臺灣博碩士論文加值系統

中文摘要

本文主要在介紹緊急研究及美國現行相關法規。第二章區辨研究和治療。第三章簡述緊急研究告知後同意之免除之歷史演進。第四章介紹美國關於緊急研究的現行法規。第五章檢驗分析此法規之優劣。第六章提出學界及筆者建言。第七章總結：儘管目前美國對於緊急研究仍有許多批評與改進之處，美國緊急研究透過現行法規展現了科技發展及病人自主權之分界，期許台灣政府能儘早制定關於緊急研究之相關法規。

ABSTRACT

This dissertation will primarily be devoted to introducing the subject of emergency research and analyzing the current regulations in the United States. It will briefly discuss emergency treatment when it is necessary for comparison with emergency research. Chapter 2 sets out the distinction between treatment and research. Chapter 3 describes the history of informed consent for emergency research and why exceptions to ordinary consent requirements are necessary. Chapter 4 describes the existing regulations and guidelines for emergency research. Chapter 5 examines the benefits of the regulations, the criticisms that have been leveled against them, and the concerns that have been raised about them – in particular the concerns about community consultation and public disclosure. Chapter 6 presents my recommendations for addressing shortcomings in the way the regulations have so far been implemented. Chapter 7 draws the conclusion that the existing regulations and guidelines for emergency research in the United States suggest a way to balance the development of technology and the autonomy of the patient. It is urgent for the United States government to think about how to improve emergency research in the United States.

TABLE OF CONTENTS

ABSTRACT OF THE DISSERTATION…………………………………………………….i
ACKNOWLEDGEMENT………………………………………………..……………….iv
CHAPTER 1: INTRODUCTION………………………………..………………………1
I. the Concept of Emergency Research……………………………………………1
II. the Need for More Consideration Regarding Emergency Research..……………3
CHAPTER 2: DISTINCTION BETWEEN TREATMENT AND RESEARCH……..………...7
I. Definition and Scope……………………………………………………………..7
A. Definition of Treatment and Research.........................................................7
B. Research– Therapeutic Research and Nontherapeutic Research…….……..7
C. Examples of Nontherapeutic Research……………………………………..9
1. the Auschwitz Concentration Camp Experiments..........................9
2. the Tuskegee syphilis Experiment................................................10
3. Grimes v. Kennedy Krieger Institute, Inc.………………………11
D. Scope……………………………………………………………………...12
II. Distinction………………………………………………………………………...12
A. There is an Increased and Unpredictable Risk of Harm in Research studies...........................................................................................................................12
B. There is a Lack of Corresponding Benefit to the Subject by Participation in the Study……………………………………………………………………………..13
C. the Researcher’s Interests May not Align with Those of the Subject……13
CHAPTER 3: EMERGENCY RESEARCH, PAST AND PRESENT……..……………….15
I. Historical Evolution……………...……………………………………………..15
A. the Nuremberg Code….…...………………………………………….…...15
B. the Declaration of Helsinki….…...…………………………………….….16
C. the Beecher Article………….……………………………………………..17
D. the Belmont Report………….……………………………………………18
E. Respective Federal Regulations from the Department of Health and Human Services (“DHHS”) and the Food and Drug Administration (“FDA”)………………19
II. Current Regulation: 1996 FDA Federal Regulations- the Emergency Research Rule (“the ER Rule”)…………………………………………………………..……..21
CHAPTER 4: EXISTING REGULATION OF EMERGENCY RESEARCH……..………..25
I. Requirements for the Informed Consent Exception…………………….............25
A. The Subjects must be in a Life-Threatening Situation.................................26
B. Available Treatments must be Unproven or Unsatisfactory........................26
C. The Safety and Effectiveness of Intervention Needs to be Determined.......26
D. Obtaining Informed Consent if Not Feasible……………………………..27
E. Participation by the Subject Offers the Prospect of Direct Benefit……….27
F. The Study Cannot Practicably be Carried Out Without the Waiver………28
G. Investigators must Attempt to Contact LAR within the Therapeutic Window………………………………………………………………………………28
H. Several Special Protections……………………………………………….29
1. Community Consultation.............................................................29
2. Public Disclosure..........................................................................31
3. Data Monitoring Committee……………………………………31
4. Investigators Attempt to Contact Subject’s Family Member within Therapeutic Window…………………………………………………………32
II. Special Responsibilities of IRBs and other related regulations of the ER Rule...33
A. Written Notification to the Investigators and Sponsors for the Non-approved Study…………………….............................................................................................33
B. Each Protocol Requires a Separate IND/IDE Application...........................33
CHAPTER 5: EXAMINATIONS/CONCERNS AND COMPLETED/ONGOING STUDIES...35
I. Examinations and Concerns…………………….................................................35
A. Ambiguous Wording……………………...................................................36
B. Community Consultation…………………….............................................38
C. Public Disclosure…………………….........................................................41
D. Other Concerns……………………………………………………………43
II. Several Completed and Ongoing Studies under the ER Rule…..........................46
A. Three Research Networks……………………............................................46
1. Resuscitation Outcomes Consortium (“ROC”)............................47
2. Neurological Emergencies Treatment Trials (“NETT”)..............48
3. Pediatric Emergency Care Applied Research Network (“PECARN”)…………………………………………………………………48
B. Completed Studies…………………….......................................................48
1. PolyHeme Study...........................................................................48
C. Ongoing Studies…………………………………………………………..51
1. Pragmatic, Randomized, Optimal Platelet and Plasma Ratios (“PROPPR”).....................................................................................................51
2. Field Trial of Hypotensive Resuscitation versus Standard Resuscitation in Patients with Hemorrhagic Shock after Trauma, A Pilot Trial (“HypoResus”)……………………………………………………………….52
III. Conclusion……………………………………………………............................55
CHAPTER 6: RECOMMENDATIONS…………………………………………...........57
I. Amend the Current Regulations….......................................................................57
A. 2006 Draft Guidance……………………...................................................57
B. 2011 Draft Guidance……………………...................................................58
1. Clearer Language on Definitions.................................................60
2. Clearer Requirements for Community Consultation....................61
3. Opt-out Mechanisms……………………………………………61
4. No Preemption to State Law or Local Law……………………..65
B. Establish One Agency to Oversee All Clinical Research............................66
CHAPTER 7: CONCLUSION……………………………………………………........69
BIBLIOGRAPHY………………………………………………………………………71
APPENDIX- 21 C.F.R. § 50.24………………………………………………………..73

