Ethics and Research Webcast Presenter: Dr. Vilia Tarvydas. >> HELEN: Hello everyone. My name is Helen Scharpz and I'm here at the Law Health Policy and Disability Center at the University of Iowa. This webcast is the fifth in a series on disability research and assistive technology as part of our Community-based Resource Center or C. B. R. C. This is one of four projects funded by the National Institute on Disability and Rehabilitation Research on technology for the independence of persons with disabilities. We invite you to learn more about these projects and their findings as well as other information on the C. B. R. C. and our training materials on disability research from the home website of the Community-based Resource Center. We are delighted to have with us this afternoon Dr. Vilia Tarvydas. Dr. Tarvydas has more than 30 years as experience as a rehabilitation educator and practicing rehabilitation professional. She is a coordinator of the graduate programs in rehabilitation at the University of Iowa and also a core researcher at the Law Health Policy and Disability Center at the University of Iowa. She has served as president of the American Rehabilitation Counseling Association and chaired the committee that developed the Code of Ethics for professional rehabilitation counselors. Currently she is chair of the Iowa State Board of Behavioral Science Examiners and president of the National Council on Rehabilitation Education. She is also a member of ethics committee and the ethics code revision task force for the American Counseling Association. Dr. Tarvydas, welcome and it's pleasure to have you with us here today. >> VILIA: Thank very much Dr. Scharpz. I appreciate having the opportunity to talk about one of my favorite topics, ethics. I especially appreciate the opportunity to make the link between ethics and the practice of community-based research. Before I launch into some of my remarks, I just wanted to overview what I would hope to do during the time we have together. The first portion of my remarks will really try to refresh your memory regarding some of the basic material that was covered in the readings. We'll overview the basic idea of ethics and how it relates to research and some of the general areas of ethical obligations that all researchers share, whether they're doing community-based or other types of research methodologies. Then I think we'll take a break and see what kinds of questions have come up for you in the audience. And then the second portion of the time we spend together, I wanted to explore a little more freely some ideas relating to issues that are of particular interest within community-based research and also look at some ideas that might challenge some of you to think more in terms of your own value systems and how they might impact your effectiveness in doing community-based research. So that will be, I think, our basic order of business as it were today and I hope it will serve us well. First of all, I think a few words are in order regarding why ethics is so important to researchers. One can take the simplistic idea that ethics is important in making sure that we do the right thing and we attend to our obligations no matter what professional role or what role of assistance we have regarding the people we're working with. Of course that's true, but in the area of research, I think if we stop and think both in terms of the things we hear about research in the general public and in the general media as well as in professional journals, we have to really understand that if a study has not been conducted with a high level of ethical obligation in mind, its trustworthiness or its basic value is questioned. The time, the resources and the good intentions of all the people, both the researchers and the people in the community that has participated are sometimes squandered or set aside as not having good importance, and this is a very serious and negative outcome of not having attended to some very basic ideas that can enhance the quality of our research. My own view of ethics is maybe a little bit different than some ethicists you might speak to. While I think it's important to know that ethics are standards for conduct and they are based on the moral principles that many of us are familiar with in our professional practice, that is, principles such as autonomy, justice, nonmalevolence and my own view is it is attended to the obligations that come from those principles, but going beyond that and speaking in terms of the obligations that are inherent in the relationships that are in the pursuit that we're attending to. In the research the relationships are maybe somewhat different than what we're used to if we're not experienced researchers. There are definitely relationships, though. As a researcher, you are basically asking for, in many cases, money; people's time, their willingness to be truthful and their investment of their interest so that they answer honestly and think carefully about what they tell us, so, therefore, we do have relationships to participant. We have relationships to other researchers, to the communities that the participants of our work come from, to policymakers who look to our research sometimes to give insights or to answer questions about what could or should be done to improve public policy, and to the practitioners of the professions. At this point in time with diminished resources and with so much attention to evidence-based practice, I would say, if anything, that the importance of these relationships and the obligations that come to us as researchers are, if anything, increased. So while you can read the materials that are on the web page to get the basic ideas as well as some of the readings, what I need you to reflect on at this point in time is really how critically important that is. It can be especially important in terms of some of the communities that you may be working with in the area of rehabilitation research. I think many of you are probably familiar with the Tuskegee experiments that occurred in the 1930's. There is a fascinating book called Bad Blood that was written about the terrible violations of ethics that occurred within the context of that study that occurred in Tuskegee individuals. At