Langston University Ethical Issues in Research on Children Psychology Essay

Langston University Ethical Issues in Research on Children Psychology Essay

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GENERAL GUIDELINES Any social research on children and adolescents in development psychology must go through stringent protocols and rules as well as have a high standard of social responsibility. Below are some of the Key Responsibilities of Investigators for the Ethical Conduct of Research Involving Infants, Children, and Adolescents (Federman, D. D., Hanna, K. E., & Rodriguez, L. L, 2003): • • • • • • • • • • • • Achieve and maintain appropriate training, credentials, and skills to perform or supervise all clinical and research procedures required for a study that includes children. Achieve and maintain appropriate training and knowledge to meet the ethical and regulatory requirements for conducting research that includes children. Ensure that research protocols involving children conform to ethical and scientific standards for such research. Submit proposals and proposal amendments for scientific and ethical review and approval before beginning or modifying research and as required, during the course of research. Conduct the study in accord with the approved protocol. Disclose potential conflicts of interest to appropriate parties. Ensure that the processes for securing parents’ permission and children’s assent to research participation meet ethical and regulatory standards and are effective and active through the duration of the study. Provide rationale and propose appropriate protections consistent with federal and state laws if a waiver of parent permission is sought. Communicate with children participating in research in developmentally appropriate ways and with guidance from their parents about what will happen to them throughout the course of the research. Support appropriate safety monitoring and reporting of adverse events. Report protocol violations, errors, and problems as required to research sponsors, regulators, or IRBs. Disclose research results to the scientific community and the public. Communicate research results, as appropriate, to research participants or participant communities. (Adapted from IOM, Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: National Academy Press): The above are general guidelines for conducting research when using children as subjects; but there may be some extra considerations in gender development research that may relate to the social environment of a child or possible emotional impact in future. This week, you will consider such considerations using two of the above criteria and applying it to the gender research. Reference: Federman, D. D., Hanna, K. E., & Rodriguez, L. L. (2003). Responsible research. [electronic resource]: A systems approach to protecting research participants. Washington, DC: National Academies Press. Ethical Issues in Research on Children One of the most common ethical concerns in research is related to the dilemma of using children as subjects, because young children are one of the most vulnerable groups who are open to exploitation by adults.1 It is imperative that nurse researchers appraise themselves of their research obligations when considering the ethical issues of their subjects or participants, whether adults, adolescents or children. Importantly, nurses and other health professionals should always consider the additional issues and research requirements involved in gaining consent or involving children or adolescents in their studies. This editorial will explore some issues related to ethical principles and practice about this to help avoid research misconduct with children. Historically, research in children before and during the World War II was marked by unethical practices in Europe and Asia. For example, in a study at Kobe Medical School in Japan in 1958, infants were used as “objects” in clinical experiments, without parental consent, to identify the best density of lactose in artificial milk. A small gastric plastic tube was inserted into the infants’ gastrointestinal tract to analyze the gastric content along the tract after feeding with various milk formulas. A number of babies in the study suffered from high fever, diarrhea, and vomiting2. In another example, in 1952 infants of the Nagoya City Infant Nursery in Japan were inoculated with coliform bacillus, resulting in severe diarrhea among the babies, and death.2 During WWII, twin children in Nazi concentration camps were subjected to cruel experimental studies, e.g. injection of different dyes into eyes to change the color of their eyes.3,4 In the Nazi Neuengamme Camp in Germany, children were deliberately infected with tuberculosis and later killed after the experiment.3 Therefore, following the Nuremberg Trials after the WWII, some of the medical researchers involved were punished and the world medical community urged for ethical principles for research. Ethical research among children was also reinforced. Gradually in a number of countries, a paradigm shift began to occur, where children became viewed as “subjects” rather than “objects” in research. However today, ethical issues still exist in many countries,5 including Thailand, where ethical review committees (or institutional review boards) for human research are not established in many places across the country, and there is a dearth of both experts with experience and knowledge in both adult and child research ethics. However, Thailand is now in the final process to enact a new law requiring all human research to be approved by standard Ethical Review Committee.6 There have been a number of statements of ethical principles produced over the years for example, The Declaration of Helsinki7 and The Belmont Report8. In 1964, The World Medical Association developed a set of ethical principles for medical research, The Declaration of Helsinki, consisting of 32 items, and which has