IRB review


Determination of human subjects research

An individual is engaged in human subjects research if they are involved in any of the following research procedures (as defined by Office of Human Research Protections guidance):

  • Receive an award through a grant, contract, or cooperative agreement directly from HHS for non-exempt human subjects research, even where all activities involving human subjects are carried out by employees/agents of another institution
  • Intervene with any human subject for research purposes by performing invasive or noninvasive procedures
    • Examples: Collecting bodily materials; administering counseling/psychotherapy; administering drugs or treatments; implanting medical devices; utilizing physical sensors; utilizing other measurement procedures
  • Intervene with any human subject for research purposes by manipulating the environment
    • Examples: Controlling environmental light/sound/temperature; presenting sensory stimuli; orchestrating environmental events or social interactions
  • Interact with any human subject for research purposes
    • Examples: Asking someone for a specimen; conducting research interviews; administering questionnaires; administering surveys (even if online)
  • Obtain identifiable private information OR identifiable biological specimens from any source for research purposes, which include any of the following activities:
    • Observing or recording private behavior
    • Using, studying, or analyzing for research purposes identifiable private information or identifiable specimens provided by another institution
    • Using, studying, or analyzing for research purposes identifiable private information or identifiable specimens already in the possession of the investigators

A living individual about whom an investigator (whether professional or student) conducting research obtains 1) data through intervention or interaction with the individual, or 2) identifiable private information.

  • If a study does not meet the definition of human subjects, you do not need HRPP oversight.
  • If you are unsure whether your project meets this definition, submit in eCompliance as normal, and HRPP will make a determination on your project.

A systematic investigation designed to develop or contribute to generalizable knowledge.

  • If a study does not meet the definition of research, you do not need HRPP oversight.
  • If you are unsure whether your project meets this definition, submit in eCompliance as normal, and HRPP will make a determination on your project.

Please note this is not a comprehensive list of the activities that may meet the definition of human subjects research. If you have questions about your research, you should contact the HRPP office.

Examples of what may be human subjects research:

  • Pilot studies conducted in order to collect information that will contribute to future knowledge
  • Surveys, interviews, focus groups, interventions completed in order to contribute to generalizable knowledge in which information is gathered ABOUT an individual (e.g. personal beliefs, life experiences, opinions, morals, etc.)
  • Studies involving private information (e.g. medical records, school records, data including names or other identifiers)
  • Studies involving the collection of biological specimens (saliva, blood, tissue, sweat, breast milk, skin cells, teeth, reproductive organ fluids, etc.)
  • Studies involving educational interventions
  • Oral histories conducted to generalize findings (draw conclusions, inform policy) or conducted to create/add to archives for the purpose of providing a research for others to do research
  • Studies involving moderate exercise or muscular strength testing, body composition assessment, and/or flexibility testing
  • Studies involving a drug or device (drugs and devices are subject to FDA regulations and the FDA definition of human subjects research)
  • Studies involving physical sensors, EEGs, EKGs, ERGs, MRIs, thermography, ultrasounds, and DXA scanning

Examples of what may NOT be human subjects research:

  • Class projects completed specifically (and only) for educational teaching purposes or for a grade or assignment
  • Research involving deceased individuals or cadavers
  • Biographies
  • Oral histories completed only to document a specific historical event with no intent to draw conclusions or generalize findings
  • Gathering information only about business practices, policies, or products and not about the human subject being interviewed
  • Quality improvement methods conducted only for internal use or evaluation
  • Research involving publicly available, de-identified data (e.g. census data)
  • Research involving de-identified specimens, or coded specimens in which the researcher cannot readily ascertain the identity of the individuals
     

Review categories

Review of a research study is classified as exempt if the study is exempt from certain requirements of 45 CFR 46. An HRPP staff member must determine that your project is exempt.

Criteria:

  • Research activities must present no more than minimal risk to subjects.
  • Study must be determined to fit into one or more exempt categories.

Expedited review does not need to be conducted by the IRB committee but instead will be reviewed internally by a designated reviewer.

