Mock Convened IRB Meeting

(display: "headercontent")(display: "menucode")<h3>Mock IRB Meeting</h3> The ethical reasoning module gave you an idea of how the ethical principles of Respect for Persons, Beneficence, and Justice can be applied in specific situations. These ethical principles can be used to guide you in forming arguments for or against the approval of the research protocols that you will review as a member of the IRB. In this interactive module, you will have the opportunity to learn a little about what it is like to attend and participate in a convened IRB meeting and how the members might present reviews of research protocols, discuss concerns, and make decisions about Board Actions. You will improve your understanding of the ethical implications, human subject protection concerns, and risk/benefit analyses that are typically considered during an IRB review. <div class="boxed"><center>**About the Activity**</center> This activity uses a "Choose Your Own Adventure" framework. You will choose to move through the mock IRB meeting as one of three different characters. Each character provides a different perspective on the IRB. You will move through the mock IRB meeting and make decisions about what type of arguments to make or accept from the point of view of your character. At the end of each passage, you will come to a link. In some cases, the link will just move you forward in the story. In other cases, you will have to make a choice about what to say or do next. Note: some links are followed by the "**&lrarr;**" symbol. This symbol indicates that clicking on the link will produce a random result. Once you work through the activity to the end, you will have the option to complete the activity again with the same character or a different one. Visit [[Navigation]] for more information about how to move through the Mock IRB passages. </div> (display: "sidearrow")   [[Next Section: IRB Meeting Procedures ->FullBoardReview]]

(display: "headercontent")(display: "menucode")<H3>Convened IRB Meeting Review Process</H3> The process of conducting a convened full IRB meeting generally completes each of the steps described below. <div class="boxed1"><center>**Conflict of Interest**</center>The IRB checks to make sure that there are no IRB member conflicts of Interest (COI) prior to conducting a research review. During the meeting the Chair will check for COI for all research protocols on the agenda. Members with conflicts will step out during the review of the affected research.</div><center><h1></h1></center><div class="boxed1"><center>**Quorum**</center>Federal regulations require a majority (half plus one) of the registered board members (a quorum) must be in attendance to conduct the meeting. The Chair ensures that quorum is present for each research protocol.</div> <center><h1></h1></center><div class="boxed1"><center>**Overview of Research**</center>The primary reviewer or IRB Chair provides an overview of research protocol. </div><center><h1></h1></center><div class="boxed1"><center>**Discussion and Documentation**</center>The IRB discusses the protocol under review; outlines questions for investigator, and documents how controversial issues are resolved. </div><center><h1></h1></center><div class="boxed1"><center>**Criteria for Approval of Research**</center>The IRB members consider each protocol, following the guidelines of the [[criteria for approval ->CriteriaForIRBApproval]] as they make their decision.</div><center><h1></h1></center><div class="boxed1"><center>**Voting**</center>Each IRB member votes for or against the protool under review or abstains. In addition to approving or disapproving, members may also vote to request modifications to the protocol or clarification from the researchers; or they may table the research. </div><center><h1></h1></center><div class="boxed1"><center>**Document IRB Determinaton**</center>The IRB documents each determination and proceeds to next item on the agenda. </div> (display: "sidearrow")   [[Return to What Happens at a Full Board Review? ->FullBoardReview]]

(display: "menucode")<H3>Mock IRB Meeting Participants</h3> Our mock convened IRB meeting will follow [[federal requirements for IRB membership ->IRBMembership]] which requires IRBs to have at least five members that meet specific criteria. There must be one community member, one member whose primary concerns are in scientific areas, one member whose primary concern is in the non-scientific area, and one member who is not affiliated with the institution. The mock IRB members described here are from diverse backgrounds (gender, race/ethnicity, culture, profession) and have the scientific, administrative, and cultural understanding necessary to review the research activities assigned to them and appropriate to the unique circumstances of the Albuquerque Area. Briefly review the character profiles below. Note that the characters are described by the role they serve on the IRB. <div class="boxed1">**Character: Community Member** The community member is a woman in her mid-40's from one of the tribal communities in New Mexico. She is a teacher in one of the community schools and has been serving on the tribal IRB for several years. </div> <div class="boxed1">**Character: Scientific Member** The scientific member is a White doctor in his early 60's who began his career providing health care through an IHS clinic. He currently works as a primary care physician through a local hospital system, but he considers his time at IHS to have been a transformational experience. He is new to the tribal IRB having served just 6 months. </div> <div class="boxed1">**Character: Non-scientific Member** The non-scientific member is an American Indian/Hispanic woman in her late 40's. She is not an enrolled member of any tribe or pueblo but is descended from more than one tribe or pueblo in the Albuquerque area. She is a lawyer and has served on the tribal IRB for 3 years. </div> <div class="boxed1">**Character: Non-affiliated Member** The non-affiliated member is a Hispanic man in his early 50's. His professional background is in public health. He worked for many years in a University clinic but has recently started working on a project that focuses on improving community health. He previously served on a different IRB. He has served on the tribal IRB for 2 years. </div> <div class="boxed1">**Character: Community Member and tribal IRB Chair** The IRB Chair is a man from one of the tribal or Pueblo communities. He has served on the tribal IRB for 7 years, longer than any of the other members. He is a associate professor at a local university and has a broad background in research. </div> (display: "sidearrow")   [[Next Section: Choose Your Character ->ChooseYourCharacter]]

(display: "headercontent")(display: "menucode")<h3>Choose Your Character</h3> For this role playing activity, you may choose to be one of the three characters listed below: (display: "sidearrow")   [[Community Member ->CommunityMember]] (display: "sidearrow")   [[Scientific Member ->ScientificMember]] (display: "sidearrow")   [[Non-Scientific Member ->NonScientificMember]]

You are a community member on the tribal IRB, and you have been assigned as the primary reviewer for a research protocol. After completing your protocol review, you have decided to recommend that the board ask the researchers to modify the protocol, but first you have to [[present ->Present]] the proposed study to the full IRB.

