Working with the WSU Institutional Review Board (IRB)

Joe Crossno: So I’ll talk a little bit first about what is human subject research. It might seem obvious, but it’s, it’s actually pretty important and sometimes misunderstood. The definitions are very particular. And that will lead us into a little bit about the difference between IRB and Human Research Protection Program and what requires review by each of those entities.

Joe Crossno: And then from there we’ll extend into, excuse me, what what review categories and processes there are. There are three different… Three different processes. And then talk a little bit about the process for submitting projects here at WSU. I’ll stop at that point with the presentation and go into the IRB system and try and walk through that a little bit.

Joe Crossno: Whether or not we have any time, left. If there is time left, I’ll cover anticipated review times. Right now with our us trying to implement ERP and then, a little bit about some common issues we run into with the applications to try and save your time, so that your projects aren’t with…, aren’t held up during review by, by having some of those common problems show up.

Joe Crossno: So jumping right into the federal definitions. Human subject, for the most part, means a living individual about whom an investigator conducting research either obtains information or bio specimens through interaction or intervention with the individual, or the second part is interaction or intervention with or identifiable private information or identifiable bio specimens. So that’s an important thing to note.

Joe Crossno: If there’s no interaction with the individual and the specimens or the private information, information is not private or not identifiable. It’s not considered human subject research. So you can collect or work with data that was originally collected from human subjects. But if it’s completely de-identified, it does not meet the federal definition. And there’s a lot of little words in here that, that are actually important, and can end up resulting in a project not being considered human subjects research.

Joe Crossno: Including the word “about”. So we have a lot of survey-like studies where, you’ll be asking about a process or about, you know, someone’s, job or about an industry. But if you’re not asking about the individual or their opinions, it’s not about the person. And it won’t meet the federal definition. The second part of the definition is research.

Joe Crossno: And in order to be considered research under the federal definition, it has to be a systematic investigation. Most of the projects we see are systematic in some way. But more importantly, it needs to be designed to develop or contribute to the development of generalizable knowledge. Meaning, if you’re doing classroom, classroom survey, to see how your teaching methodology is working in a specific classroom, it’s not likely to be generalizable if it doesn’t apply outside of that classroom.

Joe Crossno: So it has to apply to a population outside of the one under study. And importantly, it does need to meet both of these definitions to require IRB or HRB to review.

Joe Crossno: There are some non-human subject research projects under, the, the federal definition or the common rule definition that will still require review. So the definitions are slightly different under FDA regulations. So those are going to be studies involving test articles like drugs or devices. Here at WSU we have a policy that requires review of any project that occurs on tribal lands or specifically directed at tribal members, whether or not it meets the federal definition of human subject research.

Joe Crossno: And finally, there are projects involving protected information, like that covered under HIPAA or substance abuse, regulations, SAMHSA. FERPA and PERPA, for student records. And then the general data sharing policy under NIH.

Joe Crossno: The IRB is a functionally independent research review unit. It’s designated in the federal regulations. IRBs functionally independent, and the institution cannot approve research that has not been approved by the IRB or has been disapproved by the IRB. The institution can, however, disapprove research approved by the IRB. And that does happen sometimes. For example, if the institution doesn’t have an adequate facility to support the research.

Joe Crossno: The IRB is part of the Human Research Protection Program, meaning that, HRP is the larger group. The IRB is a smaller group within that program that only oversees a portion of the research. The role of both of these groups is to ensure the rights and welfare of human participants involved in research.

Joe Crossno: And, ensure all activities are compliant with regulations and university policies, as well as ethical principles.

Joe Crossno: Our staff is currently made up of six full time employees. Myself, two compliance auditors who also sometimes help with, the operations side. And then we have three coordinators, who assist with, intake and review, as well as a graduate assistant.

Joe Crossno: The boards themselves. One board currently, really. We do have two boards. But one of them only reviews emergency research and it’s a smaller subset of the of the larger board. The main board for WSU is comprised of 13 voting members. Ten of those are faculty. We also have 17 alternate, alternate members who can serve in the absence of a voting member and who assist the program with reviews at the expedited or exempt level.

Joe Crossno: We have ten consultants, in addition to those 30 members.

