Institutional Review Board

The federal definition of research under 45 CFR 46.102(l)

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Relevant to Hampden-Sydney College researchers, the following activities are deemed not to be 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.

Program evaluation and quality improvement projects are not considered human subjects research when:

• They do not involve experimental or non-standard interventions;
• Their intent is only to provide information for an about the setting in which they are conducted;
• They are conducted as part of standard operating procedures of the setting; and
• They are (usually) not subject to peer review

Some questions you can ask to help determine if your project meets this definition:

• Is the goal of the project/program evaluation to test a hypothesis or answer a research question?
  • Yes - probably research
  • No - probably not research
• Will the activity benefit people/communities/entities other than those from whom that data are collected?  Will the results be generalizable to a population beyond the study population?  Will the activity contribute broadly to knowledge?
  • No - probably not research
• Is the activity a routine operation in the setting?  
  • Yes - probably not research
• Do the investigators/people collecting the data have regular and routine contact with the data or the subjects?
  • Yes - probably not research
• Does the activity alter the timing or frequency of standard procedures?
  • No - probably not research
• Is the entity in which the activity is taking place paying for it?
  • Yes - probably not research

It is recommended that you are specific when referring to your project as either research, program evaluation, or quality improvement in publications or presentations because these are different types of projects from an IRB/regulatory perspective.

Answer the following questions:

1. Will you be gathering information or biospecimens about living subjects?
2. Will you obtain information or biospecimens through intervention with living individuals, and use, study, or analyze the information or biospecimens?
3. Will you obtain information or biospecimens through interaction with living individuals and use, study, or analyze the information or biospecimens?  Note that interaction includes indirect interaction such as a web-based survey.
4. Will you obtain, use, study, analyze, or generate identifiable private information or identifiable biospecimens?

You are working with human subjects if you answered "Yes" to 1 and 2, and "Yes" to 3 or 4

 The federal definition of human subjects data can be tricky to tease out.  The language is provided below however some key considerations are:

• Are you interacting with the subject to obtain the information?  Interaction can range from meeting the subject in a lab to collect a specimen or conduct an interview, to sending out or posting a link to an electronic survey.  You have initiated the participation and collection of data.
• The data that you are collecting is specific to the subject.  You are focusing on the person rather than policies, practices, or procedures about which the person is knowledgeable.  For example, a person may answer questions about the number of students in an academic program, average GPA, and post-graduate employment opportunities, but this is not information about that person, it is information about the program.  The person is simply the mechanism being used to provide the information and can be identified.  There is not the same expectation of privacy or anonymity.  Asking about another person/other people/policies/procedures does not make the person a human subject. 
  • Asking about private information of others (third party information) may violate privacy.  For example, asking about the mental health symptoms and diagnoses of family members.  The person with the mental health diagnosis has not had the opportunity to consent to the sharing of their data with the researchers if they have not completed the informed consent process.
• Data that are publicly available that originate from individuals (for example, test score data published by the Department of Education) are not considered to be human subjects data.  
• Data that are published in the public sphere forgo the expectation of privacy and are not considered human subjects data.  Examples include public social media posts, or comments on a public webpage.  Data that are behind some kind of wall, for example, a moderated Facebook group that you must be approved to join, should be treated as private information.

The federal definition of a human subject under 45 CFR 46.102(e)  is:

(e)(1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research:

1. (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
   (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

(2) Intervention includes both 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.

(3) Interaction includes communication or interpersonal contact between investigator and subject.

(4) 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 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).

(5) 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.

(6) An 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.