A Participant-Centered Approach to Understanding Risks and Benefits of Participation in Research Informed by the Kidney Precision Medicine Project

Kidney Precision Medicine Project

doi:10.1053/j.ajkd.2021.10.006

A Participant-Centered Approach to Understanding Risks and Benefits of Participation in Research Informed by the Kidney Precision Medicine Project

Kidney Precision Medicine Project

Research output: Contribution to journal › Article › peer-review

Abstract

An understanding of the ethical underpinnings of human subjects research that involves some risk to participants without anticipated direct clinical benefit—such as the kidney biopsy procedure as part of the Kidney Precision Medicine Project (KPMP)—requires a critical examination of the risks as well as the diverse set of countervailing potential benefits to participants. This kind of deliberation has been foundational to the development and conduct of the KPMP. Herein, we use illustrative features of this research paradigm to develop a more comprehensive conceptualization of the types of benefits that may be important to research participants, including respecting pluralistic values, supporting the opportunity to act altruistically, and enhancing benefits to a participant's community. This approach may serve as a model to help researchers, ethicists, and regulators to identify opportunities to better respect and support participants in future research that entails some risk to these participants as well as to improve the quality of research for people with kidney disease.

Original language	English
Pages (from-to)	132-138
Number of pages	7
Journal	American Journal of Kidney Diseases
Volume	80
Issue number	1
DOIs	https://doi.org/10.1053/j.ajkd.2021.10.006
State	Published - Jul 2022

Keywords

Altruism
The Kidney Precision Medicine Project
autonomy
community engagement
human subjects
informed consent
institutional review boards
kidney biopsy
non-maleficence
precision medicine
research ethics
research participation
research risks and benefits
safety monitoring

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10.1053/j.ajkd.2021.10.006

Cite this

@article{10db1f0e49c34518ad6c5e765537e84d,

title = "A Participant-Centered Approach to Understanding Risks and Benefits of Participation in Research Informed by the Kidney Precision Medicine Project",

abstract = "An understanding of the ethical underpinnings of human subjects research that involves some risk to participants without anticipated direct clinical benefit—such as the kidney biopsy procedure as part of the Kidney Precision Medicine Project (KPMP)—requires a critical examination of the risks as well as the diverse set of countervailing potential benefits to participants. This kind of deliberation has been foundational to the development and conduct of the KPMP. Herein, we use illustrative features of this research paradigm to develop a more comprehensive conceptualization of the types of benefits that may be important to research participants, including respecting pluralistic values, supporting the opportunity to act altruistically, and enhancing benefits to a participant's community. This approach may serve as a model to help researchers, ethicists, and regulators to identify opportunities to better respect and support participants in future research that entails some risk to these participants as well as to improve the quality of research for people with kidney disease.",

keywords = "Altruism, The Kidney Precision Medicine Project, autonomy, community engagement, human subjects, informed consent, institutional review boards, kidney biopsy, non-maleficence, precision medicine, research ethics, research participation, research risks and benefits, safety monitoring",

