The role of community members in Research Ethics Committees.

The meeting was organized by Florencia Luna, Liliana Siede and Patricia Saidón  in FLACSO Argentina (Bioethics Program) on September 4th, 2012.

The meeting was coordinated by Prof. María Fernanda Sabio, and presentations were given by Lic. Alicia Lanzilotta1  and Lic. Leonardo Perelis.2 
    
Alicia Lanzilotta presented the results of a study conducted during 2011, entitled “Strategies for promoting the participation of community members in Research Ethics Committees in Argentina”.
The research problem that was considered in the study is the lack of guidance in both national and international guidelines,and regulations that regulate clinical research and the activity of Research Ethics Committees (REC) about the definition, characteristics, selection, and responsibilities of the community members (CMs) that participate in these committees. There are two additional considerations: first, there are very few resources for training CMs. Secondly, CMs are few in number and are not always representative of the community participating in the studies.
The hypothesis was that elaborating on the definition, characteristics, selection, responsibilities and training of a CM would minimise the gap between society and other actors in research, in order to better protect the interests of the research community.
In the first stage of the study, the concepts of “community” and “representation” were considered in the specific context of a REC.  Strictly considered, representation is a capacity that is granted to some person to act in place of another, based on some special mandate. The representant must do whatever she thinks is best for those she represents, making decisions on their behalf. However, in the REC context, the CM cannot be considered a representative in this strict sense, and should rather be considered as a representative member: the CM does not represent the community, but is a part of it.
Regarding the concept of community, a starting point is the definition provided in the Operational Guidelines for Ethics Committees That Review Biomedical Research of the World Health Organization (WHO 2011). The Guidelines differentiate between two aspects of communities: on the one hand, a community is a group of people who live in a same village, city, country, and are geographically close to one another. On the other hand, a community is a group of people who share values, interests or medical conditions.
The norms that rule biomedical research explain how to choose a CM, what characteristics she should have, whom she should represent and what her training should be. Although all the norms acknowledge the necessity of having a CM in the committee, the CM is only mentioned in the listing the REC members and in a very general way. The term “CM” does not appear in any of the glossaries. In the regional guidelines and regulations, such as those from Mexico, Brazil and Colombia, the definition of the term is a bit more elaborated, but not discussed extensively.
On the other hand, there is a striking difference between the guidance and the practice in RECs. In Latin America, civil society is hardly present in the research regulatory system, and this is clearly a key problem for the region. In order to explain the small amount of involvement in Argentina, we should address the typical inertia that leads to civic non-involvement on the one hand, and on the other hand, the way in which medical research has been appropriated by the scientific community, which understands it as an exclusive responsibility of its own. Thus, in the context of RECs, the community representative is usually regarded as a passive observer.
During the second stage of the study, data were collected from RECs in both public and private institutions in the city and province of Buenos Aires, with the aim of identifying the characteristics, forms of selection and purpose that CMs had in this specific context. Interviews were conducted, and the following questions were asked, among various others: What is a CM? What are the interests they represent? Are these particular interests or are they common with other CMs? Are there any limitations to the participation of CMs in RECs? If so, which are these limitations? What are the specific tasks of a CM in the evaluation of research protocols? Which tasks do other members of the REC have which cannot be carried out by a CM? Do CMs have any training in research ethics? Do you believe this training is important? Are there any kinds of power imbalances between the CMs and other members of the REC?
Interviews were taken in fourteen committees. The answers revealed several similarities. Generally speaking, the CM was considered as a person from outside the medical institution, a layperson, without any medical expertise. She represents the interests of the community and is responsible, together with the other members of the REC, for protecting the patients’ rights and security. Among the limitations a CM may have, some of the main problems were to avoid the professionalization of the layperson, and to keep the confidentiality of what was discussed during the REC’s meetings. It was also pointed out that the CM does not always have the time, means and training to allow her to fully and constantly participate in the REC’s activities.
The importance of CMs is not acknowledged within the RECs. In general, neither the hospital population nor the health teams know clearly what to expect from the CM. Some answers indicated that CMs have different tasks within the REC, and are not on a par with other committee members who are medical practitioners. About half of the answers pointed at CM’s different knowledge, in particular, knowledge about research methodology, which would affect the CM’s performance and functions in the REC. However, the vast majority of CMs from the studied RECs had been trained in research ethics and all but one answer reflected the importance of this kind of training. In general, it was considered that the most important topics to include in the training of CMs are the recognition of vulnerable populations, the evaluation of the research subject’s risk/benefit ratio, the reasons for conducting research in a certain population, the normative framework that regulates research, informed consent, conflict of interests, corruption in research, the particularities of research in developing countries and an understanding of what is involved during each stage of medical research, in particular, in the stages that involve human beings.
The results of the interviews confirmed that it is necessary to train the CMs, because of the binding character of the RECs’ decisions. However, the results also indicated that is necessary to achieve some sort of balance in order to avoid the over training of the laypersons and making the CM an expert in the subject, which would undermine the main reason for including her in the REC.

