IRB Hot Topics

1) WHAT ACTIVITIES REQUIRE IRB REVIEW?

2) WHAT INFORMATION DO I NEED TO REPORT TO THE IRB WITHIN 5 WORKING DAYS?

3) WHAT IS AN UNANTICIPATED PROBLEM?

1) WHAT ACTIVITIES REQUIRE IRB REVIEW?

 

The table below describes common research activities and whether or not the activity requires submission to the IRB. The table is taken from HRP SOP:093: Activities that Require IRB Review.

***Note the updated section on classroom activities.

If you are unsure about whether or not your research activity requires review by the IRB you may request a determination.

Requesting a determination requires a truncated application in iRIS at iris.tamu.edu. In section 4.0 of the study application, select "yes" for the question: "I am requesting a determination - is my project human subjects research?" and fill out the next section with detailed information about your project.

Be sure to upload any supporting documents that may help with the determination.

Remember, you may not begin any research activity involving human subjects until the IRB has issued approval correspondence specific to that activity.

ACTIVITY

DESCRIPTION

HRPP/IRB Determination   Required

Cadaver or autopsy specimens/materials

Research involving deceased individuals does not require IRB   oversight.

NO

 

Case Report Studies

Retrospective   review of a patient’s medical record with intent to document a specific   situation or the experience of an individual without intent to form a   research hypothesis, draw conclusions or generalize findings. Data is   de-identified.

NO if using only 1-2   records.

 

YES if using 3 or   more records.

Prospective case study   with clear intent, before recruiting or interacting with the participant, to   use that data to draw conclusions and will publish or present to external   groups.

YES

Classroom Assignments/Activities

Normal educational activities conducted by the students designed   to teach students methods or demonstrate course concepts AND the activities   are not designed to create new knowledge AND are not generalized or presented   outside the classroom.

NO

 

Classroom Activities and Instructional Methods.

Educational activities conducted by faculty or instructors in   the classroom or with students and the intent is to generalize the   information outside of the classroom or publish. This includes use of student   records, interviews, surveys or other student data for prospective or   retrospective research.

YES

Clinical Investigations

Experiments using an intervention, substance or test article on   one or more human subjects to evaluate the effects of those interventions,   products or test articles on health related biomedical or behavioral outcomes   regardless of FDA status or applicability. Products include foods (dietary   supplements that bear a nutrient content claim or a health claim, infant   formulas, food and color additives), drugs for human use, medical or   diagnostic devices for human use, biological products for human use, and   energy emitting products used on humans.

YES

Focus Groups and Interviews

When discussing personal experiences or opinions and/or the   focus is on people (e.g. how do you rate your ability to handle stress; how   often do you run red-lights?)

YES

When discussing non-human topics and the focus is on things   instead of people (e.g. discussions on the differences between product A and   product B)

NO

Innovative or Novel   Procedures, Treatment, or Instructional Methods

 

Systematic investigation of   innovations in diagnostic, therapeutic procedure or instructional methods in   multiple participants in order to compare to standard of care or normal   procedure. The investigation is designed to test a hypothesis, permit   conclusions to be drawn, thus to develop or contribute to generalizable   knowledge.

YES

The use of innovative   interventions that are designed solely for therapeutic purposes to enhance   the well-being of an individual patient with a reasonable expectation of success.   The intent of the intervention is to provide diagnosis, preventive treatment,   or therapy to an individual patient. Research is not involved.

NO

Internet Research

 

Online websites set up for the   purposes of collecting human data regarding a particular topic. This may   include the completion of questionnaires/surveys, personal data, etc.

YES

Harvesting, mining, profiling,   observing or recording data from blogs, chat rooms, social media postings,   etc.

YES

Submitting information or   interacting with internet sites in order to measure influence on behaviors or   other outcomes.

YES

In Vitro Device Studies

Current FDA guidance indicates   that IRB review is required for any IVD study involving human   specimens/samples, even when the research involves no identifiers and the   biological materials cannot be linked to any identifying information.

YES

Literature Review

An   assessment of a body of published material   that addresses a research question. Identifies or summarizes what is already   known about an area of study or may identify questions a body of research   does not answer.  

NO

Pilot   Studies

 

Pilot   studies that meet the definition of human research, regardless of the number   of subjects enrolled or the duration of the studies.

YES

Professional   Recognition

Employees   or agents of TAMU involved in human research projects carried out at other   locations when the services performed merit professional recognition or   publication privileges.

YES

Public Health Surveillance Activities

Limited to those activities necessary to allow a public health authority to provide timely situational awareness or set priorities during an event or crisis that threatens public health. Researchers must have a written request, authorization or contract from a Public Health Authority.

NO 

Quality Assurance (QA)

and

Quality Improvement (QI)   Activities

Systematic, data-guided   activities involving humans designed to implement promising ways to improve   outcomes, system performance or professional development - The activity usually   occurs within standard of care or normal educational or business practices   confined to the local setting.

Guidance: Intent is only one   element considered. QI and research often overlap. The activity often   involves an iterative process that may change over time in response to   ongoing feedback. The plan may include mechanisms for assessment,   intervention, analysis and implementation. One-time activities designed to   meet personal educational requirements are generally not QA or QI.

