Determining whether a project requires review by the IRB is sometimes difficult and for this reason it is always best to consult with the Human Research Protection Office (HRPO) for guidance.
The HRPO makes the determination whether or not a project meets the definition of human subject research. Federal regulations require that proposed research involving human subjects be reviewed and approved by the Institutional Review Board prior to project initiation. If you are unsure if your project meets the definition of research or if you require documentation that your project does not require IRB review, complete and submit the Determination of Human Subject Research form.
The determination of whether or not a project or activity is defined as human subject research rests on the answers to the following three questions:
- Is it research? Federal regulation defines research as a systematic investigation, including research development, testing, and evaluation, that is designed to develop or contribute to generalizable knowledge. Research is usually described in a protocol, a formal document that describes the research question or hypothesis and how it is to be tested (methodology) to establish facts and reach conclusions.
Is the intent to produce generalizable knowledge? The intent to develop or contribute to generalizable knowledge makes an activity research. Generalizable knowledge is knowledge that is expressed in theories, principles, or statements of relationships that can be generally applied to our experiences. Activities designed to contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program. The information is collected to share with others in a discipline and is created to make a broad statement (conclusion) about a group of people, procedures, programs, etc.
*If the activity is not a systematic investigation designed to contribute to generalizable knowledge, the activity does not meet the regulatory definition of research.
Generalizable knowledge includes one or more of the following concepts: (1) The information contributes to a theoretical framework or an established body of knowledge; (2) The primary beneficiaries of the study are other researchers, scholars, and practitioners in the field of study; (3) Publication, presentation or other distribution of the results is intended to inform the field of study; and, (4) The results are intended to be replicated in other settings
- Does it involve human subjects? Although a seemingly straight-forward question, whether or not an activity involves human subjects can be somewhat confusing, especially when using coded private information or specimens. Human subjects are defined as “living individuals about whom an investigator conducting research obtains:
- Data through intervention or interaction with the individual, or
- Identifiable private information
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
For purposes of this document, coded means that:
- 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); and
- A key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.
Determinations of what does or does not involve human subject research must be made by the IRB or individuals designated by the IRB Chair who have sufficient training and expertise in making such determinations.
In analyzing a particular activity under this question, it is important to focus on what is being obtained by the investigators. If the investigators are not obtaining either data through intervention or interaction with living individuals, or identifiable private information, then the research activity does not involve human subjects.
What about Research Involving Coded Private Information or Biological Specimens?
Whether or not an activity is classified as “not involving human subjects” or qualifies for exemption under 45 CFR 46.101(b)(4) is determined by the following:
- the source of the data (primary or secondary data)
- ability or inability of the investigator to link data or specimens to specific individuals either directly or indirectly through coding systems
Research involving only coded private information or specimens is not considered human subject research if both of the following conditions are met:
- The private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals (i.e. it is pre-existing data); and
The investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because, for example:
- The investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased (note that the HHS regulations do not require the IRB to review and approve this agreement);
- There are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased; or
- There are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.
The exemption under 45 CFR 46.101(b)(4) applies to research involving private information and specimens when:
- Data is already existing at the time the research is proposed and is available publicy, or
- The information is recorded by the investigator(s) in such a manner that subjects cannot be identified, directly or through identifiers linked to subjects.
This exemption would not apply if the investigators, having obtained identifiable private information or specimens from existing records or specimens, record the data or information in a coded manner, since the code would enable subjects to be identified through identifiers linked to the subjects.