Ethical research standards
The 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:
- Developed an administrative process for responding to allegations of misconduct in science consistent with the requirements of the PHS regulation.
- Submitted an initial institutional assurance to the Public Health Services Office of Research Integrity (ORI).
- Maintained an active assurance by filing with the ORI an Annual Report on Possible Research Misconduct.
Allegations of scientific misconduct will be referred to our Institutional Review Board. The board will initiate immediate inquiry into each allegation. Allegations should be referred to the IRB chair. Any member of the board 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 isn’t limited to:
- Research proposals.
- Laboratory records, both physical and electronic.
- Progress reports.
- Oral presentations.
- Internal reports.
- Journal articles.
- Plagiarism is the appropriation of another person's ideas, processes, results or words without giving appropriate credit.
- Research misconduct doesn’t include honest error or differences of opinion.
Defining human subjects research
- Research 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’s empirically tested. If the conclusions resulting from data analysis don’t 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 Institutional Review Board’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:
- Data through intervention or interaction with the individual, or
- Identifying private information.
Research versus public health practice
The 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 aren’t, 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 the Colorado Department of Public Health and Environment (CDPHE) may be either public health practice or research (or may include a component that involves research activities).
- If the activity is public health practice, it isn\'t subject to Institutional Review Board (IRB) review or the provisions of federal Regulation 45 CFR 46.
- If the activity is research or contains a component of research, it’s subject to IRB review and the provisions of federal Regulation 45 CFR 46. However, in addition to outlining the requirements for protection of human subjects, the federal regulation also identifies categories of research that may be exempt from IRB review. The IRB chair must review the study protocol in order to determine whether the criteria for exemption are met.
Compliance with national norms of human subjects protections
Under the U.S. Department of Health and Human Services (DHHS) human subject protection regulations at 45 CFR 46, 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. Our Federalwide Assurance Number is FWA 00003044.
All our 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.
Human subjects research review process
- All research studies involving human subjects must be reviewed by the Institutional Review Board 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.
- The board’s approval must precede initiation of any work involving human subjects.
- Investigators seeking IRB approval of research must follow our IRB meeting and protocol submittal schedule.Investigators must submit to the board:
- A completed IRB Summary of Proposed Research Form.
- A complete and final research protocol.
- All associated documentation (fact sheets, consent forms, dialogue scripts, etc.).
- An IRB Summary Requirements Form must accompany all protocols submitted to the board before all levels of review (exempt, expedited or full board review).
- The form may be submitted before the full final protocol to provide the board an overview of the proposed research, and may allow a preliminary determination of the required type of review.
- At a minimum, all Colorado Department of Public Health and Environment (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 chair or by one or more experienced reviewers designated by the chair from among members of the board.
- In reviewing the research, the reviewers may exercise all 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 board.
- Protocols requiring a full board review will be assigned to a scheduled 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 board 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 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 depends on the level of risk to the research subjects associated with the research protocol, which is determined by the board.
- An IRB Continuing Review Form should be completed and submitted to the IRB before 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.
Training for investigators
Our Institutional Review Board (IRB) requires that all Colorado Department of Public Health and Environment (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. It will help investigators and their teams identify research activities that involve human participants, and protect participants\' rights and welfare. Protocol reviews and continuing reviews won’t be approved without documentation that training has been completed.
The minimum training requirement can be completed in either of two ways:
- Complete the online training "Protecting Human Research Participants," available at the National Institutes of Health website.
- The tutorial will provide investigators a Completion Certificate.
- A copy of the Completion Certificate should be sent to our IRB administrator.
- Complete the CD-based training “Investigator 101: Training for Investigators in the Responsible Conduct of Human Subjects Research.”
Substitution of the requirement described above with equivalent or similar training should be discussed with the IRB chair.
The 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, as well as to health plans and health care clearinghouses.
Although the Colorado Department of Public Health and Environment as a public health authority isn’t a covered entity under HIPAA, many of the concerns HIPAA addresses do apply to us. We’re a business associate of other covered entities in some instances and as such must comply with some parts of HIPAA.
Furthermore, much of the data we collect comes from agencies and institutions that are covered by HIPAA. By basing our policies and procedures on HIPAA we’re positioning ourselves to stay current with developments in the health care industry for privacy and security.
We’ve developed policies addressing privacy and security. One policy is specific to the protection of human subjects who participate in research activities. It 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.
- The full text of the Privacy Rule and U.S. Department of Health and Human Services educational materials on the rule can be found on the Office for Civil Rights HIPAA Privacy website.
- Health and Human Services educational materials on the Privacy Rule for the research community can be found on the Office for Civil Rights HIPAA Privacy website.
More information can be obtained from our privacy officer:
Privacy Officer/Institutional Review Board Administrator
Office of Legal and Regulatory Compliance
IRB meeting and protocol submission schedule
Our 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’s advisable to submit all materials, including supporting documentation, ahead of deadlines so there’s time for the chair to provide preliminary feedback to the principal investigator and to determine whether the protocol requires discussion during a board meeting.
The chair routes submitted and finalized protocol materials to IRB members 10 to 12 days before the meeting date.
Minutes of convened IRB meetings are not available to the public for review and are considered confidential. Access to IRB meeting minutes is restricted to IRB members, the institutional official and others deemed appropriate by the IRB, unless otherwise required by law.
IRB meeting month
Principal investigator notifies or schedules meeting with IRB chair
All protocol materials due to IRB chair
IRB meeting date