Joe Crossno: We have about 1200 submissions per year. That’s new protocols or continued reviews, amendments. And then other types of submissions. Over the last five years, we’ve ranged between 1000 and a little over 1400 submissions. We have usually around 1600 or more active protocols at any given time. So it’s a fairly robust program overall.

Joe Crossno: Though a lot of our research is exempt.

Joe Crossno: I’ll talk a little now about, different types of review or review categories. Full board is the highest level. That’s for more than minimal risk research. And then expedited is also nonexempt research, but it’s minimal risk. And it fits specifically under one of the nine categories allowed under the federal regulations. Exempt doesn’t mean completely exempt.

Joe Crossno: It means exempt once a determination of exemption has been made. There are six exempt categories that a project has to fit within to be considered exempt and then not human subject research determinations. People also refer to those as exemption, but they are a little bit different.

Joe Crossno: The IRB so not the HRPP, but the IRB itself. The board reviews all nonexempt human subject research and reviews all HIPAA waiver requests.

Joe Crossno: The HRPP, which is a larger group that includes myself and my staff reviews, exempt research, as well as non, non HIPAA privacy reviews and, and some HIPAA reviews that are allowed to go by the expedited process. I would normally say HRPP staff conduct over 60% of these reviews. This past year it’s been closer to 80%.

Joe Crossno: So we we do have, some, some problems, with faculty availability occasionally and then end up having to rely on staff reviews for a significant proportion, especially of the exempt reviews.

Joe Crossno: So a little bit more about human subject review, human subject research determinations. If we determine a project, does meet human subject research. The reason these determinations sometimes have to be made by our group is that sometimes funding agencies, collaborating institutions and publishers request this. It’s not required under the regulations. But if you want to get published and a publisher demands an independent verification, you’ll need to come to us and we’ll make an independent determination.

Joe Crossno: That said, the PI is allowed to make their own determination, and we have a form that assists you in doing that. You don’t even need to use the formula. You can use the electronic system. And hopefully it’s straightforward we do provide a lot of instruction within the system that, that I’ll show you shortly.

Joe Crossno: When it comes to exemption determinations, regulations do specify that it has to be a qualified person making the determinations. So at WSU, under our policy, that’s HRPP staff and trained on IRB members. Again, it means it does not mean exempt from review until after the determination is made. Once the determination is made, then it’s exempt from further regulatory oversight.

Joe Crossno: We get a lot of questions about when there’s an amendment requirement for an exempt project. Whenever the amendment might lead to a change in the determination of eligibility for exemption, that’s when an amendment is really required. Sometimes you’ll need to submit an amendment because funding agencies or collaborators expect it. You want to amend something like a consent form and it’s a multi-site project.

Joe Crossno: Those typically do have to come in for an amendment, even for an exempt project.

Joe Crossno: WSU utilizes six of the federally recognized exemptions. The most common at WSU are one through four, two is actually by far the most common. So exemption one is is where you find most education research. Two is for surveys, interviews and public observation, but can’t be any interactions with children. Three is benign behavioral interventions and four is research with preexisting data.

Joe Crossno: Exemption one. This is research conducted in commonly accepted educational settings. And I’ve underlined that because, commonly accepted educational settings only have to be common to what is being taught. So we’re not talking about, you know, your standard K through 12 classrooms if you’re learning first aid. Wherever first aid might classes might be taught would be considered a commonly accepted educational setting.

Joe Crossno: If you’re teaching surgical techniques, obviously, that’s that’s going to be commonly taught in, surgical theater, at a hospital, not in a classroom. So it really depends on what, what the topic is that’s being taught, whether or not it would be considered a commonly accepted educational setting. The normal educational practices part is important.

Joe Crossno: It has to involve a, a standard educational practice or could be a comparison of a standard to something else, so long as it’s not, going to be a substitute for whatever the standard educational practice is. In other words, if if you’re going to try a new methodology, you have to do that in comparison to the, to the standard, otherwise it wouldn’t fall under exemption.

Joe Crossno: Importantly, it can’t adversely impact students opportunity to learn. And that includes the students who don’t want to participate in the research. So if you’re doing a research project and you have students who don’t want to participate, and it would adversely impact their opportunity to learn, by being, in the classroom, where, what are the research is being conducted.

Joe Crossno: This cannot fall under exemption.

Joe Crossno: What note, exemption one research is not, not exempt from FERPA. So a lot, a lot of times we’ll run into really simple, straightforward survey research. Under exemption one. But FERPA still applies. And so you can’t do your, your standard online click through consent, FERPA has special consent requirements, requires a real signature.