Leonardo Perelis’ presentation was entitled “What training in research ethics must a community member have?”, and was based on his own experience in training REC and Community Advisory Board (CAB) CMs.
A CAB is a group of persons from a community that has been specifically appointed by researchers to know the opinion of community members. Their areas of expertise range from methodology to a range of research and communication issues. CABs are located in research centers, in relation to some particular research. The main characteristic of CAB community members is that they are communicators, in charge of propagating information among their communities.
CABs are a requirement from the USA National Institutes of Health (NIH), which requires that every research centre has a group of people who belong to the research community and are trained to give their opinion about the study. Research networks that receive federal funds from the USA, such as the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) and the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), have had CABs for 8 years now.
When incorporating a new CM into a CAB, the main concern is that she shows interest: she must be a good listener, help others understand, be capable of working with others, and most importantly, she must believe that her individual action can bring a positive change in her community.
Within these research networks, and in the context of CABs, community refers to the collective of people who are involved in research. It is possible to think of a community in terms of geography, for example, as in Sub-Saharan Africa or Buenos Aires. But it is also possible to understand it as a collective, as when we refer to trans-sexual people or men who have sex with men. When CABs look for the opinion of communities, it is these kinds of collectives that they have in mind.
In the context of RECs, CMs have different characteristics. In this case, we tend to think of the community as the hospital’s population, and look for a CM who is related to such, for example, a patient or a patient’s relative. The CM must be interested in communicating with researchers and other members of the REC.What is expected from the CM is that she will be capable of evaluating the impact of research in the community in which it will take place. It is important to keep in mind that both in their function and composition RECs are different from CABs. For this reason, CMs have different characteristics in each of these committees. Nonetheless, there are some common aspects that can be discussed together.
A question that must be asked is if the CM looses her naiveté once she’s been trained. Although there is much debate about the right answer to this question, training CMs is of fundamental importance due to the value of their opinion. Being trained amounts to being capable of evaluating opinions and taking responsibility for their decisions. This is the spirit that guides the training of CMs: empowering people to give their opinion based on their reasons and values.
If CMs didn’t have any training, how valuable would their intervention be? Moreover, what value would it have for them to participate in the REC’s meetings?  What value would the participation of a person who is not capable of defending their interests have for the communities they are supposed to represent?
According to all this, a training schedule for CMs should have the following characteristics: allow a person to understand what research is about, recognize different research designs, identify the ethical issues involved, and recognize what is owed to the community. (Although there is a difference between the CMs of CABs and RECs, the training they should receive is, however, the same). The person would then be able to understand priorities in research, the value of informed consent, and the potential and real risks that the research can pose in the community.
The importance of training can be easily acknowledged after comparing the agenda of researchers and CMs. Striking differences were found in the agendas in a research network that aims at reducing vertical HIV transmission and improving the health of HIV positive children and pregnant women. On the one hand, researchers were trying to expand research to other countries with different treatment options, to reduce and reorganize research expenses, to develop safe reproduction methods for sero-discordant couples and to further investigate the pharmacovigilance, tolerance and pharmacokinetics of ARV medicines in pregnant women. The community, however, was more interested in school performance of children on ARV treatment, their cognitive development, lipodystrophies and treatment adherence in teenagers, and the long term consequences of medications. The concerns of the community are more concrete and arise on a day to day basis; they are more related to what happens here and now.
The participation of CMs in CABs and RECs is a recent phenomenon, even in other countries. Training and including CMs requires a fair amount of creativity and sensibility. The training proposed aimed at empowering people so that they can understand and better protect the rights of the communities they represent.

During the subsequent discussion, participants’ questions and comments centered on the following topics:

Representation
The difference between a representative member and a representant of the community came up again in relation to local RECs. How can heterogeneous communities such as the population of hospitals in Buenos Aires, or even the communities of patients with a similar medical condition, be faithfully represented by just one person? The CM, it was answered, does not represent such communities; she simply makes decisions for others. This is because of the limitations related to the selection of CMs: since the people who participate are usually the ones that want to do it, it is difficult to ensure that the CM will fill any pre-imposed conditions for community representation. But it is also due to the nature of hospital populations themselves which usually involve groups with dissimilar social, educational, and economic characteristics as well as differing ages, sexes, occupations, interests and needs.
In order to address this difficulty, it was suggested that RECs should have a permanent CM and other CMs specially invited to evaluate research protocols that require a more specific community representation. A successful example was cited: it was once used for evaluating a research protocol on voice changing treatment for transsexual persons. Currently, when transgender persons want to change their voices, their treatment requires a surgery and a process of voice training. The research proposed that surgery was not required and that voice training was enough.
Several problems arose in relation to the identification of research subjects, the loss of confidentiality, and specifically, about when to carry on the training, since most of the transsexual collective at the hospital were sex workers, available primarily on night shifts. Two transsexual persons were invited to the REC review because regular members were not competent to answer these questions.
However, although this might be a solution for some problems of representation, it was pointed out that it can be difficult to carry out in RECs that evaluate tens of very different protocols every year.

