Ethics and Human Subjects in Research

This is a HUGE subject. There are entire classes devoted to this topic. It is an active area of research. The goal of this lecture is to introduce some of the practical implications and things you need to know.

  • What is IRB
  • Type of Research and Reviews
    • Behavioral vs. Biomedical
    • Non-human subject and Non-research
    • Exempt vs. Expedited vs. Standard
  • Where to Begin
  • The Journey of a Research Proposal

Research Ethics

Milgrim Experiment

Stanford Prison Experiment

Institutional Review Board

Some of this information is credit to Tony Medure

In response to many research and ethical controversies, Congress passed the National Research Act in 1974. This established the “National Commission for Protection of Human Subjects of Biomedical and Behavioral Research.”

  • The Belmont Report was released in 1979 as a result of the Commission’s meeting.
  • The Code of Federal Regulations (45 CFR 46) was developed from the three basic principles of the Belmont Report.

The goal of an IRB is to ensure the protection, safety, and welfare of human subjects. These are mostly run by institutions, like Notre Dame.

Things an IRB cares about:

Any time you, your research, or your data has anything to do with anything human or animal. This includes data, even public data.

If a human ever interacted, touched, or could potentially interact with your research project, then you need IRB approval.

  • Human Subjects Research
    • Clinical Investigations
    • Diagnostic or Therapeutic Procedures
    • New Interventions or Treatments
  • Data and Specimen Repositories
  • Behavior Tasks
  • Surveys, Interviews, Focus Groups
  • Humanitarian Use Devices
  • Emergency Use of Investigational Drugs
  • Internet Research
  • Pilot Studies

Things outside scope of IRB:

  • Non-human Subject (no data about a specific individual)
  • Non-research (not generalizable)- case studies, oral history, journalism

Types of IRB Review:

Behavioral vs. Biomedical

Exempt vs. Expedited vs. Standard

Non-human Subject and Non-research

Do I have to use IRB for my research?

Short answer: YES


Investigator Training (Required)

Be sure to complete the required human subjects training before submitting to the IRB. Any key study personnel (KSP) must also complete training.

CITI Program –

Continuing IRB Education/Training.

Must complete at least one hour annually.
One additional CITI module, usually focused on human subjects protections.

IRB Timing

IRB protocols must be approved before you begin any research.

Start NOW. It’s never too early to start planning and allow yourself more time than you think you need.

IRB review will take longer than you think, and it can be lengthened depending on the complexity of your study.

Respond promptly to correspondence from the IRB Committee.

IRB Resources

  • Work with mentors or other experts in your area of study.
  • Talk to colleagues that have submitted to the IRB.
  • Call the ND IRB to set up an appointment to speak with someone about your project.
  • Call or email me with any questions you have.
  • Talk to someone at ND IRB
  • Get help with literature searches from the libraries on campus.

Putting your proposal together

A typical proposal/submission includes: an application, a consent form, a protocol, and additional supporting documents (e.g., questionnaires, advertisements, brochures, interview guides, etc.). All of the forms you may need are available on the ND e-protocol website.

Then, submit your study electronically through ND e-protocol system.

IRB Review Process

Once your study is sent to the IRB, it will go through the “pre-review” process. When your study is ready, it will be sent out for review (Exempt or Expedited) or put on the next available agenda (Standard).

When the review is complete, you will receive an email from IRB with an update on the status of your study (Approved, Approved Pending, or Deferred).

If your study is approved, no other action is needed on your part. If your study is approved pending or deferred, you need to make the requested changes and submit the changes to the IRB for review. After your study is approved, any changes you want to make must be submitted as an amendment to the study prior to implementation. Any changes to Exempt studies must be done within the first year.

Expedited and Standard studies must be reviewed at least once annually (i.e., Continuing Review).

Things to Consider

You will do it wrong the first time

You will probably do it wrong the second and third times too.

  • Simple research is good research.
  • Be aware of working with vulnerable populations (e.g., children, prisoners, etc.).
  • Consider working with your advisor/mentor on one of his/her studies.
  • Allow ample time for International studies.
  • Be sure to partner with a contact abroad to make yourself familiar with the local research context.
  • You will also need approval from a local IRB, Ethics Board, Hospital Administration, or other governing body associated with the site where you plan to conduct your study. This can take a LONG time, so be proactive.

Contact Information

Questions about study design, level of review, submission requirements, and the IRB review process should be directed to Mr. Eric Felde, the Director of Research Compliance at

Questions about the e-protocol system or a specific protocol submission (including review comments) should be directed to the Notre Dame Research Compliance office at