Joe Crossno: So that can, provide a challenge for, for some classroom type research.

Joe Crossno: Exemption two is our most common at WSU. This is the surveys, interviews, and public observations. There can be any interaction with children. The only, only research involving children that can fall here is observation of public behavior where there is no interaction so the investigators can’t participate in the activity being observed.

Joe Crossno: There are three subcategories under under this, research exemption. One of them requires that no identifiers be recorded of the research data. The other one, allows for recording of identifiers, but only in instances where recorded responses would not have any risk to the participant. So no risk of criminal or civil liability, damage to their reputation and so on.

Joe Crossno: Otherwise, there’s a third category, where you would be allowed to do research involving risk. Your data, and identifiers. But then the requirements of the subject regulations apply. Specifically, it requires what we call a limited IRB review of the data management security plan.

Joe Crossno: Exemption three is benign behavioral interventions. If it’s federally funded, we really have to stick closely to these being behavioral interventions. If it’s not federally funded, we have some flexibility. So we’ve seen some interventions that might be considered, very, you know, minor physical activity, where we have allowed benign behavioral interventions to be considered, under this, category.

Joe Crossno: Similar to exemption two limited IRB review of data, security is required for sensitive research. If the research involves, minor deception, such as withholding of information, participants have to prospective prospectively agree to that withholding of information. In other words, you don’t have to tell them, what it is you’re withholding. You just have to tell them that you can’t disclose the full reason for the research because it might confound data collection.

Joe Crossno: So you do have to get their prospective agreement to, information being withheld or to any deception within exempt three. The interventions themselves have to be brief in duration, harmless, painless, not physically invasive, and not likely to have any significant adverse impact.

Joe Crossno: And finally, exemption four, this is secondary research.

Joe Crossno: Consent is not normally required for secondary research. This would be typically be be research involving, data or bio specimens that was previously collected, sometimes for non-research purposes. There are three categories. For this type of research. The identifiable private information or identifiable bio specimens are publicly available. I always have a hard time with this one because how can it be identifiable in private if it’s publicly available?

Joe Crossno: But there are there are certain types of projects where, you aggregate different types of publicly available data and potentially produce, what might be considered identifiable private information. There are requirements to aggregate or de-identified data, record data in a de-identified manner under one category. Second category allows for HIPAA regulated data to be worked with under this category.

Joe Crossno: This is the HIPAA exemption that I was mentioning.

Joe Crossno: And then, the final one, we don’t see very much of, research conducted by or on behalf of a federal department or agency.

Joe Crossno: So, preexisting data that is de-identified. Who de-identifies the data is important. Because if it’s the PI in possession of the data, it may not fall under exemption. If the data is de-identified and provided to the PI, could end up not meeting the federal definition of research. In order to qualify. Especially if this is HIPAA regulated data, it has to meet minimal criteria for de-identification.

Joe Crossno: We use the safe harbor method for de-identification as a verification. Some examples of preexisting data that’s identifiable include directory information. Information already in the possession of a researcher who has consent from a prior study for future use. It is important to note that regulations like FERPA and PPRA may still apply. This can be a challenge with preexisting data.

Joe Crossno: In particular, if the research preexisting data was collected when students were minors and have now become adults. This could lead to you having to re-consent under the regulations or de-identify.

Joe Crossno: There are two different types of nonexempt research. One is expedited. Expedited doesn’t mean fast, it just means it doesn’t have to go to the full board. It doesn’t have to wait for a convened meeting to be reviewed. This will fit into one of the expedited categories under the federal regulations. Represents no more than minimal risk to participants and can be reviewed typically by two

Joe Crossno: IRB members or a member of a staff member. Full board review is reserved for research that doesn’t fit into one of those expedited categories, or that represents more than minimal risk or more than the daily life risk, to individuals who participate.

Joe Crossno: Nonexempt categories, included clinical studies and drugs or devices that are minimal risk. Simple things like, taking blood samples or biological specimens collected in noninvasive ways. Collection of data through noninvasive procedures like EKG or ECG. Use of materials that were not collected for research purposes. Use of recordings that were made for research purposes.