(display: "menucode2")[You are the scientific member. You are listening to the community member's review. The community member recommends the IRB request modification to the protocol. To you, her recommendation seems to be based primarily on her judgment that the researchers are not really following a CBPR approach.]<first| (Click: ?first)[You are new on the IRB and do not have a lot of experience evaluating this kind of research, but you think that the researchers' goal of reducing STDs is really important.]<second| (Click: ?second)[After the community member completes her review, the IRB Chair invites discussion. Do you:]<third| (Click: ?third)[(display: "sidearrow")   (link: "Agree with the recommendation") [(goto: (either: "IAgreePositive", "IAgreeNegative"))] (display: "sidearrow")   [[Disagree with the recommendation ->IDisagreeNegative]]]

You are the nonscientific member and the primary reviewer for the protocol. You are really excited about this study and you expect it will be an easy protocol to present and will have wide support among committee members. You present your review to the IRB Committee, [saying,]<first| (Click: ?first)["This is a great opportunity to do some //wonderful// research in two of our communities and at the Los Altos school in Santa Fe. This intervention resulted in some terrific research in California. It has made a big difference out there and I am sure it would make a big difference here. The protocol is based on sound public health practice and I think we should vote to approve it so they can get started as soon as possible, and we should do whatever we can to support it."]<second| (Click: ?second)[You feel good about your presentation, [[but then... ->ChairSurprises]]]

(display: "headercontent")(display: "menucode")<h3>Mock IRB Research Protocol</h3> This Mock Convened IRB Meeting will be based on a sample training protocol that has been used in face to face mock IRBs and is the basis for the Procedural Knowledge and Mock Protocol Review that is a part of this training. A summary of the sample protocol is provided below. <div class="boxed"><center>**Mock Research Protocol Summary**</center> The primary goal of this research project is to develop a culturally relevant high risk behavior prevention intervention for Native American youth. Community readiness for a high risk behavior prevention intervention will be assessed using the Community Readiness Model. The intervention will be an adaptation of a Center for Disease Control and Prevention (CDC) Evidence-Based Intervention (EBI) that incorporates the knowledge and expertise of the community members. Using a community-based participatory research approach (CBPR), the project staff will conduct focus groups with youth and convene a Community Advisory Panel (CAP) in each community. In the two tribal communities, the CAP will involve school, clinic, and behavioral health personnel, community health representatives, parents, and elders. In the urban school for Native American youth, the CAP will involve school personnel, parents, and elders. The collaborators will determine the specific changes to the intervention for each site. The adapted curriculum will be implemented, analyzed, and disseminated to tribal communities. </div> (display: "sidearrow")   [[Next Section: Mock IRB Member Profiles ->MockIRBParticipants]].

You disagree with the primary reviewer's recommendation, [saying:]<first| (Click: ?first)["I don't think we need to request modification to the protocol. I think it is clear that the researchers intend to work in partnership with the communities - they will have community advisory panels.]<second| (Click: ?second)["And from my perspective, the informed consent documents are in good shape. The curriculum they intend to modify is a CDC evidence-based curriculum that has been implemented in several diverse communities. I think we should vote to approve the protocol."]<third| (Click: ?third)[You look around the table and see that the nonscientific member seems to agree with you, but there also seems to be a few furrowed brows around the table. Do you...]<fourth| (Click: ?fourth)[(display: "sidearrow")   [[double down and take your agrument a little further ->DoubleDown]]. (display: "sidearrow")   [[ask a thoughtful question to get the conversation moving. ->MoveDiscussion]]]

You agree with the recommendation to request modification to the research protocol, [saying,]<first| (Click: ?first)["I agree that if the researchers are using the term "CBPR" to describe their research approach but are not applying it appropriately then we should request modification."]<second| (Click: ?second)[You wanted to ask the reviewer a question, but as soon as these words were out of your mouth, the nonaffiliated member jumped in and said,]<third| (Click: ?third)["I completely disagree. I think we should approve this protocol. It is really important to find something that works to stop the risky behavior in these young people, and I don't see anything wrong with how they are going about applying the CBPR."]<fourth| (Click: ?fourth)[You are surprised. You thought everyone would agree with the primary reviewer's recommendation. The nonaffiliated member is looking right at you, and you realize he expects you to answer. Now you are rethinking your position. Do you...]<fifth| (Click: ?fifth)[(display: "sidearrow")   [[try to answer him from your perspective ->MyPerspective]] (display: "sidearrow")   [[ask a question you have about CBPR ->AskQuestionCBPR]]]

You agree with the recommendation to request modification to the research protocol, [saying,]<first| (click: ?first)["I agree that if the researchers are using the term "CBPR" to describe their research approach but are not really applying it properly then we should request modification."]<second| (click: ?second)[After you agree, you listen to other people around the table. They all seem to be in agreement. This is going fast and it would be nice to move on to the other protocols, but...]<third| (click: ?third)[You have a nagging feeling. Wouldn't it be better to request clarification from the researchers and not modification? Do you...]<fourth| (click: ?fourth)[(display: "sidearrow")   (link: "Stay quiet so the meeting can progress") [(goto: (either: "MouthShutPositive", "MouthShutNegative"))] **&lrarr;** (display: "sidearrow")   [[Ask a question ->AskQuestionPositive]]]

