On Research Podcast – Consent in Research

Darren Gaddis: From CITI Program, I’m Darren Gaddis and this is On Research. Today, consent and research, the role of the IRB and consent and how consent varies throughout the research paradigm. I spoke with Linda Reuter, the Senior IRB Director at the Biomedical Research Alliance of New York. As a reminder, this podcast is for educational purposes only. It is not intended to provide legal advice or guidance. You should consult with your organization’s attorneys if you have questions or concerns about relevant laws and regulations discussed in this podcast. Additionally, the views expressed in this podcast are surely those of the guest and do not represent the views of their employer. Hi Linda. Thank you for joining me today.

Linda Reuter: Thank you for having me.

Darren Gaddis: To get us started today, could you share with our listeners a little bit about your background and your current role that you have today with the Biomedical Research Alliance of New York or Brany?

Linda Reuter: Sure, I’d be happy to. I did some research in college as part of my undergrad degree in biology, and then as part of my master’s degree when I went for my master’s in health sciences, I worked for about three years after college in a Lyme disease research lab. My master’s thesis was related to that, the immunology of Lyme, and one aspect was related to the development of the vaccine, but I moved quickly into research administration work.

I started as an IRB/grants assistant for a local hospital. And that hospital quickly grew into a large health system with a very rapidly growing research portfolio. So there was a lot of things going on, a lot of things to be learned and managed. So thanks to some amazing people at that job who mentored me and gave me opportunity to learn and grow in that field, I sort of learned the ropes from the bottom up over what’s now a 30-year span, and I currently, am skipping a lot of details in between, but I currently work for Brany IRB as their senior IRB director, and I’ve done a lot of consulting work and teaching in this area as well.

So Brany is a company that was formed 25 years ago by four of the major New York research institutions to sort of centralize their clinical trial support services. And that included IRB review. They do more than not just IRB, but I’m focused on the IRB review. We now provide IRB services to institutions all across the country. So just to give you an idea of the scope of what I manage, our IRB currently manages about 1800 active research projects, and I help to manage an IRB team of about 20 absolutely incredible IRB professionals. So that’s my story.

Darren Gaddis: Our conversation today is all about consent and consent within research. So to set the tone for today’s conversation, what is consent within a research setting?

Linda Reuter: Sure. For research, the term consent refers to a process. And it’s a process by which a person is informed and asked to voluntarily agree to be a participant in a research project. A lot of people when they talk about consent, talk about the form and the document and getting a signature and the consent document itself is one step in this process. But in general, getting consent for research activities usually involves the use of that form that the subject will sign. But it’s also a process. It’s a conversation that helps people understand what they need to understand in order to make a decision. What are the risks? What are the benefits? What happens if I decide not to participate? What if I change my mind later after I do say yes? So all of those things play into the consent process.

And a key part of this for the person who’s being asked to participate in research is that it’s made clear that their participation is always voluntary. For the researcher, it’s important to understand that getting consent is more than just having the person sign the dotted line, that it’s more of a process beyond that as well.

Darren Gaddis: With this understanding of consent, how could consent be different in the behavioral and social sciences compared to the physical sciences?

Linda Reuter: So when you compare a social behavioral research project to say, a clinical trial of a new treatment for disease or something of that nature, the nature of the research and the risks look very different. So in turn, the consent process is going to look quite different because the information the person would need to make a decision will be very different for each of those scenarios. Things like clinical trials generally involve a person’s health. There are many factors that would be important to the consent process for a participant, like what are the risks? What are the benefits? What are the alternative treatments? What’s known about this treatment? Is it going to help me? Will I be given test results from this research? Or are they only going to be used for research purposes? What about by privacy? Are you doing genetic testing? There’s all sorts of other implications when it comes to medical research, and we often focus there on physical risks and benefits in that scenario.

And behavioral research that aims to evaluate any aspect of human behavior is very different. And many people think there are no real risks involved in behavioral research, but there are many things to consider that IRBs look at that relate to non-physical risks or social behavioral research. Things like psychological or emotional risks, things like fear and stress and confusion, depression, triggering of past experiences, things like that, and even social risks. So the risk of social stigmatization of a particular population or sometimes even economic risks we’re worried about. So those are the sorts of things that an IRB would be focused on, and they’re very different for the behavioral and social sciences compared to the physical sciences. It’s often an IRBs role to look at these things through a different lens when you’re looking at a study that’s focused on social behavioral research as opposed to medical or clinical research.

Darren Gaddis: And why is consent so important within a research study and what is the historical context of consent within research?

