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Institutional Review Board (IRB)
The Colorado Department of Public Health and Environment (CDPHE) Institutional Review Board (IRB) responsible for protecting the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the Department. The federal regulation Protection of Human Subjects, 45 CFR 46, also known as the Common Rule, governs the actions of the CDPHE IRB. The IRB's authority is granted by the U.S. Department of Health and Human Services based on a CDPHE commitment to comply with the provisions of 45 CFR 46. All research studies involving human subjects must be reviewed by the IRB regardless of the funding source. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its purview. This process is designed to ensure that research protocols protect the rights and welfare of human subjects - for example, by minimizing risks, selecting subjects equitably, obtaining informed consent and ensuring privacy and confidentiality. IRB approval must precede initiation of any work involving human subjects. The membership of the IRB is diverse while maintaining the level of expertise required to properly review human subjects research protocols. Currently there are nine members of the IRB, of whom five are CDPHE employees and three are from outside the Department. A CDPHE-affiliated member serves as the Board’s chair. The information CDPHE researchers need to successfully address human subjects research protections can be found on this Web page and by contacting the CDPHE IRB chair.
Defining Human Subjects ResearchResearch is designed to test a hypothesis through the collection and analysis of data. The resulting conclusions are used to develop or contribute to generalizable knowledge. A hypothesis is a tentative assumption that is empirically tested. If the conclusions resulting from data analysis do not support the hypothesis, it must be rejected or modified. A research study is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective. The IRB’s responsibility is to review research protocols that involve human subjects. A human subject is a living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual, or (2) identifying private information.
Research vs. Public Health PracticeThe majority of public health practices (e.g., public health surveillance, and the implementation and evaluation of disease prevention and control projects) are based on scientific evidence, data collection and analytic methods similar to those used in research. They are not, however, designed to contribute to generalizable knowledge. Their primary purpose is to protect the health of the population through such activities as disease surveillance, prevention, or control.For the most part, the term “public health practice” refers to interventions that are designed solely to enhance the well being of the community with a reasonable expectation of success. The purpose of these interventions is to provide identification, prevention, and treatment to either an individual or the community at-large. Public health activity undertaken at CDPHE may be either public health practice or research (or may include a component that involves research activities).
Additional guidance on defining the difference between Research and Public Health Practice may be found at the following websites:
Compliance with National Norms of Human Subjects ProtectionsUnder the U.S. Department of Health and Human Services (DHHS) human subjects protection regulations at 45 CFR 46.103, every institution engaged in human subjects research supported or conducted by DHHS must obtain an assurance of compliance approved by the Office for Human Research Protections (OHRP). This compliance is called a Federalwide Assurance. CDPHE’s Federalwide Assurance Number is FWA 00003044. All of the Department’s human subjects
activities and the activities of our Institutional Review Board designated
under our Federalwide Assurance, regardless of funding source, are guided
by the ethical principles in
The
Belmont Report: Ethical Principles and Guidelines for the Protection of
Human Subjects of Research of the National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research. Federal human research subjects protection policy is defined in 45 CFR 46,including conflict of interest and protection of special populations: The process of obtaining informed consent must comply with the requirements of 45 CFR 46.116. Documentation of informed consent must comply with 45 CFR 46.117. A checklist and tips on informed consent are available at the OHRP website.
