Do I Need a Review

The sole purpose of an institutional review board is to determine the ethics and safety of research involving human participants. This determination is made by reviewing proposed research prior to the commencement of a study. 

The definitive authority on human participant research in the U.S. is the federal Department of Health & Human Services. Their regulations on this topic are found in Code of Federal Regulations TITLE 45: Public Welfare, Department of Health and Human Services. PART 46: Protection of Human Subjects (“45 CFR part 46” for short).

How do researchers know if a project requires review? This section is intended to help potential researchers make this determination. Like most government documents, 45 CFR 46 takes a bit of effort to read and interpret. Several fundamental concepts are highlighted and explained here. 

HHS regulations define research at 45 CFR 46.102(d) as follows:

Research means a systematic investigation, including research development, testing & 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.” 

Consider

  1. Is your project a “systematic investigation” that features a special plan (protocol) carried out with an identified group of participants? 
  2. Are you thinking like a researcher with the idea that you will gather data (information, interviews, observations, etc.) in order to draw (generalizable) conclusions for presentation in some “public” context?

HHS regulations define human subject  & related terms at 45 CFR 46.102(f) as follows:

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information."

Consider

Will you be inviting people to participate in your project for the purpose of gathering and analyzing data?

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) & manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator & subject."

Consider

Are you conducting special, deliberate or out of the ordinary activities with the people you are engaging in your study?

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, & information which has been provided for specific purposes by an individual & 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.”

Consider

  1. Are you eliciting information a person would not typically disclose publicly in the course of a normal day?
  2. Will that information be recorded (and shared) in such a way that an outside observer could link it back to that individual? 

Note: "Healthcare” information might first come to mind, but other demographic (age, gender) or numeric data (address) count , too!

The SAIC IRB is guided by two key phrases in the HHS definition of research. In general, BOTH factors must apply for a project to be considered “Research” for review purposes.

  1. Systematic Investigation—Is there some kind of organized plan to collect “data” for later analysis & dissemination? 
  2. Generalizable Knowledge—Can and will the findings from this investigation be applied to other similar circumstances? 

Keep these two factors in mind as you contemplate a project to help determine if an IRB review is needed. At SAIC, distinguishing formal human participant research from projects of an artistic or journalistic nature is common. For example:

  • Is a photo documentary series research or art?
  • Are interviews with artists considered research or journalism?

While most research organizations (universities, large hospitals, etc.) have their own IRBs, many smaller agencies do not yet have the imperative for reviewing the ethics and safety of research projects. The IRB at SAIC evolved out of the need to support student researchers working in circumstances where no other review options were available.

In most cases, researchers from the SAIC community are conducting projects with collaborating institutions (for example, healthcare, school, or community organizations). Having an IRB review of a proposed study not only provides reassurance that the project is safe and ethical but also ensures that the partner organization adheres to their federal obligations for research involving the people their agency serves.