BIBLIOGRAPHY

1. Gail E. Gillenwater, FDA’s Emergency Research: An Inch Given, a Yard Taken, 63 FOOD & DRUG L.J. 217, 218 (2008).

2. Douglas Andrew Grimm, Informed Consent for All! No Exceptions, 37 N.M. L. REV. 39, 70 (2007).

3. Kurt M. Hartman & Bryn A. Liang, Exceptions to Informed Consent in Emergency Medicine, Hospital Physician 53, 54 (1999).

4. Norman Fostt, Waived Consent for Emergency Research, 24 AM. J.L. & MED. 163, 183 (1998).

5. Sandra J. Carnaham, Promoting Medical Research Without Sacrificing Patient Autonomy: Legal and Ethical Issues Raised by the Waiver of Informed Consent for Emergency Research, 52 OKLA. L.REV. 565, 575 (1999).

6. Catherine K. Dunn, Protecting the Silent Third Party: The Need for Legislative Reform with Respect to Informed Consent and Research on Human Biological Materials, 6 Charleston L. REV. 635, 663 (2012).

7. Alexander M. Capron, Legal and Regulatory Standards of Informed Consent in Research, in the OXFORD TEXTBOOK OF CLINICAL RESEARCH ETHICS 613, 615 (Ezekiel J. Emmanuel et al eds., 2008).

8. Tom L. Beauchamp, the Belmont Report, in the OXFORD TEXTBOOK OF CLINICAL RESEARCH ETHICS 150, 150 (Ezekiel J. Emmanuel et al eds., 2008).

9. C. Anne Morrison, Association for Academic Surgery Ethical and Legal Issues in Emergency Research: Barriers to Conducting Prospective Randomized Trials in an Emergency Setting, 157 J. SURGICAL RESEARCH 115, 117 (2009).

10. Joan P. Porter and Greg Koski, Regulations for the Protection of Humans in Research in the United States: The Common Rule, in the OXFORD TEXTBOOK OF CLINICAL RESEARCH ETHICS 156, 158 (Ezekiel J. Emmanuel et al eds., 2008).

11. Jill M. Baren, An Approach to Community Consultation Prior to Initiating an Emergency Research Study Incorporating a Waiver of Informed Consent, in ACADEMIC EMERGENCY MEDICINE : OFFICIAL JOURNAL OF THE SOCIETY FOR ACADEMIC EMERGENCY MEDICINE. 6(12):1210-5 (1999).

12. Jesse Goldner, Emergency research without informed consent, 16(3) Lahey Clinic J. of Medical Ethics 4, 7 (2009).

13. FDA Expands Guidance on Emergency Research Community Consultation, Public Disclosure, Trial Design are Detailed in Final Guidance, 18 No. 9 Guide to Good Clinical Practice Newsl. 4 (Jun. 2011).

14. Confusion over New Requirements, IRB Concerns Limit Use of FDA Emergency Consent Rule, 5 No. 3 Guide to Good Clinical Practice Newsl. 1 (Dec. 1997).

15. Shannon Benbow, Conflict+ Interest: Financial Incentives and Informed Consent in Human Subject Research, 17 NOTRE DAME J.L. ETHICS & PUB. POL’Y 181, 213 (2003).

16. Barbara A. Noah, Bioethical Malpractice: Risk and Responsibility in Human Research, 7 J. HEALTH CARE L. & POL’Y 175, 240 (2004).