Does Your Research Require IRB Review?

Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A project requires IRB review if it meets the definition of research, and involves interaction or intervention with human subjects and/or their private identifiable information.

The IRB Staff will make a final determination as to whether a project constitutes human subjects research.   Use of the following information will assist researchers in sharing pertinent details regarding their work that will be assessed in making this determination.

A Systematic Investigation is:

Typically a predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing theory.  A scientific or scholarly activity involving qualitative or quantitative data collection and/or data analysis that sets forth an objective(s) and a set of procedures intended to reach the objective(s), i.e., to acquire knowledge, develop a theory, or to answer a question.

 

INCLUDES: observational studies, interview or survey studies, group comparison studies, test development and interventional research

 

NOT SYSTEMATIC INVESTIGATIONS: oral histories, journalism, phenomenological activities

 

GRAY AREA: Program Evaluation – need to assess design and intent

Accordion content 1.

 Generalizable Knowledge

The intent or purpose of the systematic investigation is dissemination of findings (publication or presentation) outside of Swarthmore College.

 

Findings are intended to have an impact (theoretical or practical) on others within one’s discipline.

 

Dissemination with the intent to influence behavior, practice, theory, future research designs, etc. are contributing to generalizable knowledge.

 

CONSIDER: Would this project be conducted as proposed if the PI knew that he or she would never receive any form of academic recognition for the project, including publication of results or presentation of the project at an academic meeting?

A Human Subject is:

A living individual about whom an investigator conducting research:

 

Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; OR 

 

Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens

 

Intervention includes physical procedures by which data are gathered and manipulations of the subjects or the subjects’ environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subjects. The interaction may be as remote as an anonymous, online survey.

 

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/or 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 is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.  

 

Identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

Activities that are NOT human subjects research:

(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

 

(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

 

(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

 

(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions. 

 

For more information about human subjects research, please refer to the Code of Federal Regulations (45 CFR 46) at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html or contact the Swarthmore IRB at IRB@Swarthmore.edu.