industry-funded	54 (10)	19 (1)	35	11	119 (11)
Federally-funded	21 (4)	4	5	2	32 (4)
Foundation-funded	5 (1)	0	0	0	5 (1)
Non-Sponsored Studies	14 (8)	1	3 (3)	0	18 (11)
Total	94 (23)	24 (1)	43 (3)	13	174 (27)

Table 3. Total Number of Full Panel Reviews for 94 NACR Studies According to Submission Type and Sponsorship, Northwestern University, 2010 - 2011

Submission Type (# of deferred submissions)

Sponsorship

New Project

Continuing Review

Revision

Safety-Other

Total

This includes studies that require written or verbal consent as well as projects that have waived consent.

Industry-funded

54 (10)

19 (1)

119 (11)

Federally-funded

21 (4)

32 (4)

Foundation-funded

5 (1)

Non-Sponsored Studies

14 (8)

3 (3)

18 (11)

Total

94 (23)

24 (1)

43 (3)

174 (27)

**Table 4.** Total Number of Expedited Reviews for 50 NACR Studies According to Submission Type and Sponsorship Northwestern University, 2010 - 2011
	Submission Type (# of deferred submissions)
This includes studies that require written or verbal consent as well as projects that have waived consent.
Industry-funded	6	19	129	12	60	222
Federally-funded	9	34	57	0	30	131
Foundation-funded	8	8	10	0	13	39
Non-Sponsored Studies	27	55	58	1	41	182
Total	50	116	254	13	144	577

Table 4. Total Number of Expedited Reviews for 50 NACR Studies According to Submission Type and Sponsorship Northwestern University, 2010 - 2011

Submission Type (# of deferred submissions)

Sponsorship

New Project

Continuing Review

Revision

Safety-Other

Termination

Total

This includes studies that require written or verbal consent as well as projects that have waived consent.

Industry-funded

129

222

Federally-funded

131

Foundation-funded

Non-Sponsored Studies

182

Total

116

254

144

577

**Table 5.** PI-Reported Reasons for NACR by Sponsorship Categories (Number of Studies), Northwestern University, 2010 - 2011
Reason for NACR	Non-Sponsored	Industry-Funded	Federally-Funded	Foundation-Funded	Total (% of NACR)
Insufficient Study-Dedicated Resources (n = 43)	28	4	8	3	43 (30.0%)
Recruitment Issues (n = 41)	2	30	9	0	41 (28.4%)
Contract of Funding Issues (n = 32)	6	11	9	6	32 (22.2%)
Sponsor Termination (n = -17)	2	11	3	1	17 (11.8%)
Other/Reason Unreported (n = 11)	3	4	1	3	11 (7.6%)
Total	41	60	30	13	144 (100.0%)

Table 5. PI-Reported Reasons for NACR by Sponsorship Categories (Number of Studies), Northwestern University, 2010 - 2011

Reason for NACR

Non-Sponsored

Industry-Funded

Federally-Funded

Foundation-Funded

Total (% of NACR)

Insufficient Study-Dedicated Resources (n = 43)

43 (30.0%)

Recruitment Issues (n = 41)

41 (28.4%)

Contract of Funding Issues (n = 32)

32 (22.2%)

Sponsor Termination (n = -17)

17 (11.8%)

Other/Reason Unreported (n = 11)

11 (7.6%)

Total

144 (100.0%)