Review Determination Assistance
Below is a series of questions to assist in determining if your study must be submitted for review. If you believe your project does not require IRB review, but you would like to receive an official IRB determination, you must submit an Initial Review Application and supporting documents via IRBNet. Click here for instructions on submitting an Initial Review Application or a request for a not human subjects research (NHSR) determination.
Is the project research as defined by the Department of Health and Human Services (DHHS) or the Food and Drug Administration (FDA)?
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:
- Any use of a drug other than the use of an approved drug in the course of medical practice;
- Any activity that evaluates the safety or effectiveness of a device; OR
- Any activity the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit
The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for purposes of this definition.
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:
- Intervention: Physical procedures by which information or biospecimens are gathered (e.g. venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
- Interaction: Communication or interpersonal contact between investigator and subject.
- Private Information: Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g. a medical record).
- Identifiable Private Information: Information for which the identity of the subject is or may be readily ascertained by the investigator or associated with the information (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).
- Identifiable Biospecimen: A biospecimen for which the identity of the subject is or may be readily ascertained by the investigator or associated with the biospecimen.
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.
Is UC Davis engaged in human subject research activities?
UC Davis is engaged in human subject research if either:
- The institution receives an award through a grant, contract, or cooperative agreement directly from a federal agency for non-exempt Human Research; or
- The institution’s employees or agents interact or intervene with human subjects to obtain data about the subjects or obtain private, identifiable information about a living individual; or
- The intuition’s employees or agents obtain informed consent of human subjects for research.
What are the differences between Exempt, Expedited, and Full Board reviews?
The IRB assesses and evaluates during its review process whether the proposed research meets federal criteria for the level of review. The levels of IRB review may change throughout the course of a study depending on the nature and risk level of subsequent amendments or the stages of the research.
Although the category is called “exempt,” this type of research does require IRB review and registration. The exempt review process is much less rigorous than an expedited or full-committee review. To qualify, research must fall into six (6) federally-defined exempt categories (see Worksheet: Exemption Determination HRP-312). These categories present the lowest amount of risk to potential subjects because, generally speaking, they involve either collection of anonymous or publicly-available data, or conduct of the least potentially-harmful research experiments. Some examples of Exempt research are:
- anonymous surveys or interviews
- passive observation of public behavior without collection of identifiers
- retrospective chart reviews
- analyses of discarded pathological specimens without patient identifiers.
To qualify for an expedited review, research must fall into nine (9) federally-defined expedited categories (see Worksheet: Eligibility for Review Using the Expedited Procedure HRP-313). These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects. Some examples of expedited research are:
- studies involving collection of hair, saliva or dental plaque samples,
- studies of blood samples from healthy volunteers,
- analyses of voice recordings
- studies of existing pathological specimens with patient identifiers.
Expedited review as defined by federal regulations allows the IRB chairperson or one or more experienced reviewers designated by the chairperson from among members of the IRB to evaluate and approve specific types of research. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study. When a subcommittee cannot approve the research under expedited review, the study is referred to the full Committee for review.
Proposed human subject research which does not fall into either the exempt or expedited review categories must be submitted for full committee review. Please see the Committee Calendar for submission deadlines and meeting dates for all IRB Committees.
What if my research project is exempt?
DHHS regulations identify several different categories of minimal risk research as being exempt from federal policy for the protection of human subjects.
Exempt research involves human subjects, but IRB approval is not required. However, you must submit the study to the IRB. The IRB will review the application and determine that the study qualifies for the exemption. You will receive an exempt determination letter, not a letter of approval.
There are six exemption categories designated in the Common Rule that are applicable to human subject research that is federally funded or supported. UC Davis has elected to include a 7th exemption category for research that is not federally funded or supported. These categories can be found in Worksheet: Exemption Determination HRP-312. Researchers are encouraged to apply this worksheet to their study and determine whether the research is exempt because the requirements for informed consent are less stringent than the requirements for non-exempt research.
