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Foundation IRB

From Wikipedia, the free encyclopedia

The term Foundation IRB or F-IRB is an abbreviation of foundation internal ratings-based approach, and it refers to a set of credit risk measurement techniques proposed under Basel II capital adequacy rules for banking institutions.

Under this approach the banks are allowed to develop their own empirical model to estimate the PD (probability of default) for individual clients or groups of clients. Banks can use this approach only subject to approval from their local regulators.

Under F-IRB banks are required to use regulator's prescribed LGD (Loss Given Default) and other parameters required for calculating the RWA (Risk-Weighted Asset) for non-retail portfolios. For retail exposures banks are required to use their own estimates of the IRB parameters (PD, LGD, CCF). Then total required capital is calculated as a fixed percentage of the estimated RWA.

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  • ✪ Webinar: What You Should Know About IRB Review of Research
  • ✪ IRB & RCR: Part 4: Understanding Research and the Role of the IRB
  • ✪ Counterparty Risk, Credit Exposure and CVA - Dr. Jon Gregory


Participant: So, without further ado, we are going to move forward to our first speaker this afternoon. And I am really pleased to welcome a guest speaker from OHRP, Jaime Hernandez. So, Jaime Hernandez is an attorney and bioethicist who is currently a public health advisor with the Division of Education and Development at the Office for Human Research Protections or known as OHRP, affectionately to us. Before joining OHRP, Mr. Hernandez was a senior research investigator at the University of Pennsylvania in the Department of Medical Ethics and Health Policy. Prior to that, he was a litigation associate with Hughes Hubbard and Reed. He also served as administrator for the social and behavioral science IRB at the University of Pennsylvania in their Office of Regulatory Affairs. Mr. Hernandez obtained his JD at the University of California Berkeley School of Law and his maters in bioethics at the University of Pennsylvania. He also holds a bachelors in philosophy from the University of Miami. And this afternoon, Jaime is going to be speaking on what you should know about IRB review of research. Mr. Hernandez: Great. Good afternoon, everyone. Thank you, Dawn, for the introduction. And I'm sorry I have been given the responsibility to keep you awake after lunch while we talk about ethics. It is not easy but I will do my best. In discussing what you should know about IRB review, the first thing that I wanted to address is why do we need IRB review. During the last '60s and early '70s, there were a lot of public scandals that resulted from the media publishing things that scientists were doing to people in the name of medical progress. Some of these are pretty famous, such as, for example, the Willowbrook hepatitis experiments, where healthy children were being injected with the hepatitis virus. There was also the Stanford prison experiment, where undergraduate students were assigned to play roles of prisoners or prison guards. And soon after the study commenced, the roles were taken too seriously and there was a lot of abuse of the prisoners. And of course, there was the Tuskegee syphilis studies that where very poor rural African American men who had syphilis, the researchers actually withheld the cure for syphilis for many years. Many years, I am talking 30, 40 years, in order to study the natural progression of the disease. Now, keep in mind that none of these experiments were an evil scientist trying to take over the world. And also, these experiments were not Nazi experiments. These were not evil people. These were good scientists trying to do good science for the progress of humanity. But in doing this, the scientists were overlooking the harms and overestimating the benefits of their own work. And it became obvious that scientific self-regulation didn't work. What was also very scandalous at the time, is that most of this research was either conducted or sponsored by the federal government, by the United States. This of course gave Congress the green light to be able to regulate the conduct of human subject research. In doing this, Congress, in 1974, passed a National Research Act which established the National Commission for the Protection of Human Subjects in Research, or the National Commission, for short. The National Commission, in 1979, published the famous Belmont Report. The Belmont Report outlined basic ethical principles for the use of humans in research, in scientific research. In 1981, Congress acted again and enacted the regulations under 45 CFR 46. They are called the Regulations for the Protections of Human Subjects, which are the rules of the regulations as we know them today. It is key to understand IRBs and to understand these regulations that these regulations what they did was adopt the Belmont Report almost entirely. The Belmont Report, as I said, outline the basic principles for the conduct of human subject research. For example, respect for person, beneficence, and justice. In adopting the Belmont Report the regulations took respect for person and implemented the requirements for informed consent, protecting the autonomy and the voluntary participation of the subjects. The regulations took the principle of beneficence and turned it into minimizing the potential risks to the participants and a favor of risk and benefit analysis. And they took the principle of justice and they turned it into the equitable subject selection and an equitable distribution of benefits and burdens resulting from the study. In addition to adopting these basic principles for the conduct of human subject research, the regulations also established a requirement for IRB. IRBs or institutional review boards, are committees based in every institution that receives federal funds for research and it reviews the