Institutional Review Board, Ltd. is an independent institutional
require that Institutional Review Boards (IRBs) review and monitor
research in order to protect the rights and welfare of human research
subjects. Most institutions engaged in clinical research have
their own IRB but often clinical research is conducted in non-institutional
settings (e.g., private practice). Independent sites currently
make up over 40 % of all clinical research sites and independent
IRBs are used to oversee the research conducted in these settings.
Also, institutions may out-source oversight responsibility to
an independent IRB in order to reduce costs and take advantage of its
Review Board, Ltd. is asked to oversee research projects and the
investigators conducting them by its clients (including research
sponsors/institutions, Clinical Research Organizations, Site Management
Organizations, physician-sponsors, etc.). However, Goodwyn Institutional
Review Board, Ltd. operates solely in the interest of the human
subjects enrolled in these research projects.
Review Board, Ltd requires all research projects (and investigators)
for which it has assumed responsibility to be reviewed and approved
before they are initiated.
Guiding Principles and Authority
Institutional Review Board, Ltd is guided by the ethical principles
regarding all research involving human subjects as set forth in
The Belmont Report:
Ethical Principles and Guidelines
for the Protection of Human Subjects of Research, National Commission
for the Protection of Human Subjects of Biomedical and Behavioral
Research, April 18, 1979.
Institutional Review Board, Ltd. operates in compliance with:
U.S. Code of Federal Regulations,
DHHS (CFR), Title 45 Part 46, entitled Protection of Human Subjects;
CFR Title 45 Parts 160 and 164,
entitled Standards for Privacy of Individually Identifiable
FDA regulations on human subjects research
(CFR Title 21 Parts 50, 56, Protection of Human Subjects and
Institutional Review Boards, respectively);and
International Conference on Harmonization of Requirements
for Pharmaceutical Products; Good Clinical Practices: Consolidated
Guideline; Part II 62 FR 25692, May 9, 1997;
FDA Regulations on New Drugs (CFR Title 21 Part 310, entitled New Drugs);
FDA Regulations on Investigational New Drugs (CFR Title 21 Part 312, entitled Investigational New Drug Application);
FDA Regulations on Devices (CFR Title 21 Part 812, entitled Investigational Device Exemptions);
FDA Regulations on Electronic Records and Signatures (CFR Title 21 Part 11, entitled Electronic Records; and Electronic Signatures).
IRB's primary concerns are that:
the rights and welfare of the subjects are adequately
the risks to subjects are outweighed by the potential
benefits of the research,
the selection of subjects is suitable, and
informed consent will be obtained and, where appropriate,
Institutional Review Board, Ltd.
protects the confidentiality of research subjects and information
about sponsors’ products under development. All material
is assumed to be confidential, trade secret, and of commercial
interest. Members and Staff are obligated to maintain the confidentiality
of this information.