Min‐Fu Tsan
Biographic Data
| ID | 6763412 |
|---|---|
| NAME | Min‐Fu Tsan |
| GIVEN NAMES | Min‐Fu |
| FAMILY NAME | Tsan |
| SIGNATURE | TSAN M F |
| AFFILIATIONS | McGuireWoods |
| ORCID | 0000-0002-0142-1873 |
| VERIFIED | Yes |
| TOTAL WORKS | 7 |
| TOTAL CITATIONS | 10 |
| WORKS AS AUTHOR | 7 |
| WORKS AS EDITOR | 0 |
| FIRST PUBLICATION YEAR | 2013 |
| LATEST PUBLICATION YEAR | 2020 |
| H-INDEX | 2 |
How Should Organizations Respond to Repeated Noncompliance by Prominent Researchers
This article considers a case in which a prominent researcher repeatedly made protocol deviations year after year while the institutional review board and university leadership failed to adequately address his continuing noncompliance. This article argues that, in addition to reporting this researcher's pattern of noncompliance to the Office for Human Research Protections, as required by federal regulations, the university should implement a reme…
Assessing the Quality and Performance of Institutional Review Boards
How well institutional review boards (IRBs) follow Common Rule criteria for levels of initial protocol review has not been systematically evaluated. We compared levels of review as determined using the Office for Human Research Protections (OHRP) human subject regulations decision charts of 313 protocols that had been approved by IRBs. There was a 97.8% agreement between 140 protocols that were reviewed by full board and the levels of review acco…
Improving Compliance With Institutional Review Board Continuing Review Requirements
Continuing review of ongoing research is one way by which institutional review boards (IRBs) ensure protection of human subjects. Among the 25 Department of Veterans Affairs (VA) human research protection program performance metrics collected annually since 2010, lapse in IRB continuing reviews had the highest noncompliance rate. In 2013, 10 facilities with lapse rates higher than the VA national average for 3 consecutive years from 2011 to 2013 …
From Moving Beyond Compliance to Quality to Moving Beyond Quality to Effectiveness
In 2007, Taylor proposed to move beyond compliance to develop measures for assessing the ethical quality of institutional review board (IRB) reviews. To date, no such tool has been developed. In 2018, Lynch et al. proposed to move beyond quality to advance effective research ethics oversight. Instead of providing a set of measures, they proposed to define and specify ways to measure the effectiveness of IRBs in protecting human subjects. They fur…
Measuring the Quality and Performance of Institutional Review Boards
Despite the importance of institutional review boards (IRBs) in protecting human subjects participating in research and the well-known benefits of performance measurements, there has been no systematic assessment of the quality and performance of IRBs. The IRB community has frequently cited the lack of credible metrics for measuring human subject protections and the quality of IRB ethics reviews as reasons for not measuring the quality and perfor…
Effectiveness of Human Research Protection Program Performance Measurements
We analyzed human research protection program performance metric data of all Department of Veterans Affairs research facilities obtained from 2010 to 2016. Among a total of 25 performance metrics, 21 (84%) showed improvement, four (16%) remained unchanged, and none deteriorated during the study period. The overall improvement from these 21 performance metrics was 81.1% ± 18.7% (mean ± SD), with a range of 30% to 100%. The four performance metrics…
Assessing the Quality of Va Human Research Protection Programs
We compared the human research Protection Program (HRPP) quality indicator data of the Department of Veterans Affairs (VA) facilities using their own VA institutional review boards (IRBs) with those using affiliated university IRBs. From a total of 25 performance metrics, 13 did not demonstrate statistically significant differences, while 12 reached statistically significance differences. Among the 12 with statistically significant differences, f…
Measuring the Quality and Performance of Institutional Review Boards
Despite the importance of institutional review boards (IRBs) in protecting human subjects participating in research and the well-known benefits of performance measurements, there has been no systematic assessment of the quality and performance of IRBs. The IRB community has frequently cited the lack of credible metrics for measuring human subject protections and the quality of IRB ethics reviews as reasons for not measuring the quality and perfor…
Effectiveness of Human Research Protection Program Performance Measurements
We analyzed human research protection program performance metric data of all Department of Veterans Affairs research facilities obtained from 2010 to 2016. Among a total of 25 performance metrics, 21 (84%) showed improvement, four (16%) remained unchanged, and none deteriorated during the study period. The overall improvement from these 21 performance metrics was 81.1% ± 18.7% (mean ± SD), with a range of 30% to 100%. The four performance metrics…
