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Do You Need IRB Review... and Why?

Why do IRBs exist?

Simply stated, egregious human experimentation such as that conducted by Nazis during World War II and during the Tuskegee Syphilis Study resulted in the creation of regulatory and ethical safeguards designed to protect the rights and dignity of participants in clinical trials and research studies. IRBs were the ultimate result and are in place to ensure research is conducted ethically and in accordance with various sets of regulations.

Review the set of infographics Protecting Research Volunteers (https://www.hhs.gov/ohrp/education-and-outreach/about-research-participation/protecting-research-volunteers/index.html) to get an overview of the Federal system of protections. These provide an easy-to-follow introduction to human subjects’ research protections that covers topics such as why we have regulations to protect human research participants and the framework for protecting human research participants in the U.S.

Watch the video Evolving Concern: Protection for Human Subjects  (https://www.youtube.com/watch?v=_8Ku4b1fW18) to understand the historical events that provoked public concerns and led to the development of regulations and policies to protect human research participants in the U.S

Where do regulations around human subjects research come from?

At the highest level, they are governed by the United States Department of Health & Human Services' Office of Human Research Protections (OHRP) at 45 CFR part 46 and the Food and Drug Administration’s regulations at 21 CFR part 50 and 21 CFR part 56.

The Belmont Report sets forth guidelines to be followed by researchers, based on three fundamental ethical principles:

  1. Respect for persons: Protect autonomy, ensure respect, and allow for informed consent without deception.
  2. Beneficence: "Do no harm" while maximizing research benefits and minimizing participant risks.
  3. Justice: Ensure reasonable, non-exploitative, and well-considered procedures involve the fair and equal distribution of costs and benefits to potential research participants.

Researchers must also be aware of and adhere to any applicable state, local, and institutional regulations.
 

FDA regulations differ from OHRP. Please see Is Your Research FDA Regulated? for further guidance.

 

OHRP has specific definitions of "Research" and "Human Subject" provided below

If your project meets both definitions, you are conducting "Regulated Research" and IRB review is needed.


How Do the Federal Regulations Define Research?

“A systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”
 

A systematic investigation involves a methodical procedure and plan, is theoretically grounded, and specifies a focused and well-defined research problem or question, is informed by the empirical findings of others, is analytically robust, and provides a detailed and complete description of data collection methods.

Generalizable knowledge is information that is expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following:

  • Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied.
  • Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study.
  • Note that publication or other dissemination of findings does not in and of itself make the activity “research”. It has been a long-standing myth that if you publish, IRB review is required.

What is Not Generalizable?

  • A quality assurance/quality improvement/organizational effectiveness study where the intent is to assess, improve, or develop programs or services for an organization. Outcomes will remain specific to the organization, programs or services, although other organizations may use the results for their own programs.
  • An oral history or journalistic piece. These are published materials that are limited to only documenting or reporting on events, situations, policies, institutions, or systems without the intent to form hypotheses, draw conclusions, or generalize findings. It will not involve stories that will or may draw broad conclusions about the population, cultures, norms, and practices.
  • A note about class/educational “research” activities – Class projects and research methods classes may involve data collection activities for training purposes that do not require IRB review and oversight because the intent is to teach methods, not to contribute to generalizable knowledge. The intent of other class projects may be to provide the student with real world 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.
  • A note about student internships – Students within many departments or schools of the University are involved in internships or practica. Some student practica/internships may include research activities that are designed to contribute to generalizable knowledge and, thus, involve research that requires IRB review.
  • Please note --  even though a research activity may not qualify as "regulated research" now, this does not mean that you may not use these data for future "regulated research" activities. The use of data that was initially collected for non-research purposes is known as “secondary use of data not initially collected for research”.

 

How do the Federal Regulations Define Human Subject?

“A living individual about whom an investigator conducting research obtains (1) information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens” (45 CFR 46.102(f)(1)(2)).”  
                  

  • Living individual refers to data (information or specimens) collected from living subjects. For example, research using data from the 1880 Census would not be human subjects research.
  • About whom refers to the fact that the information collected must be personal information about an individual. For example, a survey that collects data about the activities of an organization, rather than its members, is not human subjects research.
  • Intervention includes physical procedures and manipulations of the subject or the subject's environment for research purposes. For example, taking a saliva or blood sample from a subject or having a subject view a video would be considered a research intervention.
  • Interaction refers to communication between the researcher and the subject. For example, research that includes face‐to-face, mail, internet and phone interactions (e.g. surveys), as well as other modes of communication would be considered an interaction.
  • Identifiable private information or biospecimen means the identity of the subject is or may be readily ascertained by the researcher or others or associated with the information. For example, research with a de‐identified data set is not research with human subjects because the data are not individually identifiable.
  • Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, or information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable in order to be considered information to constitute research involving human subjects. Examples of private information include medical or academic records or personal journals.

 

 

With these definitions in mind, there are several possible next steps.  See below to learn more about your study.

 

If You Are FACULTY, STAFF, or Other NON-UNDERGRADUATE Researcher

If your study:

Does not meet the regulatory definition of research. IRB review is not required.
Meets the regulatory definition of research, but does not involve human subjects. IRB review is not required.
Meets regulatory definitions of both research and human subjects (a.k.a. "regulated research"). IRB review IS required. Research may not begin without approval.
Is a collaborative study with another institution (including HMS, HSPH, HSDM). A reliance agreement may be possible. See "Single IRB?" tab.
Requires a Not Human Research determination for funding or other purposes. An abbreviated submission is required. See "Before You Begin to Prepare" tab.
Lacks definite plans to involve humans, but an IRB determination is needed for funding or other purposes An abbreviated submission is required. See "Before You Begin to Prepare" tab.

 

What if you are not sure? The IRB office would be more than willing to help you determine whether your activity requires IRB review or not.

Find your IRB contact person !

If You Are An UNDERGRADUATE Researcher

All undergraduate research starts with the Undergraduate Research Training Program