Participant Recruitment From Low- and Middle-Income Countries for Pivotal Trials of Drugs Approved by the U. S. Food and Drug Administration. A Cross-Sectional Analysis

Authors: Awan, F. A., Becker, A. B., Wang, Y., Kimmelman, J.

Source: Annals of internal medicine. 175(12):1675-1684

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCRN630865463&indx=1&recIds=ETOCRN630865463

Response

Authors: Shah, S. K., Kimmelman, J., Lyerly, A. D., Lynch, H. F., Miller, F. G., Palacios, R., Pardo, C. A., Zorrilla, C.

Source: Science, 2018 Jun . 360(6395), 1308-1309.

Access URL: https://www.jstor.org/stable/26498382

Bystander risk, social value, and ethics of human research

Authors: Shah, S. K., Kimmelman, J., Lyerly, A. D., Lynch, H. F., Miller, F. G., Palacios, R., Pardo, C. A., Zorrilla, C.

Source: Science, 2018 Apr . 360(6385), 158-159.

Access URL: https://www.jstor.org/stable/26498559

Nonpublication of trial results for new neurological drugs: A systematic review

Authors: Hakala, A. K., Fergusson, D., Kimmelman, J.

Source: ANNALS OF NEUROLOGY. 81(6):782-789

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCRN385125640&indx=1&recIds=ETOCRN385125640

Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines
Nanodiagnostics and nanotherapeutics: building research ethics and oversight

Authors: Kimmelman, J.

Source: JOURNAL OF LAW MEDICINE AND ETHICS. 40(4):841-847

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCCN083880902&indx=1&recIds=ETOCCN083880902

Ethics at Phase 0: Clarifying the Issues
Global health law, ethics and policy

Authors: Kimmelman, J.

Source: JOURNAL OF LAW MEDICINE AND ETHICS. 35:727-733

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCCN067139493&indx=1&recIds=ETOCCN067139493

Do We Know Whether Researchers and Reviewers are Estimating Risk and Benefit Accurately?

Authors: Hey, S. P., Kimmelman, J.

Source: BIOETHICS -OXFORD-. 30(8):609-617

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCRN381181076&indx=1&recIds=ETOCRN381181076

How do researchers decide early clinical trials?

Authors: Grankvist, H., Kimmelman, J.

Source: MEDICINE HEALTH CARE AND PHILOSOPHY. 19(2):191-198

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCRN377605857&indx=1&recIds=ETOCRN377605857

Late, never or non-existent: the inaccessibility of preclinical evidence for new drugs

Authors: Federico, C. A., Carlisle, B., Kimmelman, J., Fergusson, D. A.

Source: BRITISH JOURNAL OF PHARMACOLOGY. 171(18):4247-4254

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCRN359074175&indx=1&recIds=ETOCRN359074175

The Risk-Escalation Model: A Principled Design Strategy for Early-Phase Trials

Authors: Hey, S.P., Kimmelman, J.

Source: KENNEDY INSTITUTE OF ETHICS JOURNAL. 24(2):121-140

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCRN356854870&indx=1&recIds=ETOCRN356854870

Consent for Nondiagnostic Research Biopsies: A Pilot Study of Participant Recall and Therapeutic Orientation

Authors: Abadie, R., Kimmelman, J., Lafleur, J., Lemmens, T.

Source: IRB. 36(3):9-15

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCRN353757920&indx=1&recIds=ETOCRN353757920

Are Phase 1 Trials Therapeutic? Risk, Ethics, and Division of Labor

Authors: Anderson, J. A., Kimmelman, J.

Source: BIOETHICS -OXFORD-. 28(3):138-146

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCRN348172450&indx=1&recIds=ETOCRN348172450

Consider drug efficacy before first-in-human trials

Authors: Kimmelman, J., Federico, C.

Source: NATURE -LONDON-. 542(7639):25-27

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCRN382360600&indx=1&recIds=ETOCRN382360600

Therapeutic Optimism in the Consent Forms of Phase 1 Gene Transfer Trials: An Empirical Analysis

Authors: Kimmelman, J., Palmour, N.

Source: Journal of Medical Ethics, 2005 Apr 01. 31(4), 209-214.

Access URL: https://www.jstor.org/stable/27719377

Reporting practices of pharmacodynamic studies involving invasive research procedures in cancer trials

Authors: Freeman, G. A., Kimmelman, J., Dancey, J., Monzon, J. G.

Source: BRITISH JOURNAL OF CANCER. 109(4):897-908

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCRN337851986&indx=1&recIds=ETOCRN337851986

Position Statement on the Provision and Procurement of Human Eggs for Stem Cell Research

Authors: Haimes, E., Skene, L., Ballantyne, A. J., Caulfield, T., Goldstein, L. S., Hyun, I., Kimmelman, J., Robert, J. S., Roxland, B. E., Scott, C. T.

Source: CELL STEM CELL. 12(3):285-291

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCRN331910854&indx=1&recIds=ETOCRN331910854

Informed consent documents do not encourage good-quality decision making

Authors: Brehaut, J.C., Carroll, K., Elwyn, G., Saginur, R., Kimmelman, J., Shojania, K., Syrowatka, A., Nguyen, T., Hoe, E., Fergusson, D.

Source: JOURNAL OF CLINICAL EPIDEMIOLOGY. 65(7):708-724

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCRN326144834&indx=1&recIds=ETOCRN326144834

Analysis of Consent Validity for Invasive, Nondiagnostic Research Procedures

Authors: Kimmelman, J., Lemmens, T., Kim, S.Y.H.

Source: IRB. 34(5):1-7

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCRN319576159&indx=1&recIds=ETOCRN319576159

ETHICS, AMBIGUITY AVERSION, AND THE REVIEW OF COMPLEX TRANSLATIONAL CLINICAL TRIALS

Authors: KIMMELMAN, J.

Source: BIOETHICS -OXFORD-. 26(5):242-250

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCRN312013913&indx=1&recIds=ETOCRN312013913

THE ETHICS OF MANAGING AFFECTIVE AND EMOTIONAL STATES TO IMPROVE INFORMED CONSENT: AUTONOMY, COMPREHENSION, AND VOLUNTARINESS

Authors: BRAUDE, H., KIMMELMAN, J.

Source: BIOETHICS -OXFORD-. 26(3):149-156

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCRN306629084&indx=1&recIds=ETOCRN306629084