Is it IRB-Regulated Research?

Summary

This document provides information regarding the federal definition of research and what it means to complete a “systematic investigation” and “contribute to generalizable knowledge.” This document should clarify issues regarding research and assessment, evaluation, class projects, pilot work, feasibility studies, presentations, and dissemination of data and findings. An activity may be research, but may not meet the criteria for regulated research as defined by the federal regulations governing research with human subjects (45 CFR 46).

Full Description

Regulatory Definition of "Research"

The federal regulations governing research with human subjects defines research as, “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” At W&M, the federal definition for "research" is applied to all projects regardless of funding.  

There are two aspects of this definition that make a research project regulated by the IRB. Both aspects must be present in a research project for it to be reviewed and approved by the IRB. These aspects include the practice of a systematic investigation and the contribution to generalizable knowledge.  

IRB OVERSIGHT FLOW CHART (pdf) 

What is meant by a “systematic investigation?” 

• Involves a methodical procedure and plan  
• Is theoretically grounded and rooted in current literature and research 
• Is focused and has a well-defined research problem, hypothesis, or question   
• Is informed by the empirical findings of others  
• Is analytically robust  
• Findings and recommendations are intended 
• A detailed and complete description of data collection methods can be provided  
• Involves a prospective research plan that incorporates data collection and data analysis   

What is meant by “contribute to generalizable knowledge?”  

• “Generalizable knowledge” is knowledge that is expressed in theories, principles, or statements of relationships that can be generally applied to our experiences. 
  • Activities designed to contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual(s) or an internal program(s)   
  • The information is collected to share with others and is created for the purpose of making a broad statement (conclusion) about a group of people, procedures, or programs.  
• The intent to develop or contribute to generalizable knowledge makes an activity research. 
  • The intent to contribute to “generalizable (scholarly) knowledge” makes an experiment or data collection research, regardless of publication or presentation.  
  • Research that is never published or presented is still research. Participants in research studies deserve protection whether or not the research is eventually published.  
  • Useful guiding question: Do you have more than a 51% chance of publishing or presenting the results of the study? If yes, that means you have intent.  
• A research project is considered “contributing to generalizable knowledge” when any of the following activities will occur: 
  • The information contributes to a theoretical framework or an established body of knowledge. 
  • The information expands the knowledge base of a scientific discipline or scholarly field of study. 
  • Generalizability is applied by researchers in an academic setting. It can be defined as the extension of research findings and conclusions from a study conducted on a sample or group. 
  • The primary beneficiaries of the study are other researchers, scholars, stakeholders, and practitioners in the field of study where they may use the end product to inform their daily practices, policy, or their research design, instruments, devices, data collection methods, and drugs or biologics. 
  • Publication, presentation, or other distribution of the results are intended to inform the field of study.  
    • Distribution of results may involve an oral presentation such as a lecture or conference talk, a written presentation such as a published research article, scholarly book, conference poster, other display that is made available to persons beyond the College.   
  • The findings are intended to be replicated in or transferable to other settings.  
    • Transferability is applied by the readers of research. Although generalizability usually applies only to certain types of quantitative methods, transferability can apply, in varying degrees, to most types of research, including qualitative research.  
    • Unlike generalizability, transferability does not involve broad claims but invites readers of research to make connections between elements of a study and their own experience.   
      • Note: Oral histories (opens new webpage) may be transferable, but they are not considered a “systematic investigation,” as they are not attempting to answer a research question, address a hypothesis, nor are the oral histories analyzed in a systematic manner intended to demonstrate findings.  
  • The findings are intended to inform a larger study, the design of a device, drug, or biologic, or to aid in future planning of research activities such as a pilot study.   
  • If it is likely that members of the public will make inferences from the data collected and the findings planned to be shared, this is an indicator the research is designed to contribute to generalizable knowledge.   
    • A member of the public is an individual person from the general population, acting as an ordinary citizen rather than in an official, professional, or corporate capacity. A member of the public represents an average person or bystander, not a specialist or someone in a specific, designated role. 
  • Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships. This includes pilot work and some feasibility studies.
• Auto/Duo/Tri-Ethnography  
  • A type of ethnographical research where the researcher themselves is the center of the data collection and data analysis for a larger cultural interpretation of their experience.  
  • “Autoethnography…1) uses a researcher’s personal experience to describe and critique cultural beliefs, practices, and experiences; 2) acknowledges and values a researcher’s relationships with others; 3) uses deep and careful self- reflection—typically referred to as “reflexivity”—to name and interrogate the intersections between self and society, the particular and the general, the personal and the political; 4) Shows people in the process of figuring out what to do, how to live, and the meaning of their struggles; 5) balances intellectual and methodological rigor, emotion, and creativity; and 6) strives for social justice and to make life better (Adams, et al., 2015, p. 2).  
  • This also may include information about third parties.  
  • Autoethnography is a self-reflective method where the researcher(s) analyze their own personal experiences to understand broader cultural, social, or political contexts and interpret the meaning from those experiences. Conversely oral history involves collecting and preserving the memories and personal narratives of others to document past events 
• Narrative Inquiry  
  • The narrative approach weaves together a sequence of events, usually from just one or two individuals to form a cohesive story.  
  • Researchers conduct in-depth interviews, read documents, and look for themes; in other words, how does an individual story illustrate the larger life influences that created it.  
  • The final narrative doesn’t need to be in chronological order; it can be presented as a story (or narrative) with themes and can reconcile conflicting stories and highlight tensions and challenges which can be opportunities for innovation. 
  • Narrative inquiry is a research method that analyzes the structure and meaning of personal stories to understand a participant's lived experience. Conversely, oral history is a method focused on collecting, preserving, and interpreting firsthand accounts of historical events to fill gaps in the public record. While both use in-depth interviews, oral history aims for historical preservation, whereas narrative inquiry focuses on interpreting the meaning of those stories.