initial conduct or the initial submission of research involving human subjects. It does this through an expedited or a full board mechanism of which we are going to talk about in a few minutes. But also the IRB is responsible for overseeing the ongoing conduct of research. So not only does the IRB reviews and ensures compliance with the regulations before the research starts, but it also oversees the ongoing compliance by continuing review every year, usually, review of the protocol modifications or amendments, anything that changes the protocol or changes the risk level of the study needs to be submitted to the IRB on an ongoing basis, and also adverse events, tracking and reporting adverse events to OHRP. But what requires IRB review? Not everything that looks like research or is research requires IRB review. Like Misti mentioned earlier in her morning presentation, the first question that we ask ourselves is whether the activity that we are considering is research. If it is not research, the regulations don't apply. If the activity is research, then we ask the second question: Does it involve human subjects? If it doesn't involve human subjects, again, the regulations don't apply. If it does involve human subjects, however, we ask ourselves whether it qualifies for exemption. These exemptions are a few categories that the regulations exempt from its applicability. In other words, the rationale behind these exemptions is that if the research meets the criteria for one of those exemptions, it is considered to be low risk enough that the regulations for the protection of human subjects shouldn't apply. So, if the research is exempt, then the regulations, again, don't apply, which, in practice it is often the IRB the one making the determination of exemption and this is because the criteria is not very easy to apply. So, many institutions, and definitely this is the practice that OHRP also recommends, even though they are not required to look at exempt research, they prefer to be the ones making the exempt determination and not the scientist. But if the research is not exempt, if we have an activity that is research, that it involves human subjects, and that it is not exempt from the regulations, then IRB review is required. This initial IRB review will be done through one of two mechanisms, the expedited mechanism or the full board, also called the full committee mechanism. Qualifying for expedited review, the difference between the two is really an issue of timing. When you qualify for expedited review, the protocol is going to be reviewed by an experienced reviewer and it often leads to a quicker turnaround than if you have to submit to the full committee where many people would rate your protocol, will discuss it and often you have to wait until the committee meets. So, the only difference between the two is that expedited, as the name implies, may be a bit faster. And you qualify for expedited review if the procedures in your research are listed under a list of categories that is attached to the regulations and your study is also minimal risk. Note that if the procedures in your study are included in the list of categories, and your study is not minimal risk, you are not going to be able to qualify for exemption -- I'm sorry -- for expedited. Both of these have to be complied with. Full board review will take care of everything else that is, again, human subject research but more than minimal risk of procedures that are not listed in that addendum. Note, however, that the IRB requirements for approval are the same, whether your study is being reviewed through the expedited or the full board mechanism. This includes the criteria for approval and the requirements for informed consent, which leads to the question that everyone asks. This is possibly the question we get asked the most: How to pass the IRB? I don't like that question. If you look at the definition of the verb to pass, according to, it means to move past, to let go with our attention, to leave unconsidered, disregarded or overlooked, to go through or beyond a barrier, to endure or undergo and this is not the purpose of the IRB. The IRB is not there as an obstacle to your research. The IRB is there to protect the safety and the rights and the well-being of the humans that are participating in that research. The IRB seeks to strike a very difficult balance between this protection of human subjects and promoting the advancement of research. If we want to do research very fast, if we do research without any ethics, we will definitely get scientific results faster. But if we look at Nazi Germany, that is a very good example of what happens when you do research without ethics. There is a human cost to that, and that human cost is precisely what the IRB tries to avoid. So, if we keep the IRB, if we look at the IRB as institutional body in charge of striking that balance between the progress in science and the protection of the human participants, then we shouldn't ask how to pass the IRBs. A better question should be how to write an effective IRB submission. This implies a protocol submission that proposes a research that is as ethically sounds as it is scientifically sound. So, if the question is how do write an effective IRB submission, the answer is already in the regulations. The regulations under Section 46.111 give you the complete criteria for initial IRB approval of research, including that the risk to participants are minimized, that the risks are reasonable in relation to the anticipated benefits, that there is an equitable selection of subjects, that when appropriate -- there is a data safety monitoring committee, when appropriate the privacy and confidentiality of the data is protected and in today's world, privacy and confidentiality is almost an issue -- it is an issue in almost every single study these days. It also requires that additional safeguards are implemented for participants are likely to be vulnerable to coercion or undue influence