Responsible Research A Systems Approach to Protecting Research Participants (2003) / Chapter Skim
Currently Skimming:
1 Introduction
1 Introduction
Pages 29-44
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 29... ...
A series of events in the late 1990s involving mishaps and errors some tragic in the conduct of human research focused renewed attention on the ethical requirement to protect the rights and welfare of those who volunteer 1This committee has elected to use the term "participant" rather than "subject" to reflect its belief that optimal functioning of research oversight programs necessitates the meaningful integration of research participants and their perspectives (IOM, 2001a)
|
From page 30... ...
developed terminology to describe a set of activities and functions critical to protecting research participants. The term "Human Research Participant Protection Program" (HRPPP)
|
From page 31... ...
BASIC TENETS OF ETHICAL HUMAN RESEARCH It is widely recognized that research involving humans must follow general ethical principles. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978)
|
From page 32... ...
The moral imperative that answering the research question should be of justifiable value to society is articulated in every professional code of research ethics, including the Nuremberg Code and the Declaration of Helsinki, and in federal regulations governing human research (Nuremberg Code, 1949; World Medical Association, 2000; 45 CFR 46; 21 CFR 50 and 56)
|
From page 34... ...
A clinical trial can be designed and supported for commercial reasons, such as approval of a new drug, or in response to interest by an individual investigator or research group. Drug companies are required to submit data from clinical trials in order to receive new drug approval.
|
From page 35... ...
Also, on the basis of the growth of organizations dedicated to managing clinical trials and other evidence, it appears that the number of privately financed clinical trials has grown dramatically over the past decade (Rettig, 2000~. Furthermore, many trials are multicenter trials involving participants drawn from academic medical centers, private physicians' practices, community hospitals, clinics, and other institutions and are therefore not subject to a single formal oversight structure.
|
From page 36... ...
RECENT EVENTS Much of the recent debate and analysis about the protection of research participants has focused on the federal and local institutions and agencies charged with this task, including the federal regulatory agencies, academic and industrial laboratories, IRBs, and funding organizations. To a great extent, examinations have focused on IRBs the bodies responsible for reviewing the ethical acceptability of proposed human research.
|
From page 37... ...
Attention was already focused on the protection of human research participants in 1999 when 18-year-old Jesse Gelsinger died in a Phase 1 gene transfer study at the University of Pennsylvania. He was a relatively healthy (i.e., medically stable)
|
From page 38... ...
conflicts of interest of the investigators and the Institutions, ~nsutt~c~ent mon~toring upon trial commencement, a questionable scientific review procedure, and inadequate resources for comprehensive and stringent review and oversight. At the institutional level, OPRR/OHRP sanctions have been imposed when systematic deficiencies and concerns regarding systemic protections for human research participants have been found.
|
From page 39... ...
and 21 CFR 50 and 56 (FDA regulations) provide a regulatory framework through which to implement the ethical principles incumbent to human research.
|
From page 40... ...
THEMES AND ORGANIZATION OF THIS REPORT As Figure 1.1 demonstrates, the well-being and interests of participants should be considered at all phases of the research process, from conception of the research question (i.e., will answering this question serve a purpose worthy of exposing human participants to even minimal risks or unnecessary inconvenience?
|
From page 41... ...
Consideration of the rights, interests, and safety of participants is fundamental to the ethical conduct of each of prior to the recruitment and enrollment of participants, consideration and integration of the perspectives of potential participants is central to ensuring comprehensive protection. With the entrance of an individual participant into a study, informed consent and safety monitoring provide the most direct protection mechanisms to safeguard volunteers and facilitate responsible research.
|
From page 42... ...
The diligent application of HRPPP policies and practices will ensure that individual participants in any research project are protected against undue risk, that they provide informed consent to the research, and that their safety, rights, privileges, and privacy are protected. The precise composition of an HRPPP within a given organizational setting depends on the applicable circumstances and context.
|
From page 43... ...
In the process of its work, the committee heard concern that draft accreditation standards would require the elaboration of formal policies and documentation that would be irrelevant for IRBs that primarily review social science, behavioral research, anthropology, sociology, oral history, epidemiology, and population studies (Levine, 2001b; Overbey, 2001; Shopes, 2001~. However, pleas to exempt nonbiomedical research from oversight were not heard; rather, the committee received suggestions to reduce paperwork, to develop criteria sensitive to social and behavioral research, and to expand the categories of research exempt from review when the risks of nonmedical research are inherently minimal and informed consent can be "presumed" (e.g., by returning a survey form or answering interview questions)
|
From page 44... ...
However, in doing so, it should be realized that we have a solemn responsibility to protect research participants and to ensure that this protection is integral to every aspect of the research process. Our current system of protection, however, is not functioning as intended, a message that this committee as well as a long line of analysts and observers have delivered.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.