Joe Crossno: And then the most common is category seven, which is research on individual or group behavior. So this’d be where all of our survey, research, interviews, focus group, etc. that doesn’t qualify for exemption under category two. It almost all comes here for expedited review under category seven. And again, full board is only for more than minimal risk or research that doesn’t fit into an exempt or expedited category.

Joe Crossno: And the review process for exempt exempt research and research determination requests. Starting March 17th, we’ve asked that all new exempt projects have to be submitted to our electronic system. In order to get to the system, we have to go to myresearch.wsu.edu. Select compliance, create new form. And there’s a quick start guide on our web page.

Joe Crossno: And I’m going to stop the.

Joe Crossno: Presentation briefly here.

Joe Crossno: So a couple important things. We’ve been running into a lot of problems. You do have to be logged in to VPN in order to access the system and get full use of it. So you want to log into the VPN before connecting to MyResearch. To get into MyResearch just requires a normal WSU login. From there you go to Compliance, IRB, My protocols.

Joe Crossno: And then create a new form.

Joe Crossno: We put a lot of explanation in here. If you’re familiar with IRB applications, you probably won’t need a lot of it. We kind of designed this system for everyone. So from beginners to people who have a lot of experience. So there is a lot of, hover over, a lot of, a lot of links, a lot of hover over information sections.

Joe Crossno: There’s a lot of explanation in here about what exactly the IRB needs to do a review.

Joe Crossno: In the first section here, you just fill in basic information about, yourself. Your study team. Whatever the whatever the project title is. If there’s a grant title, can often be helpful for us to be able to look up the grant. Particularly if there is a tight deadline for a turnaround.

Joe Crossno: You do want to save, frequently. Typically when you navigate from page to page, it will save on its own. But I wouldn’t count on that working 100%. At least I don’t.

Joe Crossno: I do want to make sure that you have at least one, contact designated.

Joe Crossno: One nice thing about this system is it automatically uploads training from CITI. So you no longer have to do that. No longer need to print off PDFs and send those into our office. System does that automatically for you.

Joe Crossno: And again, a lot of this is going to be very familiar from our current application for or from past applications at other institutions. We want to know about the qualifications of the research team to do the research, what the research is about, what the questions are, are being asked for. Purpose. And then a sequence of procedures, in the order that participants will see them.

Joe Crossno: And this is the part that I was talking about, where you can do research determinations right in the system. Gives a lot of explanation about the types of activities that would not be considered research. And then you can answer “No” if it’s not systematic investigation, it’s going to tell you “research does not meet the definition.” You go on and answer questions about FDA.

Joe Crossno: And if all you’re needing is a research determination, this is all you might need. You may be able to just save this, print a copy of the worksheet for your records. Sometimes, particularly publishers are going to want to see a letter from us, in which case, you can submit this for review.

Joe Crossno: If, on the other hand, it is research. You answer yes to it being a systematic investigation of or involving, living persons or identifier. But identifiable private information or bio specimens.

Joe Crossno: We’ll ask some questions about funding. That’s important because different funding agencies have different regulatory requirements. Specifically, if you’re funded by, Department of Defense, Department of Energy, they have particular requirements that we have to include in a review that are not necessarily found under the common rule. And the Department of Justice is another, so we are going to want to know about funding agency and whether or not you intend to apply for funding.

Joe Crossno: This can also come into play. Funding projects are more likely to have conflicts of interest that need to be disclosed to be an informed consent.

Joe Crossno: So there will be a section here on conflict of interest. And want to know about both financial and non-financial conflicts. Anything that gives the appearance of a conflict. And that’s just to decide whether or not it’s a significant enough conflict that it should be disclosed via informed consent, or if it does require a conflict of interest management plan.

Joe Crossno: The next section, you’ll answer questions about whether or not you have external collaboration. Whether we need to, reliance agreement for an external group to rely on us. We have different methods of doing that. So there’s a lot of information in this section that’s really not going to be relevant to most research. But it is very it should be very helpful for individuals who have multi-site studies.

Joe Crossno: And then finally we come to, the determination of whether or not the project is more than minimal risk. Most of our research is not. We’ll also ask some questions about, whether or not research is considered classified. And then before you can get into exemption determinations, we’ll need to know, whether or not the research involves prisoners.

Joe Crossno: If prisoners are included, it can’t be exempt.

