Does program evaluation Need IRB approval
This is the first of four steps in determining whether your planned activity requires IRB review. Show
Why this matters
Two definitions of “research”Definition 1Research is a systematic investigation, including research development, testing, and/or evaluation, designed to develop or contribute to generalizable knowledge. Systematic investigation: A detailed or careful examination that has or involves a prospectively identified approach to the activity based on a system, method, or plan. Generalizable knowledge: The information is expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following:
Definition 2The activity is research if both of the following conditions are met:
Special casesActivities can be considered research even if they are also considered to be program evaluation, quality improvement, public health surveillance, preliminary work, or pilot studies. For more information about these and other special situations, consult the HSD document entitled GUIDANCE Is It Research? Request a determination (optional)Follow these directions if you’d like to have a formal determination about whether your activity is research. Example situations for which a determination might be appropriate: (1) you need a determination in order to obtain or access data from a source; (2) you think you might need a determination later when you publish results; (3) you have a complicated project.
Next step, if you think your activity is researchDetermine whether your activity involves human subjects. More information
In some instances publishers, financial sponsors or others may require an official IRB determination that a project is not human subjects research (NHSR). If you need an official NHSR determination you must submit an abbreviated application for initial review. In This Section
Related Topics
Interactive QuestionnairesHuman Subjects Research Determination: This dynamic series of questions helps you determine if your project must be submitted to the IRB. While the questionnaire provides information about when IRB review is required, it does not provide an official IRB determination. Quality Assessment/Quality Improvement/Program Evaluation Projects: Program evaluation and quality improvement efforts can be especially difficult to assess for IRB review requirements. This series of questions is meant to help you determine if your QA/QI project must be submitted to the IRB. While the questionnaire provides information about when IRB review is required, it does not provide an official IRB determination. Is IRB Review Required?Below are three questions to assist in determining if your study must be submitted for review.
For the purpose of IRB review a project is considered research if it meets the definition of research provided by either DHHS or the FDA. a. Research as defined by the DHHS A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A “systematic investigation” is an activity that involves a prospective plan to obtain data and conduct an analysis to answer a question. Research often includes interventions and interactions with human participants. Data can also be obtained by reviewing documents or other materials. Knowledge is “generalizable” when the conclusions drawn from the data analysis will be applied to populations outside of the specific study population. In other words, if the results of the systematic investigation are expected to be generalized to a larger population beyond the site of data collection and replicated in other settings, then the knowledge is generalizable. b. Research (i.e. clinical investigation) as defined by the FDA Any experiment that involves a test article and one or more human subjects, and that meets any one of the following:
The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for purposes of this definition. 2. Does the project involve human subjects as defined by the DHHS or FDA? Human Subject as defined by DHHS: A living individual about whom an investigator (whether professional or student) conducting research obtains (1) information or biospecimens through Intervention or Interaction with the individual, and uses, studies or analyzes the information or biospecimens or (2) uses, studies, analyzes or generates identifiable private information or identifiable biospecimens. For the purpose of this definition:
In other words, if you are interacting (communicating or observing) or intervening (administering a procedure, changing the environment, etc.) with humans to obtain information or biospecimens about them for research purposes, then you must submit the project is human subject research and should be submitted to the IRB. Likewise, if you are obtaining for research purposes private information that is identifiable to the individual about whom it pertains, then you must submit the project is human subject research and should be submitted to the IRB. Human Subject as defined by FDA: An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. A human subject includes an individual on whose specimen a medical device is used. If you think that your project is indeed research involving human subjects or a clinical investigation, you should submit your project to the IRB. The IRB will conduct a preliminary review and inform you by letter if the project is not “human subject research.” The IRB may also inform you that that the project involves human subjects but UC Davis is not engaged in the “human subjects” part of the research. 3. Is UC Davis engaged in human subject research activities? UC Davis is engaged in human subject research if either:
Note: The IRB, not the investigator, determines if the institution is engaged in research. If your project meets the criteria of a research project involving human subjects submit a new project to the IRB. In some instances, UC Davis employees attend an external University or College and conduct human subject research to meet the requirements of the external institution. In these instances, the student is not considered “engaged” in human subject research for UC Davis when the research is not being conducted under the direction of a UC Davis department director, chair, or dean. How to Request a Not Human Subjects Research DeterminationTo request a prospective determination of “not human subjects research” (NHSR), create a new project in IRBNet and submit HRP-210 FORM: Request for Determination. You do not need to complete human subjects research training. The purpose of completing the HRP-210 FORM is to provide the IRB with sufficient information about the activity to make an informed determination. When completing the HRP-210 FORM:
An NHSR determination may be granted if:
Or
What if my project involves only analysis of data or specimens?Unless the research is subject to FDA oversight the need for IRB review when analyzing existing data or specimens is usually determined by the investigator’s ability to ascertain the identity of the individual to whom the data or specimen pertain. There may be different review requirements for research that involves only analysis of data or specimens. To determine the level of review it is important to make the distinction between anonymous, de-identified and coded, and identifiable data/specimens.