author = "{Kidney Precision Medicine Project} and Butler, {Catherine R.} and Appelbaum, {Paul S.} and Heather Ascani and Mark Aulisio and Campbell, {Catherine E.} and {de Boer}, {Ian H.} and Dighe, {Ashveena L.} and Hall, {Daniel E.} and Jonathan Himmelfarb and Richard Knight and Karla Mehl and Raghavan Murugan and Rosas, {Sylvia E.} and Sedor, {John R.} and O'Toole, {John F.} and Tuttle, {Katherine R.} and Waikar, {Sushrut S.} and Michael Freeman and Theodore Alexandrov and Alpers, {Charles E.} and Anderton, {Christopher R.} and Joseph Ardayfio and Tanima Arora and El-Achkar, {Tarek M.} and Azeloglu, {Evren U.} and Olivia Balderes and Balis, {Ulysses G.J.} and Shweta Bansal and Barasch, {Jonathan M.} and Daria Barwinska and Jack Bebiak and Blanc, {Victoria M.} and Blank, {Kristina N.} and Bomback, {Andrew S.} and Brown, {Keith D.} and Bush, {William S.} and Taneisha Campbell and Canetta, {Pietro A.} and Jonas Carson and Leslie Cooperman and Crawford, {Dana C.} and D'Agati, {Vivette D.} and Dagher, {Pierre C.} and Stephen Daniel and Frederick Dowd and Dunn, {Kenneth W.} and Eadon, {Michael T.} and Sean Eddy and Elder, {Michele M.} and Ferkowicz, {Michael J.} and Gaut, {Joe P.} and Yury Goltsev and Agustin Gonzalez-Vicente and Nir Hacohen and Jens Hansen and Lynda Hayashi and Oliver He and Cijang He and Hedayati, {S. Susan} and Leal Herlitz and Hodgin, {Jeffrey B.} and Hoofnagle, {Andrew N.} and Hoover, {Paul J.} and Ravi Iyengar and Sanjay Jain and Nichole Jefferson and Stacey Jolly and Kellum, {John A.} and Kelly, {Katherine J.} and Asra Kermani and Krzysztof Kiryluk and Robert Koewler and Matthias Kretzler and Lake, {Blue B.} and Laszik, {Zoltan G.} and Lecker, {Stewart H.} and Lee, {Simon C.} and Chrysta Lienczewski and Lu, {Christopher Y.} and Mariani, {Laura H.} and McClelland, {Robyn L.} and McMahon, {Gearoid M.} and Steven Menez and Rajasree Menon and Tyler Miller and Moe, {Orson W.} and Dennis Moledina and Mooney, {Sean D.} and Jane Nguyen and Garry Nolan and George Oliver and Edgar Otto and Palevsky, {Paul M.} and Ellen Palmer and Annapurna Pamreddy and Parikh, {Chirag R.} and Samir Parikh and Christopher Park and Harold Park and Ljiljana Pasa-Tolic and Roy Pinkeney and Emilio Poggio and Parmjeet Randhawa and Helmut Rennke and Roberts, {Glenda V.} and Avi Rosenberg and Matthew Rosengart and Brad Rovin and Neil Roy and Kamalanathan Sambandam and Minnie Sarwal and John Saul and Jennifer Schaub and Rachel Sealfon and Ning Shang and Stuart Shankland and Kumar Sharma and Anna Shpigel and Tara Sigdel and Becky Steck and Isaac Stillman and Stutzke, {Edith Christine} and Sutton, {Timothy A.} and Jose Torrealba and Toto, {Robert D.} and Olga Troyanskaya and Mitchell Tublin and Ugochukwu Ugwuowo and Miguel Vazquez and Dusan Velickovic and Manjeri Venkatachalam and Anitha Vijayan and Corona-Villalobos, {Celia P.} and Nancy Wang and Astrid Weins and Adam Wilcox and Kayleen Williams and Mark Williams and Wilson, {Francis P.} and Seth Winfree and Yuguang Xiong and Kun Zhang and Guanshi Zhang",