that time African American men who had Syphilis, the course of their Syphilis was followed and the treatments that were available were not administered to them and they continued to deteriorate and eventually die of their Syphilis. When this information became well known, not only did it raise a human cry and basically I think if anything was the origin of our tremendous concern about ethics in research, the study was it, but more importantly, and the reason I also bring this up now, you might think that happened in the 1930's, but those people who studied research ethics will tell you that even to the present day, in certain communities and certain portions of the African American community, as those people who live in that community remember and think about back about the lack of ability to trust at that point to any culture researchers who came into their community and offered a study, they continue in those communities to be skeptical of future research efforts and in some cases many people, as it may not sound sensible to us now, at the beginning of the AIDS epidemic, some individuals in those communities were open to the explanation that AIDS had been in fact another creation of the scientific researchers. And it was being tested in their community. So while that may not sound as a sensible solution, I think it gives you -- if you stop and think about it, this many years, decades later, the sense that these kinds of events, while they may seem like footnotes in our research literature, have ripple effects in our society and erode the trust that the entire communities will have in the scientific and the research work that we do. So to be a good researchers, you have to have trustworthy, that is valid and reliable results, be competent in your skills, attend to the ethical requirements and also be aware of the political and cultural sensitivities that are involved in doing your research project. So I think that -- I would hope that that would set the stage for you really devoting yourself to thinking about and reading about some of the particular requirements that we have laid out for you in some of the reading materials. Let me just talk, for a few minutes anyway, about a couple of the general responsibilities that are involved, and some of the poor areas of ethical obligations that I think are thought of as being fairly standard, whether you're using qualitative or quantitative research methods. Clearly, the role of ethics in research is two-fold, to protect the rights and the dignity of the individuals who participate in our research projects, and as I had already said, it assists in assuring the quality of the project outcomes and making sure that they are believable results. The kinds of values that we have lead us in the research pursuit to make sure that we are attending to some specific values that we think -- in the actions that we think come from these obligations. First of all, we develop the research projects based on specific protocols that help us think through whether or not the issues that we're looking at are really important enough. There are a lot of things that we think may be important, but once we begin speaking of them to our colleagues, to members of the community, they may not be something that is the best use of either the research dollars or the participant's time and effort. So one of the things that we value is the idea that it may not be that many opportunities we have to go into a community and find out things and prevail on people's time and interest. So we need to choose wisely, and we need to make sure that our methods are well done so that if they spend the time, something meaningful and valuable can be generated that will help people. Secondly, of course the major reason that we hear so much about things like IRB's, that is Institutional Review Boards, and other groups of peers that review projects is that our value is that we need to protect people who participate from both psychological and physical harm. Another point is that obviously when you are concerned with individuals, you need to also be concerned with helping them maintain their right to privacy and keeping any information that they may share with us confidential. People also need to have the right to consent freely and knowingly to their participation, and they also have to have the right to withdraw their consent at any point in the project without any negative effects to them. And they need to be assured of this and they need to know of this before they consent to participating. Finally, individuals who are involved in research have the right to -- after the conclusion of their participation -- find out about what the project involved. They have the right of debriefing, in other words. In this process, the goals and the methods of the research are shared with individuals and they -- if it's appropriate are allowed to review the research or provided with a manner in which they can access the results of the research. So those are very broad kinds of areas that we have obligations to deal with, and they also bring some much more specific obligations with them. Because it's so important, I think it would be a good idea to just review the eight points which are in your written materials about informed consent because those are very important aspects of this obligation we have to ensure that people are freely consenting to their participation. When you obtain informed consent -- this is actually a process. While we think of it may be as a form or we think of it as something to get our work approved through an IRB, I think we have to keep in mind the spirit of this. That sometimes truly obtaining consent for a research project involves, as I said, a process. It involves forming a good, comfortable relationship with the individual so that you can be assured that, first of all, you're being understood by those individuals and that they feel comfortable with you so that if they have concerns, so that if they look as if they're not sure, it would be comfortable enough for them to ask or for you to ask them. In other words, certain kinds of common sense things are implied, that there is enough time, that you don't rush people, that you have them in comfortable