Regulatory Barriers to Research in Deceased Organ Donor Care
D'Aragon, Frederick1,2; Akthar, Aemal3; Arseneau, Erika3; Hand, Lori3; Masse, Marie-Helene2 Meade, Maureen3,4
1. Department of Anesthesiology, Universite de Sherbrooke, Sherbrooke, Quebec, Canada
2. Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
3. Department of Health Evidence & Impact, McMaster University, Hamilton, Ontario, Canada
4. Department of Medicine, McMaster University, Hamilton, Ontario, Canada
INTRODUCTION: Improving the care of deceased organ donors could increase the number of organs recovered by 20%. Clinical research contributes to improvements in care. The medical management of deceased organ donors is an emerging field of research in critical care that faces unusually complex challenges, many of which are regulatory in nature.
OBJECTIVE: To report on the regulatory barriers to research in this field as experienced in the context of the Canada-DONATE National Cohort Study currently underway in four Canadian provinces.
METHODS: This study is nested within a 12 month, observational study in 34 active deceased donation hospitals in Canada. This study enrols consecutive adult deceased donors, following a neurological (NDD) or a circulatory (DCD) death and their corresponding organ recipients with a waiver of research consent. To systematically assess some important challenges to this research, we documented the times to regulatory approvals by: hospital research ethics boards, privacy offices, and contracts offices, as well as organ donation organization and other provincial privacy offices (where applicable). We also documented specific issues that resulted in approval delays.
RESULTS: We had a total of 15 unique Research Ethics Boards (REBs) for 34 sites, 9 of which were hospital/institute specific, and six provincial. There was no significant difference between mean time for applications that went through a hospital compared to provincial REB (46.56 days (SD: 29.72) vs 20.67 days (SD: 20.05), p =0.1). Eight sites required local privacy office reviews prior to study start day, for purposes of data sharing agreements. In most cases, this was completed concurrently during the time of clinical trial agreements and research ethics, but caused a delay in the startup of one site. Provincial privacy reviews were required for data sharing agreements with three organ donation organizations. We have completed two privacy reviews, which took an average of 113 days. Although this process did not cause a delay in implementing the study, it has hindered Canada-DONATE from collecting recipient data in one province. This application is still ongoing after 646 days. Lastly, the clinical trial agreements took on average 115 days (SD: 45.24) from when the site first received a template copy until the contract was fully executed. The variability in regulatory processes across sites is likely due to 1) unique requirements at the site level (e.g. internal privacy office), 2) provincial legislation, 3) the need for REB approval for both donors and recipients and 4) the perception that donation and transplantation should be keep separated.
CONCLUSION: Research in organ donor care has unique regulatory and ethical barriers. Current research frameworks should be adapted to fit this reality and must take into consideration provincial legislation.
Regulatory Barriers to Research in Deceased Organ Donor Care
D'Aragon, Frederick1,2; Akthar, Aemal3; Arseneau, Erika3; Hand, Lori3; Masse, Marie-Helene2 Meade, Maureen3,4
1. Department of Anesthesiology, Universite de Sherbrooke, Sherbrooke, Quebec, Canada
2. Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
3. Department of Health Evidence & Impact, McMaster University, Hamilton, Ontario, Canada
4. Department of Medicine, McMaster University, Hamilton, Ontario, Canada
INTRODUCTION: Improving the care of deceased organ donors could increase the number of organs recovered by 20%. Clinical research contributes to improvements in care. The medical management of deceased organ donors is an emerging field of research in critical care that faces unusually complex challenges, many of which are regulatory in nature.
OBJECTIVE: To report on the regulatory barriers to research in this field as experienced in the context of the Canada-DONATE National Cohort Study currently underway in four Canadian provinces.
METHODS: This study is nested within a 12 month, observational study in 34 active deceased donation hospitals in Canada. This study enrols consecutive adult deceased donors, following a neurological (NDD) or a circulatory (DCD) death and their corresponding organ recipients with a waiver of research consent. To systematically assess some important challenges to this research, we documented the times to regulatory approvals by: hospital research ethics boards, privacy offices, and contracts offices, as well as organ donation organization and other provincial privacy offices (where applicable). We also documented specific issues that resulted in approval delays.
RESULTS: We had a total of 15 unique Research Ethics Boards (REBs) for 34 sites, 9 of which were hospital/institute specific, and six provincial. There was no significant difference between mean time for applications that went through a hospital compared to provincial REB (46.56 days (SD: 29.72) vs 20.67 days (SD: 20.05), p =0.1). Eight sites required local privacy office reviews prior to study start day, for purposes of data sharing agreements. In most cases, this was completed concurrently during the time of clinical trial agreements and research ethics, but caused a delay in the startup of one site. Provincial privacy reviews were required for data sharing agreements with three organ donation organizations. We have completed two privacy reviews, which took an average of 113 days. Although this process did not cause a delay in implementing the study, it has hindered Canada-DONATE from collecting recipient data in one province. This application is still ongoing after 646 days. Lastly, the clinical trial agreements took on average 115 days (SD: 45.24) from when the site first received a template copy until the contract was fully executed. The variability in regulatory processes across sites is likely due to 1) unique requirements at the site level (e.g. internal privacy office), 2) provincial legislation, 3) the need for REB approval for both donors and recipients and 4) the perception that donation and transplantation should be keep separated.
CONCLUSION: Research in organ donor care has unique regulatory and ethical barriers. Current research frameworks should be adapted to fit this reality and must take into consideration provincial legislation.