note = "Funding Information: In addition to authors Applebaum, Ascani, Aulisio, Campbell, de Boer, Dighe, Hall, Himmelfarb, Knight, Mehl, Murugan, Rosas, O'Toole, Tuttle, and Waikar, the KPMP collaborators are Theodore Alexandrov (European Molecular Biology Laboratory), Charles E. Alpers (University of Washington), Christopher R. Anderton (Pacific Northwest National Laboratories), Joseph Ardayfio (Patient Partner), Tanima Arora (Yale University), Tarek M. El-Achkar (Indiana University), Evren U. Azeloglu (Mount Sinai), Olivia Balderes (Columbia University), Ulysses G.J. Balis (University of Michigan), Shweta Bansal (UT Health San Antonio), Jonathan M. Barasch (Columbia University), Daria Barwinska (Indiana University), Jack Bebiak (Patient Partner), Victoria M. Blanc (University of Michigan), Kristina N. Blank (University of Washington), Andrew S. Bomback (Columbia University), Keith D. Brown (Patient Partner), William S. Bush (Case Western Reserve University), Taneisha Campbell (Patient Partner), Pietro A. Canetta (Columbia University), Jonas Carson (University of Washington), Leslie Cooperman (Cleveland Clinic), Dana C. Crawford (Case Western Reserve University), Vivette D. D'Agati (Columbia University), Pierre C. Dagher (Indiana University), Stephen Daniel (University of Washington), Frederick Dowd (University of Washington), Kenneth W. Dunn (Indiana University), Michael T. Eadon (Indiana University), Sean Eddy (University of Michigan), Michele M. Elder (University of Pittsburgh), Michael J. Ferkowicz (Indiana University), Joe P. Gaut (Washington University St. Louis), Yury Goltsev (Stanford University), Agustin Gonzalez-Vicente (Cleveland Clinic), Nir Hacohen (Broad Institute), Jens Hansen (Mount Sinai), Lynda Hayashi (Patient Partner), Oliver He (University of Michigan), Cijang He (Mount Sinai), S. Susan Hedayati (UT Southwestern), Leal Herlitz (Cleveland Clinic), Jeffrey B. Hodgin (University of Michigan), Andrew N. Hoofnagle (University of Washington), Paul J. Hoover (Broad Institute), Ravi Iyengar (Mount Sinai), Sanjay Jain (Washington University St. Louis), Nichole Jefferson (Patient Partner), Stacey Jolly (Cleveland Clinic), John A. Kellum (University of Pittsburgh), Katherine J. Kelly (Indiana University), Asra Kermani (UT Southwestern), Krzysztof Kiryluk (Columbia University), Robert Koewler (Patient Partner), Matthias Kretzler (University of Michigan), Blue B. Lake (UC San Diego), Zoltan G. Laszik (UC San Francisco), Stewart H. Lecker (Beth Israel Deaconess), Simon C. Lee (UT Southwestern), Chrysta Lienczewski (University of Michigan), Christopher Y. Lu (UT Southwestern), Laura H. Mariani (University of Michigan), Robyn L. McClelland (University of Washington), Gearoid M. McMahon (Brigham & Women's Hospital), Steven Menez (Johns Hopkins University), Rajasree Menon (University of Michigan), Tyler Miller (UT Southwestern), Orson W. Moe (UT Southwestern), Dennis Moledina (Yale University), Sean D. Mooney (University of Washington), Jane Nguyen (Cleveland Clinic), Garry Nolan (UC San Francisco), George (Holt) Oliver (Parkland), Edgar Otto (University of Michigan), Paul M. Palevsky (University of Pittsburgh), Ellen Palmer (Cleveland Clinic), Annapurna Pamreddy (UT Health San Antonio), Chirag R. Parikh (Johns Hopkins University), Samir Parikh (Ohio State University), Christopher Park (University of Washington), Harold Park (UT Southwestern), Ljiljana Pasa-Tolic (Pacific Northwest National Laboratories), Roy Pinkeney (Patient Partner), Emilio Poggio (Cleveland Clinic), Parmjeet Randhawa (University of Pittsburgh), Helmut Rennke (Harvard University), Glenda V. Roberts (Patient Partner), Avi