surroundings, not for you -- for them in terms of putting them as much at ease as possible so that they can truly focus on what they're doing and what you're telling them. Once you've done that, you also need to provide the information I'm going to describe and then check back with individuals. You need to be sure you're providing it to them in a form that is the most understandable to them. For instance, that is in their first language or if they are using sign language, that either you sign -- you have someone from the community preferably who is a certified interpreter who can attend to their obligation -- ethical obligations as an interpreter or you find some other way in which this is sure to be understood by individuals. And that has to be individualized to the people you're enlisting in working with you in the study. So when you're doing this informed consent, you make sure that your participants know about the purpose of the research. That's the first point, what you're expecting as the duration, how long it will last and the types of procedures you're going to use. Secondly, you emphasize their right to decline participation or to withdraw if they wish at any point. Thirdly, you talk to them about the consequences that you could see in declining or withdrawing. You then, fourth, talk about the factors that may be experiencing their ability to participation, if there are any discomforts or adverse effects. It could be as simple as talking to them about the need for them to come to a particular location twice on two Tuesday evenings and the cost of doing so or coming to a particular location that might be identified as related to substance abuse counseling that might have some stigma attached to that. Fifth, you have to talk about any perspective research benefits and this is usually the easy part. We're as researchers are pretty convinced that there is a positive benefit, but the challenge here is to think it through in terms of from the participants' perspective, what do they think in their eyes would be a benefit either to them or to their own community or their families and people they care about. It could be a direct benefit in their own local system or it could be in a policy context, and might have some information that could be provided that would assist in reviewing policy that might be important to them, too. You talk about the limits of confidentiality and the steps you're going to take to keep materials confidential. You talk about any incentives that are available for the individuals who participate, and finally, you let them know who they should contact if they have questions about the research or if they have concerns about their rights and other aspects of the research. So those are very, I think, basic yet important things that I think we do need to at least mention to you. How you do that -- I can't stress this enough -- needs to be thought through carefully in terms of the kinds of individuals, the kind of community context and while those elements need to be there, they need to be provided in a way that works within that particular context. So that's important. Now, another important thing to think about is the degree to which individuals are truly actually able to give consent after they have gotten the information that we've described. I think that you can quite easily read the basic conditions, the individuals need to have the capacity to understand the information and make decisions, the information needs to be provided in a written, oral or other format that's understandable to them, they need to have a full opportunity to ask questions and think about this, in other words, no rushing people into closing the deal. They need to have the opportunity to both deliberate about it and consult any other individuals that might be necessary for them, and you need to be sure that this is truly a voluntary decision that they're making, that there is not really any coercion or the individuals haven't been unduly influenced. There is quite a bit of controversy about this point and let me give you two kind of elements that people are thinking more deeply about now. The first one is one that makes -- that makes a lot of sense within the context of some types of disabilities that people may have. The idea that an individual may not be fully competent is an old legal idea, but within rehabilitation I think our standard is to go above and beyond and to make it certain that you are certainly talking to the individual that can give legal consent, but if an individual has some limited cognitive capability or needs assistance in understanding or using information, that we have consulted with the correct person to assist them and we have legal consent, but on the other hand it is as important, if not more important, ethically to assure ourselves that while consent is a legal idea and people give consent, that the individual who has the disability that would be participating in a study has every opportunity to understand and to give their opinions to the degree they can. And we call that assent, rather than consent, and both aspects needs to be carefully attended to and we need to make sure that the individual who is involved in the research is comfortable with and desirous of doing that even if we do need to get legal consent from someone else. Culturally another issue might come forward. For instance, in some cultures, American Indian cultures, women who are married or of a certain age would feel very uncomfortable with themselves giving consent without consulting the tribal elder or other individuals in the group. Now, legally, that woman can give consent, but I think it's really very important to allow her the opportunity to give consent in a way that's culturally comfortable and appropriate and to be in a process with a researcher representing some other group and being asked if she will agree to something might be very difficult for that individual to say no or to even reply, but if we set up a process where the individual can consult with other individuals and provide a type of consent that's comfortable and sensitive to what she needs to go through in order to fully feel that she is getting agreement, then I think we really fulfilled the spirit of the idea