Joe Crossno: And from there, you’ll pick,

Joe Crossno: Either exempt one of the exempt categories or if your research is more than minimal risk or doesn’t fall on exempt categories, you would select none of these categories.

Joe Crossno: And then you, step by step, answer the questions. Some questions will lead to other questions. We wanted to highlight as many of the questions that are not relevant as possible. So only if you answer affirmative to your question, will you see some other questions pop up. Otherwise you’ll have the the most basic, version of the application, sitting in front of you when you first start working on it.

Joe Crossno: So what I’ve done here is just filled out a very simple, survey research with adults. Actually I put, educational tests, but it doesn’t matter. It’s adults only. The only interaction is a survey. Information’s recorded without identifiers. This is about the simplest type of research we might see. Then you have an opportunity to say if the research will include something else.

Joe Crossno: So if it includes surveys and, maybe also an analysis of preexisting data. Exempt two and exempt four would be appropriate. You click yeas and it’ll take you back to exemption four.

Joe Crossno: If you have secondary subjects. In other words, if you’re collecting data about individuals who are not participants in the research, perhaps you’re asking your participants information about their family members. We’ll ask some questions about that. That’s not very common. And then next you have to go on to describe your participant groups. This is most helpful to our reviewers.

Joe Crossno: If there are multiple participant groups. If there aren’t, it’s pretty straightforward. Power analysis is only required for more than minimal risk research. But if you have done one, you with that here. This section is a little bit overdone, but it does help us to decide.

Joe Crossno: Whether or not, any special protections for vulnerable participants are necessary. At some point, we hope to have a single question where, if there are no vulnerable participants at all,

Joe Crossno: You’ll just be able to check that one box and bypass this whole section. Otherwise, you can just give a very simple rationale for why, why there’s purposeful inclusion. And in particular because if you’re including children, we want to know why and what safeguards you have in place for the inclusion of that vulnerable population.

Joe Crossno: Next you’ll put. Upper and lower age limits. If you don’t know an upper age limit, you can just put a ridiculously high number in there and we’ll get the point. If any of your subjects don’t speak English, we need to know that because that impacts informed consent, might require translation of consent materials. We need to know the location because there are different, different regulations for international research.

Joe Crossno: Now, the system started acting funny.

Joe Crossno: Okay, well, hopefully that doesn’t happen to you. The system froze up on me there, so we’ll go on with the presentation now.

Joe Crossno: So if you go to irb.wsu.edu there’s a direct link to MyResearch. Our email, if you need to contact us. Quick start guide that I mentioned in in the slide. This is a fairly helpful. Other link to.

Joe Crossno: MyResearch database. And then for submission support, we have this bookings app set up. So you can go in here and just ask for help, with the IRB system or with anything else, really. And this will automatically assign you a meeting through Teams with one of our staff members.

Joe Crossno: So also, back to March 17th. We started accepting some new nonexempt projects in the system. This is, kind of a slow rollout. Not because of any problem with the form, but because of some difficulties on the review side. Necessary to be a little bit more precise when comparing versions of an application with nonexempt research, and we’re having some difficulty getting that functionality to work.

Joe Crossno: As soon as we have that working, we’ll have no reason not to move fully into the system. But for now, we’re kind of going slow, taking the minimal risk projects first. Kind of like we did with exempt. We started back in October accepting some limited submissions. Just to troubleshoot the system, make sure everything works well.

Joe Crossno: But for the most part, you still want to go to our webpage, the forms tab on our web page. You’ll select the Nonexempt application, complete the application and all of the other participant basic materials and submit those, to our email address. So that’s still the process we’re using for nonexempt for the time being.

Joe Crossno: Although if you do have a nonexempt project, that’s fairly simple. Feel free to reach out because we are looking for some nonexempt applications to come through the system.

Joe Crossno: A little bit about review times, and expected timelines. These numbers are at face value. Not going to look like they stack up very well, but there are some important difference as and how, most institutions, AAHRPP accredited institutions report their metrics and how we’re able to collect them. And this is actually something that the eIRB system is going to do for, for me and my staff that we can’t do with our current review process.

Joe Crossno: And that is get better metrics. So for example, 800 accredited institutions report, their, their review times based on complete submission to approval. We don’t really have a way to do that without going through and looking at every step in the process to figure out when the application was actually completed. So our review times are reported from initial submission, and there’s a significant difference.