Linda Reuter: So the current regulatory requirements and the regulations that we need to follow, they all have their history and things that went bad with research in the past where people were involved in research either without their consent or where things went terribly wrong. We can spend a lot of time talking about history and how we got to where we are today when it comes to consent, there’s a lot to be told there. But the things that I’ll just spend a minute on are things like the human experimentation that’s placed in the Nazi concentration camps, the thalidomide tragedy that occurred in this country in the 1950s, we have the syphilis study. That’s another famous study that was something that went terribly wrong without properly informing participants of what was going on with the study, and lots of others, the human radiation experiments, the Willowbrook study. So we don’t have time to get into all these today, but just to know that they all represent research atrocities, I would use that word, where people were harmed because they were included in research without being fully informed and without their voluntary consent.

And in some cases this was physical harm, especially when we talk about the Nazi experimentation. And in some cases, the results of that research participation was death, but also non-physical harm. Those things that happened led to the development of what we now have as rules and regulations that would help to prevent those harms from occurring. And consent is important for this reason. And consent within a research study is important because the person who’s asked to participate should always be given a choice, and they should also fully understand the research and all its implications before making that choice, especially when participating involves risks or in the case of medical treatment, very often when they think they may not have another choice or that potential treatment is going to be beneficial, but it needs to be clear that it may or may not be. That’s why we’re doing the research to see if it may or may not be.

The history sort of led to the rules and regulations that we have today, and that the intent is to prevent such harms from occurring that have happened in a historical context, and also to make sure people are fully informed and making a decision based on the information that would be most important to them.

Darren Gaddis: Knowing All this, what role does the IRB play informing consent within a research study?

Linda Reuter: So IRBs are tasked with protection of human subjects and research. That is their role. And one aspect of this is of course, reviewing consent documents and also the process that we’ve talked about that will be used to document this voluntary participation choice from participants. IRBs are asked a lot of questions about consent, and we spend a lot of time on consent documents themselves, editing, writing, changing, rearranging, all of these things a lot of time is spent on consent. And since there are so many regulatory requirements, IRBs pay a lot of attention to the consent forms and processes as part of reviewing the protocol, and that’s one to make sure that participants are going to be properly informed, but also to ensure that researchers are aware of the requirements and are compliant with the rules that pertain to them so that they don’t get themselves into trouble down the road by having a consent process that was inadequate.

So researchers are usually the ones who prepare the consent and submit to the IRB for review with their research applications. That would include the protocol and the consent and recruitment materials and training of research staff and all of those things. But IRBs often do get involved in the process by helping provide guidelines and templates, consent form templates, sometimes helping to write or edit the consents based on the nature of the research before they come to the IRB. The IRB does play a role in helping to draft and edit these consents as well as reviewing and editing after the fact to maintain compliance with all the different rules we need to follow.

Darren Gaddis: And how can consent vary depending on a research study?

Linda Reuter: The complexity of the consent form itself and the process is usually tied to the level of risk involved in the research. For some low risk research, the requirement for consent can actually be waived altogether or sometimes certain aspects of consent are waived. So that list of required elements may be a little bit shorter for some research to which some of those elements are just not applicable. Sometimes we can waive the requirement for a written signature on a consent to allow for more of a verbal consent process without an actual sign the dotted line process being in place. Lower risk research that requires consent, most likely would have a consent that’s on the shorter side. So we see some lower risk studies that have one or two paid consent forms.

Whereas high risk research has been known to have consents that are even over 50 pages long. I’ve definitely seen consent forms for high risk medical research that are more than 50 pages, and we can talk about that, and that’s another conversation about how to deal with these long consent forms. We should also talk a little bit about research that involves people who need additional protection. So what do we do about research and children who can’t legally consent for themselves or research involving adults who don’t have the capacity to consent for themselves. Maybe they’re temporarily incapacitated because they’re coming into the ER in the midst of a stroke or heart attack, or maybe they have a disease that has diminished their capacity to make a decision for themselves. So there are also extra protections for these cases that IRBs consider as well.

Darren Gaddis: Lastly, any closing thoughts you would like to leave us with today on consent within research?

Linda Reuter: For me, the biggest thing for researchers to remember when it comes to consent is that consent is more than just getting a person to sign a form. It shouldn’t be a check the box, one and done sort of thing. Consent is a process where researchers communicate with the people they wish to include in their research, and it’s a process that should be ongoing for the life of the study to keep people informed about what’s involved, give them the information they should know before they decide whether to say yes or no. This should be an ongoing process in some cases, when the research lasts for a long time, such as a treatment protocol where people are treated over months or years and sometimes followed for a very long time.

There should always be that open communication with the researcher and the participant should be given information that would be relevant as they journey through that project. Maybe new information is developed during the course of a study that might be relevant to a person’s willingness to continue on the study. Maybe a new alternative treatment comes up or maybe something else that has been developed as far as knowledge about the intervention that they need to be aware of. So remembering that consent is about good communication and not just a one-time sign the dotted line process, to me is the most important thing to remember about informed consent and research.

Darren Gaddis: Linda, thank you for joining me today.

Linda Reuter: Thank you.

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