of gaining consent and getting the correct factors in play. From are quite a number of other obligations that I think I'll just basically mention in passing, and then we'll kind of take a few minutes and see if we have some questions either on anything I've said to this point or on the general reading materials. In the area of core ethical obligations, we need to be looking at things like what I've just mentioned in my illustration, accommodating cultural factors and diversity and how we do things, inviting people from the community, for instance, to participate, deviating from standard practices. Now, if we do anything that, for instance, uses an assessment device in an unstandard way, we need to consult with colleagues and take precautions to avoid injury and we need to try to do research, be it qualitative or quantitative that minimally disrupts or interferes with peoples' lives. If there is unnecessary intrusion, that is thought to violate the idea of autonomy. We've talked a bit about informed consent and the topics disclosed. We also need to know the deception -- unless it's absolutely required in the design of the experiment is not permitted, and even in the area of experiment or a situation where you don't want to reveal the exact core of what you're interested in, you should be truthful as you can about the general purposes or the general reason why you're working with this group or the general topic areas that you will be discussing with the group as individuals in the community, even if you don't share the specific particulars at the outset. There can be a variety of different arrangements to gain informed consent that we've talked about. Let's skip to two things that I just want to mention in passing that you will want to review maybe on your own. As you look to the idea of reporting results, you have to report things within an appropriate context in terms of the limitations, in terms of the cultural context, in terms of the community that it's important to note so that people can make decisions about how much this research represents just the group a that was studied or whether or not there are opportunities to generalize the work more broadly. It's really critical to attend to making accurate reports and providing enough information that people can fully understand what you did and how you did it. So, in other words, it could be replicated. Another one is that you have an obligation to report unfavorable results if that's what you have found, and you also need in your reporting, of course, at all tiles to attend to making sure that you've preserved confidentiality of your participants. As you do qualitative research in community-based settings, this is sometimes a challenge because to the degree you provide those thick, rich descriptions that people talk about or that if you are painting, if you will, thick word pictures about the individuals who have participated, it takes extra care to make sure that you're not so finely tuning that description that you are in fact potentially exposing the individuals that have shared information with you. And oftentimes the use of direct quotes in qualitative research has to be balanced with the idea that those quotes will empower and lend validity to much what of you're trying to describe in your finding, but on the other hand you need to make sure the idiosyncrasies of speech or any reference to location are not left in there so that individuals would be identified. Finally, in the publications or dissemination of findings, I think most of that is the topics considered or things you're probably expecting to see there. In other words, recognizing all the people who made contributions, avoiding plagiarism, recognizing all contributors and if you're professionally reviewing something and not using those findings without attributing them, and a variety of things like that. Now, when we go to community-based or participatory action -- recognizing all the members of the community and their contributions isn't just an ethical obligation -- of course it is -- but it is also something that I think can set your work apart and truly make it a stronger and more powerful work if the readers of your work can see the broad-based community focus and context that has been used to generate the work that you've done. So it is, yes, of course, your ethical obligation to recognize those people, but again it goes back to one of my first comments, that if you do all these elements of ethical obligation properly, it does contribute to the standing and the power of your findings. So I think what I'll do at this point is to say let's take a break from my discussion and see what thoughts and questions you may have. >> HELEN: Dawn, do we have any questions? >> DAWN: Not at this time. >> HELEN: Well, I had a couple of thoughts as you were talking, Dr. Tarvydas. One of the things that comes to mind is when I teach ethics to students and research ethics in particular, it's this idea of perspective taking, that they really need to be able to take the perspective of the participants; to put themselves in that position and if they're able to do that, then I think they can really understand what information it is that the participants need to know in order to make that informed choice about whether they want to participate or not. >> VILIA: That's a very good point. >> HELEN: And the other thing which usually leads to the next thought in Participatory Action Research which is the central themes of this C. B. R. C. project is the idea that individuals from the community are involved in the whole process, and I wonder how some of the ethical things that we consider to be ethical violations over the years, the projects, how that would have changed if people in the community had actually been involved in the planning and the designing and the work with that. I wonder if you'd give some comments or if you have some thoughts on how Participatory Action Research might change or might influence some of the ethical issues you've talked about? >> VILIA: Well, I think this is a -- you must have planned this. It's a perfect segue to the second half of what I really wanted to spend a few minutes on. Because you've introduced as we talk more particularly about