Government Policy Experiments and Informed Consent

2018 ◽  
Vol 12 (2) ◽  
pp. 188-201 ◽  
Author(s):  
Douglas MacKay ◽  
Averi Chakrabarti

Abstract Governments are increasingly making use of field experiments to evaluate policy interventions in the spheres of education, public health and welfare. However, the research ethics literature is largely focused on the clinical context, leaving investigators, institutional review boards and government agencies with few resources to draw on to address the ethical questions they face regarding such experiments. In this article, we aim to help address this problem, investigating the conditions under which informed consent is required for ethical policy research conducted or authorized by government. We argue that investigators need not secure participants' informed consent when conducting government policy experiments if: (i) the government institution conducting or authorizing the experiment possesses a right to rule over the spheres of policy targeted by the research; and (ii) data collection does not involve the violation of participants' autonomy rights.

Author(s):  
Jacob Szpernal ◽  
Joseph Carroll ◽  
Ryan Spellecy ◽  
Jane A. Bachman Groth

Standards in pupil dilation practices regarding the safety of human subjects are not present in vision research despite the potential for significant adverse effects. We developed two surveys to examine current practices around pupil dilation among vision researchers and individuals associated with oversight of human subjects research. While both groups note an absence of adverse events associated with pupil dilation, vision researcher practices differed with informed consent use and measures taken to minimize complications. For Institutional Review Boards, general risk assumption associated with dilation was not unanimous and there was a lack of specific guidance available to researchers for minimizing risk. These results uncover the need for standardized practices regarding pupil dilation in human subjects research.


Author(s):  
Christian B. Ramers

Ethics and conflicts of interest are important considerations when planning and carrying out research. It is the role of the institutional review board to weigh these against protection of the research subject when evaluating research proposals. The ethical considerations when performing research include basic ethical principles (e.g., autonomy, confidentiality, non-maleficence, informed consent, beneficence, justice, and utility), as well as nuances such as appropriate study designs, investigator conflict of interests, and bias in all its forms. To help guide clinicians, a number of professional and governmental organizations have published guidelines and recommendations on various aspects of clinical research (e.g., the American Medical Association, the National Institutes of Health, and the US Food and Drug Administration).


2015 ◽  
Vol 23 (4) ◽  
pp. 455-464 ◽  
Author(s):  
Christine Øye ◽  
Nelli Øvre Sørensen ◽  
Stinne Glasdam

Background: The increase in medical ethical regulations and bureaucracy handled by institutional review boards and healthcare institutions puts the researchers using qualitative methods in a challenging position. Method: Based on three different cases from three different research studies, the article explores and discusses research ethical dilemmas. Objectives and ethical considerations: First, and especially, the article addresses the challenges for gatekeepers who influence the informant’s decisions to participate in research. Second, the article addresses the challenges in following research ethical guidelines related to informed consent and doing no harm. Third, the article argues for the importance of having research ethical guidelines and review boards to question and discuss the possible ethical dilemmas that occur in qualitative research. Discussion and conclusion: Research ethics must be understood in qualitative research as relational, situational, and emerging. That is, that focus on ethical issues and dilemmas has to be paid attention on the spot and not only at the desktop.


1994 ◽  
Vol 3 (4) ◽  
pp. 510-521 ◽  
Author(s):  
William L. Freeman

The mission of the Indian Health Service (IHS) affects what research is done and how It is reviewed and managed and in turn affects the forms and process used to obtain informed consent. Consent forms must be Informative and understandable to American Indian and Alaska Native (AI/AN) potential volunteers; the process used to obtain informed consent must minimize any institutional pressure to participate. The IHS Institutional Review Boards (IRBs) developed seven research Model Volunteer Consent Forms (available from the author).


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