Guidance for Completing the IRB Application

The following list represents examples of different types of research and what information/details should be included in your IRB application for each type. A study may incorporate multiple items from the list.

• Secondary Research Use of Identifiable Private Information or Identifiable Biospecimens: Describe the nature of the information or biospecimens; the source/provider; the purpose/manner it was originally collected; how the information/specimens will be transferred or transported; the timeline for collection/transfer; and the timeline for destruction or disposal. “Secondary research” is defined as: re-use of identifiable information or biospecimens that were/will be collected for some other primary/initial purpose or activity (research or non-research).  Examples: use of information from a databank or records, use of biospecimens from a pathology laboratory, use of “excess” portion of blood that was drawn for clinical purposes. Note: when information / biospecimens are or will be de-identified before you receive/collect them and you will not have access to direct/indirect identifying information, this does not constitute human subject research and IRB review is not required. Consult OHRP Decision Chart 1 to determine if the project constitutes human subject research.  

• Questionnaire or Survey: Describe the topic of the questions and whether the data collected could impact the subjects’ financial standing / employability / reputation if a data breach occurs; the survey medium to be used (online, paper, etc.); and whether individually identifiable information will be collected and/or recorded about subjects. Upload finalized survey instruments.

• Interview: Describe the duration of the interview; the topic and whether the data collected could impact the subjects’ financial standing / employability / reputation if a data breach occurs; whether individually identifiable information will be collected and/or recorded about subjects; and whether audio / video recording will occur.  Upload finalized questions / prompts.

• Focus Group:  Describe the duration of the focus group; the discussion topic and whether the data collected could impact the subjects’ financial standing / employability / reputation; any special privacy issues for the group setting; whether individually identifiable information will be collected and/or recorded about the subjects; and whether audio / video recording will occur.  Upload finalized focus group questions / prompts.

• Audio/Video Recording of Subjects: Describe the type and method of recording; how recordings will be managed, stored, & destroyed; plans for transcription; and whether the data recorded could impact the subjects’ financial standing / employability / reputation. 

• Non-English Speaking Subjects: List the languages and describe how the research team will communicate with subjects, in written form and verbally. Describe how research instruments (such as questionnaires) and Informed Consent documents will be translated, and provide the qualifications of the translator for each language/item. Upload copies of all translated documents with your application.

• Observations of Private Behavior:  Describe the setting for the observations; the specific types of observation data that will be collected about the subjects; whether individually identifiable information will be collected and/or recorded about the subjects; and whether audio / video recording will occur.  Upload copies of observation data collection sheets.

• Noninvasive Physical Measurements:  List and describe the measurements to be collected from the subjects (i.e. heart rate, height, weight, temperature) and equipment or devices needed to collect the measurements.

• Behavioral, Cognitive or Perceptual Experiment: Describe all the steps involved with the experiment, including any stimuli that will be presented to the subjects and all of the different data collection methods that will be used to collect subject data. Upload copies of the data collection instruments. 

• Psychological Test: List and describe the test(s) to be administered; upload finalized copies of each test. 

• International Research: Describe the international setting(s) and context; the local cultural norms for research, age of majority, and any special localized risks; any local regulations that might impact the research; the languages in which the research study will be conducted; and whether approval is required from a local IRB Committee or comparable ethics board (see the OHRP International Compilation of Human Research Standards for assistance). If local approvals are required, explain this process and the current approval status.     

• Educational Research: Describe the type(s) of instructional strategies, techniques, curricula, or classroom management methods to be studied (and which are experimental); the specific classes or setting(s), an explanation of the different subject groups and control groups and how students are assigned; description of educational interventions and materials used; and all the types of subject data & data collection methods to be used. Upload tests and educational materials. Explain if there is a potential for the intervention to impact the students’ opportunity to learn required educational content or the assessment of educators who provide instruction.

• Induction of Mental Stress: Describe the type of stress expected (unwanted feelings, embarrassment, depression, anger, suicidal ideation, etc.); procedures for induction of stress; and behavioral endpoints.

• Deception or Incomplete Disclosure: Describe the procedures and justification for the incomplete disclosure / deception; any undisclosed risks that may be more than minimal; the plan for debriefing subjects when possible; & any opportunities for subjects to exclude their data once the deception is revealed. If the study is federally funded or FDA regulated, upload Form 3 to formally request a waiver of some or all elements of consent.

• Collection of Blood: Describe the frequency & amount of draw(s) and methods of collection (i.e. venipuncture, venous catheter); procedures for transport, storage, and destruction of collected blood samples; and plans for potential future research use. 

• Collection of Other Biological Specimens (Hair, tissue, saliva, etc.): Describe the type of specimen(s) and methods of collection; procedures for transport, storage, and destruction of collected specimens; and plans for potential future research use. 

• Induction of Physical Stress: Describe the type of stressors used (exercise, physical performance, etc.); procedures for the physical stress and/or exercise; and potential endpoints for safety.

• Medical & Clinical Imaging: Describe the modality and procedures for the imaging; a description of the imaging equipment used; types of images to be collected; and the amount of energy introduced to subjects.

• Medical Devices:  Provide a layman’s explanation for using the device; the type of device and procedures for using it; the FDA approval status of the device; and specific data to be collected about the device (i.e. safety, effectiveness, effect on biological function). Complete Form 4 for Devices and upload along with the device manual / documentation in the electronic system.

• Drugs and/or Biologics:  Provide a layman’s explanation for using the drug; the type of drug and procedures for administering it; the FDA approval status of the drug; and specific data to be collected about the drug (i.e. safety, effectiveness, effect on structure or function). Upload the drug package insert / Investigator’s Brochure / documentation.

• Induction of Heat and/or Cooling Modalities: Describe the device / method of heating or cooling; the temperature range of each method; amount of energy introduced to the subject; and whether microwave technology is used.

• Genetic Research: Describe the DNA samples to be collected; the coding / labelling system for samples; plans for sample storage and retention; description of planned analysis (i.e. microarray, RNA sequencing); plans for return of results to subjects, if applicable.

• Clinical Trial (A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes): Describe the health condition or disease to be studied (physical or behavioral); all medical or behavioral procedures & interventions; subject groups (control group, intervention groups, etc.); and randomization procedures.  Note: Clinical Trials funded by NIH require protocol personnel to complete training for Good Clinical Practice (GCP). If applicable, describe how GCP standards will be implemented in the laboratory/research.