YES – must have a determination

 

 

Proposed QI/QA activities that   may have research intent, address a specific deficit in scientific knowledge   or are intended to be generalized beyond the local setting require submission   to the IRB for a determination.

YES

Records, Repositories,   Registries or other Data or Specimen research

Proposed activity involves accessing   student, health or other private records, data banks, repositories or any   other mechanism by which identifiable human records, data, tissue, blood, or   genetic materials will be obtained.

YES

Proposed activity involves accessing   stored human tissue, blood, genetic material or private identifiable data   that will be de-identified by study personnel at the time of collection or   when the investigator has access to a code or link that enables   re-identification of data or specimens.

YES

Private information or   specimens are being collected specifically for the proposed research through   interaction or intervention with living individuals.

YES

Proposed activity involves   accessing specimens or cell lines from a commercially operated or established   biorepository where the investigator does not receive under any circumstances   personal identifiers, or links, or codes that enable identification;

NO

Proposed activity involves accessing PUBLICALLY available specimens or data. NOTE: if subjects are inadvertently identified when combining more than one publically available data sets you must contact the IRB, immediately.

NO

Scholarly and Journalistic Activities (oral history, journalism, literary criticism, historical scholarship, biography, legal research)

 

Oral histories or journalism that focuses directly on the specific individuals about whom the information is collected and there is no intent to generalize the information to others. Legal research must focus on the circumstances of specific plaintiffs or parties involved in a case; Legal research is not a particular field.

NO 

Scholarly and Journalistic activities that involve the testing or confirmation of a hypothesis that is intended for generalization to others.

YES 

Self - Experimentation

Any human research were the investigator is also a subject   (investigator self-experimentation) requires IRB review and approval.

 YES

Standard Diagnostic or Therapeutic procedures

The collection of data about established and accepted diagnostic, therapeutic procedures, or instructional methods is intended for dissemination or contribution to generalizable knowledge.

YES

There is an alteration in   patient care or assignment for research purposes or the alteration is in a   way that standard diagnostic or therapeutic procedures are not completely up   to the discretion of a practitioner.

YES

A diagnostic procedure is   added to a standard treatment for the purpose of research.

YES

An established and accepted   diagnostic, therapeutic procedure or instructional method is performed only   for the benefit of a patient and not for research purposes.

NO

Student Conducted Research

Thesis or dissertation projects   involving human subjects research conducted to meet the requirements of a   graduate degree.

YES

 

Surveys

Interacting with participants   directly or through third party survey administrators to answer a research   question about humans requires submission to the HRPP/IRB for a determination   even if not collecting identifiable information.

YES

 

Human Factors Evaluation

Observing, recording, measuring or testing human behavior, cognition, interaction, performance, psychophysiology or anthropometry in a natural or laboratory environment for research applications.

YES 

 

2) WHAT INFORMATION DO I NEED TO REPORT TO THE IRB WITHIN 5 WORKING DAYS?

 

  1. Harm: Any harm experienced by a subject or other individual, which in the opinion of the investigator is unexpected and probably related to the research procedures. Example: Serious Adverse Event or Unanticipated Problem
  2. Risk: Information that indicates a new or increased risk or a new safety issue. For example: safety monitoring report, drug or device changes, interim analysis or investigator finding.
  3. Non-compliance: Non-compliance with the federal regulations governing human research or with the requirements or determinations of the IRB, or an allegation of such non-compliance.
  4. Audit: Audit, inspection, or inquiry by a federal agency or government agency.
  5. Report: Written reports of study monitors or DSMB Reports.
  6. Deviation (Researcher error): Failure to follow the protocol due to the action or inaction of the investigator or research staff.
  7. Confidentiality: Breach of confidentiality.
  8. Unreviewed change: Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a subject.
  9. Incarceration: Incarceration of a subject in a study not approved by the IRB to involve prisoners.
  10. Complaint: Complaint of a subject that cannot be resolved by the research team.
  11. Suspension: Premature suspension or termination of the research by the sponsor, investigator, or institution.
  12. Unanticipated adverse device effect: Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with a device.

 

*** Please note: Individual Adverse Events that do not meet the criteria for an Unanticipated Problem, do not have to be submitted to the IRB. Please see revised document HRP-029 SOP: Reportable New Information Items.

 

3) WHAT IS AN UNANTICIPATED PROBLEM?

 

Unanticipated problems, in general, include any incident, experience, or outcome that meets all of the following criteria:

1. unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; (b) the characteristics of the subject population being studied; and

2. is related or possibly related to the research (this means that it is more likely than not, the incident, experience, or outcome was caused by the procedures involved in the research); and

3. suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

There are other types of incidents, experiences, and outcomes that occur during the conduct of human subjects research that represent unanticipated problems but are not considered adverse events.  For example, some unanticipated problems involve social or economic harm instead of the physical or psychological harm associated with adverse events.  In other cases, unanticipated problems place subjects or others at increased risk of harm, but no harm occurs.

Please consult the HRP-029 SOP: Reportable New Information Items. for an algorithm to help you decide when an adverse event needs to be reported as an unanticipated problem, within 5 days of discovery. 

Contact the IRB if you have any question regarding this information.