Rosenberg (Johns Hopkins University), Matthew Rosengart (University of Pittsburgh), Brad Rovin (Ohio State University), Neil Roy (Joslin Diabetes Center), Kamalanathan Sambandam (UT Southwestern), Minnie Sarwal (UCSF), John Saul (Patient Partner), Jennifer Schaub (University of Michigan), Rachel Sealfon (Princeton University), Ning (Sunny) Shang (Columbia University), Stuart Shankland (University of Washington), Kumar Sharma (UT Health San Antonio), Anna Shpigel (Patient Partner), Tara Sigdel (University of California, San Francisco), Becky Steck (University of Michigan), Isaac Stillman (Beth Israel Deaconess), Edith Christine Stutzke (Patient Partner), Timothy A. Sutton (Indiana University), Jose Torrealba (UT Southwestern), Robert D. Toto (UT Southwestern), Olga Troyanskaya (Princeton University), Mitchell Tublin (University of Pittsburgh), Ugochukwu Ugwuowo (Yale University), Miguel Vazquez (UT Southwestern), Dusan Velickovic (Pacific Northwest National Laboratories), Manjeri Venkatachalam (UT Health San Antonio), Anitha Vijayan (Washington University St. Louis), Celia P. Corona-Villalobos (Johns Hopkins University), Nancy Wang (UT Southwestern), Astrid Weins (Brigham & Women's Hospital), Adam Wilcox (University of Washington), Kayleen Williams (University of Washington), Mark Williams (Joslin Diabetes Center), Francis P. Wilson (Yale University), Seth Winfree (Indiana University), Yuguang Xiong (Mount Sinai), Kun Zhang (UC San Diego), and Guanshi Zhang (UT Health San Antonio). Catherine R. Butler, MD, MA, Paul S. Appelbaum, MD, Heather Ascani, MBA, Mark Aulisio, PhD, Catherine E. Campbell, DNP, MBA, Ian H. de Boer, MD, Ashveena L. Dighe, MS, MPH, Daniel E. Hall, MD, Jonathan Himmelfarb, MD, Richard Knight, MBA, Karla Mehl, MD, Raghavan Murugan, MD, Sylvia E. Rosas, MD, John R. Sedor, MD, John F. O'Toole, MD, Katherine R. Tuttle, MD, Sushrut S. Waikar, MD, MPH, and Michael Freeman, MD, MA. The KPMP is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grants U2C DK114886, UH3DK114861, UH3DK114866, UH3DK114870, UH3DK114908, UH3DK114915, UH3DK114926, UH3DK114907, UH3DK114920, UH3DK114923, UH3DK114933, and UH3DK114937. Dr Butler has received research funding and/or stipends from the University of Washington Department of Medicine, the National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK), the Veterans Affairs Health Services Research & Development, and the American Society of Nephrology. Dr Rosas has received research funding from NIDDK, Bayer Healthcare, AstraZeneca and has scientific advisory board memberships for Reata, Relypsa, and Bayer. Dr Tuttle has received 4 NIDDK/National Institutes of Health (NIH) grants, one National Institute for Advancing Translational Sciences/NIH grant, one National Institute on Minority Health and Health Disparities/NIH grant, and a Centers for Disease Control and Prevention contract; research grants from Goldfinch Bio, Bayer, and Travere; and consulting fees for diabetes and chronic kidney disease from Eli Lilly, Boehringer Ingelheim, AstraZeneca, Gilead, Goldfinch Bio, Novo Nordisk, and Bayer. The remaining authors declare that they have no relevant financial interests. Received June 30, 2021. Evaluated by 2 external peer reviewers, with direct editorial input from an Associate Editor and a Deputy Editor. Accepted in revised form October 12, 2021. Funding Information: The KPMP is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grants U2C DK114886, UH3DK114861, UH3DK114866, UH3DK114870, UH3DK114908, UH3DK114915, UH3DK114926, UH3DK114907, UH3DK114920, UH3DK114923, UH3DK114933, and UH3DK114937. Publisher Copyright: {\textcopyright} 2021 The Authors",