The following projects are not considered research:   

• Internal reporting activities to sponsors, supervisors, and offices such as annual reports.  
• Program assessment and evaluation (opens new webpage) where the intention is for program improvement or measurements of outcomes and not intended to generalize to others.  
• For example, a quality assurance/quality improvement/organizational effectiveness study where the intent is to assess, improve, or develop programs or services for an organization is not research, because  outcomes will remain specific to the organization, programs or services, although other organizations may NOT use the results for their own programs. 
• In some cases, W&M may be asked to participate in national research initiatives, during which data will be collected from the W&M population. In such cases, W&M will receive de-identified data from the national research initiative. W&M is not considered "engaged" in the research project, as it is only implementing the procedure for assessment purposes. The national research project has likely received IRB approval elsewhere. 
• Classroom or educational research activities and class projects assigned and conducted to teach methods, not to contribute to generalizable knowledge. The intent may be to provide the student with practical experiences, information gathering techniques, and report writing. However, when the primary focus and initial intent of the class activities are to collect data to be used by students or other researchers beyond the classroom, thereby contributing to “generalizable knowledge,” IRB review may be needed. Please see Appendix and W&M’s guidance for class projects (opens new webpage) for more details.  
• Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information. 
  • An oral history (opens new webpage) or journalistic piece is published materials that are limited to documenting or reporting on events, situations, policies, institutions, or systems without the intent to form hypotheses, draw conclusions, synthesize information about, or generalize findings.  
  • Such oral histories or journalism will not involve stories that will or may draw broad conclusions about the population, cultures, norms, and practices.   
• Public health surveillance activities, typically completed by a government agency or government contractor, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease  outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during an event or crisis that threatens public health (including natural or man-made disasters).  
• Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.  
• Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions  
• Biography research involving a living individual that is not generalizable beyond that individual.

Appendix A

“Does this count as research subject to IRB review and approval?”   

 If you are completing research with human subjects and disseminating the results, it is one of the ways considered “contributing to generalizable knowledge” Below is a list of mediums that can be considered as platforms to contribute to generalizable knowledge.   

William & Mary Symposiums 

Symposiums are forums wherein W&M faculty, staff, and students disseminate findings from their research projects. As a result, any project presented at a W&M Symposium that involves research with human subjects – requires IRB review and  approval. Some symposiums are noted below.   

• W&M Symposiums that DO require IRB review and approval 
• W&M Graduate Research Symposium  
• W&M Undergraduate Research Symposium 
  • Class projects that originally had no intent to share findings beyond the classroom but are later deemed appropriate to present at this symposium, the research project may be approved under the use of "secondary data." 
  • If a class project intended to disseminate findings outside the classroom, IRB review must be sought prior to presenting at the symposium. W&M Spring Honors Research Symposium 
• W&M Symposiums that DO NOT require IRB review and approval 
  • W&M Undergraduate Research Opportunities Fair  
  • W&M Catron Scholars Exhibition and Reception  
  • W&M SURE Undergraduate Research Conference  

Oral History

Review: IRB & Oral History Guidance (opens new webpage)

The field of study and a method of gathering and preserving the voices and memories of people, communities, and participants in past events. Oral history is when the collection and use of the information is limited to recounting or documenting information about specific individuals themselves and is not for generalizing to other individuals, groups, or situations. An oral history is made up of materials on events, situations, policies, institutions, or systems without the intent to form hypotheses, draw conclusions, synthesize information about, or generalize findings.  Such oral histories will not involve drawing broad conclusions about the population, cultures, norms, and practices.  