Joe Crossno: So the total time for review, for most of them projects, if.

Emily Brashear: You don’t let me fit.

Joe Crossno: That. I’m sorry. I didn’t catch that.

Emily Brashear: Oh, sorry. One, one question in the chat is if we’re conducting K through 12 classroom observations and collecting samples of students work with name identifiers, would we fill file the non and exempt form.

Joe Crossno: Probably that’s probably going to go under exemption one. There are some cases where it might have to go under Nonexempt. Expedited review. The important thing there is if you’re using identifiers, you’re probably going to need to, for compliant consent. And what that entails is the consent has to specifically address who’s going to have access to the materials, the educational materials, for how long?

Joe Crossno: For what purpose? And then there’s a fourth one, that’s not coming to end right now. There are specific requirements for for consent. And it does have to actually be signed and dated. That may be the fourth consideration. I think you. Okay. So you typically can’t do it electronically.

Emily Brashear: Awesome. And then what’s your definition of general as general generalizable knowledge?

Joe Crossno: Yeah. So if you think about, like I said, classroom research, if you’re doing research only on your classroom, and your findings are going to apply to your teaching method or to the individuals in that specific class, so it doesn’t apply outside of that setting. It’s not generalizable. In order to be generalizable. It has to apply to individuals who from from whom the participants are a subset, essentially.

Joe Crossno: So it has to apply to a larger population than the one under study.

Joe Crossno: All right. So anticipated timelines. Again, most accredited institutions, report seven and a half days for pre-review. After pre-review, you would consider, submission complete. And then 11 days from complete submission to approval. So 18.5 days for an exempt eighteen and a half business days for an exempt determination is the average for accredited institutions.

Joe Crossno: Right now we’re ranging 21 to 33 days. Again, that’s from initial submission. Not complete submission. So that’s if you add in our five days for pre review. We’re about eight days slower than we would want to be right now. A big part of that is that in 2024, we’ve been working really hard on implementing the electronic IRB, which should give us more efficiency.

Joe Crossno: The good news there is that the exempt processing so far in the electronic system, is many days faster than the process using the paper applications. So we expect to be back in this range, if not better. Hopefully by the end of the year for exempt research. And then nonexempt research. We were already better than average for most nonexempt research until this past year.

Joe Crossno: So we expect to be significantly better for nonexempt, by the time the system fully implemented. But right now, I would I would acknowledge and, and actually warn people that we are a little bit slower than we want to be right now. Particularly over the holidays, we ran into, a real bottleneck where we didn’t have enough reviewers.

Joe Crossno: We had a lot more submissions than we did in any other time during the year. And we were trying to roll out our, eIRB system from October through December. Really became a challenge. And we fell pretty far behind. So there were probably, you probably heard a number of people grumbling about how long reviews were taking, and that is completely founded.

Joe Crossno: Our reviews were very slow. Towards the end of 2024.

Joe Crossno: So some suggestions about getting through the process quickly. Develop research project as soon as you can. I’m recommending right now that you submit 2 to 3 months prior to your anticipated start date, at least 1 to 2 months for exempt applications. We don’t we don’t want to hold up anybody’s research. So if you’re able to get to get it to us sooner, you’re almost you’re much more likely to to not be up against a deadline and asking us where your, project is.

Joe Crossno: Our processing, notice of a reviewer assignment typically takes five business days. We were taking a little bit longer than that towards the end of last year, but we’ve caught back up. You typically will receive your required or recommended changes within 15 to 20 days after you’ve submitted. Again, that depends on reviewer availability. There are certain types of times of year where our faculty reviewers just are not as available.

Joe Crossno: Particularly around final examination weeks, things like that. When you get a request to submit revisions, even if you find them annoying, do it quickly. So one of the one of the biggest reasons for lags in our review times is slow submission of revisions. Every time we have have a revised protocol come in, it has to go back through the, review process by HRPPP staff, get sent back to the assigned review… faculty reviewer.

Joe Crossno: So you want to make sure that you’re submitting your revisions as quickly as you can. The most common issues that we are seeing right now with applications and these all significantly slow down review. Incomplete application, or other missing, missing participant facing materials.

Joe Crossno: So this would include recruitment materials. Those are frequently missing from applications. The second one is missing or incomplete training. Again, in the IRB system, it automatically links. So you don’t have to worry about printing out your certificates like you used to, but you still need to complete responsible conduct of research, which is a requirement for everyone that does research.