Participatory Action Research and other community-based research methods, you've introduced to me one of the most critical factors in all of this and that's the idea of -- you called it perspective taking or empathy and for me at the beginning are words in that same category is attending to the relationships, and I think that that is one of the strengths of the community-based research models, the PAR models, to calling on individuals in the community to be identified in joining the research team and interacting with the entire team to talk about what does this mean from the perspective of the individuals who might be involved in this or what might be their reactions to certain questions we might ask or to certain locations that we might go to. That perspective taking, I think, not -- it isn't just respectful to the participants, it also ensures a better, if you will, buy-in so that you do have when you get people responding more credible responses. You've put them in positions where you're asking them questions that are more likely to call forth the actual critical information. You're making them -- because you've attended to some of the sensitivities about whether or not this is safe or whether or not this is seen as fair or exploited, you've put them in a position to trust you as much as possible and therefore we would hope be more open and maybe even if they talked this through in the process, discover new insights themselves into some of the issues or some of the ideas that they're exploring as they respond to us. So this issue of perspective taking is probably one of the most valuable aspects I think of the PAR approach and it is certainly important to all of research ethics, but especially at the a forefront of the variety of techniques we use there. So the involvement in those people from that community, I think, would obviously have changed so many of the approaches that we see in some of the worst violations of research ethics we have seen. >> HELEN: I know one of the comments that has come through recently that I have seen at least is to view your research participants like you would your granting agency. They're your consumers. >> VILIA: That's a very healthy and equalizing manner to think about that. Now, I think that one of the things that we also have to think about if we take on that challenge of perspective taking is -- and this is one of the topics I just wanted to throw out there and see what people would react to because I don't want to just review the material that I have written for this unit; but one of the interesting questions that comes up is Participatory Action Research, many of the qualitative methods used this community-based work capitalize on the sensitivity of the researchers, be they people drawn from the community or from the scientific community, to think of themselves as -- you hear this all the time -- as the primary instruments in the research design. So what does that mean? Well, I think that means that we may have a real ethical challenge here in terms of really needing to examine who we are as researchers, be we from the community that's being studied or be we from the more traditional research community. Our research really is influenced by who we are as people and the perspective we have and we bring to our research, how we hear certain words, how we interpret certain descriptions is so critical in forming the base of findings in this kind of research. We have to then begin to kind of say things to ourselves like, just because I'm doing participant action research does not mean I am free of values or free of biases. We all have biases and values. Hopefully they're useful ones, but we have to get aware of what they are. For instance, one thing I think that badly done PAR can do, that's Participatory Action Research, can inject critically an event to a political activism agenda. I'm not saying political activism is bad, but in doing research, your credibility as a researcher is in fact to be fairly and directly reporting objectively the material that your community or that would your participants are reporting to you. So we have to then become aware of -- in PAR how carefully we're listen to our community and to our participants and making sure that we're not taking unusual or agendaed interpretations of the things that we're finding. And this isn't something that's often talked about. Now, a lot of the same methods that you would use to assure the rigor of Participatory Action Research can be used to double-check yourself as a researcher as long as you make yourself also a topic of examination along with the data, and you begin to ask whether or not I have a bias or whether my bias is coming through or your research team, including those people you draw from the community feel free to challenge your interpretation of that theme or that content or why you've chosen to go to this community and not to that community. So this is really important. Research is a culture and we can become just as involved as a biased group. For instance, many people talk about research as being -- having a particular world view and that's why we have Participatory Action Research, it concerns itself with the community perspectives and the rights and the well-being of the community from which the participants are drawn. However, the more classic type of empirical research is based on a positivist viewpoint. It views logic as really being critically important. You might be working in a community and doing PAR work with a community that doesn't view it as necessary to have answers as much as to engage in a respectful process of getting individuals together and being in a community with each other around certain topics or around certain functions. So it becomes almost like motivational interviewing for any of you who are out there who are counselors or psychologists. You have to use quite a bit of cultural sensitivity and skill to even develop a good understanding within your PAR team about what truly are our goals and what are our community's goals and to find ways that motivate the community participants over things that are truly meaningful to them, not things that we think should be meaningful to them. Like finding the absolute rate of tuberculosis