Getting Started with the IRB

IRB review is required for project activities that are considered “Research” as defined by the OHRP guidance at 45 CFR 46.102(d) and other federal agencies. Based on this definition, Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. 

Activities that meet this definition constitute research for purposes of federal policy. This qualification is regardless of whether project activity is conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. 

For clarification, the following definitions are provided:

• Systematic Investigation: An activity that plans (prospectively) to incorporate data collection (quantitative or qualitative) and data analysis to answer a question. Activities are not research if they do not involve a systematic approach involving a predetermined method for studying a specific topic, answering a specific question, testing a specific hypothesis, or developing theory.

• Generalizable Knowledge: Activities designed (with intent) to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publication or presentation). The intent to develop or contribute to generalizable knowledge makes an activity research. Results do not have to be published or presented, to qualify the activity as research.

Examples of activities that are typically considered systematic investigations include interviews, focus groups, surveys, questionnaires, analysis of data and specimens, observational studies, epidemiological studies, or the review of medical records as part of systematic investigation.

For more information on research determination, see the OHRP Guidance at 45 CFR 46.102(d).

Clinical investigations are considered Research and require IRB review and approval. FDA guidance defines a clinical investigation as any experiment that:

• Involves a test article and one or more human participants/subjects, and that
• Either is subject to the requirements for prior submission to the FDA under section 505(i) or 520(g) of the FD&C Act, or
• Need not be subject to the requirements for prior submission to the FDA under relevant sections of the Act, but the results of which are intended to be later submitted or held for inspection by the FDA as part of an application for a research or marketing permit (21 CFR 50.3(c), 21 CFR 56.103(c), 21 CFR 312.3(b), and 21 CFR 812.3(h)).

For clarification, a test Article is any drug, biological product, medical device, human food additive, color additive, electronic product, or any other article for human use that is subject to FDA regulations.

Examples of activities that are clinical investigations include clinical trials that involve investigational drugs or devices, research testing the safety and effectiveness of a device, or medical outcome studies comparing approved drugs or devices.

For more information on clinical trial investigation determination, see the FDA Guidance at (21 CFR 50.3(c), 21 CFR 56.103(c), 21 CFR 312.3(b), and 21 CFR 812.3(h)).

IRB approval is required for research or clinical trials that involve human participants/subjects. Once the study has been determined as “Research”, the next step is to determine if human subjects/participants are involved.

A human subject/participant is a living individual about whom research is conducted through:

• The collection of information or biospecimens through intervention or interaction with the individual for use, study, or analysis, or
• The acquisition, use, study, analysis, or generation of identifiable private information or identifiable biological material.

The OHRP Chart 01: Is an Activity Human Subjects Research Covered by 45 CFR Part 46? is available to assist with determining if a research project involves human subjects/participants.

Projects that are not defined as “Research” are excluded from federal regulation 45 CFR 46 “Protection of Human Subjects,” also known as the Common Rule and, thus, are excluded from the requirements of IRB review and approval. However, the Howard University Graduate School and some project sponsors may request an official letter from the IRB that verifies this determination. In these cases, it is required that an IRB application is submitted for verification.

Studies in basic and applied sciences such as Engineering, Physics, Computer Sciences, Chemistry, and others that are defined as “Research,” but do not involve interactions or interventions with human participants, biohazards or animals are usually excluded from the requirements for IRB review and may qualify for an Exclusion review. Regardless of discipline, all exclusion reviews requested by student applicants must include a RCR Workshop certification of completion from the Graduate School.

Studies that do not fall under the definition of "Research" and do not involve human participants are considered Exceptions of the requirements for IRB review and do not require a submission to the IRB. However, it is recommended to contact the ORRC to validate this. Studies that are Exceptions from IRB review requirements include:

• Oral histories and journalistic activities designed exclusively to create a record of specific individuals or events.
• Training activities when they are NOT intended to contribute to generalizable knowledge.
• Classroom activities where the objective of the activity is to teach proficiency in performing certain tasks or using specific tools or methods, when the activity is NOT intended to contribute to generalizable knowledge. 
• Biographies.
• Service or course evaluations.
• Services, courses, or concepts where the results are NOT intended to be shared beyond the Howard University Community.
• Classroom exercises specifically designed to fulfill course requirements or to train students in the use of specific methods or devices.
• Quality assurance activities designed to continuously improve the quality or performance of a department or program, and there is NO intention to share the results beyond the Howard University Community.
• Case reports, which are a retrospective analysis of one, two, or three clinical cases that describe an interesting treatment, presentation, or outcome. More on case studies and case reports can be found at Case Report Guidance.

• Belmont Report
• CITI Program
• Education and Training | OHRP
• Human Research Protection Training | HHS
• Human Research Protection Foundational Training | OHRP

Forms and Tools

• iRIS Platform
• Ethical IRB Guidelines and Principles
• GCP Training Requirement
• Guidance for Case Reports
• Guidance for Faculty and Research Staff
• Guidance for Students
• Guidance on Recruitment Material
• IRB Charge Policy
• IRB SOP
• IRB SOP Supplement
• IRB SOP DoD Addendum
• Limited IRB Review
• Review of PHI-Related Protocols
• Template: Assent Form (Download)
• Template: Informed Consent Form (Download)
• Template: Interview Preamble (Download)
• Template: Survey Preamble (Download)
• Typical IRB Review Timelines

Links

• 45 CFR 46: The Common Rule | eCFR
• 21 CFR 50: FDA regulations on the protection of human subjects | eCFR
• 21 CFR 56: FDA regulations on Institutional Review Boards (IRBs) | eCFR
• A How to Guide: The Use of Social Media in Research | NIH
• Belmont Report
• Human Research Protection Program Resources | HHS
• Office for Human Research Protections (OHRP) | HHS