and it requires the informed consent of each prospective participant and that is also documented. Remember, like I said earlier, this initial IRB criteria -- this criteria for initial IRB approval of research applies equally, whether your study is being reviewed by an expedited or full board mechanism. But how do we translate this legal jargon into a research proposal that satisfies the requirements that we had in the slide before? The answer is not a secret. You already have a roadmap or a guide on what the minimal requirements are for your study to satisfy the IRB requirements. If you already have a roadmap, then what is left is nothing but an exercise in good writing. First, you should write for an inexperienced reviewer. And by inexperienced I don't mean inexperienced in reviewing protocols. I mean that that reviewer is inexperienced in your particular discipline or specialty or field of work. Keep in mind that an IRB committee requires to have at least one member that is a non-scientist and also it is required to have at least one member that is not affiliated with institution. This member may or may not be a scientist. Keep these people I mind when you write your protocol. Keep in mind that you are writing to non-scientists. Don't assume that they are familiar with the background or the jargon of your own specialty. Second, organize your writing and use headings, use subheadings. This sounds pretty standard of an advice but the person reviewing your protocol is likely to have another five to ten protocols to review. And if your protocol is disorganized, it is going to go into the pile that requires additional attention. It is not going to go into the direct approval pile. Leave no loose ends. Anticipate questions from the reviewer and answer them. Submit a complete protocol. Include all the instruments, all the surveys, and all the measurements that you are going to use. And don't just copy and paste. If you copy and paste, you may end up with information that used to make sense in the document that you were copying from but it doesn't make sense now and that will delay your approval. Also, think through the implementation of your project at every point. If you copy and paste from perhaps a grant proposal, for example, keep in mind that when you are writing a grant, you are writing for peer reviewers in your field that are reviewing that proposal mostly through the lens of good scientific research. But when you submit to the IRB, the IRB is going to review your protocol through the lens of the protection of human subject research. So, when you copy and paste, even though you are providing good information regarding the protection of subjects, you may not be providing all the details necessary for the IRB to make an approval. Let's look at these as an example. Let's say that you are writing about the equitable selection of subjects. And these are only some ideas to keep in mind when writing about equitable selection. This is by no means a list of everything that you need to know or that you need to write about. At first, explain why the subjects that you are using in your trial are the scientifically appropriate population for this study. The fact that the subjects are accessible to the investigator doesn't make it necessarily the most scientifically sounds population. And at the same time, you should address not only the inclusion but also the exclusion criteria in your study. Use different subheadings for each exclusion criteria. These people will be excluded. Why? Inclusion criteria. These people will be included. Why? Also address the likelihood of coercion or undue influence. This is very important because we tend to think of coercion and undue influence only when there are populations that are in some form of disadvantage. For example, if you are doing research with handicapped or demented patients or you are doing research, for example, that regulations have special requirements for when you are doing research with pregnant women, prisoners or children. But many populations can be at risk of coercion or undue influence in different situations. As students may be, for example, coerced into participating in a study that the professor is conducting on them, they may think that they need to do this to get a good grade in class. Or employers may be coerced when their boss is the one recruiting them to participate in the research study. They may feel like they may lose their job or have a bad employment review if they don't participate. Coercion can even happen in healthy adults. If you paid them enough money, if you paid them a lot of money, that would be considered, perhaps, undue influence to participate in that research study. So, coercion and undue influence come in many flavors and it is not always in disadvantaged populations. So, keep that in mind but don't just mention that there is likelihood of coercion or undue influence. You should also explain what measures will you implement in your study to minimize the possibility of that coercion or that undue influence. And then look at this in a concrete study. Let's say that we are doing a study assessing the effect of MDMA, also known as ecstasy, the party drug known as ecstasy, in addition to cognitive and behavioral therapy, CBT, to treat resilient depression, patients with depression that have failed to respond to conventional treatments and who receive CBT only for symptom management will be randomized to CBT only on one arm and on the other arm, they will receive MDMA therapy plus CBT. Women and patients taking SSRIs such as Prozac will be excluded from the study. And you are writing the equitable selection of this section. Explain why this is the most appropriate population. In this case, you can explain, for example, that these subjects have not responded to any of the conventional therapies. So it is, perhaps, a beneficial risk-benefit proportion to them to give it a shot with a less conventional therapy. I would then explain the inclusion