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Results: Genetic research offers both benefits and harms to our pediatric population. Consideration of their use as research participants requires that we pay respect to their collective best interests as well as individual rights. Risks and benefits have to be weighed against not only their present vulnerable dependence, but also over their future decades of life. While patients and families perceive their decisions to be independent and fully informed, overt gaps relating to their protection as research participants have been identified. As a result, we have developed an internal policy that better defines our ethical obligations as researchers to pediatric participants of genome studies.


Perceptions of Benefits of Participating in HIV Treatment Clinical Trials

The study aimed to address the following objectives: a) To describe to what extent benefits of offered in a clinical trial influenced participants’ decision to participate in the research. b) To describe the types of benefits that participants expected to receive from the study. c) To investigate participants’ opinions on who should make decisions of what is offered as benefits in research and why. d) To make recommendations to the researchers and the regulating bodies about participants’ views on benefits of research so as to influence the decisionmaking purposes. An exploratory study was carried out to answer these questions. The study used a close-ended questionnaire on participants of an anti-retroviral treatment clinical trial. The questionnaire focused on the following areas: 1. Reasons/motivations for participation in research 2. Expectations on benefits before participation 3. Perceptions of benefits received in the study 4. Decisions made on benefits

Rosemary Musesengwa, MPH, CRA; Melody E. Phiri-Shana Medical Research Council of Zimbabwe

This basic questionnaire was intended to make it clear if participants had an opinion in these issues and if they were ready to be engaged in these types of discussions.

Problem Statement: A major issue arising from the literature is that research in developing countries should not be exploitative in nature, but should provide participants with benefits. Decisions about benefits of research are normally based on international guidelines, ethics committee decisions, and rarely on participants’ views. Given the limited empirical

Methods: A questionnaire was administered to 100 participants of a clinical trial to find out their views about what type of benefits they expected to receive and which ones, if any, influenced their decision to participate. Results: The participants of this study can be classified broadly as the “urban poor,” but are literate. Willingness n ove m b e r 7- 9 , b os t on , m as s ac hu s e t t s


Conclusions: Our findings highlight the need for more targeted interventions as part of pediatric consent for genome sequence studies, decisional support for patients and their families, and education of our staff on the necessary protections of the participants involved in this type of research. Our preliminary observations reflect consistent opinion among stakeholders that researchers have a dutiful obligation to: modify the consent documents to better address the unique needs of this patient population (10 minimum consent elements have been identified), take additional precautions during the consent process when dealing with families of children with potentially fatal and/ or progressive diseases, inform patients and their families about health implications that are significant and immediately actionable, prohibit full access to these data at least until the child reaches legal age of majority, honor requests made by mature adolescents, and to hold these duties at a higher level if the general practitioner or clinician is in frequent contact with the research participants. These collective guidelines may be useful to other institutions considering or currently conducting genomic research on children.

data documenting understanding and voluntariness in international research, studies need to be carried out to determine how participants in international research define benefits and which of the benefits they consider to influence their decisions to participate. A pilot study was carried out to explore the perceptions of participants in a clinical trial on the issue of benefits in research. The study sought to answer the following questions: 1. What are the reasons for people to participate in research? 2. What types of benefits do participants expect to receive when they volunteer for research? 3. What do participants think of the benefits they receive in studies? 4. Who do participants think should make decisions on benefits of research?

2013 AER Conference Guide  

Digital version fo the Conference Guide for the 2013 Advancing Ethical Research Conference

2013 AER Conference Guide  

Digital version fo the Conference Guide for the 2013 Advancing Ethical Research Conference