Preventing Unethical Research: Purpose of the Institutional Review Board (IRB)

00:01 Hi, I'm Doctor Rhonda Laws, and I want to talk to you today about the purpose of the IRB. Now this is part of our series of preventing unethical research.

00:10 So let's get started.

00:12 The Institutional Review Board is one of the most important components in the field of research ethics.

00:18 The IRB ensures the protection of human subjects participating in research studies. Now, IRBs are typically established by academic institutions, healthcare organizations, or other entities that are conducting research involving human participants. I want to make a quick note before we go on.

00:36 The term IRB is a US term.

00:39 Now, other countries have similar bodies, but they may use the firm ethical board or ethics board, but it's going to mean the same type of activities.

00:49 Now, the purpose of the IRB or the Ethics Board is primarily to review and approve research protocols to safeguard the rights, welfare and well-being of human subjects. It's an independent body that assesses the ethical, methodological, and scientific aspects of research studies.

01:08 Now there are six key functions of the IRB and of the ethics boards.

01:12 The first one is ethical review.

01:15 The IRBs conduct a thorough ethical review of the research proposals.

01:19 We want to make sure that the rights and privacy of participants are protected.

01:24 These boards assess the potential risks and benefits of the research to ensure a favorable balance.

01:30 Now, how they do this is through a very complex application that the researcher has to complete in order to submit for the IRB review.

01:40 The second function of the IRB is risk assessment, so they evaluate the potential risks associated with the research.

01:47 They take into account physical, psychological, social, and legal aspects.

01:51 Now they require the researchers to implement measures to minimize any risk and to ensure participants are safe.

01:59 Now, the third is confidentiality and privacy.

02:02 IRBs assess how researchers plan to protect the confidentiality and privacy of the participants. They scrutinize data storage, handling, and dissemination procedures to prevent unauthorized access.

02:15 Okay, we've gone through the first three.

02:18 Now, I want to make sure that you're still with me.

02:21 So if you are wanting to pursue a study, what are the things IRB would look at? Well, overall we know ethics, right? They're going to make sure that they do a thorough ethical review because of the nightmares we've had with things like the Tuskegee study, etc..

02:38 Now then we talked about risk assessment.

02:40 Right. They're going to make sure they look at through objective eyes.

02:42 They're not the researcher who just really wants to publish it, but they're going to be very objective of what risks there would be to a participant who participates in your study. Confidentiality and privacy.

02:53 Well, this isn't new to healthcare people.

02:55 We're all about HIPAA, right? So IRBs assess how researchers are going to take care of that data like we talked about and...

03:02 Wow. Does that get complicated.

03:04 Now they're going to make sure that the patients understand what they're signing up for that the participants in the study know what's being offered.

03:12 Remember, those in the Tuskegee study had no idea.

03:15 They thought they were just getting health care.

03:17 They didn't realize that they had syphilis, and the physicians just wanted to observe untreated syphilis progress.

03:23 So hence they're going to be critically reviewing every opportunity for informed consent.

03:29 IRBs have the responsibility to monitor ongoing research to ensure that it continues to adhere to ethical standards.

03:37 They don't just give you one.

03:38 You're good to go.

03:39 They still have the responsibility of monitoring ongoing research.

03:44 They also have the authority they can suspend or terminate studies that deviate from the approved protocols or pose unforeseen risks.

03:52 Education and training are really positive aspects.

03:55 IRBs provide education and training to researchers, staff, and students on ethical principles and regulatory requirements for conducting research involving human subjects.

04:07 Now, here are the non-negotiables for IRBs.

04:10 The membership of the Institutional Review Board must be diverse.

04:15 IRBs consist of members with diverse expertise, including scientists, non-scientists, and individuals from different disciplines.

04:22 This diversity is what helps us ensure a comprehensive evaluation of research proposals. The second non-negotiable for IRBs is unbiased decision-making . IRBs strive for impartial decision-making by avoiding conflicts of interest and ensuring that members with potential conflicts recuse themselves from the review process.

04:43 Now, adherence to regulation.

04:44 It's the IRBs that operate in accordance with regulation, such as common rules in the United States or other relevant guidelines, depending on the country or institution.

04:54 So, in summary, the Institutional Review Board plays a critical role in upholding ethical standards in research involving human subjects.

05:01 The IRB ensures that studies are conducted with integrity and respect for the rights and well-being of their participants.