and exclusion criteria. Why are you excluding patients who take SSRIs? If there is a clinical explanation for this, include it in the protocol and cite the prior research that suggests that patients taking SSRI are excluded from the study. Also why are you excluding women? Is it because of a pregnancy issue? Because if that is the case, you should perhaps exclude only pregnant women or you should inform the women in the consent form not to get pregnant while they are participating in the trial. But is there any other reason why you will be excluding women? And if so, explain it in your submission. Also absent from this short description is any mention about the age of the subject. Are you using adults only? If this is an adults-only clinic -- I'm sorry, would you exclude subject under 18 and why? And if you are going to include subjects under 18, not only now you have to comply with regulations, additional regulations, but also explain why. Cite to prior similar studies that have been done in children that suggest that this is an appropriate population for this. Also, address the likelihood of coercion and undue influence. In this case, failure to respond to conventional treatment in the past tends to create undue influence on potential participants that are desperate for an effective treatment. If nothing else has worked for them, they may be too eager to participate in any clinical trial in hope for benefit. How would you minimize this, not just take into consideration and address that, but also address clearly in the protocol under separate subheadings how will you minimize the likelihood of the potentiality of coercion? For example, you can work with treating physicians to ensure that potential participants are able to consent and understand that this is only an experimental treatment, that they may not benefit, that the depression may not get better. Also, this is possibly one of the most important things to keep in mind: anticipate and address reasonable questions from the reviewer. If the reviewer is somebody not in your field, what are all the reasonable questions that a reasonable person not in your field will have about this study? This may require you for a second to step out of your discipline's hat and think of a person that doesn't have your training. For example, will you exclude subjects with a history of substance abuse? This may be very obvious to you in your field of study but a reviewer who doesn't practice the same kind of medicine or in the same discipline, looks at the study that you are doing with MDMA and cognitive and behavioral therapy and one reasonable question is oh, my God, there is a higher incidence of substance abuse among people with depression. Do any of these people have a substance abuse problem? Are you going to exclude them? Giving MDMA an additional drug that is otherwise illegal to these subjects, will this pose an additional risk? Those are all reasonable questions that a person who doesn't practice your discipline may have. Address it in your protocol. Even if you don't think it is an issue, you should anticipate them and address them and in the way they are answered first time that the protocol is reviewed and there is no need to put the protocol -- to withhold approval and put the protocol on hold. For example, also another reasonable question: Can severely depressed people consent to participate in research or do we need a legal guardian? If you are practicing in this field, you will probably know that there is a lot in the literature about depression and consent. Address those issues. Cite to the literature ahead of time because any reasonable person could have the question of are these people capable of consenting. Let's look at another example. This time it is a writing about minimizing the risk to subjects. Identify first the study intervention. The only thing that you are required to minimize by the regulations is minimize potential risks that are reasonably expected to result from the study intervention. So, the first thing that you should do and, again, this is not an all-inclusive list of things that you should do, these are only examples, but you should very clearly identify what is the study intervention. Use a different heading for each of the study interventions. And for each of the study interventions, you should use different subheadings for each potential risk resulting from that intervention, and then address how you are going to minimize that risk. Now, there is no one way of minimizing risks. Every risk can be minimized in a different way. Some risks may be minimized by just putting it in the consent form and alerting the potential participants that that risk may occur. Other risks may require you to have access to an emergency room, in case the risk manifests in one of the participants they can be taken to the emergency room right away. It depends on the study. But the best way to catch every potential risk is to outline them one by one and to think through them one by one individually, again, without copying and pasting and that will allow you to have a much more complete IRB submission. Again, these will pop up over and over. Anticipate and address all the reasonable concerns that a person not in your field may think could result from the study. For example, it may be that you know that because you practice this type of science, this discipline, you know that this risk is really not likely to result. However, you know that a reasonable person will think of this risk. Don't just ignore it. Because if your reviewer is from a different discipline, your reviewer is going to be wondering about that risk that every reasonable person will think about. You know the answer because you practice in that area but your reviewer doesn't know the answer, which means that the reviewer is not going to presume what your answer would be. That reviewer is going to put your protocol on hold until he contacts you and asks for clarification. And again, this is very