This section of the Investigator Manual coves special procedures: recordings, deception, radiation, and controlled substances.
Use of Video or Audio Recording
If you plan to record subjects (audio and/or video) or take full face photographs, the consent form and, if applicable, HIPAA authorization form must include information about these procedures. In addition, the consent form should include information about how long these materials will be maintained, how they will be protected from risk of breach of confidentiality, who will have access to the recording materials (e.g., study team only) and whether they will be used for future, unspecified research.
If video recording will occur in a K-12 educational setting, all students and instructors in that class must sign consent forms, or video recording will not be allowed. Individuals may not want to be videotaped for many reasons, including cultural and religious considerations. Technical and logistical limitations make it nearly impossible to “exclude” images from those not consenting to video recording, so informed consent is required from all those within the room or other setting where recording will occur. (If students are minors, parental consent is also required.) In all cases, the preferences of students, parents, and instructors/staff must be respected.
If you will videotape in a UWHC or UWMF facility or publish full face photographs or videos of UWHC and/or UWMF patients, you are required to follow UHWC and UWMF institutional policies and procedures.
Research which requires deception regarding the purpose of the research or any other necessary element of consent is permissible when justified by prospective scientific, educational, or applied value, when effective non-deceptive alternative procedures are not feasible and only with study components that involve minimal risk (as determined by the IRB). Please note, the omission of information about the known risks of a research intervention is not an acceptable case of deception.
Whenever feasible, researchers must debrief subjects (or their legally authorized representative) about the use of deception. Generally, subjects should be debriefed immediately following their participation. There may be situations where debriefing the subjects immediately is not possible, such as when it could compromise study results. If that is the case, subjects may be debriefed following the completion of all study interventions for all subjects.
You must provide a prompt opportunity for participants to obtain appropriate information about the specifics about the deception that was used, the rationale for the deception, and a corrected account of the information that was false or incomplete, and then take reasonable steps to correct any misconceptions that participants may have. If a participant in a study involving deception chooses to withdraw consent following the debriefing, the data collected in that case may not be included in the analysis of the study. When the deception involved in a study includes audio or video recording subjects without their knowledge, the IRB will generally require that subjects are given the opportunity to withdraw from the study.
There may be situations where debriefing subjects would be inappropriate, such as when the debriefing could cause more harm to the subject than the deception itself. Such cases are expected to be rare, and would require a strong justification be provided for IRB evaluation.
Deception is a form of alteration of the consent process and alteration of the consent documentation. You should review HRP 410-CHECKLIST-Waiver or Alteration of Consent Process to ensure that you have provided sufficient information regarding the need for a waiver or alteration of the consent process.
If your study interventions involve the use/administration of radiation, additional state law requirements apply that are outside IRB purview. For information and assistance with these requirements, see the Radiation Safety website.
If you are conducting research with controlled substances, you must comply with federal and state requirements for use of these substances. These requirements are rigorous and the investigator is responsible for ensuring compliance with these requirements.
Controlled drugs fall into five different categories, from Schedule I (substances which do not have a legitimate medical use in the United States and which can be addictive – such as LSD and heroin) to Schedule V (drugs which have a clear medical use, low potential for abuse and limited psychological and physical dependence – such as cough medications with small amounts of codeine).
Use of controlled substances for research requires registering with both the federal government (through the Drug Enforcement Agency) and the State of Wisconsin (through the Controlled Substances Board). Penalties for using such drugs without proper registration can be severe. The regulations strictly limit who can handle or administer the drugs and impose both physical security and inventory requirements. Some key points concerning the regulations:
- The permitting process is between an individual researcher, the DEA and the State of Wisconsin.
- Registrants cannot share controlled substances with non-registered users who are not under their supervision (e.g., another research laboratory in their department).
- Possession of expired drugs also poses a risk to researchers from the USDA since administration of expired controlled substances is not allowed.
- Disposal is also strictly regulated. Only the DEA Special Agent in Charge can authorize the disposal of controlled substances.
The Research Animal Resources Center has more information on the requirements regarding the use of controlled substances. This information is provided only as a reference for researchers, who are solely responsible meeting regulatory requirements. If you need assistance with these processes, contact the IRB office.