Institutional Review Board

Research conducted by students as a part of classroom assignments does not typically fall under the federal regulation of research as it is not intended to or likely to lead to generalizable results. Rather, the activities are resources of teaching which facilitate learning of concepts and the opportunity to practice various procedures, including research methods (interviewing, observation and survey techniques, as well as data analysis).
While most assignments for class do not require IRB review, some do as a result of the vulnerability of subjects or the potential risk to subjects including:

• Studies in which children will be interviewed or surveyed.
• Studies in which children are being observed, and data collected, where the investigator is also a part of the activities being observed.
• Studies involving prisoners, the mentally disabled, or pregnant women.
• Studies that ask subjects about illegal activities and which place the data at risk for subpoena and/or the subject at risk for loss of civil liberties.
• Studies in which subjects are at risk of breach of confidentiality, such as ones that ask sensitive or intrusive questions about behaviors.
• Studies that place subjects at risk due to emotionally charged subject matter.
• Instructors are advised to discuss these issues with their students and clarify the role of the IRB should the student be interested in pursuing a research activity that might necessitate IRB review. Instructors are expected to review the proposed research to determine if it meets the definition of student research and is permissible under these guidelines.

In instances where a class of students will be conducting group or individual research projects as a part of the classroom instruction, and the instructor believes that IRB approval is required, the instructor shall present for IRB approval one application setting forth the information requested within IRB documents.

Student researchers should also note that if there is any likelihood that the results of the project might later be used for research that does lend to generalizable knowledge (ex. within a publication or a presentation to a group other than the class in which it was assigned), IRB approval must be obtained prior to conducting the research project. IRB approval cannot be granted retroactively. It is expected that any data collected as a class project/assignment will be destroyed after grading of the project has been completed.

*Please refer to the form entitled “IRB Policies and Procedures for In-Class Research” for more information regarding student research.

*Please refer to the form entitled “Research Conducted with Students as Subjects” for more information regarding using students as research participants.

No review required but there are additional requirements regarding confidentiality, possible damage (criminal or civil), participation, relationships to the researcher (students to faculty), children or other subjects with impaired abilities. Some examples of exempt research are:

• Research involving the collection or study of existing data that is publicly available or recorded so that subjects may not be identified.
• Research conducted in established or commonly accepted educational settings involving normal educational practices.
• Research involving the use of educational tests (cognitive, aptitude, achievement) if the data are recorded so that subjects cannot be identified either by use of names or special code identifiers.
• Research involving only observation of public behavior.
• Research involving only surveys or interviews if:
  • The subject’s responses (if they became public) will not place the subject at risk of criminal or civil liability, to be damaging to the subject’s financial standing or employability.
  • The subject’s responses do not deal with sensitive aspects of personal behavior: for example, illegal conduct, drug use, sexual behavior, or use of alcohol.
  • The project is not specifically designed to involve subjects in high-risk groups (minors, pregnant women, prisoners, mentally retarded, physically disabled, mentally disabled, psychiatric patients, institutionalized, PC students – Please refer to the form entitled “Research Conducted with Students as Subjects” for information regarding using students as research participants).
  • Research involving only taste and food quality evaluations.
  • Research using survey or interview procedures when the respondents are elected or appointed public officials or candidates for public office.
• If the research involves students, the research must also not be likely to adversely impact the student’s opportunity to learn required educational content or the assessment of educators who provide the instruction.

PLEASE NOTE: Although no review is required for research falling under the Exempt category, it is still necessary to register the research with PC’s IRB by submitting the appropriate paperwork so that 2 members can approve exempt status.

Review of protocol by two members of the IRB. Applies to certain types of low or minimal risk research. Minimal risk means that probability or magnitude of physical or psychological harm does not exceed that encountered in ordinary life or during routine physical or psychological examination or tests. Some examples of research requiring expedited review are:

• Research involving the Collection of hair or nail clippings (in a non-disfiguring way), deciduous teen and permanent teeth if patient care indicated a need for extraction.
• Collection of excreta and external secretions including dental plaque, sweat, uncannulated saliva, urine, etc.
• Voice recordings of subjects 18 years of age or older.
• Moderate exercise by healthy volunteers
• Study of identifiable existing data, documents, records, specimens not otherwise exempt.
• Research on individual or group behavior or characteristics (e.g., game theory).
• Recording of data using noninvasive procedures.
• Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.
• The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
• Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate the subjects’ behavior and the research will not involve stress to subjects.

Review of protocol by a quorum of IRB members (5 members). Necessary for research involving risk of physical or psychological harm greater than that encountered in daily life or during routine examinations or tests. Research involving deception also requires quorum review.
PLEASE NOTE: There are additional requirements regarding consent and protection of identity whenever children (under age 18) or subjects with impaired ability to consent are involved.