important, cite to prior research. It shows the reviewers that you have done your research, that you know what you are talking about, and it allows the reviewers to go to one of those studies and be like oh, yes, look. It makes sense, this risk that I was thinking about. It is really not something that I should be worrying about in this case. Let's look again at the MDMA study but this time, let's write about minimizing risk. First, clearly identify the study intervention. In this case, the intervention is the MDMA therapy, not the cognitive and behavioral therapy. Notice that all participants are already undergoing CBT, whether or not they are participating in the study. So, if you are writing this protocol, and you have clearly identified the study intervention, then you need to address only those risks that are reasonably related to the MDMA therapy, but you don't need to address the risks that are reasonably related to cognitive and behavioral therapy. Now, identify reasonable potential risk resultant from the MDMA therapy, for example, difficulty sleeping. How are you going to minimize that risk? Explain, for example, you will provide sleeping pills or the participants will not be allowed to leave the clinic until the effect of the MDMA has subsided. There is also the potential risk for hyperactivity. Explain, again, that this research is going to be done in a controlled clinical setting, subjects will not leave the clinic until it is determined that it is safe for them to leave. And in this way, you are addressing, again, by using headings and subheadings, you are clear like in a clear and organized manner addressing one of the requirements, the most important requirements for your study to be approved, which is that you are minimizing the risks. Again, anticipate and address all the reasonable risks related to the study. Let's say that I am that reviewer reading this protocol and I don't know anything about MDMA. In fact, I am a radiologist. And I remember in medical school something about people in the '90s overdosing on MDMA and dehydrating. If that is absent from your protocol and I am your reviewer, I am going to be like well, that is all I know about MDMA. This person is not giving me any more information. And you know for example that with the dose of MDMA that is going to be given to the participants, this is not a problem and the participants are going to be kept hydrated throughout the study, again, this is done in a controlled clinical setting. But if you don't include that in your initial protocol submission, the reviewer doesn't know anything about the dosage, or the risks related to that dosage because the reviewer is not a specialist in this type of research. Another example, can patients become addicted to MDMA? Now, if you practice in the field, you may think this is an absolutely ridiculous question, like MDMA is not addictive; the dosage that we are giving is too small to create any problem in addiction. But I don't know that. All I know of MDMA is what I read in the papers growing up in the '90s in Miami and there is not anything good about it. So, the moment that I see that you are giving an illegal drug to the participants in the research, I am like, oh, my God, can these people become addicted to this drug? All drugs are addictive, right? So, it is your job as the person writing this proposal to give me all the information so I can approve your protocol right away. And if you think is not a risk, again, address it nonetheless because is reasonable for somebody else not in your field to have these concerns about your study. Also, in order to receive IRB approval, one of the requirements is also the informed consent and the documentation of consent. When you write a protocol, address and design the consent process as a process, not just as a one-time yes or no question. Provide sufficient opportunity for the participants to consider participating in the study. Use a language that is reasonable for the participants to understand. If you, for example, if you go back to the MDMA study and your consent form opens with "we are asking you to participate in this study because we think that you are going to benefit from using methylenedioxymethamphetamine", that really means nothing to anyone. First, you are promising a benefit that is likely there, likely not. Second, methylenedioxymethamphetamine, it is a biochemical name. I cannot even pronounce the name without cracking up. Why don't you just call it MDMA, parenthesis the drug that people know as ecstasy, so people know, actually can review the form in a language that they can relate to and understand what they are reading. The requirements of consent, there are several requirements for the consent form to have to be complied with. One of those, for example, or two or those, for example, are the description of reasonable foreseeable risks and a statement that participation is voluntary. That statement, if you just write participation is voluntary, that is an empty statement. It just really means nothing. How about you write something like participation is voluntary? If you decline to participate, you will not lose any benefit. You can continue to be my patient. Nothing will happen to you. Something that it is meaningful, relatable, and that assures the participant or the potential participants that they can say no, if they want. And that there is a voluntary element to participation. There are additional elements of consent that are only required when applicable. For example, in what circumstances will you, as the PI, the principal investigator, terminate the subject's participation. Or is there any additional costs to subjects that may result from participating? If any of these things are relevant to your study, these are elements that have to be included in the consent form. And lastly, there is certain requirements for the documentation of consent form -- for the documentation of consent. The actual process of signing and recording the