The Human Subjects Research Review ProcessAll research studies involving human subjects must be reviewed by the IRB regardless of the funding source. This process is designed to ensure that research protocols protect the rights and welfare of human subjects - for example, by minimizing risks, selecting subjects equitably, obtaining informed consent and ensuring privacy and confidentiality. IRB approval must precede initiation of any work involving human subjects. Investigators seeking IRB approval of research must follow the CDPHE IRB Meeting and Protocol Submittal Schedule. Investigators must submit to the IRB a completed IRB Summary of Proposed Research Form, a complete and final research protocol, and all associated documentation (fact sheets, consent forms, dialogue scripts, etc). IRB Summary Requirements Form must accompany all protocols submitted to the CDPHE IRB prior to all levels of review (exempt, expedited, or full board review). The IRB Summary Requirements Form may be submitted in advance of the full final protocol to provide the IRB an overview of the proposed research and may allow a preliminary determination of the required type of review. At a minimum, all CDPHE or affiliated principal investigators, planning or engaging in research involving human subjects, must complete a human participant protections tutorial. Substitution of this requirement with equivalent or similar training should be discussed with the IRB chair. The IRB may review research protocols through the expedited or full board review process. Protocols accepted for an expedited review may be reviewed by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review by the full IRB. Protocols requiring a full board review will be assigned to a scheduled CDPHE IRB meeting. The principal investigator and/or designee(s) will attend this meeting to discuss the protocol with members of the board. The board will deliberate in private session following discussion with the investigators. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its purview. Once the IRB is satisfied that required modifications have been completed and all documentation has been submitted to the IRB in final form, the IRB will provide the principal investigator a Protection of Human Subjects, Assurance Identification/Certification/Declaration Form (as-fm310), which should be forwarded by the investigator to the funding agency if required. Federal regulations require a that all IRB approved research, whether through the expedited or full board review process, receive continuing review no less than once within a 12-month period from the approval date shown on the Protection of Human Subjects Assurance Form (as-fm310). The frequency of review is dependent on the level of risk to the research subjects associated with the research protocol, which is determined by the IRB. An IRB Continuing Review Form should be completed and submitted to the IRB prior to the end of the 12-month review period. If human subjects are harmed, including physical injury, improper disclosure of private information, economic loss or other harmful occurrences, the IRB must be notified. IRB Meeting and Protocol Submission ScheduleThe CDPHE Institutional Review Board (IRB) will meet on the dates indicated in the table below. Please check with the IRB chair for date changes and meeting locations. The table also lists deadlines for scheduling and material submission. It is advisable for all materials (that includes supporting documentation) to be submitted in advance of deadlines so that there is time for the Chair to provide preliminary feedback to the PI, and to determine if the protocol requires discussion during a board meeting. The chair routes submitted (and finalized) protocol materials to IRB members 10 to 12 days prior to the meeting date.
Contact the IRB ChairCarol Stanton Ethical Research StandardsThe Public Health Service (PHS) regulation, 42 CFR 50, Subpart A, places several requirements on institutions applying for or receiving Public Health Service research funds. These regulatory obligations are consistent with the obligations imposed upon institutions by Congress in Section 493 of the PHS Act. By applying for or accepting PHS funds, an institution assumes legal and financial accountability for the awarded funds and for the performance of the supported activities. To comply with these requirements, the Colorado Department of Public Health and Environment has (1) developed an administrative process for responding to allegations of misconduct in science consistent with the requirements of the PHS regulation; (2) submitted an initial institutional assurance to the Public Health Service’s Office of Research Integrity (ORI); and (3) maintained an active assurance by filing with the ORI an Annual Report on Possible Research Misconduct. Allegations of scientific misconduct will be referred to the CDPHE IRB. The IRB will initiate immediate inquiry into each allegation. Allegations should be referred to the IRB chair, Carol Stanton. Any member of the IRB who has a real or apparent conflict of interest will be excluded from any inquiry or investigation. Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. The research record is the record of data or results that embody the facts resulting from scientific inquiry, and includes, but is not limited to, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, and journal articles. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or differences of opinion. For more information, contact the IRB chair and visit the federal Office of Research Integrity web page.
HIPAA RequirementsThe privacy provisions of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), apply to health information created or maintained by health care providers who engage in certain electronic transactions, health plans, and health care clearinghouses. Although CDPHE as a public health authority is not a covered entity under HIPAA, many of the concerns HIPAA addresses do apply to CDPHE. CDPHE is a business associate of other covered entities, in some instances, and must comply with some parts of HIPAA as a business associate. Furthermore, much of the data CDPHE collects comes from agencies and institutions that are covered by HIPAA. By basing the CDPHE policies and procedures on HIPAA we are positioning ourselves to stay current with developments in the health care industry for privacy and security. The Department developed policies addressing privacy and security. One policy is specific to the Protection of Human Subjects who Participate in Research Activities. This policy defines the procedures to be followed by staff before collecting or releasing personal health information for research purposes. Investigators should review the
key
research sections of the HIPAA Privacy rule. More information can be obtained from the CDPHE HIPAA Compliance Coordinator: Michelle Lavigne
michelle.lavigne@state.co.us Training for InvestigatorsThe CDPHE Institutional Review Board (IRB) requires that all CDPHE or affiliated principal investigators, planning or engaging in research involving human subjects, complete a human participant protections tutorial. Other responsible members of research teams are encouraged to also complete the tutorial. The tutorial presents common concepts, principles, and issues related to protection of human research subjects. The tutorial will help investigators and their teams to identify research activities that involve human participants, and to protect participant’s rights and welfare. Protocol reviews and continuing reviews will not be approved without documentation that training has been completed. The minimum training requirement can be completed in one of two ways:
Substitution of the requirement described above with equivalent or similar training should be discussed with the IRB chair. |
The full text of the Privacy rule and
U.S. Health and Human Services educational materials on the Rule can be
found on the