Research on Community Engagement: Principles and Practices

Community engagement has been a mainstay of research in the HIV/AIDS arena. However, continuing challenges exist in implementing effective strategies for community engagement while keeping up with the rapid pace of research and changes in technology and public health practice. Community Advisory Boards (CABs) have served a critical function in providing input to researchers and sponsors about community perspectives on research, yet community engagement efforts need to be broader and more diverse to effectively address the multiple challenges of education, communication and dialogue about complex research and public health issues.

Projects to address community engagement could include, but are not limited to, the following:

Assessment of community perceptions and understanding of research programs; including disagreements or conflicts within communities around research or public health issues, if any; developing interventions to improve communication and understanding at the community level;

Assessment of the role of community engagement existing strategies and interventions in collaborative research including rationale, experience, effectiveness and lessons learned; assessing benefits and burdens of community engagement;

Designing and evaluating new community engagement interventions; developing strategies to ensure that minority voices or views in communities are heard, or strategies to activate community representation in settings where no representative structures exist; and exploration of CAB alternatives;

Developing tools and strategies for measuring benefits and burdens of research at the community level; ethical analysis of appropriateness of benefits of burdens in different kinds of community settings;

Developing and testing mechanisms for carrying out community based participatory research (CBPR).

Ethics of Research Involving Adolescents and Young Adults

Care and treatment efforts for HIV-infected adolescents and young adults in the US and around the world as well as prevention efforts for those at risk of infection are compromised by a lack of rigorous clinical trial evidence to support management approaches and treatment choices. A vast proportion of biomedical interventions and therapies used in these populations are implemented in the absence of specific data to support indications for their use and are often justified by extrapolation from studies in much older adult populations. Substantial biomedical and psychosocial data suggest that adolescents are simply not smaller adults and that such dogmatic approaches result in less than optimal care.

Investigators frequently encounter a variety of difficulties in working with youth which create a disincentive to carry out research in these populations, such as individual factors (non-adherence, risk behaviors and other psychosocial challenges) and structural barriers (ethical, legal and regulatory issues). There have been important milestones achieved in HIV prevention and treatment; however, concerns about adherence problems in youth are barriers to their implementation in this group. There is an urgent need for primary and secondary prevention among youth populations who are at high risk of acquisition or transmission of HIV, both globally and domestically. An adolescent’s evolving autonomy, decisional capacity and individuality argues for a right to independence and self-determination when it comes to their health care. However, there are ethical, legal and regulatory considerations that vary by jurisdiction and geography which impact these rights and create obstacles to research and health care. Projects to address issues related to adolescents in research could include, but are not limited to, the following:

Conceptual and empirical work on issues of evolving adolescent autonomy, decisional capacity, consent, assent and parental permission, particularly in regard to youth at risk for HIV infection and other STDs in the US and in other countries;

Analysis of legal provisions for protection of confidentiality of minors and for rights to self-determination and decision-making by adolescents about participation in research; analysis of these legal and ethical issues in various research settings. Relevant research contexts include research on mood disorders, sexual behaviors, and substance use, as well as other potential risk determinants for HIV acquisition, such as homelessness, incarceration, truancy, and other circumstances and conditions;

Projects to gather and analyze biomedical, behavioral and other psychosocial data related to adolescents and young adults to create a scientific and ethical framework for analyzing risks and benefits of research with youth; legal and ethical analysis of minimal risk standard for research as applied to adolescents.

Ethical Issues in Research on an HIV Cure

A new area in HIV research is the search for a means to eradicate the virus from the body—an HIV “cure.” While effective antiretroviral treatment has been hugely successful in reducing morbidity and mortality from HIV infection, the virus is never wholly eliminated from the body and patients must remain on lifelong treatment. The goal of cure research is to determine where and how the virus lies dormant and develop treatment algorithms that stimulate and eliminate virus reservoirs. A significant ethical challenge with this area of research is that early phase and translational trials will need to be conducted with relatively healthy HIV-infected patients. Specifically, risks and benefits of this type of research are difficult to assess, and patients may develop misconceptions about the likelihood of success. Projects addressing these issues could include the following:

Analysis of risks and benefits of HIV cure research to individuals and future patients, including social value of research for developing future biomedical interventions;

Developing mechanisms for stakeholder engagement and communication about ethical challenges in HIV cure research;

Learning from and applying ethical frameworks from early phase research in other disease areas; conducting comparative ethical analysis of early phase research in different settings.