year = "2022",

month = jul,

doi = "10.1053/j.ajkd.2021.10.006",

language = "English",

volume = "80",

pages = "132--138",

journal = "American Journal of Kidney Diseases",

issn = "0272-6386",

number = "1",

}

TY - JOUR

T1 - A Participant-Centered Approach to Understanding Risks and Benefits of Participation in Research Informed by the Kidney Precision Medicine Project

AU - Kidney Precision Medicine Project

AU - Butler, Catherine R.

AU - Appelbaum, Paul S.

AU - Ascani, Heather

AU - Aulisio, Mark

AU - Campbell, Catherine E.

AU - de Boer, Ian H.

AU - Dighe, Ashveena L.

AU - Hall, Daniel E.

AU - Himmelfarb, Jonathan

AU - Knight, Richard

AU - Mehl, Karla

AU - Murugan, Raghavan

AU - Rosas, Sylvia E.

AU - Sedor, John R.

AU - O'Toole, John F.

AU - Tuttle, Katherine R.

AU - Waikar, Sushrut S.

AU - Freeman, Michael

AU - Alexandrov, Theodore

AU - Alpers, Charles E.

AU - Anderton, Christopher R.

AU - Ardayfio, Joseph

AU - Arora, Tanima

AU - El-Achkar, Tarek M.

AU - Azeloglu, Evren U.

AU - Balderes, Olivia

AU - Balis, Ulysses G.J.

AU - Bansal, Shweta

AU - Barasch, Jonathan M.

AU - Barwinska, Daria

AU - Bebiak, Jack

AU - Blanc, Victoria M.

AU - Blank, Kristina N.

AU - Bomback, Andrew S.

AU - Brown, Keith D.

AU - Bush, William S.

AU - Campbell, Taneisha

AU - Canetta, Pietro A.

AU - Carson, Jonas

AU - Cooperman, Leslie

AU - Crawford, Dana C.

AU - D'Agati, Vivette D.

AU - Dagher, Pierre C.

AU - Daniel, Stephen

AU - Dowd, Frederick

AU - Dunn, Kenneth W.

AU - Eadon, Michael T.

AU - Eddy, Sean

AU - Elder, Michele M.

AU - Ferkowicz, Michael J.

AU - Gaut, Joe P.

AU - Goltsev, Yury

AU - Gonzalez-Vicente, Agustin

AU - Hacohen, Nir

AU - Hansen, Jens

AU - Hayashi, Lynda

AU - He, Oliver

AU - He, Cijang

AU - Hedayati, S. Susan

AU - Herlitz, Leal

AU - Hodgin, Jeffrey B.

AU - Hoofnagle, Andrew N.

AU - Hoover, Paul J.

AU - Iyengar, Ravi

AU - Jain, Sanjay

AU - Jefferson, Nichole

AU - Jolly, Stacey

AU - Kellum, John A.

AU - Kelly, Katherine J.

AU - Kermani, Asra

AU - Kiryluk, Krzysztof

AU - Koewler, Robert

AU - Kretzler, Matthias

AU - Lake, Blue B.

AU - Laszik, Zoltan G.

AU - Lecker, Stewart H.

AU - Lee, Simon C.

AU - Lienczewski, Chrysta

AU - Lu, Christopher Y.

AU - Mariani, Laura H.

AU - McClelland, Robyn L.

AU - McMahon, Gearoid M.

AU - Menez, Steven

AU - Menon, Rajasree

AU - Miller, Tyler

AU - Moe, Orson W.

AU - Moledina, Dennis

AU - Mooney, Sean D.

AU - Nguyen, Jane

AU - Nolan, Garry

AU - Oliver, George

AU - Otto, Edgar

AU - Palevsky, Paul M.

AU - Palmer, Ellen

AU - Pamreddy, Annapurna

AU - Parikh, Chirag R.

AU - Parikh, Samir

AU - Park, Christopher

AU - Park, Harold

AU - Pasa-Tolic, Ljiljana

AU - Pinkeney, Roy

AU - Poggio, Emilio

AU - Randhawa, Parmjeet

AU - Rennke, Helmut

AU - Roberts, Glenda V.