in a particular group of people. I think I remember reading some work done about the Aboriginal cultures in Australia, and the time spent in researching is truly amazing in Australia, and someone was saying, this is probably the most researched and yet the poorest and most badly served of all communities on the face of the earth. And I think a lot of that had to do with the idea that the kind of work that's being done does not fit with the Aboriginal community is buying into and in fact will pick up on and use once those resources that we thought we knew they needed once we got if answers to the research were provided. So that's really an important aspect that I think is sometimes not as well attended to in terms of truly going to that community and PAR and not just to the leaders and the people that are easy to get to, but the true leaders within the community not just those that are identified in the agencies or the places that -- the people outside of the community are used to interacting with. So I think that is really an important part of what we're doing. Another couple of ideas, too, that go along with this idea of entering into a community and being part of that community in a qualitative research paradigm or a PAR paradigm, I think we also have to be sensitive to -- while we're in this process of truly getting to know that community and listing community participants that we are also aware that we don't want too set ourselves up for this kind of see ducks and abandonment kind of phenomenon you're talking about a lot in the context of especially an throw Poe logical research. Sometimes research teams will get very excited about their work and about being with the community and will begin to either imply that they're going to be, you know, supporting a particular perspective or political action or will be part of that community long term, you know, and at the conclusion of the project, they may promise literally what was promised -- they may deliver what's promised within the research contract, if you will, but leave the impression that they were still going to be coming back to the community or they were still going to be participating in certain activities in the community and they don't. And that can leave some very bad impressions within that community that here again we've had a group of outside researchers come in and just give us only what they had to and it seemed like they were part of us and then they left. And that requires some, again, empathy and understanding of the types of impressions you might give as you engage yourselves in certain ways in the community. So think that those are at least a couple of issues that I think have not been as widely attended to in the community-based or the PAR type perspective that I think that might be worth considering a little more deeply. And I'd be curious as to -- as people think about or have done Participatory Action Research, if you have concerns or questions in your own experience that are raised by some of these ideas that I have thrown out. >> DAWN: I do have one question that's come in. This is dawn. How will researchers know if they were to recruit the assistance of a culturally sensitive person that the person was highly knowledgeable in that particular culture? >> VILIA: Well, that is an important question you're asking, and just the fact that you have raised it I think is very helpful. I think the worst violations occur when people sort of uncritically adopt the idea that this person has come forward and they were presented as the elder of the group or they were presented by maybe one other person as someone who is really embedded in the culture, and you basically take that at face value and don't make further attempts to widen out your network. I think that you can respectfully ask that individual for other persons in their community with whom you can consult and I would never recommend just consulting with one individual from a particular group. I would be reaching out to form a bit of a network and in that process of familiarizing yourself with that community, you can discretely begin to understand the kind of connections that first person may have or not have in the community and they may be fine as a portion of the community but there may be entire groups of individuals that can be more responsive if they were contacted by another individual. So it's not a bad idea to ask that individual for other leads and also to speak to just individuals in the community and say if you have questions or if you have problems in your community, to whom do you go for guidance? >> DAWN: That's it for the E-mail questions right now. >> VILIA: Okay. >> HELEN: I had a couple of thoughts. We were talking a lot about some orientation, understanding big issues, can you talk a little bit about -- a little more practical orientation. I know that there were a number of ethical guidelines that come from professional organizations, so if you're a member of a professional organization, you need to adhere to those, and there are also a set of federal guidelines -- federal requirements for organizations that receive any sort of federal funding. >> VILIA: Yes. >> HELEN: and so within those can you talk a little bit about sort of a practical -- how one goes about the process of figuring out within those federal guidelines what's acceptable research or what one needs to do to adhere to those? >> VILIA: Well, first of all, let me just mention more specifically a couple of the documents and resources that you were referring to, Dr. Scharpz. I think it's always important to -- not just to consult the codes of ethics that may be pressing on those groups that you belong to, but to look broadly regarding what the codes of ethics are in various other groups that may have relevance to what you're doing. So, for instance, the American Psychological Association has recently revised its codes of ethics and in fact I think they have a pretty tight group of ideas about how you approach certain topics within your responsibilities and research. Similarly, the American Counseling Association has its own guidelines that were currently revising, and finally, there are other codes of ethics, for instance, the American Anthropological Association