Definitions

For the online application

Read these definitions and examples when answering the introductory questions on the Trinity College IRB online application:

1) Does an external funder or academic publisher require you to submit proof of a completed IRB review?

• • • YES (or maybe) [Automatically sends you to complete IRB form]
    • NO [Continues to next question]

Some external funding agencies and academic journals require researchers to submit proof of a completed IRB review before they can receive a grant or publish their study.

2) Will you obtain or use identifiable private information about living humans?

• • • YES (or maybe) [Continues to next question]
    • NO [This stops the online form, because your project does not require Trinity IRB approval. But you are still responsible for upholding ethical standards when conducting your work.]

A. Examples of YES:

1. 1. Biomedical procedures or psychological tests with identified participants
   2. Confidential interviews, where researchers collect participants’ private identifiable information (such as names, address, voice recordings, etc.), and promise not to reveal this information
   3. Confidential surveys, where researchers collect participants’ private identifiable information (such as names, address, etc.) and promise not to reveal this information
   4. Focus groups, where participants hear statements made by other identifiable members of the group
   5. Observations of human behavior in non-public settings (where people have some expectation of privacy), and researchers record identifiable details that can be traced back to specific individuals (such as field notes with real names or initials, close-up video of people’s faces, etc.)
   6. Obtaining private data that includes participants’ names or other identifiable details (such as date of birth, social security number, photo, or agency identification code)

B. Examples of NO:

1. 1. If you use aggregated data about groups of people (such as US Census tract demographics, or school-level test scores), which cannot be traced back to specific individuals, this is not “identifiable” data.
   2. If you use individual-level data that has been collected previously by another party, which no one on your research team can trace back to specific living individuals, this is not “identifiable” data.
   3. If you observe public behavior or conduct anonymous interviews or surveys, and no one on your research team collects participants’ names or personal details that could be traced back to specific individuals, this is not “identifiable” data.
   4. If you observe students in a typical educational setting, and do not collect their names or personal details that could be traced back to specific individuals, this is not “identifiable” data.
   5. If you conduct an interview with a consenting adult who agrees to be publicly named (as is commonly done in journalism, oral history, and sometimes in other social sciences), this is not “private” information. But you are still responsible for upholding the ethical standards in this field of study, such as asking for the participant’s consent to archive or publish their account, in print and/or on the web.
   6. If you interview a government official or candidate for public office, this is not “private” information.​
   7. If you use publicly available data that includes individual details (such as political campaign donations, which are required by law to include names and addresses), this is not “private” information.
   8. If you collect data from people solely about products, procedures, or policies, rather than their personal decisions or opinions, this is not information “about” the individual. For example, if an interviewer asks an educator only to describe a school policy, rather than his/her personal opinion or experiences, no data “about” the individual is collected.

3) Will your research place participants at greater than minimal risk OR involve vulnerable populations?

• • • YES (or maybe) [Automatically sends you to complete IRB form.]
    • NO [Continues to next question.]

A. Minimal risk

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Examples of minimal risk:

1. 1. Routine, non-sensitive data gathered for educational or employment purposes, where there is an expectation of standardized tests or regular examinations
   2. Measures of mental status or memory functioning, outside of a clinical setting
   3. Standardized intelligence tests
   4. Personality inventories
   5. Consumer preference surveys

B. Examples of GREATER than minimal risk:

1. 1. Collection of individually identifiable data that could result in embarrassment or other personal harm due to a breach of confidentiality
   2. Use of identifiable medical records or protected health information
   3. Covert observations in settings where privacy is expected
   4. Procedures that use deception or mislead participants
   5. Infliction of significant pain, physical discomfort, or emotional distress

C. Vulnerable populations:

1. 1. Children (anyone under the age of 18)
   2. Prisoners or parolees
   3. Pregnant women or fetuses
   4. People with diminished capacity to freely give informed consent, due to such factors as limited mental capacity, limited education, or lack of fluency in the language of the research materials

4)Will your study produce generalizable research AND will it be widely distributed?

• • • YES (or maybe) [Automatically sends you to complete IRB form.]
    • NO [This stops the online form, because your project does not require Trinity IRB approval. But you are still responsible for upholding ethical standards when conducting your work.]

A. Generalizable research

Generalizable research means a systematic investigation that is designed to contribute to knowledge beyond the specific population that was studied. For example, if a researcher collects data from a sample of people in group X, in order to produce new claims about group X, this is “generalizable” research.

B. Examples of widely distributed research:

1. 1. A researcher presents a study at an academic conference or off-campus public event.
   2. A researcher submits a full research study (more than an abstract or brief summary) to a journal, or uploads it to the Trinity Digital Repository, or publishes it on the web.

C. Exceptions:

1. 1. If a professor instructs students to conduct a research project to demonstrate or verify existing findings in the academic literature, this is not “generalizable” research.
   2. If you conduct a program evaluation to assess or improve services for a specific organization, this is not “generalizable” research, according to the federal definition.
   3. If you conduct a research study and present it at an on-campus event or poster fair, this is not “widely distributed” research.
   4. If you conduct a research study, and send the full text to a limited audience (such as an off-campus collaborator, or as part of a graduate school application), this is not “widely distributed” research.
   5. If you conduct a research study, and submit only the abstract or a brief summary to the Trinity Digital Repository, or limit access of the Repository copy to the Trinity campus, or publish only a limited portion on the web, this is not “widely distributed” research.

Regarding adverse events

All adverse events must be reported to the IRB immediately. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research (modified from the definition of adverse events in the 1996 International Conference on Harmonization E-6 Guidelines for Good Clinical Practice).

More detailed information can be found at the U.S. Health and Human Services website here.