become the foundation of human ethics for research across the world.7 This Declaration recognizes the vital significance of medical research to advance understanding and development of medical interventions. But it is the researcher’s duty to promote and safeguard the health, wellbeing and human rights of their human subjects. It is therefore important to weigh up and evaluate the potential risks, burden or benefit of the research to the subjects. Only if the benefit(s) of a study is greater than the risks, it is acceptable.7 Later in 1977, the National Commission of the Protection of Human Subjects of Biomedical Behavioral Research in the USA produced the Belmont Report, which had three core principles: a) respect of persons Vol. 20 No. 4 271 (autonomy protection), b) beneficence (do no harm and maximize benefit), and c) justice (no bias for risk and benefit).8 These three principles can apply to research in both adults and children. 1. Respect for persons. The two requirements are that the researcher should a) respect the autonomy of subjects, and b) protect those with diminished autonomy. In respect of autonomy, it is required that any subject needs to enter into any investigation process voluntarily and with adequate information from the researcher. Parental consent/permission for children aged below 18 to participate in any research is also required. Children aged 7-18 are able to provide their assent in research participation.1 2. Beneficence. It is the obligation of the researcher to secure the health and wellbeing of the subjects by: a) doing no harm and b) maximizing possible benefits and minimizing possible harms. Throughout the research, the researcher should have carefully thought in advance of any possible risk or discomfort that might occur and plan ahead to prevent them. Emergency care or alleviating measures should be planned in advance. In most clinical trials trying to find effective treatments for pediatric illnesses, the subjects themselves may not directly gain benefit from the experimental research, but hopefully this will further benefit the future advancement of knowledge for treating illness in the future.1,9 3. Justice. – Questions to ask in terms of this are: Who will gain benefit and who bear the risk/burden? Why are the children subjects? Why not adults? What are reasons to justify the need for study? Are the subjects treated equally? It is critical that the burdens and benefits should be equally distributed with respect to the merit of a study.9 Children’s autonomy and the assent form The autonomy of subjects can be better ensured by providing informed consent and informing them they can withdraw from the study without any negative consequences from the researchers. Parents and caregivers are important persons for researchers to involve, for they need to grant permission for studies on their children. The researcher needs to try to gain children’s active agreement using an assent form and passive agreement using a consent form signed parent(s) or caregiver(s). For passive agreement or permission, the researchers should provide parents with clear and understandable information about their research in order to try to gain truly informed consent. Older children are able to actively explore the information provided by the researchers and express their wish as to whether to participate.9 The child and adolescent permission form, the so-called assent form, is used among children aged 12 and above, as their normal cognitive ability is at formal operational stage. The process of getting assent from children needs to include: 1. Giving content about the research activities, offering information as appropriate to their age and reading ability. 2. Avoiding medical/technical terms that unfamiliar to them. Pictures and user-friendly language for explanation is recommended. 3. Providing in writing the necessary information about research background, process, risk and benefit of the study and persons to contact (addresses and telephone numbers of both researchers and a contact person within the ethical review committee should be given). 4. Avoiding coercion and informing them that if they want, they can withdraw from the study at any time without negative effect on their usual service such as health care or education processes. 5. Allowing sufficient time for parent(s) or caregiver(s), and children to make a decision as to whether to join the study. 272 Pacific Rim Int J Nurs Res • October – December 2016 6. Inviting any questions before, during, and after the study period. 7. Inviting parents to stay with children when administering drugs or other interventions. 8. When children understand and are willing to participate, with the permission of their parents, they are invited to sign their name.1,10,11 Parental permission or informed consent can be waived in cases of research: 1. Involving child protection, such as dealing with child abuse, child neglect, and domestic violence; or 2. Where, the privacy of the child or adolescent can be violated.11 For example, when parents are asked to give permission in studies about drug use or sexual behaviors in adolescents, most parents will scrutinize their child’s behaviors. This can cause a violation of privacy and make adolescents feel uncomfortable and not provide the truth about the topic to the researcher. Ethical issues in research designs Various research situations/designs may raise concerns in research on children. For example: Clinical trials: When children are subjects of invasive treatment, researchers should carefully consider the risks of such treatment. For example, what is a safe dose for a new drug experiment? How much blood can be taken from children? According to Howie in the WHO Bulletin, the maximum allowable blood volume in healthy children is 0.8-4.0 ml./kg. of body weight within 24 hour and less than 8 ml./kg. within 4-8 weeks. In sick children, it is
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