and others have guidelines for the kind of research that they would do. So if you're doing more qualitative research that would be a direction to go in as well. Probably what Dr. Scharpz -- you were referring to most directly is the federal law that governs the function of the institution review board or the human subject review boards that are constituted, that are -- that are set up to approve any research at an institution that receives any kind of federal funding for research. And I'd like to make a distinction, although it is maybe not critical one for some people, I think it's important to keep in mind. There is a difference between the IRB requirements which are quasi-legal in essence, they are based on federal law. They are critically important if you have federal funding. They do use the core ethical responsibilities to to how you protect those subjects and need to be consulted, but they are much more pointed and much more legalistic in their process than the codes of ethics that provide general guidance and then rely on the -- on judgment of trained researchers to actually fit the specific requirements of their research into what the IRB might require and what might be relevant to the type of research projects that they're doing. I think as a practical matter, one of the first things it may actually sound kind of silly to be this basic, is that if you're involved in a research project that is any federal dollars or is in an institution that receives them, you need to actually take the basic institutional review board training. Every one of these institutions, by law, has a standardized training process. Many times this is an online course that you can take that reviews the federal guidelines in specific detail. It generally will describe the particular committees that are constituted at the institution that you are going to be working through, and gives deadlines and a variety of other kinds of very practical steps that must be taken. Usually at your institution you will also find online the forms that are necessary to be filled out that will guide you through the process of making sure, for instance, that your letter or that your informed consent documents are written in the proper fashion and in a fashion that fully protects the kinds of individuals that you are planning to involve in your study. There are extra guidelines to attend to, for instance, and think through when you get into certain kinds of vulnerable populations. Vulnerable populations has specific meaning within the context of IRB's and it could mean individuals who are either under the age of 18, who are not fully competent to consent because of a cognitive deficit or some kind of a developmental problem. It may be an individual who is in a setting that diminishes their ability to freely consent where there might be some implied coercion. For instance, inmates of correctional institutions would be one example. To some degree, in rehabilitation you have to think carefully, too, about individuals who may be in more restrictive environments than they would like to be, for instance, individuals who are living in nursing homes and who are given the chance to participate in a certain research. Are they freely consenting if going to participate in that focus group is the only way they can get out of that setting within six months. Is that truly free participation? Or is that kind of a subtle kind of benign coercion that's occurring. So there are certain kinds of things that the IRB training and the documents will call upon you to think about as you design your study methodology, as you think about how to approach your participants and discuss their informed consent with them. And generally on most campuses, with the IRB's, there are certain identified individuals within schools or departments that either sit on the committee or have been trained and identified as liaisons by these committees that can provide you with specific consultation on the specifics of your project and it's a good thing to approach those individuals early on in your project as you're just starting to think about your methodology and the kinds of individuals you'll be working with, especially as a new researcher, they can be very helpful. They can be kind of detail your end, hold on to our hats, but you'll find as time goes on that they're just raising questions, for instance, if you had a member, I've seen those individuals on the IRB's that ask questions that maybe a member of that community might have asked, you know, is this truly free consent? What would -- what are you doing to make sure that nobody has access to that information? Those are things that many members are very good in playing devil's advocate about that while they may sound annoying when you're trying to get the work done are actually a real positive part of the checks and balances of going through the process and you should look at them as peer consultants, as much as some kind of a formal administrative hurdle that you need to go through. I don't know, Dr. Scharpz, did that answer your question? >> HELEN: I think it did. I know that some of these -- if you're at an academic institution, the idea of the IRB and how that whole process works is fairly familiar to you, usually, but if you're not at an academic institution or just in a community organization just starting out to do research the whole idea might be quite frightening and you need to apply to somebody and they may need to approve what you do. >> VILIA: Yeah, and I think that is the correct mind frame that it is -- you should think of it as an ongoing process and you should think of them as consultants to the degree that you think of them as a hurdle to be overcome or adversaries, I think you're walling yourself off from some very useful -- potentially useful consultation and especially as new researchers or as researchers trying to move into a new area of practice. And I think we just really have to think about them as individuals that can be helpful. >> HELEN: I know we have also worked with at least a few organizations who were just starting out doing research who had not done research before and actually needed to set up their own IRB's, and apply for assurance to say that their whole institution