Research involving existing anonymous or de-identified and coded data/specimens where the investigator will not have access to private identifiable information and no contact with the subjects is not human subject research. Upon receipt of a submission involving this type of research, the IRB will issue a determination of “Not Human Subjects Research”. Research involving access to existing data/and or specimens containing identifying information and the investigator 1.) does not record any identifiers and 2.) does not apply a code to the recorded data that is linked to the individuals’ identities, the IRB will will issue a determination of “Exempt“. The IRB has developed this flowchart to assist in understanding the appropriate review level for analysis of data or specimens. Note: If the identifiable information constitutes PHI (Protected Health Information) and the PHI will be accessed, but not recorded by the investigator, the HIPAA Privacy Rule applies and the investigator will need to comply with the regulatory requirements to access the PHI, which could include:
What if my project is a QA/QI activity?Quality assurance/quality improvement activities conducted by one or more institutions whose purposes are limited to:
The intent to publish the results of such projects does not make them research. The DHHS website has a helpful FAQ section addressing QA/QI projects here. However, in certain cases, a QA/QI activity may constitute human subjects research. The table below can assist with making the determination whether this is a QA/QI activity or research with human subjects. QA/QI vs ResearchQA/QI
Research
Examples of QA/QI projects are:
What if my project involves case studies?Case reports or case series must be submitted to the UC Davis IRB for review if the definition of “Human Subjects Research” as defined in the regulations by DHHS is met. While many institutions require a case series of two, three, or more cases be submitted to the IRB, at UC Davis the requirement for IRB submission is based on the intent of the report, not on the number of cases to be reviewed. A case report or case series does NOT meet the federal definition of “Human Subjects Research” if all of the following conditions are met:
Many journals require a letter from the IRB stating that the project was approved or IRB review was not required. To obtain this letter, please submit your protocol to the IRB. Click here for instruction on submitting a new project. Note: That while a project may not require IRB review and approval, there may be implications for HIPAA compliance when accessing medical records. Please visit the UC Davis Health System Compliance Office for assistance and guidance here. Also, the HIPAA Privacy Rule protects individually identifiable health information about a decedent for 50 years following the date of the death of the individual. Under federal regulations a covered entity can provide access to protected health information (PHI) for decent research purposes with no identifiers linked to living persons. Requests for such access must be approved by UCDMC Compliance and requires completion of a decedent research application available on the Compliance’s website here. What about Oral History and Journalism Projects?Oral History: The National Oral History Association (OHA) defines oral history as “a method of gathering and preserving historical information through recorded interviews with participants in past events and ways of life”. Oral history is a recorded conversation about the past with named individuals in which knowledge about specific events and individual lives is narrated in story form and made available to the public through deposit in archives. Oral history projects are not considered human subjects research. Journalism: Activities that focus on the collection, verification, reporting and analysis of information or facts on current events, newsworthy issues or stories about people or events do not constitute human subjects research. However, exercise of professional ethics is expected. NOTE: students conducting a master thesis or doctoral dissertation are required to submit their projects to the IRB for determination regardless if the research is an Oral History or Journalism. For more information, review our guidance on student researchers here. Research Involving Deceased Persons or CadaversUnder federal law, research involving deceased persons generally is not human subjects research and does not require review IRB review and approval. However, there are three exceptions.
Research involving State of California-produced death data files that do not contain personal identifying information does not need to be approved by an IRB. NOTE: Access to State of California-produced death data files that include personal identifying information also requires review by the State of California Committee for the Protection of Human Subjects (CPHS). Researchers apply for CPHS review when ordering the data from the State of California. The State of California requires that researchers have a “valid scientific interest” in order for the IRB to approve such a study. Which type of review does not require IRB approval?Examples of Studies that Generally Do Not Require IRB Review
Data collected for internal departmental or administrative purposes, such as teaching evaluations, student performance data, etc. Activities designed solely for quality improvement or evaluation of a program, course, etc.
What activities require IRB approval?Experiments using a test article (e.g., investigational drug or biologic, or device) on one or more human subjects, or on the specimen of a human subject, that are regulated by the Food and Drug Administration (FDA) or support applications for research or marketing permits for products regulated by the FDA.
Is a program evaluation research?What's the difference between evaluation, research, and monitoring? Evaluation: Purpose is to determine effectiveness of a specific program or model and understand why a program may or may not be working. Goal is to improve programs. Research: Purpose is theory testing and to produce generalizable knowledge.
What documents require IRB approval?IRB Submission Checklist. Application.. Consent Document(s). Recruitment Materials.. Study Instrument(s). Permission Letters (if applicable). Certificate of Education (if not already on file). Grant proposal narrative (if applicable). The application materials have been made into one PDF.. |