AU - Rosenberg, Avi

AU - Rosengart, Matthew

AU - Rovin, Brad

AU - Roy, Neil

AU - Sambandam, Kamalanathan

AU - Sarwal, Minnie

AU - Saul, John

AU - Schaub, Jennifer

AU - Sealfon, Rachel

AU - Shang, Ning

AU - Shankland, Stuart

AU - Sharma, Kumar

AU - Shpigel, Anna

AU - Sigdel, Tara

AU - Steck, Becky

AU - Stillman, Isaac

AU - Stutzke, Edith Christine

AU - Sutton, Timothy A.

AU - Torrealba, Jose

AU - Toto, Robert D.

AU - Troyanskaya, Olga

AU - Tublin, Mitchell

AU - Ugwuowo, Ugochukwu

AU - Vazquez, Miguel

AU - Velickovic, Dusan

AU - Venkatachalam, Manjeri

AU - Vijayan, Anitha

AU - Corona-Villalobos, Celia P.

AU - Wang, Nancy

AU - Weins, Astrid

AU - Wilcox, Adam

AU - Williams, Kayleen

AU - Williams, Mark

AU - Wilson, Francis P.

AU - Winfree, Seth

AU - Xiong, Yuguang

AU - Zhang, Kun

AU - Zhang, Guanshi

N1 - Funding Information: In addition to authors Applebaum, Ascani, Aulisio, Campbell, de Boer, Dighe, Hall, Himmelfarb, Knight, Mehl, Murugan, Rosas, O'Toole, Tuttle, and Waikar, the KPMP collaborators are Theodore Alexandrov (European Molecular Biology Laboratory), Charles E. Alpers (University of Washington), Christopher R. Anderton (Pacific Northwest National Laboratories), Joseph Ardayfio (Patient Partner), Tanima Arora (Yale University), Tarek M. El-Achkar (Indiana University), Evren U. Azeloglu (Mount Sinai), Olivia Balderes (Columbia University), Ulysses G.J. Balis (University of Michigan), Shweta Bansal (UT Health San Antonio), Jonathan M. Barasch (Columbia University), Daria Barwinska (Indiana University), Jack Bebiak (Patient Partner), Victoria M. Blanc (University of Michigan), Kristina N. Blank (University of Washington), Andrew S. Bomback (Columbia University), Keith D. Brown (Patient Partner), William S. Bush (Case Western Reserve University), Taneisha Campbell (Patient Partner), Pietro A. Canetta (Columbia University), Jonas Carson (University of Washington), Leslie Cooperman (Cleveland Clinic), Dana C. Crawford (Case Western Reserve University), Vivette D. D'Agati (Columbia University), Pierre C. Dagher (Indiana University), Stephen Daniel (University of Washington), Frederick Dowd (University of Washington), Kenneth W. Dunn (Indiana University), Michael T. Eadon (Indiana University), Sean Eddy (University of Michigan), Michele M. Elder (University of Pittsburgh), Michael J. Ferkowicz (Indiana University), Joe P. Gaut (Washington University St. Louis), Yury Goltsev (Stanford University), Agustin Gonzalez-Vicente (Cleveland Clinic), Nir Hacohen (Broad Institute), Jens Hansen (Mount Sinai), Lynda Hayashi (Patient Partner), Oliver He (University of Michigan), Cijang He (Mount Sinai), S. Susan Hedayati (UT Southwestern), Leal Herlitz (Cleveland Clinic), Jeffrey B. Hodgin (University of Michigan), Andrew N. Hoofnagle (University of Washington), Paul J. Hoover (Broad Institute), Ravi Iyengar (Mount Sinai), Sanjay Jain (Washington University St. Louis), Nichole Jefferson (Patient Partner), Stacey Jolly (Cleveland Clinic), John A. Kellum (University of Pittsburgh), Katherine J. Kelly (Indiana University), Asra Kermani (UT Southwestern), Krzysztof Kiryluk (Columbia University), Robert Koewler (Patient Partner), Matthias Kretzler (University of Michigan), Blue B. Lake (UC San Diego), Zoltan G. Laszik (UC San Francisco), Stewart H. Lecker (Beth Israel Deaconess), Simon C. Lee (UT Southwestern), Chrysta Lienczewski (University of Michigan), Christopher Y. Lu (UT Southwestern), Laura H. Mariani (University of Michigan), Robyn L. McClelland (University of Washington), Gearoid M. McMahon (Brigham & Women's Hospital), Steven Menez (Johns Hopkins University), Rajasree Menon (University of Michigan), Tyler Miller (UT Southwestern), Orson W. Moe (UT Southwestern), Dennis Moledina (Yale University), Sean D. Mooney (University of Washington), Jane Nguyen (Cleveland Clinic), Garry Nolan (UC San Francisco), George (Holt) Oliver (Parkland), Edgar Otto (University of Michigan), Paul M. Palevsky (University of Pittsburgh), Ellen Palmer (Cleveland Clinic), Annapurna Pamreddy (UT Health