agreement of the participants. And always keep in mind that you should be using the consent form that has been approved by the IRB. So, as a summary, if I were to give you tips for better IRB submission, they would almost all be tips related to the process of providing a clear understandable submission. It is really an exercise in good writing. Write for a reviewer with different expertise than your own. Or even better, when you are drafting your protocol, how about you try writing for a non-scientist, which you will have to do also when you are writing the consent form. Organize your writing. Use the section 46.111 as a roadmap. It is giving you the answer of what the IRB will expect of you. Address each one of those elements separately and explain completely and clearly how it is that you are addressing those elements in your submission. Anticipate reasonable questions from the perspective of protecting the well-being of the subjects. Again, the reviewer may be from a different discipline. I know I keep saying this over and over again but it is one of the reasons why submissions get stuck in the IRB approval process is because a reviewer from a different perspective, from a different discipline is not given all the information in the protocol to be able to make an approval determination. Always cite, reference in support of your writing. Submit a complete protocol. Include all the surveys, all the instruments that you are using. A typical scenario looks something like this. This is a minimal risk -- it is an initial submission of a protocol. Minimal risk study about studying habits of first year medical students. There is a survey missing from the submission. So, the IRB reviewer cannot approve the protocol because the survey is missing. She gets back to the PI, the principal investigator requests the survey. Eventually, the PI submits the survey and the reviewer sees that question number 25 in the survey asks the participants if they have ever bought Adderall in the black market during finals. Also, there is follow-up questions. So, the surveys also include the email address of the participant. So, out of the sudden, this is not a minimal risk study anymore because you are asking about illegal behavior and you have the identity of the participants. So, without the survey, it is really impossible for the IRB to make a final determination of approval. And again, don't just copy and paste. But the most important tips that I can give you are communicate with your IRB. Call them on the phone. Go visit them. They are not there as an obstacle to your career. They are there to work with you towards what it is the shared responsibility of you as the scientist and the IRB, which is the protection of human subjects. Invite the IRB to your department for a training session. This is a training in both directions. Your department can train the IRB on research methods that are commonly used in your department and the IRB can train your department in how to submit a more clear IRB proposal. Ask the IRB to let you sit in the meeting as an observe. I am not saying that all IRBs in the United States will be willing to do this but almost always they should be willing to do this. You are just not going to be able to vote as an IRB member but you can sit there and see how they are addressing the protocols. What are the things that they are looking at? What are the things that are often missing from the protocols? And in a way, you are learning how to write an IRB proposal through the lens of the protection of the human subjects, not through a lens of just pure scientific research. And the most important tip is don't just write to pass the IRB. Instead, write a protocol that is both scientifically and ethically sound. It is the responsibility of every scientist to do research in an ethical manner. The days of research without ethics are over and this is a shared responsibility that we in the federal government share with your institution and with each one of you as an investigator. Thank you very much and I can take any questions. Participant: Thank you very much, Jaime. I think that the topic that you spoke about this afternoon is also, it is very timely for our segue this afternoon, which is really moving into having our completed research projects presented to our research community here, both from our residents and from our investigators. And so I think this is a great presentation as far as just reinforcing the importance of the IRB as a partner in the research process and why it is so important. And I really, really like how you have stressed that it is very much a partnership, that we are all working for the same purpose, and that is for the protection of those individuals that do volunteer to be participants in the studies. So, again, I will just reiterate to those folks who have joined us new in the afternoon that we are taking questions using the chat function. So, we will ask individuals to submit questions by just clicking on the chat box. We do have a central ChatMaster here, where all the questions will come in. So, you won't be sending them out to everybody who is part of the conference this afternoon and then we can relay them through to Jaime. And again, I encourage people to think about questions that you would like to pose. Perhaps there is something that has resonated with Jaime's talk because we do have an opportunity to hear directly from a representative of OHRP. Maybe just while we are waiting for some questions, Jaime, one of the things that struck me as I was listening to your presentation is you were talking about the criteria for IRB approval and, again, talking about risks that are reasonable. And of course, that word reasonable can mean different things for different people. And I know that you have had experience both as an investigator and both as an administrator on the IRB side of things. So, I just wondered if you might talk a little bit about that word reasonable and perhaps different perspectives