was going to be in compliance and that, again is a whole other process that some of our listen R s might have to consider if they're moving into research and their institution has not done research in the past. That there are -- that there are requirements as to how to set up an IRB or how to link yourselves with an existing IRB to meet those fed guidelines because those federal guidelines have become important for any institutions that are receiving federal funding that are going to do research. >> VILIA: Well, they certainly are. Johns Hopkins actually had its entire stream of federal research dollars cut off a couple of years ago because they had an unreported adverse effect and they had to do a variety of corrective actions before their research monies would be rereleased. So obviously the death of a participant is a very serious event and I think when I talk to the people at Johns Hopkins they were at first of course very shocked that the IRB would take such a radical action, but after further reflex, I admire the way they stepped up to the bat and recognize that you run the risk as much as their excellent researcher of becoming somewhat jaded and not really seeing the IRB as an important partner in preserving the -- what did I say -- the first obligation is to protect subjects from harm. And so I think that they really reframed how they were thinking of them. Now, I know that within certain places there have been others discussions that have occurred about IRB's and I think individuals who participate in IRB's and/or form them also have to look to some ethical issues that have a risen regarding the functioning of IRB's. In a couple of situations, IRB's have held up research approval not based on the ethical concerns regarding the treatment of human subjects and the protection of human subjects, but for other reasons. For instance, financial -- so that the moneys could be assured and the indirect as flowing to the right places before they would sign off on the ethical clearance, the human subject clearance. Another instance might be, for instance, where administration requires that not just the human subjects review occur, but the human subjects review is held up until the research is reviewed by administration to see if it fits the image of the university or if there is some other reason the research shouldn't go forward, for instance, like researcher in another department has another project that might be competing. Now, those might be very valid questions for administrators to ask, but the issue arises when you link the ethics approval through the HRB with some of these either monetary or administrative or political considerations and some people in the research community are becoming very concerned about the increased tendency to especially link those two administrative functions. So, you know, IRB's also are called upon to monitor their own activities and make sure that they're attending directly to their responsibility to human subjects and that's their primary focus. >> HELEN: So I think that -- if nothing else it's very clear that the idea that the concern that we have for the communities for the participants and their well-being in the topic of ethics is really the critical and core component of what we should be considering here. And I do think that if you spend time working with the IRB's, if you spend time truly speaking with your colleagues openly and freely about your methodological concerns, your concerns about making sure that you're actually enlisting the right people from the community and fully ting them and your goals are consistent with the community that you're trying to research, I think not only will you have a project that will clear processes like the IRB and that is ethical, but you'll of have a much more powerful piece of research that will get closer to the phenomenon that you're trying to research because you'll have more valid and reliable information that you're receiving. It's clear, you can effectively conduct research and a more slip shod manner and get results. What the meaning of those results are and whether they're actually able to predict anything or actually able to effectively impact the phenomenon you're studying is less clear and is much more likely to happen if you truly attend to the well-being of the people that you're working with. So I guess that would conclude I guess my general remarks and before we go forward I guess we should see if there are any other questions at this point. >> DAWN: No ma'am, none have come in on the web. >> HELEN: Dr. Tarvydas, thank you so much for providing us with this information. You truly have given us I think some great ideas and some great issues and things that we need to think about when planning these research projects, people that need to be involved and as well as sort of the practical -- some of the practical nuts and bolts issues that need to be resolved as you do this. So thank you very much for this great presentation today. I also want to thank ILRU, our partner in these webcast ventures, the ILRU Independent Living Research Utilization program has served as a national center for information, training, research and technical assistance in independent living since 1977 and its goal is to expand the body of knowledge on independent living and to improve utilization of research programs and demonstration projects in the field. It is a program of TIRR, the The Institute for Rehabilitation and Research, a nationally recognized medical rehabilitation facility for Americans with disabilities located in Houston. And I want to do a special thanks to ILRU's webcast team, Dawn Heinsohn, Marj Gordon, Mark Richards and Sharon Finney and the people without whom we would not have a webcast, rob -- whose name I will probably mispronounce, Dickehuth, the web technician and Marie Bryant the realtime captioner. I hope you will join us for future webcasts and Dr. Tarvydas, again, thank you so much. >> VILIA: You're welcome and I would just say if people would like further readings they should look at the recommended reading list and I'd be happy to provide further resources if they wanted to E-mail me on a particular topic. >> HELEN: Great. Thank you for that resource. Good day everyone.