This "Investigator's Guide" was prepared to help researchers comply with Baptist Health System policies and Federal regulations. This Guidebook includes detailed information concerning:
- Federal and institutional requirements for the protection of human research subjects;
- The Human Research Review Board's role and responsibilities;
- The requirements and procedures for initial and continuing review;
- The responsibilities of investigators during the review and conduct of research;
- Requirements and procedures for notifying the Human Research Review Board of serious, unanticipated problems or events involving risks to the subjects, as well as any other unexpected adverse event;
- FDA requirements for emergency use of test articles;
- Informed consent requirements; and
- Issues to consider regarding special categories of research and subjects.
If you need more information or would like to discuss specific aspects of your research with someone from the Baptist Health System Human Research Review Board, please contact the office at 205-715-5308. All efforts have been made to ensure that the information in this Guidebook is consistent with applicable Federal and State laws and regulations, and with Baptist Health System policies regarding the use of human subjects in research. However, as changes in laws and polices occur the Guidebook will be revised. In addition, suggestions for improving the information contained in the Guidebook and its presentation are always welcome.
Purpose and History of the Institutional Review Board
FEDERAL REQUIREMENTS FOR THE PROTECTION OF HUMAN SUBJECTS
The formal requirements for the establishment of IRBs first became effective on May 30, 1974. Promulgated by the Department of Health, Education and Welfare (DHEW), those regulations raised to regulatory status NIH's Policies for the Protection of Human Subjects, which were first issued in 1966. The regulations established the IRB as one mechanism through which human subjects would be protected. In 1981, both the Department of Health and Human Services (DHHS, formerly DHEW) and the FDA promulgated significant revisions of their human subjects regulations. The DHHS regulations are codified at Title 45 Part 46 of the Code of Federal Regulations. The FDA regulations are codified at Title 21 Part 56. Those basic regulations became final on January 16, 1981 and were revised effective March 4, 1983 and June 18, 1991. The June 18, 1991 revision involved the adoption of the Federal Policy for the Protection of Human Subjects. The Federal Policy (or "Common Rule," as it is sometimes called) was adopted by the Federal agencies that conduct, support, or otherwise regulate human subjects research. As implied by its title the Common Rule is designed to make uniform the human subjects protection system in all relevant Federal agencies and departments.
BAPTIST HEALTH SYSTEM OVERSIGHT OF THE PROTECTION OF HUMAN SUBJECTS
Baptist Health System, its clinical staff, residents, and employees are guided by the ethical principles regarding all research involving human subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the "Belmont Report) regardless of whether the research is subject to Federal regulation or with whom conducted or the source of support.
The Human Research Review Board at the Baptist Health System is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted at all inpatient facilities and/or diagnostic or treatment facilities in a hospital owned or operated by the Baptist Health System. The Baptist Health System Human Research Review Board is also responsible for ensuring institutional compliance with those ethical considerations contained in the Common Rule. The Human Research Review Board maintains guiding principles and operating policies demanding the highest professional standards in dealing with human subjects and reviews all research projects involving humans subjects to ensure that appropriate standards are met and do not infringe upon the safety, health, welfare, or life of those subjects.
Safeguarding the rights and welfare of human subjects in research is a general institutional policy delegated by the BHS Board of Trustees through the President's Advisory Group to the Human Research Review Board. The Chairman of the Human Research Review Board is responsible for exercising appropriate administrative oversight to ensure that the Baptist Health System's policies and procedures designed for protecting the rights and welfare of human subjects of research are effectively applied in compliance with its Federalwide Assurance from the Office of Human Research Protections (OHRP).
Authority of the Human Research Review Board
The Human Research Review Board has the authority and responsibility to approve and monitor for compliance with institutional policy all research involving acute care/inpatient procedures or involves the use of any outpatient diagnostic or treatment facility in a hospital owned and/or operated by the Baptist Health System, Inc. for the purpose of experimental research involving human subjects. The purpose of this review process is to ensure the safety and welfare of human subjects in research. In particular, the Human Research Review Board has the authority to:
- Approve or disapprove an application or to require modifications of an application (including the protocol or consent form) as a condition for approval;
- Monitor the involvement of human subjects in a study and require progress reports; and
- Suspend or terminate a study, or impose restrictions or require modifications to a study as a condition for continuation.
The Human Research Review Board does not have the authority to grant retroactive approval should a research study be initiated without prior Human Research Review Board review.
No Baptist Health System administrator, clinical staff, or employee can reverse Human Research Review Board decisions that involve disapproval, deferral, suspension or termination of a research study.
Jurisdiction of Human Research Review Board
All research involving human subjects, and all other activities which even in part involve such research, regardless of sponsorship, must be reviewed and approved by the Human Research Review Board. No intervention or interaction with human subjects in research, including recruitment, may begin until the Human Research Review Board has reviewed and approved the research protocol.