that individuals might have and how you find common ground with that. Mr. Hernandez: Yes, sure. Regarding the requirements for approval of research, the first one is that the risks are minimized. And the risks, again, that are minimized are risks that are reasonably expected to result from the study intervention. The reasonable standard is something that we can find in every area of law and there is no short one-sentence answer that I can give you as to what it means. It means precisely that, that it is reasonable. It is better understood through examples. If we look at the MDMA trial that I gave as an example, what are reasonable risks that could result from this trial? I mentioned some, for example, dehydration and hyperactivity. But when a scientist is writing a protocol submission to the IRB, it also needs to address risks that other people will think of reasonable, even though being in your field you know that those risks are unreasonable. Because, again, that reviewer may be somebody from a different discipline. So for example, is it reasonable that a sociologist reviewing this protocol maybe worried about overdosing or maybe worried about people with depression having a higher incidence of substance abuse. Those are all things that are reasonable to expect somebody to raise those questions. So, while in the legal sense, in the compliance sense reasonable means something, in the colloquial everyday speech, reasonable is likely broader. That is what I recommend. That is the approach that I recommend investigators to take, the broader more colloquial approach to reasonable, rather than the stricter more scientific approach when writing a protocol to the IRB. I hope I answered your question. Participant: Yes, thank you. We did have a question that came in. You know we hear this morning from Ms. Tebot (phonetic) some of the proposed changes to the Common Rule. And the question was can you discuss any significant changes that are being proposed regarding IRB review criteria or processes in the new Common Rule regulations that are being developed? Mr. Hernandez: Yes, there are some changes that are proposed to the process. The IRB criteria for approval remains the same. There is a few changes that clarified meaning of certain terms here and there but most of other changes that are not related to vital specimens that are proposed are regarding the process of IRB approval. For example, so now we have activities that are exempt and then research studies reviewed expedited or full board. Some of the changes create an additional category which are called excluded. Some of what is now exempt will move to excluded and some of what is now expedited will move to exempt. Also, the list of expedited -- of procedures that qualify for expedited review if they are also minimal risk have not been updated since like 1983, I believe, 81, something like that. One of the changes that is coming up is a commitment by OHRP to update that research every, I believe, seven to eight years. So, there are changes that are coming up to the process but I don't think there is any proposed changes that will directly affect the criteria for approval. And again, these are all proposals. We really don't know what, if any, of these changes will end up in the final rule or not. Participant: Correct. Thank you, Jaime. Mr. Hernandez: You're welcome. Participant: Just maybe one last, a general question is when you talked at the beginning of your presentation about what requires IRB review slide. And the question was: Can you make a comment about the distinction between is it research is it QI? Of course, that is a question that often comes up. Mr. Hernandez: Yes, there is -- if you look at the way the regulations define research as a systematic review designed to contribute to generalizable knowledge, often QA or QI, quality assurance or quality improvement activities, are designed to, as the name implies, improve the quality of that specific program. That is often not generalized or simply cannot be generalized from a scientific perspective to other programs in other places. Therefore, for example, if I am evaluating the process through which my department receives complaints from the public, that may result in a document that addresses only the specific issues in my department but it cannot be generalized to say every department like mine in the world will have the same issues or could improved their processes by following these directives. Therefore, the inability to generalize the conclusion makes it not comply with the definition of research. Now, the incoming changes to the regulations have tried to explain more what QI, QA, or what type of QI, QA is determined to not be covered by the regulation. Again, we don't know if this is going to pass or not, but in the actual regulations as they exist today, it is a case by case determination. And one advice that I always give to people that are not sure whether what they are doing is QI or QA or whether it meets the criteria for research and should go to the IRB, is pick up the phone and call the IRB. That is what they are there for. Talk to them. Ask them. Explain to them what it is that you are doing. And if you are not sure, involve them in the decisionmaking and that way, you get it right. Participant: That is a wonderful response. Thank you, Jaime. And I think it ties in really nicely with a comment I just want to share that came in via chat from one of our participants that just sums it up nicely. And it says so the IRB office is here to help researchers. The IRB does not exist to be a wall, to be execution of research. As you said, invite your IRB to your research meetings. They want to be your compliance partner. And I think that's very much the message that you've given us, as well. >>Good. Very nice comment, I have to say. >>So again, I'd just like to thank you very much for being our speaker from OHRP this afternoon. We really appreciate you sharing your perspective. And thank you very much.