When the IRB determines that a project is exempt, the reviewer will then determine if the following additional requirements are met:
- The research must involve no more than minimal risk to subjects
- Selection of subjects must be equitable (That is, the research is appropriate for the population being studied).
- If there is recording of identifiable information, there are adequate provisions to maintain the confidentiality of the data
- There are adequate provisions to maintain the privacy interests of the subjects.
- If there are interactions with human subjects, there will be consent process:
- The consent process will disclose that the activities involve research
- The consent process will disclose the procedures to be performed
- The consent process will disclose that participation is voluntary
- The consent process will disclose the name and contact information for the investigator
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.
- Anonymous data or specimens: The investigator is not able to ascertain the identity of the individual because no information is included that could lead to the identity of the individual and there is no other method the investigator can use to identify to whom the data or specimen pertains. For a list of direct of identifiers that must not be included click here.
- De-identified data or specimens: Data that has been stripped of all “direct identifiers” to prevent identification of the individual.
- Coded data or specimens: The data or specimen include a code (the code has no relation to the individual to whom the data or specimen pertains), and no other identifying information is included. The code is linked to a key that enables linkage between the identifying information and the code.
- identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code)
- Identifiable data or specimens: The investigator can readily ascertain the identity of the individual to whom the data or specimen pertains.
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:
- implementing a practice to improve the quality of patient care, and
- collecting patient or provider data regarding the implementation of the practice for clinical, practical, or administrative purposes do not constitute human subjects research.
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 Research
- Intent – identify, control a problem or improve a program/service
- Benefit to participants or participant’s community
- Data collected to assess/improve the problem, program or service
- Knowledge is not generalized beyond scope of the activity
- No experimental activities
- Intent – generalizable knowledge to improve practice
- Benefit extends beyond participants – usually to society
- Data collected exceeds requirements for patient care
- Project activities may be experimental
Examples of QA/QI projects are:
- Evaluating procedures administered to patients in usual care practices
- Reduction in in-patient admissions and length of stay
- Reduction of morbidity and mortality
- Classroom course evaluations
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:
- The activities are limited to only reporting the facts. There is no intention to form a hypothesis, draw conclusions or generalize findings to a population outside of the sample case(s); AND
- Identifiable information is NOT obtained from a State of California Agency (such as CA Dept. of Public Health, county registrar, etc.); AND
- There is no plan to collect information that would not normally be placed in the records.
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.
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?
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.
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.
Research Involving Deceased Persons or Cadavers
Under 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.
- If the data or samples contain personal identifiers, the research is subject to HIPAA. In this case, IRB approval of the research is not required, but the investigator must obtain authorization from the deceased individual’s legally authorized representative or must obtain approval from the UCDMC Compliance Department.
- If the information collected from a cadaver will result in an investigator obtaining information about the cadaver’s living relatives (e.g., genetic studies) IRB approval is required. These activities meet the definition of human subjects research because the researcher will collect private, identifiable information about third parties.
- If the research involves State of California-produced death data files containing personal identifying information then IRB approval may be required. State of California-produced death data files which require IRB approval include:
- All files that can be linked to other death files using the certificate number (e.g., Death Address Files, Multiple Cause of Death Files); and
- All files that are provided with personal identifiers (e.g., Death Statistical Master Files, Merged Death Files, Fetal Death Statistical Master Files).
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.
Report to the IRB using Form: Reportable New Information (HRP-214), any information items listed on this form within five to ten business days. The IRB will review the submission to determine if any of the information items meet the definitions of serious noncompliance, continuing noncompliance or an unanticipated problem involving risks to subjects or others (UPIRTSO), as listed in SOP: Definitions (HRP-001).
Submit an updated disclosure of financial interests within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new financial interest. For additional information, see SOP: Financial Conflicts Of Interest (HRP-055).
For more information on Reporting to the IRB go here.