San Antonio), Chirag R. Parikh (Johns Hopkins University), Samir Parikh (Ohio State University), Christopher Park (University of Washington), Harold Park (UT Southwestern), Ljiljana Pasa-Tolic (Pacific Northwest National Laboratories), Roy Pinkeney (Patient Partner), Emilio Poggio (Cleveland Clinic), Parmjeet Randhawa (University of Pittsburgh), Helmut Rennke (Harvard University), Glenda V. Roberts (Patient Partner), Avi Rosenberg (Johns Hopkins University), Matthew Rosengart (University of Pittsburgh), Brad Rovin (Ohio State University), Neil Roy (Joslin Diabetes Center), Kamalanathan Sambandam (UT Southwestern), Minnie Sarwal (UCSF), John Saul (Patient Partner), Jennifer Schaub (University of Michigan), Rachel Sealfon (Princeton University), Ning (Sunny) Shang (Columbia University), Stuart Shankland (University of Washington), Kumar Sharma (UT Health San Antonio), Anna Shpigel (Patient Partner), Tara Sigdel (University of California, San Francisco), Becky Steck (University of Michigan), Isaac Stillman (Beth Israel Deaconess), Edith Christine Stutzke (Patient Partner), Timothy A. Sutton (Indiana University), Jose Torrealba (UT Southwestern), Robert D. Toto (UT Southwestern), Olga Troyanskaya (Princeton University), Mitchell Tublin (University of Pittsburgh), Ugochukwu Ugwuowo (Yale University), Miguel Vazquez (UT Southwestern), Dusan Velickovic (Pacific Northwest National Laboratories), Manjeri Venkatachalam (UT Health San Antonio), Anitha Vijayan (Washington University St. Louis), Celia P. Corona-Villalobos (Johns Hopkins University), Nancy Wang (UT Southwestern), Astrid Weins (Brigham & Women's Hospital), Adam Wilcox (University of Washington), Kayleen Williams (University of Washington), Mark Williams (Joslin Diabetes Center), Francis P. Wilson (Yale University), Seth Winfree (Indiana University), Yuguang Xiong (Mount Sinai), Kun Zhang (UC San Diego), and Guanshi Zhang (UT Health San Antonio). Catherine R. Butler, MD, MA, Paul S. Appelbaum, MD, Heather Ascani, MBA, Mark Aulisio, PhD, Catherine E. Campbell, DNP, MBA, Ian H. de Boer, MD, Ashveena L. Dighe, MS, MPH, Daniel E. Hall, MD, Jonathan Himmelfarb, MD, Richard Knight, MBA, Karla Mehl, MD, Raghavan Murugan, MD, Sylvia E. Rosas, MD, John R. Sedor, MD, John F. O'Toole, MD, Katherine R. Tuttle, MD, Sushrut S. Waikar, MD, MPH, and Michael Freeman, MD, MA. The KPMP is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grants U2C DK114886, UH3DK114861, UH3DK114866, UH3DK114870, UH3DK114908, UH3DK114915, UH3DK114926, UH3DK114907, UH3DK114920, UH3DK114923, UH3DK114933, and UH3DK114937. Dr Butler has received research funding and/or stipends from the University of Washington Department of Medicine, the National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK), the Veterans Affairs Health Services Research & Development, and the American Society of Nephrology. Dr Rosas has received research funding from NIDDK, Bayer Healthcare, AstraZeneca and has scientific advisory board memberships for Reata, Relypsa, and Bayer. Dr Tuttle has received 4 NIDDK/National Institutes of Health (NIH) grants, one National Institute for Advancing Translational Sciences/NIH grant, one National Institute on Minority Health and Health Disparities/NIH grant, and a Centers for Disease Control and Prevention contract; research grants from Goldfinch Bio, Bayer, and Travere; and consulting fees for diabetes and chronic kidney disease from Eli Lilly, Boehringer Ingelheim, AstraZeneca, Gilead, Goldfinch Bio, Novo Nordisk, and Bayer. The remaining authors declare that they have no relevant financial interests. Received June 30, 2021. Evaluated by 2 external peer reviewers, with direct editorial input from an Associate Editor and a Deputy Editor. Accepted in revised form October 12, 2021. Funding Information: The KPMP is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grants U2C DK114886, UH3DK114861, UH3DK114866, UH3DK114870, UH3DK114908, UH3DK114915, UH3DK114926, UH3DK114907, UH3DK114920, UH3DK114923, UH3DK114933, and UH3DK114937. Publisher Copyright: © 2021 The Authors