Some formulae in internal-ratings-based approach

Some credit assessments in standardised approach refer to unrated assessment. Basel II also encourages banks to initiate internal ratings-based approach for measuring credit risks. Banks are expected to be more capable of adopting more sophisticated techniques in credit risk management.

Banks can determine their own estimation for some components of risk measure: the probability of default (PD), exposure at default (EAD) and effective maturity (M). The goal is to define risk weights by determining the cut-off points between and within areas of the expected loss (EL) and the unexpected loss (UL), where the regulatory capital should be held, in the probability of default. Then, the risk weights for individual exposures are calculated based on the function provided by Basel II.


Below are the formulae for some banks’ major products: corporate, small-medium enterprise (SME), residential mortgage and qualifying revolving retail exposure.

IRB Basel2.jpg


  • 10 Function is taken from paragraph 272
  • 11 Function is taken from paragraph 273
  • 12 Function is taken from paragraph 328
  • 13 Function is taken from paragraph 229

In Basel II: International Convergence of Capital Measurement and Capital Standards: a Revised Framework (BCBS) (November 2005 Revision)

  • PD = the probability of default
  • LGD = loss given default
  • EAD = exposure at default
  • M = effective maturity

The advantages

  • Basel-II benefits customers with lower probability of default.
  • Basel-II benefits banks to hold lower capital requirement as having corporate customers with lower probability of default (Graph 1).


  • Basel-II benefits SME customers to be treated differently from corporates.
  • Basel-II benefits banks to hold lower capital requirement as having credit card product customers with lower probability of default (Graph 2).



This page was last edited on 8 May 2019, at 10:43
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