Table 8, Perceived Desire for IRB Guidance From the Federal Government (N = 265)a - Developing Recommendations for Oversight of Patient-Centered Outcomes Research—The PCOROS Study

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Table 8Perceived Desire for IRB Guidance From the Federal Government (N = 265)^a

Potential topics of federal guidance	IRB volume, % responding very or somewhat helpful					PCOR experience, % responding very or somewhat helpful
Potential topics of federal guidance	N = 249^b	Low (n = 88)	Medium (n = 78)	High (n = 83)	P value	N = 250^b	None (n = 79)	A little, some, or a lot (n = 171)	P value
Training for PIs regarding IRB issues specific to PCOR research	83.2	85.9	86.3	77.5	0.247	83.4	89.3	80.7	0.096
Training for IRB members regarding PCOR-related research in general	79.9	85.9^c	86.5^c	67.5^c	0.003^c	80.2	88.0^c	76.6^c	0.041^c
Policies regarding COIs among individuals serving as both subjects and in nontraditional roles in PCOR	78.1	79.5	80.3	74.7	0.659	78.0	90.5^c	72.2^c	0.002^c
Informed consent for patients serving in nontraditional roles	76.5	80.9^c	82.4^c	66.2^c	0.030^c	77.6	78.7	77.1	0.788
Standardization across IRBs in policies/practices related to PCOR research in general	75.3	78.8	81.1	66.2	0.066	75.6	82.7	72.5	0.087
Training for patients serving in nontraditional roles	73.6	78.8	74.3	67.5	0.253	74.8	78.7	73.0	0.352
Policies related to the use of EHRs in PCOR research	72.1	76.2	71.6	68.3	0.533	73.3	85.1^c	68.1^c	0.006^c
Policies related to the participation of patients in grant development activities	65.3	69.4	64.9	61.2	0.544	65.3	72.0	62.3	0.142

: Abbreviations: COIs, conflicts of interest; EHRs, electronic medical records; PCOR, patient-centered outcomes research; PIs, principal investigators.
: ^aFrom Weissman JS et al. Journal of Empirical Research on Human Research Ethics. 13(4):421-431.
: Reprinted with permission from Journal of Empirical Research on Human Research Ethics (Copyright © 2018). Sage Publications. All Rights Reserved.
: ^bTotals may vary due to missing data.
: ^cBoldface numbers refer to significant results.

From: Developing Recommendations for Oversight of Patient-Centered Outcomes Research—The PCOROS Study

Cover of Developing Recommendations for Oversight of Patient-Centered Outcomes Research—The PCOROS Study

Developing Recommendations for Oversight of Patient-Centered Outcomes Research—The PCOROS Study [Internet].

Weissman JS, Cohen IG, Campbell E, et al.

Washington (DC): Patient-Centered Outcomes Research Institute (PCORI); 2020 Aug.

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Table 8Perceived Desire for IRB Guidance From the Federal Government (N = 265)a

Table 8Perceived Desire for IRB Guidance From the Federal Government (N = 265)^a