IRB Hot Topics

1) Use of drawings in human research

2) What activities require IRB Review?

3) What information do I need to report to the IRB within five working days?

4) What is an unanticipated problem?

 

1) Use of Drawings in Human Research

DON’T RUN AFOUL OF TEXAS GAMBLING LAWS: WHAT HUMAN SUBJECTS RESEARCHERS NEED TO KNOW ABOUT THE ACCEPTABLE USE OF DRAWINGS AS COMPENSATION OR AN INCENTIVE TO PARTICIPATE IN RESEARCH

To avoid running afoul of Texas gambling laws, researchers need to determine whether or not their use of a drawing for a chance to win a prize constitutes a lottery. Lotteries are illegal because they are considered “gambling” under Texas Penal Code Chapter 47.

A “lottery” is defined as any scheme or procedure whereby one or more prizes are distributed by chance among persons who have paid or promised consideration for a chance to win anything of value, whether such scheme or procedure is called a pool, lottery, raffle, gift, gift enterprise, sale, policy game, or some other name.

Given the possible implications to researchers using drawings as a form of compensation or an incentive to participate in research, the Division of Research, in conjunction with the Office of General Counsel, has identified a framework for the acceptable use of drawings in human research at Texas A&M:

1. The compensation is appropriate when it is not large enough to be considered an inducement (undue influence).
2. The participant is not told that entry or eligibility for the drawing is conditioned on completing the study. This means that everyone is eligible for the drawing upon providing consent to participate in the study and cannot be told they must complete the study.
3. The time, effort, and inconvenience of the participant cannot be substantial.
Substantial time and effort is determined on a case by case basis and considers the procedures involved such as what is asked of the participant and the amount of time involved.
4. This approach is not limited to exempt research.

 

2) 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.

Research involving deceased individuals does not require IRB oversight.

HRPP/IRB Determination Required: NO

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.

HRPP/IRB Determination Required: 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.

HRPP/IRB Determination Required: YES

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.

HRPP/IRB Determination Required: NO

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.

HRPP/IRB Determination Required: YES

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.

HRPP/IRB Determination Required: YES

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?)

HRPP/IRB Determination Required: 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)

HRPP/IRB Determination Required: NO

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.

HRPP/IRB Determination Required: 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.

HRPP/IRB Determination Required: NO

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.

HRPP/IRB Determination Required: YES

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

HRPP/IRB Determination Required: YES

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

HRPP/IRB Determination Required: YES

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.

HRPP/IRB Determination Required: YES

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.  

HRPP/IRB Determination Required: NO

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

HRPP/IRB Determination Required: YES

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

HRPP/IRB Determination Required: YES

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.

HRPP/IRB Determination Required: NO

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.

HRPP/IRB Determination Required: 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.

HRPP/IRB Determination Required: YES

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.

HRPP/IRB Determination Required: 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.

HRPP/IRB Determination Required: YES

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

HRPP/IRB Determination Required: 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;

HRPP/IRB Determination Required: NO

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

HRPP/IRB Determination Required: NO

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.

HRPP/IRB Determination Required: NO

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

HRPP/IRB Determination Required: YES

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

HRPP/IRB Determination Required: YES

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

HRPP/IRB Determination Required: 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.

HRPP/IRB Determination Required: YES

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

HRPP/IRB Determination Required: 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.

HRPP/IRB Determination Required: NO

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

HRPP/IRB Determination Required: YES

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.

HRPP/IRB Determination Required: YES

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

HRPP/IRB Determination Required: YES

3) What Information Do I Need to Report to the IRB within five 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.

4) 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 five days of discovery. 

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