Criteria:

  • Research activities must present no more than minimal risk to subjects.
  • Minor changes in previously approved research during the period (of one year or less) for which approval is granted.
  • Research which includes noninvasive procedures, collection of specimens from healthy individuals, and social and behavioral methods.
  • Study must meet one or more expedited criteria.
  • Research activities present more than minimal risk to subjects.
  • The study does not meet the criteria for exempt or expedited review.
  • The study involves the use of deception of subjects.
  • The study involves vulnerable populations such as: minors, incarcerated individuals, or pregnant women.
  • The IRB committee determines that the following criteria are met for your project:
    1. Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
    2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
    3. Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
    4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by §46.116.
    5. Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.
    6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
    7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Review times + deadlines

Exempt

  • A reviewer will typically respond to you within 5-7 business days. An exempt review will typically take 5-10 business days; however, approval times vary based on the study.
  • Annual review is not required. HRPP may require that you check in 3 years after your approval date to determine if your project is still active.
  • Since certain changes in procedures may alter the review determination, you are required to submit modifications under certain circumstances to HRPP.

Expedited

  • A reviewer will typically respond to you within 5-7 business days. An expedited review will typically take 5-14 business days; however, approval times vary based on the study.
  • Annual review is required.
  • You are required to submit and receive approval from HRPP for any changes to your project.
  • Committee review will typically take 3-6 weeks. The IRB Committee reviews studies on the first Thursday of every month.
  • You are required to submit and receive approval from HRPP for any changes to your project.

Modifications

Projects with an expedited determination or projects that require committee review will need to submit all modifications to HRPP. Certain projects with an exempt determination will need to submit to HRPP.

Examples of exempt projects that require modification:

  1. Change to the principal investigator
  2. Addition of a federal funding source
  3. Inclusion of children/minors in your research study that previously only included adults
  4. Inclusion of identifiable or coded biological specimens or existing data
  5. Addition of new interventions
  6. Your procedures will require that you now collect identifiers or videos/voice/image recording (when not previously collected and data collected may be sensitive in nature)
  7. Your procedures now include questions that are sensitive in nature (e.g. illegal activity, drug/alcohol use, sexual behaviors) or could cause participants a loss of employability or affect their reputation
  8. Inclusion of incarcerated individuals in your research study
  9. Disclosing a new financial interest
  10. Use of a device or drug/supplement/food/additive
  11. Collection of biospecimens (e.g. blood, saliva, ear wax, hair or nail clippings, vaginal swabs, rectal swabs).
  12. Inclusion of invasive procedures (e.g. procedures that require you to enter the body; inputting energy into the body)

Examples of exempt projects that do not require modification:

  1. Addition of study team members, but it’s recommended that all study team members complete the training before they conduct research procedures
  2. Editing/adding interview/survey questions that still fall within the original scope of the approved questions (e.g. not sensitive in nature)
  3. Editorial or administrative changes to the consent document or study documents
  4. Adding a new recruitment material, assuming it follows HRPP recruitment/advertisement recommendations
  5. Increasing/decreasing the number of subjects you are recruiting, as long as it does not include a new subject population (e.g. children/minors, incarcerated individuals)

​For minimal risk studies, a modification review will typically take 7-10 business days. For more than minimal risk studies, the modifications will need to be reviewed by the full committee and this will typically take 3-4 weeks.

 

 


Continuing reviews

Coming soon.

Find instructions for submitting a continuing review on the IRB submission webpage.


Reporting new information

You will need to report any unanticipated information to HRPP by submitting an RNI (Reportable New Information) report. An RNI report encompasses any information that affects the confidentiality of the research participants, or any information regarding a situation with a participant that is beyond the risks of the consent form.

Examples of information that would need to be reported:

  1. Any unfavorable medical occurrence in a human subject, including abnormal sign, symptom, or disease that is associated with the participation in the research. These can be caused by one or more of the following:
    • The procedures involved in the research
    • An underlying disease, disorder, or condition of the subject
    • Other circumstances unrelated to either the research or any underlying disease, disorder, or condition of the subject
  • Any incident or experience that is unexpected
  • Any suggestion of a greater risk to harm than originally expected

2021 IRB meetings