Standards of Care and the Interaction of Statistics and Ethics in Clinical Trial Design

Ethical dilemmas in the choice of standard of care or prevention in clinical trials have been deep and enduring. Key considerations in clinical trials, such as the need to provide adequate benefit to trial participants, the need for research to be socially valuable and useful, the need for rigorous design that enables sound scientific inferences, and the need for efficiency, often result in difficult tradeoffs in trial design. Trial designs that maximize one important aspect may, to some extent, sacrifice others. Discussions of optimum design must include stakeholders with expertise in statistics, clinical medicine, health policy, and ethics. Interdisciplinary projects addressing standards of care or prevention could include the following:

Ethical and scientific analysis of current clinical trial design approaches to address changing standards of care in HIV prevention and treatment;

Conceptual research in bioethics addressing stakeholder obligations in standard of care dilemmas in HIV-related research;

Analysis of ethical and scientific advantages and disadvantages of innovative statistical methods and trial designs to HIV related research to address changing standards of care; methods for predicting value of different trial designs for decision making in clinical care and health policy; ethical and policy analysis of social value of different trial designs.

Effectiveness of Research Ethics Committee Review

The process of research ethics oversight by ethics committees and IRBs, a critical part of the ethical conduct of research, by necessity creates some burden on the research enterprise. It is essential to ensure that these review processes are effective and efficient. Multi-center clinical trials and international collaborative research projects pose particular challenges for ethics/IRB review. Some approaches include, but are not limited to, the following:

Developing methods for ongoing education and communication amongst IRBs, ethics committees and researchers about scientific developments and ethical challenges in HIV research;

Development of tools for the measurement of the effectiveness of ethics committees/IRB deliberations and substantive decision-making (as distinct from adherence to bureaucratic procedures), both in the US and in other countries;

Development of models for coordination and communication between and among IRBs and ethics committees, including shared or collaborative review processes, where appropriate, with particular focus on international collaborative research;

Programs to assess challenges, opinions and expectations of research ethics committees in international HIV/AIDS-related research and to develop tools to strengthen capacity and improve performance.

Ethical Issues in HIV Research Using New Forms of Technology

New technological developments or adoption of technologies in the research setting may raise ethical concerns relating to protection of research participants and their communities. For example, privacy and confidentiality concerns may arise in the context of internet research such as online recruitment or data collection. Use of technologies such as mobile communication devices and home testing kits could raise issues about communication of health information and complexities of family and partner relationships in the context of testing and disclosure. Worries about privacy and confidentiality may be particularly acute in HIV related research due to continued stigma and risk of social harms from disclosure of actual or presumed HIV status. Other new technologies, including biomedical technology as well as electronic tools, may pose new challenges for the ethical conduct of research. Projects to assess ethical issues arising in use of new technologies could include, but are not limited to, the following:

Empirical assessments and ethical analysis of documented harms and benefits associated with the use of new forms of technology in HIV research, including effects on individuals, communities, clinical practice, public health and science;

Development of best practices for minimizing risks, monitoring adverse events and social harms, or addressing these consequences as they arise when data are collected remotely using internet, mobile devices or other technology;

Research to determine best practices for ethics committees and IRBs, both in the US and in other countries, when providing oversight of research using newer forms of technology.

Research in Settings of Stigma, Discrimination and Oppression

There is widespread stigma, discrimination and oppression directed at men who have sex with men (MSM), sex workers, and intravenous drug users (IDU) throughout the world, which, beyond direct adverse effects on these groups, hampers HIV prevention, care and treatment efforts. For these groups, criminal sanctions exist in many countries and both the threat and reality of incarceration are widespread. Women and girls at risk for, or experiencing, violence or sexual abuse are at increased risk of HIV acquisition, and may face additional barriers in accessing appropriate care. In addition to these conditions, disclosure of HIV status continues to be a major challenge for people living with HIV around the world. Access to care and treatment, social support, coping, and prevention of transmission of HIV to others are all adversely affected by difficulties with HIV disclosure.

Projects addressing these issues could include, but are not limited to, the following:

Ethical analysis of potential obligations of stakeholders, including researchers and research sponsors, to address background conditions in the context of research studies with oppressed groups; development and assessment of training tools for investigators and research staff to promote appropriate and ethical conduct of research with vulnerable populations;

Analysis of risks and benefits of conducting research in these settings; determining ethical approaches to conducting research while minimizing risks of further harms; assessment of potential for research to contribute to, exacerbate, or alleviate inadvertent disclosure or stigma;

Gathering and analyzing information from stakeholders (patients, clinicians, researchers, ethics committees/IRBs, regulators) about ethical priorities and challenges in research with individuals living with HIV, or at high risk of HIV infection, facing stigma, discrimination, legal sanctions and/or interpersonal violence;

Use of rapid policy assessment and other analytic approaches to evaluate legal, economic or political barriers to research in settings of stigma or oppression; developing ethical and policy frameworks to appropriately guide research in difficult political contexts.

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