IRB

Institutional Review Boards and Research Ethics

Explanation of Review Categories

What’s an IRB?
An IRB or Institutional Review Board is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.

Why have an IRB?
Establishment of an IRB provides the opportunity to formalize protection of the rights and welfare of those who volunteer to participate in research at Presbyterian College. The IRB also provides an avenue to evaluate research conducted on our campus by other institutions or individuals.  And finally, IRBs are required for institutions that receive federal funding for research and other purposes.

PC’s IRB Policy
Presbyterian college requires IRB review and approval of all activities which involve using human subjects in research.  Approval of the IRB must be obtained prior to involvement of human subjects.  Failure to have human subjects research reviewed by the IRB, including those protocols believed to be exempt, is in violation of College policy and will be reported to the Provost of Arts and Sciences or the Dean of Pharmacy.  Possible sanctions include loss of faculty development funding, participation in the Summer Fellows program, and/or other research grant opportunities. Disciplinary action is ultimately at the discretion of the Provost of Arts and Sciences or the Dean of Pharmacy. IRB approval is valid for a period of one year from the date that the approval is issued.  If your research project extends for more than one year, you will need to apply for an extension.

For the purposes of the IRB, research falls into four categories:
1.     IN-CLASS  RESEARCH – 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.
2.  EXEMPTION REQUESTED REVIEW—No review required but there are additional requirements regarding confidentiality, possible damage (criminal or civil), participation, relationships to 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 education 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.

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.
3.  EXPEDITED REVIEW – 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 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.

4.  FULL COMMITTEE REVIEW – 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.
Additional Information and Resources:
A Guide to Understanding Informed Consent, National Cancer Institute
http://www.cancer.gov/clinicaltrials/conducting/informed-consent-guide/page4

Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services. http://www.hhs.gov/ohrp/

Contact Information:

Presbyterian College’s Institutional Review Board procedures, meeting schedules, and other materials will be available online at www.presby.edu. For additional information, please contact:

Nancy G. Pedigo, IRB Co-chair, (School of Pharmacy): ngpedigo@presby.edu, or 864-938-3836.

Troy Nash, IRB Co-chair, (Arts and Sciences): tnash@presby.edu, or 864-833-8402.

Forms

Checklist

Application

Proposal

Statement of Assurance

Policies and Procedures

Research Conducted with Students as Subjects

Amendment