Assessing the Quality and Performance of Institutional Review Boards
How well institutional review boards (IRBs) follow Common Rule criteria for levels of initial protocol review has not been systematically evaluated. We compared levels of review as determined using the Office for Human Research Protections (OHRP) human subject regulations decision charts of 313 protocols that had been approved by IRBs. There was a 97.8% agreement between 140 protocols that were reviewed by full board and the levels of review acco…
Assessing the Quality of Va Human Research Protection Programs
We compared the human research Protection Program (HRPP) quality indicator data of the Department of Veterans Affairs (VA) facilities using their own VA institutional review boards (IRBs) with those using affiliated university IRBs. From a total of 25 performance metrics, 13 did not demonstrate statistically significant differences, while 12 reached statistically significance differences. Among the 12 with statistically significant differences, f…
Assessing the Quality of Va Human Research Protection Programs
We compared the human research Protection Program (HRPP) quality indicator data of the Department of Veterans Affairs (VA) facilities using their own VA institutional review boards (IRBs) with those using affiliated university IRBs. From a total of 25 performance metrics, 13 did not demonstrate statistically significant differences, while 12 reached statistically significance differences. Among the 12 with statistically significant differences, f…
Effectiveness of Human Research Protection Program Performance Measurements
We analyzed human research protection program performance metric data of all Department of Veterans Affairs research facilities obtained from 2010 to 2016. Among a total of 25 performance metrics, 21 (84%) showed improvement, four (16%) remained unchanged, and none deteriorated during the study period. The overall improvement from these 21 performance metrics was 81.1% ± 18.7% (mean ± SD), with a range of 30% to 100%. The four performance metrics…
Measuring the Quality and Performance of Institutional Review Boards
Despite the importance of institutional review boards (IRBs) in protecting human subjects participating in research and the well-known benefits of performance measurements, there has been no systematic assessment of the quality and performance of IRBs. The IRB community has frequently cited the lack of credible metrics for measuring human subject protections and the quality of IRB ethics reviews as reasons for not measuring the quality and perfor…
Improving Compliance With Institutional Review Board Continuing Review Requirements
Continuing review of ongoing research is one way by which institutional review boards (IRBs) ensure protection of human subjects. Among the 25 Department of Veterans Affairs (VA) human research protection program performance metrics collected annually since 2010, lapse in IRB continuing reviews had the highest noncompliance rate. In 2013, 10 facilities with lapse rates higher than the VA national average for 3 consecutive years from 2011 to 2013 …
From Moving Beyond Compliance to Quality to Moving Beyond Quality to Effectiveness
In 2007, Taylor proposed to move beyond compliance to develop measures for assessing the ethical quality of institutional review board (IRB) reviews. To date, no such tool has been developed. In 2018, Lynch et al. proposed to move beyond quality to advance effective research ethics oversight. Instead of providing a set of measures, they proposed to define and specify ways to measure the effectiveness of IRBs in protecting human subjects. They fur…
How Should Organizations Respond to Repeated Noncompliance by Prominent Researchers
This article considers a case in which a prominent researcher repeatedly made protocol deviations year after year while the institutional review board and university leadership failed to adequately address his continuing noncompliance. This article argues that, in addition to reporting this researcher's pattern of noncompliance to the Office for Human Research Protections, as required by federal regulations, the university should implement a reme…
Assessing the Quality and Performance of Institutional Review Boards
How well institutional review boards (IRBs) follow Common Rule criteria for levels of initial protocol review has not been systematically evaluated. We compared levels of review as determined using the Office for Human Research Protections (OHRP) human subject regulations decision charts of 313 protocols that had been approved by IRBs. There was a 97.8% agreement between 140 protocols that were reviewed by full board and the levels of review acco…
Ethics in Clinical Research (5 works) · Institutional review board (5 works) · Medicine (5 works) · Political science (5 works) · Psychology (5 works) · Business (4 works) · Health Systems, Economic Evaluations, Quality of Life (4 works) · Quality (philosophy (4 works) · Biomedical Ethics and Regulation (3 works) · Ethics committee (3 works)