Regulatory Barriers to Research in Deceased Organ Donor Care
D'Aragon, Frederick1,2; Akthar, Aemal3; Arseneau, Erika3; Hand, Lori3; Masse, Marie-Helene2 Meade, Maureen3,4
1. Department of Anesthesiology, Universite de Sherbrooke, Sherbrooke, Quebec, Canada
2. Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
3. Department of Health Evidence & Impact, McMaster University, Hamilton, Ontario, Canada
4. Department of Medicine, McMaster University, Hamilton, Ontario, Canada
INTRODUCTION: Improving the care of deceased organ donors could increase the number of organs recovered by 20%. Clinical research contributes to improvements in care. The medical management of deceased organ donors is an emerging field of research in critical care that faces unusually complex challenges, many of which are regulatory in nature.
OBJECTIVE: To report on the regulatory barriers to research in this field as experienced in the context of the Canada-DONATE National Cohort Study currently underway in four Canadian provinces.
METHODS: This study is nested within a 12 month, observational study in 34 active deceased donation hospitals in Canada. This study enrols consecutive adult deceased donors, following a neurological (NDD) or a circulatory (DCD) death and their corresponding organ recipients with a waiver of research consent. To systematically assess some important challenges to this research, we documented the times to regulatory approvals by: hospital research ethics boards, privacy offices, and contracts offices, as well as organ donation organization and other provincial privacy offices (where applicable). We also documented specific issues that resulted in approval delays.
RESULTS: We had a total of 15 unique Research Ethics Boards (REBs) for 34 sites, 9 of which were hospital/institute specific, and six provincial. There was no significant difference between mean time for applications that went through a hospital compared to provincial REB (46.56 days (SD: 29.72) vs 20.67 days (SD: 20.05), p =0.1). Eight sites required local privacy office reviews prior to study start day, for purposes of data sharing agreements. In most cases, this was completed concurrently during the time of clinical trial agreements and research ethics, but caused a delay in the startup of one site. Provincial privacy reviews were required for data sharing agreements with three organ donation organizations. We have completed two privacy reviews, which took an average of 113 days. Although this process did not cause a delay in implementing the study, it has hindered Canada-DONATE from collecting recipient data in one province. This application is still ongoing after 646 days. Lastly, the clinical trial agreements took on average 115 days (SD: 45.24) from when the site first received a template copy until the contract was fully executed. The variability in regulatory processes across sites is likely due to 1) unique requirements at the site level (e.g. internal privacy office), 2) provincial legislation, 3) the need for REB approval for both donors and recipients and 4) the perception that donation and transplantation should be keep separated.
CONCLUSION: Research in organ donor care has unique regulatory and ethical barriers. Current research frameworks should be adapted to fit this reality and must take into consideration provincial legislation.
Regulatory Barriers to Research in Deceased Organ Donor Care
D'Aragon, Frederick1,2; Akthar, Aemal3; Arseneau, Erika3; Hand, Lori3; Masse, Marie-Helene2 Meade, Maureen3,4
1. Department of Anesthesiology, Universite de Sherbrooke, Sherbrooke, Quebec, Canada
2. Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
3. Department of Health Evidence & Impact, McMaster University, Hamilton, Ontario, Canada
4. Department of Medicine, McMaster University, Hamilton, Ontario, Canada
INTRODUCTION: Improving the care of deceased organ donors could increase the number of organs recovered by 20%. Clinical research contributes to improvements in care. The medical management of deceased organ donors is an emerging field of research in critical care that faces unusually complex challenges, many of which are regulatory in nature.
OBJECTIVE: To report on the regulatory barriers to research in this field as experienced in the context of the Canada-DONATE National Cohort Study currently underway in four Canadian provinces.
METHODS: This study is nested within a 12 month, observational study in 34 active deceased donation hospitals in Canada. This study enrols consecutive adult deceased donors, following a neurological (NDD) or a circulatory (DCD) death and their corresponding organ recipients with a waiver of research consent. To systematically assess some important challenges to this research, we documented the times to regulatory approvals by: hospital research ethics boards, privacy offices, and contracts offices, as well as organ donation organization and other provincial privacy offices (where applicable). We also documented specific issues that resulted in approval delays.
RESULTS: We had a total of 15 unique Research Ethics Boards (REBs) for 34 sites, 9 of which were hospital/institute specific, and six provincial. There was no significant difference between mean time for applications that went through a hospital compared to provincial REB (46.56 days (SD: 29.72) vs 20.67 days (SD: 20.05), p =0.1). Eight sites required local privacy office reviews prior to study start day, for purposes of data sharing agreements. In most cases, this was completed concurrently during the time of clinical trial agreements and research ethics, but caused a delay in the startup of one site. Provincial privacy reviews were required for data sharing agreements with three organ donation organizations. We have completed two privacy reviews, which took an average of 113 days. Although this process did not cause a delay in implementing the study, it has hindered Canada-DONATE from collecting recipient data in one province. This application is still ongoing after 646 days. Lastly, the clinical trial agreements took on average 115 days (SD: 45.24) from when the site first received a template copy until the contract was fully executed. The variability in regulatory processes across sites is likely due to 1) unique requirements at the site level (e.g. internal privacy office), 2) provincial legislation, 3) the need for REB approval for both donors and recipients and 4) the perception that donation and transplantation should be keep separated.
CONCLUSION: Research in organ donor care has unique regulatory and ethical barriers. Current research frameworks should be adapted to fit this reality and must take into consideration provincial legislation.
