1. QI project or research? Thomas F. Byrd M.D. HRRC Chair Subcommitees 2 and 4 December 3, 2013

2. US Department of Health and Human Services (HHS) definition of research Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities

3. Differences between QI projects and research QI is designed to bring about immediate improvements in healthcare delivery QI is designed to have its findings applicable only to the local institution QI is designed to sustain the improvements QI does not require rigid, fixed protocols; within QI activities it is acceptable to adapt the project over time

4. QI Projects It is a given that QI is a necessary activity for institutions taking care of patients There is an institutional responsibility (clinical and administrative leadership) to insure that QI projects do not expose patients to more than minimal risk “..there is a responsibility that health care providers improve quality” and that patients are responsible to “cooperate with improvement efforts”* “..patients must be kept safe from harms and violations of their rights”* *Ann Intern Med. 2007;146(9):680-681

5. Possible publication of QI project – considerations at the outset Would publication of the project’s findings be desirable? Dissemination of information outside the project’s institution has implications for demonstration of oversight. If no upfront desire is expressed to publish the project’s findings, the internally situated work is considered QI and the oversight deemed necessary falls at the level of routine internal oversight of good clinical and management practice. When there is no perceived extra risk to patients, IRB approval may be excluded

6. Possible publication of QI project – considerations at the outset Examine the project’s safety for patients. QI activity implies that the intervention is at least as safe as routine care. If there is more risk, IRB oversight is required at the outset to demonstrate to the internal and external medical community that the project is a thoughtful and well-designed research study

7. Possible publication of QI project For publication purposes there is a need to demonstrate how oversight was conducted When a QI project is an intervention and the manuscript contains patient data (even if averaged and de-identified), it can be argued that the bar for demonstrable oversight is increased One important consideration will be confidentiality of data ie, whether HIPAA guidelines were maintained during the study An HRRC review is indicated to ensure that patient safety was upheld and that HIPAA guidelines were followed

8. Exempt research activities Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management method Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter(b)(2)

9. Exempt research activities Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture

10. References http://answers.hhs.gov/ohrp/categories/1569 Am J Crit Care 2007;16:424-426 Ann Intern Med 2007;146(9):680-681