[You respond to the scientific member: "I agree. I don't think it matters what they call it. They have described the design in detail and it has at least some elements of CBPR included."]<first| (Click: ?first)[The community member lets out a deep sigh. She isn't really getting a lot of support from the rest of the committee. The meeting is starting to run long and several of the members are looking impatient.]<second| (Click: ?second)[You say, "I recommend we approve the protocol."]<third| (Click: ?third)[The Chair thanks you for your review and recommendation and asks if anyone has anything else to say before we vote. No one says anything.The Chair calls for the vote and the protocol is approved 4 to 1.]<fourth| (Click: ?fourth)[You feel good about the vote and happy that the protocol was approved, but at the same time, you wonder if you should have asked the community member to explain her concerns in a little more depth. Maybe then you could have made an argument that would have changed her mind. You resolve to try harder in the future to hear what the other members are saying, especially when they disagree with you.]<fifth| (Click: ?fifth)[<center>[[The End ->TheEnd]]</center>]

After listening to some of what the community member is concerned about, you still don't agree with her assessment. You respond, [saying,]<first| (Click: ?first)["The researchers are using CBPR. The communities will have multiple opportunities to include their input in the adaptation of the curriculum. The researchers have taken steps to protect the privacy of the participants. The risk posed by the proposed research really is low."]<second| (Click: ?second)[The community member responds, saying, "The protocol says that they are employing a CBPR approach, but they clearly aren't. CBPR is about forming equitible partnerships with communities. The protocol submitted by the researchers violates multiple principles of CBPR.]<third| (Click: ?third)["It may be true that the communities have multiple opportunities to offer their recommendations about how the curriculum could be modified, but because this is not an equal partnership, there is no guarantee that the researchers will implement those suggestions. To top it off, the researchers say they will disseminate the curriculum to project partners, etc., but they do not say that they will obtain approval from the tribal communities to publish their findings."]<fourth| (Click: ?fourth)[When the community member brought up the issue of data sovereignty she piqued the interest of the committee. The discussion continues for a few minutes, focusing on minor points and then the IRB Chair asks if you were ready to make your recommendation or if there should be more discussion. Do you...]<fifth| (Click: ?fifth)[(display: "sidearrow")   [[Make your recommendation ->NonScientificRec]] (display: "sidearrow")   [[Ask the community member a question ->AskCommMember]]]

After listening to some of what the community member is concerned about, you still don't agree with her assessment. You respond, [saying,]<first| (Click: ?first)["In my opinion, this protocol meets all of the criteria for approval of a research project. Whether we personally like the research proposed or not, we have to consider the facts and the fact is this proposal meets the requirements for approval so I recommend that we approve it."]<second| (Click: ?second)[The scientific member nods his head and says, "I agree."]<third| (Click: ?third)[The community member says, "Well, I think if you look a little more closely at the principles and requirements of CBPR you will find that this protocol is inaccurate, and I don't think it satisfies the requirement for sound research design. It would be a mistake to approve it without some modification." The IRB Chair calls for a vote and the protocol is approved by a vote of 3 to 2.]<fourth| (Click: ?fourth)[<center>[[The End ->TheEnd]]]

["I agree the the scientific member," you say.]<first| (Click: ?first)[The nonaffiliated member says, "I can say that the university IRB I served on would have approved this, but they don't have the mandate to consider the community in the way that we do on the tribal IRB. I think maybe we are being a little bit hasty by not exploring what it means to have a study design that says it is doing one thing but really does another. How does that affect the community and the individuals participating in this research?"]<second| (Click: ?second)[Then, the scientific member surprised you, and says to the community member:]<third| (Click: ?third)["Like I said before, I am not an expert in CBPR, and so I guess I would like to know what you think is lacking in their description of how it would be applied? What's missing?"]<fourth| (Click: ?fourth)[The community member [[looks up ->CBPRLight2]]]

After giving an overview of the facts about the study, [you list the primary considerations:]<first| (click: ?first)[“The primary considerations on this review are whether this is really using CBPR. It seems like they may not be using the term appropriately for what they are suggesting.]<second| (click: ?second)[Another concern is that they are not asking approval from the tribal councils – only the two groups that are directly in a tribal community are seeking approval. The group in the urban area is only seeking approval from the school board.]<third| (click: ?third)[Also, the child assent is not clear in terms of describing any of the cultural impacts that this might have. But, the biggest concern is that they are assuming that a Western-based intervention is appropriate to use in all American Indian communities."]<fourth| (click: ?fourth)[The Chair thanks you for your review and asks if anyone has any questions.]<fifth| (click: ?fifth)[The scientific member and the nonscientific member both begin to speak and you are interested to see (link: "which one will win out.") [(goto: (either: "ScientificWins", "NonScientificWins"))] **&lrarr;**]

(display: "menucode")(h3)Federal Requirements for IRB Membership(/h3) "§46.107 IRB membership. (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects. (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the instituton's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB shall include at least one member whose primary concerns are in the scientific area and at least one member whose primary concerns are in nonscientific areas. (d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. (e) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. (f) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB." 46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28028, June 18, 1991; 56 FR 29756, June 28, 1991; 78 FR 16401, Mar. 15, 2013 Source: <a href="https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.107" target="_blank">Federal Regulations for IRB Membership</a> (display: "sidearrow")   [[Return to Mock IRB Member Profiles ->MockIRBParticipants]]

[You decide not to hold up the group by asking your question. You trust that the other members know what they are talking about and feel okay about going along with their recommendation. You think you can always read up on it later.]<first| (Click: ?first)[The members vote to request modification to the research protocol, and the next protocol review begins.]<second| (Click: ?second)[Amazingly, this research protocol involves CBPR as well. As the discussion gets underway, it becomes clear that this time the members are split about how to vote and the issue holding everyone up has to do with the research approach.]<third| (Click: ?third)[You are in an uncomfortable position. If you ask for clarification about the CBPR process now, it will be clear to the other members that you didn't understand the issue when you voted on the last protocol. But this time, the study is higher risk, and there is no one for you to follow. You absolutely cannot vote on this protocol without understanding all the issues.]<fourth| (Click: ?fourth)[You take a deep breath and ask your question. The other IRB members are quick to respond and you feel relieved. You realize how important it is to ask questions //when// you have them.]<fifth| (Click: ?fifth)[<center>[[The End ->TheEnd]]</center>]

[You decide not to hold the group up and you don't ask a question, but you continue to feel like clarification would be the way to go. It seems to you that the researchers are following CBPR, so why should they have to modify their protocol? It seems like the IRB is just making the researchers do more work.]<first| (Click: ?first)[You are regretting your decision to stay silent, but then you hear the nonscientific member asking the primary reviewer what seemed off about the researcher's description of their CBPR approach.]<second| (Click: ?second)[You realize your vote is important and resolve that, from this point forward, you will always ask questions when you have them.]<third| (Click: ?third)[You listen carefully to the reviewer's [[explanation ->CBPRLight]].]

