Source: http://goodwynirb.com/goodwynirb2.htm
Timestamp: 2013-05-19 12:16:58
Document Index: 735108463

Matched Legal Cases: ['art 46', 'arts 160', 'arts 50', 'art 310', 'art 312', 'art 812', 'art 11']

Clinical Research, FDA, Good Clinical Practices - Goodwyn IRB
National Expertise. Individual Protection
Goodwyn Institutional Review Board, Ltd. is an independent institutional review board.
Federal Regulations 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 focused resources.
Goodwyn Institutional 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.
Goodwyn Institutional 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
Goodwyn 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.
Goodwyn 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 Health Information;
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).
Goodwyn IRB's primary concerns are that: the rights and welfare of the subjects are adequately protected, 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, documented.
Goodwyn 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.