PY - 2022/7

Y1 - 2022/7

N2 - An understanding of the ethical underpinnings of human subjects research that involves some risk to participants without anticipated direct clinical benefit—such as the kidney biopsy procedure as part of the Kidney Precision Medicine Project (KPMP)—requires a critical examination of the risks as well as the diverse set of countervailing potential benefits to participants. This kind of deliberation has been foundational to the development and conduct of the KPMP. Herein, we use illustrative features of this research paradigm to develop a more comprehensive conceptualization of the types of benefits that may be important to research participants, including respecting pluralistic values, supporting the opportunity to act altruistically, and enhancing benefits to a participant's community. This approach may serve as a model to help researchers, ethicists, and regulators to identify opportunities to better respect and support participants in future research that entails some risk to these participants as well as to improve the quality of research for people with kidney disease.

AB - An understanding of the ethical underpinnings of human subjects research that involves some risk to participants without anticipated direct clinical benefit—such as the kidney biopsy procedure as part of the Kidney Precision Medicine Project (KPMP)—requires a critical examination of the risks as well as the diverse set of countervailing potential benefits to participants. This kind of deliberation has been foundational to the development and conduct of the KPMP. Herein, we use illustrative features of this research paradigm to develop a more comprehensive conceptualization of the types of benefits that may be important to research participants, including respecting pluralistic values, supporting the opportunity to act altruistically, and enhancing benefits to a participant's community. This approach may serve as a model to help researchers, ethicists, and regulators to identify opportunities to better respect and support participants in future research that entails some risk to these participants as well as to improve the quality of research for people with kidney disease.

KW - Altruism

KW - The Kidney Precision Medicine Project

KW - autonomy

KW - community engagement

KW - human subjects

KW - informed consent

KW - institutional review boards

KW - kidney biopsy

KW - non-maleficence

KW - precision medicine

KW - research ethics

KW - research participation

KW - research risks and benefits

KW - safety monitoring

UR - http://www.scopus.com/inward/record.url?scp=85124655636&partnerID=8YFLogxK

U2 - 10.1053/j.ajkd.2021.10.006

DO - 10.1053/j.ajkd.2021.10.006

M3 - Article

C2 - 34871700

AN - SCOPUS:85124655636

SN - 0272-6386

VL - 80

SP - 132

EP - 138

JO - American Journal of Kidney Diseases

JF - American Journal of Kidney Diseases

IS - 1

ER -

A Participant-Centered Approach to Understanding Risks and Benefits of Participation in Research Informed by the Kidney Precision Medicine Project

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