You decide this is important enough to ask a question even if it means the meeting goes a little late. You [say,]<first| (Click: ?first)["You know, after thinking about this a little more, I wonder if we should ask for clarification instead? I mean, I am not an expert in Community Based Participatory Research, and so I guess I would like to know what you think is lacking in their description of how CBPR would be applied?]<second| (Click: ?second)[You continue, "I see that they are taking a partnership approach and working with community advisory groups. What's missing?"]<third| (Click: ?third)[You look around the table. Several members smile or nod their heads. No one is bothered by your question.]<fourth| (click: ?fourth)[[[The community member says... ->CBPRLight]]]

["We might be tempted to say, well, what they are describing is close enough, but we really should make sure that the protocols are accurate."]<first| (Click: ?first)["Community Based Participatory Reasearch, or CBPR, is a partnership approach to research in communities that puts a strong emphasis on REAL community participation. And, this participation starts from the very beginning of the project."]<second| (click: ?second)[The nonscientific member interjected, saying, "But the researchers are involving the community from the beginning of the project by using the Community Readiness Assessment."]<third| (click: ?third)["That is true, but the researchers are assessing the communities' readiness to confront a health problem that the //researchers// have identified. The research problem should really be selected by the community. In this case, it seems like the researcher is coming along and saying, 'Hey, I want to do research on STDs in diverse communities with "at-risk-youth," and yours looks good to me!']<fourth| (Click: ?fourth)["On top of that, the researchers have identified an intervention ahead of time and are offering to implement that intervention, with some modification, rather than developing a culturally appropriate intervention through an equitable partnership with the community. I don't think their assertion that because the curriculum worked well in an urban, Latino population it is a culturally appropriate intervention for Amerian Indian kids from different communities."]<fifth| (Click: ?fifth)[The community member made a strong argument. Most of the members seem to accept this argument. You decide that, after more consideration, you:]<sixth| (Click: ?sixth)[[[Agree ->AgreeAndEnd]] (link: "Just don't agree.") [(goto: (either: "JustDoNotAgree", "JustDoNotAgreeHarass"))]]

You look at the nonaffiliated member and [say,]<first| (Click: ?first)["Don't get me wrong, I think this research is very important and could benefit the communities, but at the same time there are some other issues with the protocol. The researchers do not explain what CAP is until severalpages into the protocol - CAP is the acronym for community advisory panels - that should be explained in the beginning. That is just a small issue, but it is something that should be corrected.]<second| (Click: ?second)["I am also concerned that the citations do not match the references, and that the researchers took some pretty big liberties in how they described the curriculum. This protocol is the foundation for the research and we should make sure it is done right."]<third| (Click: ?third)[The nonaffiliated member listened to your argument. Then you...]<fourth| (Click: ?fourth)[(display: "sidearrow")   [[make a decision. ->AskQuestionCBPR1]]]

You decide to ask your question. You [say,]<first| (Click: ?first)["I agree with you that this research is very important. I am not an expert in CBPR, and so I guess I would like to know what is wrong with their description of how it would be applied? I am not ready to approve this protocol just yet, but I wonder if we should consider asking for clarification instead of modification?"]<second| (Click: ?second)[The nonaffiliated member nods his head, and flips through the papers in front of him. Then]<third| (Click: ?third)[[[the community member says... ->CBPRLight]]]

You decide to [build on your initial argument:]<first| (Click: ?first)["Look, maybe they don't have a lot of experience writing protocols for research involving CBPR and don't know what we are looking for in the review. But they are clearly pursuing participatory action research, they are trying to show respect for the communities and the culture, and they intend to share the knowledge produced.]<second| (Click: ?second)["This research could really benefit the community, and I don't think holding them up for further review over this CBPR thing is necessary."]<third| (Click: ?third)[When you finish making your argument, you feel good. You think to yourself, science is science, and this is an //evidence-based curriculum.// It just isn't that complicated.]<fourth| (Click: ?fourth)[You direct your attention to the primary reviewer who is about to [[respond]].]

[You decide to take a step back and ask a question to get the conversation going in a positive direction.]<first| (Click: ?first)[You say, "I guess I just don't see this as a big problem. What am I missing?"]<second| (Click: ?second)[[[Then... ->respond]]]

The community member in charge of the review responded, [saying:]<first| (Click: ?first)["It isn't just about the CBPR thing. There are multiple issues with this protocol, and a lot of the issues have to do with it not acknowledging the potential cultural impacts that an intervention like this can have on the students and the communities."]<second| (Click: ?second)[You think about this for a minute, and you decide that you:]<third| (Click: ?third)[[[agree ->AgreeAndEnd]] [[disagree ->Disagree]]]

[You realize that you agree with the reviewer - there are quite a few issues with the protocol that require the attention of the researchers. You think about how many different perspectives there are in research and, especially in regards to cultural issues. Thinking about research in terms of the potential community impacts is complicated, and sometimes recommendations go against your initial impressions.]<first| (Click: ?first)[But you are learning how to look at a protocol from the perspective of multiple stakeholders, and you feel more comfortable with the process with every protocol you review as part of the tribal IRB.]<second| (Click: ?second)[The Chair calls for the vote, and you vote to request modifications to the protocol.]<third| (Click: ?third)[<center>[[The End->TheEnd]]</c>]