Joe Crossno: at WSU, not just people involved in human subjects research. And then the Basic Human Subject Research course, through CITI is also required. There are some other training requirements for people that do clinical research or work on training grants, but these are the two main ones for most people. We do have significant problems with data, the data management and security planning.

Joe Crossno: That comes up a lot. The reason we spend so much time on that is that it is the most likely risk involved with minimal risk research, of which 60 to 75% of WSU’s would be that minimal risk research where the most likely risk is data breach. And insufficient consent process, also can be a problem for some, reviews.

Joe Crossno: Failure to disclose conflicts of interest, financial or otherwise. Not wanting to disclose that you need to withhold information. Things like that. Make it impossible for a person to make an informed decision about participating and will slow up the review process.

Joe Crossno: A little more about… How are we doing for time? Getting close. I want to waive at least five minutes for questions. So if we don’t get through these, I’ll just, for the end here, it’s mainly about data security, and I’ll share the slides so that you can review those on your own if you want.

Joe Crossno: So again, we’re… we often see either recruitment or informed consent missing. You do need both. And so if you’re using your informed consent, for example, if you’re doing an online survey and you expect your consent to also serve as a recruitment, that’s fine. You just have to explain that the consent and recruitment are the same.

Joe Crossno: That does happen quite a bit.

Joe Crossno: Sometimes we get these applications submitted without the survey instrument or other materials. Anything that the participant is going to see in the high IRB review or needs to see. So if there’s a participant facing material, we need to see it.

Joe Crossno: Missing or incomplete training is also a frequent problem. Again, RCR training is required. HSR training is required for clinical trials and other federally funded projects. Good clinical practice and conflict of interest training may also be required. If you have a multi-site research or if you have non-WSU collaborators, they can access our CITI training without cost.

Joe Crossno: That really simplifies the the process of getting training for everyone on the protocol.

Emily Brashear: Real quick question. Is it reasonable to submit an IRB application before the prelim exams?

Joe Crossno: Yes. Very reasonable. In the coming, why do you want to submit before prelim and whether or not.

Joe Crossno: Yeah, we should talk more later, but yes, definitely. Is the earlier the better.

Emily Brashear: Okay. Earlier the better.

Joe Crossno: This is probably the biggest issue we have with early application. So data management, security planning, in particular, compliance with, use executive policy eight. That’s ITS policy. We would have have to have two contacts under that policy in order to comply with WSU, requirement for data security and I would say probably 50% of our applications either have the incorrect people listed or no one listed.

Joe Crossno: That will slow up the processing of your application. It’s just a matter of entering, entering the right person. A lot of times, people don’t know who’s supposed to be entered in, into that spot.

Joe Crossno: As I mentioned, the most probable risk to participants is data breach. Most of our research being minimal risk. We want to make sure that we are handling data appropriately. Using WSU devices.

Joe Crossno: I think I have a little bit more on this in the later slides that you’re welcome to look at, a little bit about how to how to find out who your ATO, who your data custodian is for your department. If you don’t have an area technology officer, it’s likely to be chair or dean or assistant dean for research.

Joe Crossno: That serves in that role under EP08. The primary purpose for that is to make sure that in addition to the PI, someone else at WSU would have have the ability to access the data.

Joe Crossno: Again, insufficient consent process has been a problem with some applications. Mainly failure to fully disclose the purpose of the research is the one where we have the biggest problem. But also failure to disclose conflicts of interest, particularly if you have sponsored research and industry sponsored research or someone stands to gain financially from the outcome.

Joe Crossno: And back to data security. Again, I have a lot more on this, but it looks like we’re running out of time. So I think I’m going to stop and see if there are any questions.

Emily Brashear: I don’t see any in the chat at this time, but if anybody wants to jump on and ask, we can do so.

Emily Brashear: Not so much. Is there anything in your wrap up? That people can contact you if they do have questions? Just go to your website.

Joe Crossno: Yeah, I would go to the website. You can contact me directly, or you can go to the,

Joe Crossno: The bookings app. The bookings app will give you.

Joe Crossno: Bookings that will give you access to whoever is available next. On the interview staff. But you can always contact me directly.

Emily Brashear: All right. Sounds good. Well, thank you for your time.