IRB Ethics Guidebook

Time to Read: <4 Minutes

I have had the pleasure to serve on an Institutional Review Board since 2016. The experience has benefitted me time and again as a researcher and as a friend to researchers. I have helped many of my peers with this daunting process and have realized two things:
  1. No matter which Univeristy in which state someone is attending, there are some common misconceptions about how IRB works.
  2. There is not much written specifically about the process to guide people through it.
To fill that gap, I will periodically be posting about the IRB process.

Note: My advice is general and will vary from school to school. I am not a lawyer or a compliance officer... just someone who wants to help.

Background

The whole point of an IRB is to protect humans used as guinea pigs for research. Prior to the passage of the National Research Act in 1974, a series of unregulated experiments resulted in the suffering and deaths of unwilling participants. The most famous include experiments by Nazi doctors during World War II and the Tuskegee Syphilis Study in which doctors denied diagnoses and treatment to patients in order to study the progression of the disease, even after a cure was developed.

IRB Guiding Ethics

Every IRB is concerned with three basic ethical principles for research with human subjects:
  • Respect for Persons
  • Beneficence
  • Justice
Remember that research participants are humans who are entitled to freedom, justice, and protection from harm.

Respect for Persons

Respect for persons is about autonomy in two parts, which happen to contradict each other: 
  1. Researchers acknowledge personal freedom of participants. This means people should make their own decision about participating in research after being informed of its purpose and potential risks.
  2. Researchers protect people with diminished autonomy. Some examples: 
    • children
    • prisoners
    • employees with bosses getting a doctorate
    • students with professors conducting research
    • people on tight budgets who need money
    • study participants who changed their mind after they started but feel bad about quitting

This means taking steps to ensure participation is voluntary and may mean excluding certain groups for their own protection.

Although it is frequently clear which groups need protection, it is not always. Researchers must be able to justify exclusion criteria and demonstrate that participants freely made an informed decision about taking part in a study. 

Respect for Persons is addressed in procedures for informed consent/assent, participants, and recruitment. There are likely whole sections in your IRB application dedicated to these three areas. When responding, be sure to consider potential participants' autonomy and diminished autonomy.

Beneficence

Beneficence says researchers maximize potential benefits and minimize potential harms. This is not to say that no risk is allowed... an IRB approved the first human laser-eye surgery after all. 

Researchers are obligated to consider participants, nonparticipants, and society at large when weighing whether potential benefits justify potential harms in a study and include them in consent/assent procedures. An important part of autonomy (see Respect for Persons above) is that potential participants are informed of risks and benefits.

Risks

Here is a short list of risks that come up sometimes:
  • Allergic reaction to adhesive on bandage
  • Embarrassment as a result of data leak 
  • Reliving a traumatic experience
  • Inadvertently admitting to a crime that is legally required to be reported to authorities
  • Finding out you are considered ugly
  • Friends learning you cannot read
  • Getting fired
  • Getting left out because you are the one kid whose parents did not consent to you being in a study
  • Findings that can be misinterpreted and used against entire groups of people (e.g. economically disadvantaged students correlated with lower test scores)
  • Death
  • Deportation
You should have a plan to minimize each risk that is present in your study, and be ready to justify the risks that you cannot completely omit. For example, to minimize the risk of an allergic reaction to adhesive you can ask participants if they have ever had an allergic reaction from an adhesive. To minimize risks to humans, the first laser eye surgeries were conducted on rabbits.

Benefits

Potential benefits are typically less extreme than potential risks. A rookie mistake is overstating them on an application. Benefits can likely be gleaned from your problem statement and research purpose. Additionally, it is a good idea to seek out ways to directly benefit participants, perhaps by sharing relevant findings with them.

Your IRB application will have a whole section on Risks and Benefits, which will give you the opportunity to show that you considered beneficence, justify potential risks, and highlight the ways you will decrease risks and increase potential benefits. Other sections where you will be expected to cover beneficence include data collection, recruitment, data security, and study location.

Justice

Justice is about fairness in distributing the risks and benefits of a study. The Belmont Report mentions five distinct ways risks and benefits might be distributed:
  1. to each person an equal share
  2. to each person according to individual need 
  3. to each person according to individual effort
  4. to each person according to societal contribution
  5. to each person according to merit
Questions of justice can seem a little philosophical, but they are important to consider when selecting participants. It affects individuals who may be selected for risky research due to their undesirable status (e.g. prisoners), and it affects certain groups (e.g. welfare patients) who tend to be over-represented in studies simply because they are easily available or easy to manipulate. Be prepared to justify your participant selection in terms of their relationship to the purpose of the study... not your convenience as a researcher.

Based on material produced by the Office for Human Research Protections, including the Belmont Report (1974) and Human Research Protection Foundational Training.

Looking Forward

Future posts will be dedicated to helping researchers practically apply these three basic ethical principles to their studies, anticipate and respond to IRB objections, and hopefully speed up the approval process.