You think about it and you just can't understand what the community member is talking about. You [say,]<first| (Click: ?first)["But the //entire// point of this protocol is to adapt this evidence-based curriculum and make it culturally appropriate! I don't know how you can argue that they are not focussing on the cultural impact that this intervention will have on the participants"]<second| (Click: ?second)[The community member responds, saying: "If you think about it, half of the population of some of these communities might be Catholic, in which case, implementing an intervention that has as its objective increased use of condoms by teenagers might not be culturally appropriate..."]<third| (Click: ?third)[Just then the nonscientific member jumped into the conversation and said, "Teenagers are going to engage in sexual behavior - we can't bury our heads in the sand and blame it on culture!"]<fourth| (Click: ?fourth)[As you listen to the conversation, you feel like you agree with the nonscientific member's argument, but then the Chair, responds to her. You listen to the Chair's [[response.->ChairSaysSomething]]]

The Chair responded to the nonscientific member, [saying: ]<first| (Click: ?first)[That is an argument primarily focused on the individual. We should also take care to consider the benfits and risks to the communities. How might the research interventions support or erode their cultural values - Catholicism is just one example of how this kind of intervention can have an impact and just because a researcher says they want to do what is culturally appropriate doesn't mean they are doing that."]<second| (Click: ?second)[As the group considered the Chair's words, the nonaffiliated member chimed in:]<third| (Click: ?third)["You know, I am looking at the informed consent forms the researchers provided. You are right that the child assent forms didn't address potential cultural impacts or harms. I am also noticing that I don't see where the researchers define their partners - the ones they intend to share their research findings with."]<fourth| (Click: ?fourth)[After a little more discussion, the Chair asks if the committee is ready to vote on the protocol. You are still wondering about why the description of CBPR isn't good enough, and think you might want to ask your questions. Finally you decided to:]<fifth| (Click: ?fifth)[(display: "sidearrow")   [[ask about CBPR ->AskQuestionCBPR1]] (display: "sidearrow")   [[vote ->ReadyToVote]]]

[You decide that you have heard enough and are ready to move on.]<first| (Click: ?first)[When the IRB Chair calls for the vote, you decide to vote:]<second| (Click: ?second)[(display: "sidearrow")   [[In favor of requesting modifications ->AgreeAndEnd]] (display: "sidearrow")   (link: "Against requesting modifications") [(goto: (either: "JustDoNotAgree", "JustDoNotAgreeHarass"))]**&lrarr;**]

You decide to [ask a question:]<first| (Click: ?first)["I am not an expert in CBPR, and so I guess I would like to know what you think is lacking in their description of how it would be applied? What's missing?"]<second| (Click: ?second)[You wait for the primary reviewer to [[respond ->CBPRLight3]].]

[You just do not agree with the recommendation to request modifications. You express your intent to vote against that recommendation.]<first| (Click: ?first)[It was an awkward feeling, seeing the protocol differently from everyone else, but you appreciated that the other members did not try to pressure you to change your vote.]<second| (Click: ?second)[The Chair called for the vote and you voted against the recommendation.The vote was recorded as 4 in favor and 1 against.]<third| (Click: ?third)[<center>[[The End ->TheEnd]]</center>]

[You just do not agree with the recommendation to request modifications. You express your intent to vote against that recommendation.]<first| (Click: ?first)[You thought that would be the end of it, that you would vote and the meeting would move on, but that didn't happen.]<second| (Click: ?second)[Several of the members felt very strongly that the protocol required modification, and even though they had the votes they needed, they continued to try to convince you to change your mind.]<third| (Click: ?third)[You began to feel very uncomfortable until the Chair stepped in and reminded the other members that IRB members are not supposed to pressure each other to vote in any particular way.]<fourth| (Click: ?fourth)[It was an awkward feeling, seeing the protocol differently from everyone else, but you felt better when the Chair defended your right to vote the way you saw fit.]<fifth| (Click: ?fifth)[The Chair called for the vote and you voted against the recommendation. The vote was recorded as 4 in favor and 1 against.]<sixth| (Click: ?sixth)[<center>[[The End ->TheEnd]]</center>]

(display: "headercontent")(display: "menucode")<h3>The End</h3> Congratulations! You completed this online mock IRB meeting scenario! If you would like to try again, please click on a character below. You can select the same character you just had and make different decisions or you can select a different one and work through the meeting from a different point of view. ➤   [[Community Member ->CommunityMember]] ➤   [[Scientific Member ->ScientificMember]] ➤   [[Nonscientific Member ->NonScientificMember]] If you are finished, close this window.

The voice of the scientific member overcomes the nonscientific member and she addresses you, [saying,]<first| (click: ?first)["Based on your review, I can anticipate that you will recommend that we request clarification or modifications. I don't think we need to request either. I think it is clear that the researchers intend to work in partnership with the communities, and they will have community advisory panels.]<second| (click: ?second)[From my perspective, the informed consent documents are in good shape and the curriculum they intend to modify is an evidence-based curriculum that has been implemented in several diverse communities. I think we should vote to approve the protocol."]<third| (click: ?third)[The nonscientific member follows up, saying: "I think we should approve this protocol as well. We all know that teenagers are going to engage in sexual activity and we need to give them the tools they need to make better choices."]<fourth| (click: ?fourth)[The scientific and the nonscientific members seem to be in full agreement with each other. You feel a little less sure of yourself now. Do you...]<fifth| (click: ?fifth)[(display: "sidearrow")   [[change your recommendation ->GiveIn]] (display: "sidearrow")   (link: "defend your position") [(goto: (either: "ScientificDefense", "NonScientificDefense"))] **&lrarr;**]