Training
There was wide agreement about the importance of training CMs, although some disagreements arose about the content of such training. First, some people claimed that training should contemplate the relevant laws that protect patients. However, although this information was considered relevant overall, it is not currently provided in the training programs that the lecturers presented, since it is assumed that the RECs are responsible for compliance to the law and to make sure that the patients’ rights are properly protected.
Another problem was raised in relation to excessive training, and it was acknowledged that increasing experience as a REC member could turn a CM into an expert in matters of health and research. In order to avoid this lost of spontaneity, the need to rotate the CM was emphasized.  However, although this is applicable to all members of RECs, in the case of CMs, rotation is more difficult because of the limited availability of people who could participate as CMs.

Selection
In practice, CMs in RECs are not selected according to any specific method, but are incorporated according to their interest and availability. The availability of suitable candidates is usually very limited. REC members ask the people they know if they want to participate in the REC and, if they find someone who is interested, the person is invited to participate.  
A person from the public voiced her concern about the bias involved in this form of selection. She explained that in the committee she belongs to, most CMs are people that have been previously involved in research and have, for this reason, some sort of connection with the researchers.
Another difficulty relating to the lack of clear proceedings for the inclusion of CMs arises from disagreement within the REC regarding the character of CMs. Since it is not clear what kind of person is required as a CM, the search for a suitable person becomes more difficult.
Taking these difficulties into account, public recruitment in the hospital was suggested as a way to reach a wider population. In order to do this, some open activities should take place in order to let the population learn about the REC and become interested in its work. However, there is no tradition of public participation in institutional decision-making that would facilitate the access of patients and other people to the REC.
It was also pointed out that there are some conditions for participation that make it difficult for some people to commit as CMs. Unlike other REC members who work at the hospital, CMs must come to the institution especially to participate in the REC meetings, and are not reimbursed for their time and other travel expenses.

Conditions of participation
Although the members of the REC who work at the hospital do not receive any special payments for their participation, part of their work time is devoted to the committee. In contrast, external members of the REC are not reimbursed for their time and commitment. The question of whether it is ethical to not pay CMs for their time or at least their travel expenses was raised.  
It also was pointed out that a greater involvement of CMs could make ethical evaluation more transparent and less corrupt. In some countries, for example in Northern Europe, the participation of CMs is much more important, reaching up to 50% of REC members.

Function
A protocol that is poorly designed is not necessarily good for the community. Shouldn’t the CM decide if the research is valuable for the community she belongs to? Shouldn’t she be able to recognize if there are other priorities that are not being addressed by the proposed research? Training seems to be currently centered on the needs of researchers and sponsors and not around the needs and interests of the community.
For this reason, it is necessary to decide what kind of knowledge should be expected from a CM. It was pointed out that training should centre on the communities’ interests rather than on research-related technicalities. CMs should know and defend the best interests of the community and evaluate research in the light of these interests. Someone pointed out that in some cases in Brazil, for example, the community directly monitors research and makes sure that there are real benefits for the community involved.
However, supposing that a CM can effectively defend the best interests of her community, doubts arouse about whether the rest of the REC members would endorse her opinion and prioritize her evaluations over other concerns, such as other economic concerns.
Empowering CMs and allowing them to be the community’s voice will be a long process and require a slow learning curve. For this reason, it is necessary to recognize the challenges and develop strategies to overcome them.  Community representation is a major human rights advance. When people organize and educate themselves, they are able to make research decisions that directly benefit them.
CMs not only have the ethical function of protecting patients’ rights and community interests. CMs can also contribute with suggestions about the design of a research protocol, for example, with suggestions about logistics on how to conduct the protocol in ways that will not be intrusive for patients.
The proposal of a Brazilian author was discussed, in which the author proposes to consider the subjects that participate in research as a community in its own right. Subjects can then communicate with each other and help each other, avoiding isolation and defending their interests as research participants.
Another issue that came up had to do with the requirement that the CM communicate with her community in order to ensure an active representation. How can such communication be achieved? In response to this concern, some reflections were made in relation to the understanding of community.

Community
On the one hand, differences were stressed between communities of patients that are highly informed and organized, such as epileptic or HIV patients, and other heterogeneous communities such as the population of a general hospital. In response to this, one participant argued that HIV is not in itself a unifying criterion. HIV positive people are a heterogeneous community as well, in terms of age, sex, occupation, economic situation, etc. She pointed out that CMs are not elected by their communities as representatives, but are selected by the REC members. In this way, they reflect the REC’s view of the community, rather than the view the community has of itself.
While a representative of a Native American tribe might emerge from the community itself, in the case of other communities, CMs are selected by the REC through proceedings that are not transparent and might represent the bias and prejudices of the people who are in charge of the selection.

1 Alicia Lanzilotta is a premanent Consultant of the Central Ethics Committee for Health Research from the Ministry of Health of the City of Buenos Aires and Member  of the Ad Hoc Committee of the National Committee for Health Research, from the National Ministry of Health.  
2 Leonardo Perelis is President of the Ethics Committee of the Ramos Mejía Hospital, Coordinador of Community Advisory Boards for the INSIGHT and IMPAACT NIH Networks in Latin America, and member of the Central Ethics Committee for Health Research from the Ministry of Health of the City of Buenos Aires.