Holly Fernandez Lynch

Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations

The use of social media as a recruitment tool for research with humans is increasing, and likely to continue to grow. Despite this, to date there has been no specific regulatory guidance and there has been little in the bioethics literature to guide investigators and institutional review boards (IRBs) faced with navigating the ethical issues such use raises. We begin to fill this gap by first defending a nonexceptionalist methodology for assessing social media recruitment; second, examining respect for privacy and investigator transparency as key norms governing social media recruitment; and, finally, analyzing three relatively novel aspects of social media recruitment: (i) the ethical significance of compliance with website “terms of use”; (ii) the ethics of recruiting from the online networks of research participants; and (iii) the ethical implications of online communication from and between participants. Two checklists aimed at guiding investigators and IRBs through the ethical issues are included as appendices.

The rights and wrongs of intentional exposure research: contextualising the Guatemala STD inoculation study

In its recent review of the US Public Health Service Sexually Transmitted Disease Inoculation Study, conducted in Guatemala from 1946 to 1948, the Presidential Commission for the Study of Bioethical Issues identified a number of egregious ethical violations, but failed to adequately address issues associated with the intentional exposure research design in particular. As a result, a common public misconception that the study was wrong because researchers purposefully infected their subjects has been left standing. In fact, human subjects have been exposed to disease pathogens for experimental purposes for centuries, and this study design remains an important scientific tool today. It shares key features with other types of widely accepted research on human subjects and can be conducted ethically, provided certain safeguards are implemented. That these safeguards were not implemented in Guatemala is what made that study wrong, rather than the fact of intentional exposure itself. To preserve public trust in the clinical research enterprise, this conclusion ought to be stated explicitly and emphasised.

Revised ‘Common Rule’ Shapes Protections For Research Participants

Investigators and institutions have begun to prepare for new federal protections of study participants set to take effect in 2018.

Confronting Biospecimen Exceptionalism in Proposed Revisions to the Common Rule

On September 8, 2015, the Department of Health and Human Services issued a Notice of Proposed Rule Making to revise the Federal Policy for the Protection of Human Subjects, widely known as the “Common Rule.” The NPRM proposes several changes to the current system, including a dramatic shift in the approach to secondary research using biospecimens and data. Under the current rules, it is relatively easy to use biospecimens and data for secondary research. This approach systematically facilitates secondary research with biospecimens and data, maximizing the capacity for substantial public benefit. However, it has been criticized as insufficiently protective of the privacy and autonomy interests of biospecimen and data sources. Thus, the NPRM proposes a more restrictive regime, although more so for biospecimens than data. Both the status quo and the NPRMs proposal are critically flawed.

Federal Right-to-Try Legislation — Threatening the FDA’s Public Health Mission

A bill passed by the Senate would sharply curtail the FDA’s oversight of access to investigational drugs. Although its impact would probably be limited, the motivation behind it threatens to weaken the FDA’s ability to pursue its public health mission.

Regulating Research with Biospecimens under the Revised Common Rule

Since 2011, the research community had waited with bated breath as regulators contemplated for the first time bringing secondary research with nonidentifiable biospecimens under the Common Rule and dramatically tightening the criteria for waiving consent to biospecimen research. After considerable pushback from both researchers and patients and amid rumors of intractable disagreement among Common Rule agencies, the Final Rule published on the last day of President Obamas administration left out these troubling changes, and there was a collective sigh of relief. Relief is appropriate, but celebration premature: researchers have little reason to avail themselves of the new broad consent option offered in the Final Rule, and the question of whether biospecimens ought to be treated as inherently identifiable has merely been postponed.

A Framework for Ethical Payment to Research Participants

Ethical Payment to Research Participants The authors propose a framework for evaluating the appropriateness of payments to research participants. They distinguish three acceptable rationales for pa...

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Womens Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval.

Ethical evasion or happenstance and hubris? The U.S. Public Health Service STD Inoculation Study.

Its tempting to explain the Guatemala STD inoculation study as an attempt to evade the strictures of U.S research ethics. In fact, the researchers appear to have had benign reasons for going abroad. Only after they reached Guatemala did the study fly out of control.

Streamlining Review by Accepting Equivalence

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