The nonscientific member [says,]<first| (click: ?first)["I don't understand what you mean by 'the biggest concern is that the resesarchers think that a Western-based intervention is appropriate to use in all American Indian communities.' The researchers are using CBPR, and the communities will have multiple opportunities to include their suggestions in the adaptation of the curriculum."]<second| (click: ?second)[Your heart is beating a little fast. Making arguments to support your reviews still makes you a little bit nervous, especially when you know not everyone will agree with you.]<third| (click: ?third)[You say, "The researchers are taking a Western-based model for an intervention and making small changes to make the messaging and some of the materials more culturally appropriate. If they were really doing CBPR, they would be creating a curriculum that had at its foundation the community and cultural values and ways of knowing appropriate to each community in partnership with each community."]<fourth| (click: ?fourth)[You continue, "The communities serve an advisory role here but they don't have any real power to direct the research or design the intervention. They didn't even get to select the issue targeted by the research - the researchers came into the communities, told them that they had a problem, and told them what intervention they should adapt to do something about it."]<fifth| (click: ?fifth)[The nonscientific member responded, [[saying... ->NonScientificResponse]]]

You decide to change your recommendation. You trust the judgment of your fellow IRB members, and you think the scientific member probably knows more about research protocols than you do. As the discussion winds down, the Chair says, "Now that we have addressed any questions, [what is your recommendation?]<first| (click: ?first)[You say, "Well, I guess I recommend that we approve the protocol."]<second| (click: ?second)[The Chair gets a thoughtful expression and says, "I just want to point out, before we vote, that you are correct in your assertion that the research approach falls short of CBPR."]<third| (click: ?third)[You look around the room. You have no idea how the vote is going to go.]<fourth| (click: ?fourth)[The Chair calls for the vote and it is 3 to 2 against approving the protocol - the IRB will request modifications instead.]<fifth| (click: ?fifth)[<center>[[The End ->TheEnd]] </center>]

You aren't sure whose point to respond to first but you decide to answer the scientific member. You [say,]<first| (click: ?first) ["I can see that on the face of it, the protocol seems pretty straight forward. We might be tempted to say, well, what they are describing is close enough, but we really should make sure that the protocols accurately describe the research design.]<second| (click: ?second)["CBPR requires a real partnership with the community in which the researchers and the community have equal footing - it is not good enough for the researchers to say that the community can weigh in on how the curriculum is modified, but they don't have any power in the final decision. In CBPR the community would have selected the research problem and created a culturally appropriate intervention in collaboration with the researchers. That didn't happen here."]<third| (click: ?third)[The room was silent as the members thought over your argument. The Chair asks for your recommendation, and you recommend modifications.]<fourth| (click: ?fourth)[The members vote on your recommendation and it passes 5 to 0.]<fifth| (click: ?fifth)[<center>[[The End ->TheEnd]]</center>]

You decide to respond to the nonscientific member. You [say,]<first| (click: ?first)["I completely agree with you that we need to find the best way to give kids the tools they need to make good choices and protect their health and their future. I think research, and CBPR in particular, definitely has a role to play in that.]<second| (click: ?second)["That is why the way this study is set up concerns me. CBPR employs an assets-based approach. That means that it honors and builds on the strengths of the community. This study is based on a deficit model - from the very beginning it paints a negative picture of our American Indian youth. And even though it aims to create a culturally sensative curriculum, it doesn't really treat the culture as an asset. And it doesn't address any upstream factors which could serve to strengthen the culture and improve the decisions these students make."]<third| (click: ?third)[The nonscientific member says, "That sounds good, but I don't think it means we shouldn't approve this study. Overall, this protocol checks all the boxes in the criteria for approval. It could benefit the community with very little risk to the research participants so I think we should approve it."]<fourth| (click: ?fourth)[You aren't sure what to say. This member's mind seems to be made up.]<fifth| (click: ?fifth)[Then you [[say ->SecondThought]]]

...the IRB Chair says something that surprises you. The Chair [says,]<first| (click: ?first)["Well, we shouldn't be endorsing any kind of research. Our nonscientific member is very excited, but are there any other considerations we should think about before we move on to the vote?"]<second| (click: ?second)[You feel your face turn red. You realize you have let your personal interest in this kind of research influence your presentation. But, when you think about the protocol, you can't think of anything wrong with it. You smile and nod your head. Then you say,]<third| (click: ?third)["Yes, sorry, are there any questions?"]<fourth| (click: ?fourth)[The community member raises her hand slightly because she wants to say something. You can tell from her face that she does not share your point of view. The scientific member also wants to speak - you don't always agree with him. They both stop and look to you to decide who speaks first.]<fifth| (click: ?fifth)[You gesture to... [[the community member ->AngryCommunity]] [[the scientific member ->SupportiveScientific]]]

You take a deep breath and gesture to the community member. She seems irritated when she [says,]<first| (click: ?first)["I don't know how anyone would think this proposed protocol would be good for our communities.This protocol is riddled with problems. There is no way I would vote to approve it."]<second| (Click: ?second)[The scientific member interjects, "I don't see anything wrong with this protocol. Their methodology and data collection looks good. They are basing the intervention on an evidence-based intervention that has shown good results in diverse communities from Philidelphia to Oakland. They are building on a good foundation. And the statistics they cite in the background section are striking. This is a serious issue and this research will benefit the community."]<third| (click: ?third)[The community member responds, saying, "I disagree - even the consent forms state 'you may not benfit from this research.' And yes, this intervention has been used in diverse URBAN communities where the participants were primarily African American or Latino students who were attending alternative schools. The cultural context was completely different."]<fourth| (click: ?fourth)[You listen to the community member's objections but (link: "you totally disagree.") [(goto: (either: "TotallyDisagreePositive", "TotallyDisagreeNegative"))] **&lrarr;**]

