Objective Some researchers claim that the quality of informed consent of clinical research participants in developing countries is worse than in developed countries. To evaluate this assumption, we reviewed the available data on the quality of consent in both settings. Methods We conducted a comprehensive PubMed search, examined bibliographies and literature reviews, and consulted with international experts on informed consent in order to identify studies published from 1966 to 2010 that used quantitative methods, surveyed participants or parents of paediatric participants in actual trials, assessed comprehension and/or voluntariness, and did not involve testing particular consent interventions. Forty-seven studies met these criteria. We compared data about participant comprehension and voluntariness. The paucity of data and variation in study methodology limit comparison and preclude statistical aggregation of the data. Results and Discussion This review shows that the assertion that informed consent is worse in developing countries than in developed countries is a simplification of a complex picture. Despite the limitations of comparison, the data suggest that: (1) comprehension of study information varies among participants in both developed and developing countries, and comprehension of randomisation and placebo controlled designs is poorer than comprehension of other aspects of trials in both settings; and (2) participants in developing countries appear to be less likely than those in developed countries to say they can refuse participation in or withdraw from a trial, and are more likely to worry about the consequences of refusal or withdrawal.

Recruitment is a challenge for many biomedical research studies with human participants. Strategies to increase the speed and ease of recruitment are therefore valuable. One way to improve these strategies is to design them so as to make use of other factors that play a role in potential participants’ decisions. In this paper, we analyze the noncoercive ways in which researchers can use knowledge about the decision‐making tendencies of potential participants in order to motivate them to consent to research enrollment. We identify which modes of influence preserve respect for participants’ autonomy and which disrespect autonomy, applying the umbrella term “manipulation” to the latter. We then apply our analysis to a series of cases adapted from the experiences of clinical researchers in order to develop a framework for thinking through the ethics of manipulating people into research participation. All manipulation disrespects autonomy and is therefore pro tanto wrong. However, only deceptive manipulation invalidates the consent that results from it. Use of the other forms of manipulation can be permissible, but only if the outcome of using manipulation is sufficiently good, and the research cannot be carried out using ethically preferable means to obtain consent.

As analytic tools for genomic sequencing improve, biomedical research will increasingly use this method to draw inferences based on comparisons between the genetic data of a set of individuals thought to be related to each other. Cases in which genomic sequencing will be very useful include those in which a child has a rare or undiagnosed disease that might have an underlying genetic etiology. Researchers will be able to sequence the pediatric proband and both parents to compare their genomes in hopes of finding novel variants that point toward a diagnosis and perhaps to treatment. However, researchers are sure to discover that, in a growing number of cases, the assumed biological relationships between the individuals do not actually exist. Consequently, they will have to grapple with decisions about whether to return incidental findings of misattributed genetic parentage on a much larger scale than ever before. While we make no normative claims about whether individuals ought to value genetic relationships, the disclosure of information about misattributed parentage has the potential to affect familial relationships and notions of personal identity in many ways. Researchers need a decision‐making framework about disclosing this information that accounts for nonclinical factors alongside factors that the incidental findings literature already emphasizes as relevant. We argue that nondisclosure should be the default position for researchers. We begin by assessing the limited guidance that can be found in the literature on incidental research findings and on disclosure of misattributed parentage in the clinical setting. We then sketch the normative argument that underlies our position, providing a taxonomy of the possible harms and benefits of disclosure. We close by considering three objections: that nondisclosure may cause false beliefs in participants, that researchers may have relationships of trust with their participants that entail a duty to disclose, and that participant preferences should be solicited and followed. We close by suggesting ways in which the consent process could minimize possible harms related to nondisclosure.