Some oral history projects may meet the definition of IRB regulated research because they involve other research procedures or because the oral history project interviews are used for more than documenting or recounting an individual's experience. The IRB needs to make decisions about projects on a case-by-case basis. When IRB approval overlaps with oral history, the Informed Consent process and consent form must be separated from any documents that include exculpatory language of "release" or “data ownership.” For these documents, please do not provide them to the IRB office for review, but you should use the W&M templates. For questions about this template please reach out to Swem Library. 

IRB approval is NOT needed to disseminate recordings, transcripts, or summaries of experiences to the following Libraries’ Special Collections, but you likely need to use the W&M templates for information release : 

• Libraries Special Collections: Oral Histories 
• Libraries Special Collections: The Stephens Project 

Dissertations and Thesis   

All thesis and dissertation projects that meet the definition of “research” as described in this guidance and that involve human subjects, must undergo IRB review and receive approval before implementation. This does not include dissertations or theses that solely employ oral history. 

Capstone Projects   

A capstone project may require IRB review and approval under certain circumstances. If the capstone project is meant to serve as a final product, presentation, or performance not intended to contribute to  generalizable knowledge, and it is not published, posted in a public forum or the library (not including special collections), then it will not require IRB review and approval before implementation. However, if the project will be published in the library (much like a thesis) or another public forum (not just a website), then it likely will require IRB review and approval before implementation.   

Class Projects  

IRB & Class Projects Guidance (opens new webpage)

The primary goal of class projects is to provide students with experiential learning in research methods, including study design, data collection, analysis, and report writing. Refer to W&M’s guidance for Class Projects.  

Podcasts   

A podcast is a method for communicating and broadcasting ideas to the public. It provides the opportunity to reach a large audience, while also targeting content towards the audiences’ interests. Some podcasts are designed for entertainment, act in a journalistic manner, or share oral histories. Other podcasts intended to make theoretical or academic ideas accessible to a broad audience may require IRB approval before implementation of the research.  

Podcasts are considered a method for disseminating findings from a research project and IRB review and approval would be required to use this medium to share findings from research with human subjects. When IRB approval overlaps with the creation of a podcast, the Informed Consent process and consent form must be separated from any documents that include exculpatory language of "release" or “data ownership.” For these documents, please do not provide them to the IRB office for review, but you should use the W&M templates and edit them to match your project. For questions about this template, please reach out to the Swem Library. 

Press Releases and News Articles  

Occasionally, a press release or a news article can be used to disseminate information, ideas, and to make theoretical or academic ideas more accessible to people. This includes disseminating research findings. If the press release or news article does not discuss research findings that can be generalized or transferred, then the release or news article will not require IRB review and approval. However if findings are shared, then your project should have undergone IRB approval before recruitment, consent, data collection, or analysis of identifiable data. If you are completing a project solely for journalistic endeavors, then your project does not require IRB approval.  

Magazines   

A magazine is a periodical publication containing articles and illustrations, typically covering a particular subject or area of interest. Oftentimes contributing to a magazine does not require IRB review and approval because it is a journalistic endeavor. Occasionally, a magazine can be used to disseminate information, ideas, and to make theoretical or academic ideas more accessible to people. This may include disseminating research findings. If the contribution to the magazine represents findings that can be generalized or transferred, then the project will require IRB review and approval before recruitment, consent, data collection, or analysis of identifiable data. “Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.”  

Newsletters   

A newsletter is a publication that gets circulated at regular intervals to a targeted audience. The publication typically pertains to issues that the subscribers are interested in. Oftentimes contributing to a newsletter does not require IRB review and approval. Occasionally, a newsletter can be used to disseminate information, ideas, and to make theoretical or academic ideas more accessible to people, including the dissemination of research findings. If the contribution represents findings that can be generalized or transferred, then the project will require IRB review and approval before recruitment, consent, data collection, or analysis of identifiable data. “Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.”  

Pilot Study and Feasibility Work  

Procedure 18: Pilot and Feasibility Work (opens new webpage)

A pilot study is a preliminary investigation usually conducted on a small scale that may be exploratory in nature, designed to test or develop procedures, to test study design (including survey or instrument development), or to test methods that are intended for a larger study. A pilot study is usually completed with a participant group related to the intended target population. Feasibility work is an assessment of the practicality of a proposed plan, method, or use of an instrument for data collection, often involving colleagues or experts who can evaluate if the proposed method/design/instrument will result in sufficient information to answer the research questions.  

Documentaries  

A documentary is a nonfiction film or video designed to document real-life events, people, or issues, primarily for education, instruction, or historical record. These films use interviews, archival footage, and observational techniques to tell a story or explore a specific viewpoint. When IRB approval overlaps with the creation of a documentary, the Informed Consent process and consent form must be separated from any documents that include exculpatory language of "release" or “data ownership.” For these documents, please do not provide them to the IRB office for review, but you should use the W&M templates and edit them to match your project. For questions about this template please reach out to Swem Library.