You ask the scientific member what he wanted to say. He [says,]<first| (click: ?first)["Thanks. Putting our nonscientific member's excitement aside, this is a low-risk intervention. The primary goal of this intervention is to reduce the number of American Indian youth who have unprotected sex, which is associated with increased risk of HIV, STDs, and unplanned pregnancy. The researchers intend to incorporate culturally appropriate material and messaging into the curriculum and they will follow a CBPR approach in order to do it. This is an easy one - we should vote to approve it."*]<second| (click: ?second)[The community member responds, "But this isn't CBPR!"]<third| (click: ?third)["Sure it is," says the scientific member.]<fourth| (click: ?fourth)[The nonaffiliated member says, "I think this research is important, but I have to agree that this is not true CBPR."]<fifth| (click: ?fifth)[The scientific member says, I'm no expert on CBPR, but isn't it close enough? Whatever you call it, it seems to be a sound design, don't you think?"]<sixth| (Click: ?sixth)[(link: "You completely agree.") [(goto: (either: "CompletelyAgreePositive", "CompletelyAgreeNegative"))]**&lrarr;**]

(display: "headercontent")(display: "menucode")<H3>§ 46.111 Criteria for IRB approval of research.</h3> (a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied: (1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. (4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by § 46.116. (5) Informed consent will be appropriately documented, in accordance with, and to the extent required by § 46.117. (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

[You realize that you agree with the community member - there are quite a few issues with the protocol that require modification. Thinking about research in terms of the potential community impacts of a study design is complicated, and sometimes your initial impression is wrong.]<first| (Click: ?first)[But you are learning how to look at a protocol from the perspective of multiple stakeholders, and you feel more comfortable with the process with every protocol you review.]<second| (Click: ?second)[The Chair calls for the vote, and you recommend the board request modifications to the protocol. The board votes to request modifications by a vote of 5 to 0.]<third| (Click: ?third)[<center>[[The End->TheEnd]]</c>]

You decide to hear the community member out, [asking:]<first| (Click: ?first)["You said the protocol violated the principles of CBPR in multiple ways. Can you say more about that?" The community member looks relieved that you are listening to her and says,]<second| (Click: ?second)["Sure. I'd be happy to. In CBPR, the research problem should really be selected by the community it should be an issue of concern to the community. In this case, the researchers have identified an issue they want to research and the communities are really an after thought. On top of that, the researchers have identified an intervention ahead of time and are offering to implement that intervention, with some adaptation, rather than developing a culturally appropriate intervention through partnership with the community.]<third| (Click: ?third)[The community member continues, "If you'll notice, in this protocol, the researchers indicate that the three participant groups they have identified have 'expressed interest' in participating. Community Based Participatory Research is a time-intensive process that is focused on building trust and long term partnerships between researchers and communities - it doesn't seem like these researchers have spent much time in the communities at all.]<fourth| (Click: ?fourth)[While the research may be minimally risky, the protocol does not accurately describe their methods. We should request modification."]<fifth| (Click: ?fifth)[The IRB Chair asks for your recommendation. You...]<sixth| (Click: ?sixth)[[[Recommend modification ->Modification]] [[Recommend approval ->Approval]]]

[The community member made a strong argument in support of modifying the protocol so you recommend modification.]<first| (Click: ?first)[The Chair calls for the vote and the committee votes unanimously to request modification to the protocol.]<second| (Click: ?second)[<center>[[The End ->TheEnd]]</center>]

[Your conviction that the protocol meets the criteria for approval hasn't changed so you recommend approval.]<first| (Click: ?first)[The Chair calls for the vote and the committee votes 4 to 1 against approval, instead voting to request modification to the protocol.]<second| (Click: ?second)[<center>[[The End ->TheEnd]]</center>]

["Most of the boxes are checked, except the one that says that research should employ sound research design. If the researchers are misrepresenting the research design, then we should not approve the research."]<first| (click: ?first)[It seemed that no one was satisfied with the discussion. Some of the members wanted to approve the protocol, others wanted modification, another member suggested that they ask the researchers for clarification.]<second| (click: ?second)[Finally, it was decided that the IRB would invite the researchers to talk to the IRB and answer the questions that some of the members had about the proposed research. The IRB also concluded that it would be wise to have someone with more expertise in CBPR attend the next meeting so that they could sort out the issues.]<third| (click: ?third)[<center>[[The End ->TheEnd]]</center>]

The nonscientific member responded, [saying,]<first| (click: ?first)["This research is important and I think the benefit to the community of finding or creating interventions that will help students who are likely to make poor decisions and engage in risky behaviors is pretty significant."]<second| (click: ?second)[You respond, saying, "Of course it is important, but an intervention that strengthens community values and honors culture would have a greater impact on them in terms of making good choices!"]<third| (click: ?third)[The IRB Chair contributed to the discussion, saying: "I feel like we are moving more into personal opinions in this discussion. If there are no more questions about the protocol, what do you recommend?"]<fourth| (click:?fourth)[The discussion hasn't changed your mind at all. You recommend that the IRB request modification of the protocol. The Chair calls for the vote and your recommendation passes 3 to 2.]<fifth| (click: ?fifth)[<center>[[The End ->TheEnd]]</center>]

The community member looks thoughtfully around the table and [says,]<first| (Click: ?first)["As you all know, CBPR is a partnership approach to research in communities that puts a strong emphasis on //equitable// community participation. And, this participation starts from the very beginning of the project - really before the project."]<second| (Click: ?second)[You are trying to be patient but you can't help saying: "But the researchers are involving the community from the beginning of the project by using the Community Readiness Assessment."]<third| (Click: ?third)[The community member says, "That is true, but the researchers are assessing the communities' readiness to confront a health problem that the //researchers// have identified. The research problem should really be selected by the community. Rather than listening to the community about what they feel should be a research priority, the researcher is coming along and saying, 'I want to do research on risky sexual behavior in at-risk adolescents from culturally diverse communities like yours."]<fourth| (Click: ?fourth)[The community member continues, saying, "On top of that, the researchers have identified an intervention ahead of time and want to implement that intervention, with no modification in the first group and some modification in the second, rather than developing a culturally appropriate intervention through an equitable partnership with the community."]<fifth| (Click: ?fifth)[The community member made a strong argument. Most of the members seem to accept this argument. The Chair asks for your recommendation and you:]<sixth| (Click: ?sixth)[[[Recommend modification of the research protocol ->AgreeAndEnd]] [[Recommend approval of the research protocol ->DisagreeAndEnd]]]

[You just do not agree with the the community member. She seems to have made a strong enough argument to garner the support of the other committee members. You hold fast to your recommendation to approve the protocol.]<first| (Click: ?first)[The Chair calls for the vote and the vote was recorded as 4 against your recommendation and 1 in favor. A new motion was made to request modification to the protocol which passed 4 to 1.]<second| (Click: ?second)[It was an awkward feeling, seeing the protocol differently from everyone else, but in the end, you voted the way you felt most strongly about and you felt good about that.]<third| (Click: ?third)[<center>[[The End ->TheEnd]]</center>]

(display: "headercontent")(display: "menucode")<h3>Full Board Review</h3> Federal regulations require a convened IRB to review studies involving more than minimal risk. This review is called a Full Board Review. Days before the meeting, the board members spend a significant amount of time reviewing research protocols, informed consent forms, and other documents related to the research under review. Depending on the number of protocols on the agenda, each board member will be assigned to serve as the primary reviewer on a protocol. Being the primary reviewer means the member is responsible for presenting the protocol to the full board. This advanced preparation allows for careful consideration of each protocol and improves efficiency during the convened full board meeting. **So what happens at a Full Board Review?** At each meeting, the IRB Chair leads the members in a discussion of the minutes from the previous meeting and provides a report of the previous month’s non-Full Board activities. This is followed by new business which includes initial review of research protocols. For each review, the members of the IRB consider multiple issues including: informed consent, risk/benefit analysis, subject selection, privacy and confidentiality, scientific merit, costs and/or compensation to participants, and conflicts of interest. The IRB makes a determination on each review resulting in a Board Action for each protocol reviewed. This Mock IRB Meeting activity will focus on the Full Board Review of one mock research protocol. (display: "sidearrow")   [[Learn more about IRB meeting procedures ->IRBMeetingProcedure]] (display: "sidearrow")   [[Next Section: Mock IRB Research Protocol ->MockProtocol]].

<h2>**SOUTHWEST TRIBAL INSTITUTIONAL REVIEW BOARD**</h2>

<div id="menu">(display: "AAIHBLOGO")  (display: "sidearrow")   [[Home ->MockIRBMeeting]]  (display: "sidearrow")   [[Navigation ->Navigation]]  (display: "sidearrow")   [[Full Board Review ->FullBoardReview]]  (display: "sidearrow")   [[Meeting Procedure ->IRBMeetingProcedure]]  (display: "sidearrow")   [[Mock Protocol ->MockProtocol]]  (display: "sidearrow")   [[Mock IRB Profiles ->MockIRBParticipants]] </div>

The community member responds, [saying:]<first| (Click: ?first)["We might be tempted to say, well, what they are describing is close enough, but we really should make sure that the protocols are accurate," explained the primary reviewer.]<second| (Click: ?second)["CBPR is a partnership approach to research in communities that puts a strong emphasis on real community participation. And, this participation starts from the very beginning of the project."]<third| (Click: ?third)[The nonscientific member interjected, saying, "But the researchers are involving the community from the beginning of the project by using the Community Readiness Assessment."]<fourth| (Click: ?fourth)["That is true," the community member responded, "but the researchers are assessing the communities' readiness to confront a health problem that the researchers have identified. The research problem should really be selected by the community. And really, I don't think that assessment is culturally appropriate either."]<fifth| (Click: ?fifth)[The community member continues, [[saying ->CBPRLIGHT3]]]

[You present your review, starting with the facts of the study:]<first| (click: ?first)[“This is a study which proposes to decrease STDs in at risk Native American youth. The researchers want to use a Community Based Participatory Research (CBPR) approach to modify an existing curriculum that has been shown to be effective in other settings and contexts, and they think it would be appropriate to use with American Indians.]<second| (click: ?second)["There are three groups that will need to provide informed consent: a group that pilots the existing curriculum, an advisory group that will provide feedback and suggestions for curriculum modification, and a third group that pilots the modified curriculum. The proposed research will take place in two tribal communities and at the Los Altos school in Santa Fe.”]<third| (click: ?third) [[[Continue ->CommunityMember2]]]

["On top of that, the researchers have identified an intervention ahead of time and are offering to implement that intervention, with some modification, rather than developing a culturally appropriate intervention through an equitable partnership with the community.]<first| (Click: ?first)["I don't think their assertion that because the curriculum worked well in an urban, Latino population it is a culturally appropriate intervention for Amerian Indian kids from different communities."]<second| (Click: ?second)[The community member made a strong argument. Most of the members seem to accept this argument.]<third| (Click: ?third)[You decide that, after more consideration, you: [[Agree ->AgreeAndEnd]] (link: "Just don't agree") [(goto: (either: "JustDoNotAgree", "JustDoNotAgreeHarass"))] **&lrarr;**]

<div id="menu">(display: "AAIHBLOGO") </div>

(display: "headercontent")(display: "menucode")<h3>Navigating the Mock IRB Meeting</h3> Once you have selected your character, you will enter the mock IRB scenario. You will be presented with details about what your character is doing, thinking, and saying. The descriptions are presented in small installments of text. See the image below. (display: "Instructions") Click on text that appears bold (and turns turqoise when you move your mouse over it) to move on to the next installment. Once you click on bolded text, it will turn back to a plain text appearance. Once you have made your way to the end of the passage, you will see a link or links that allow you to make a choice about where the story goes, or you will simply continue to a predetermined passage.