Jordan Paradise

Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations

No consensus yet exists on how to handle incidental findings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are findings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed.

The Law of Incidental Findings in Human Subjects Research: Establishing Researchers' Duties

Research technologies can now produce so much information that there is significant potential for incidental findings (IFs). These are findings generated in research that are beyond the aims of the study. Current law and federal regulations offer no direct guidance on how to deal with IFs in research, nor is there adequate professional or institutional guidance. We advocate a defined set of researcher duties based on law and ethics and recommend a pathway to be followed in handling IFs in research. This article traces the underlying ethical and legal theories supporting researcher duties to manage IFs, including duties to develop a plan for management in the research protocol, to discuss the possibility of and management plan for IFs in the informed consent process, and to address, evaluate, and ultimately offer to disclose IFs of potential clinical or reproductive significance to research participants when they arise.

The Challenge of Developing Oversight Approaches to Nanobiotechnology

This symposium of 19 articles grows out of a 4-year project funded by the National Science Foundation (NSF) (grant #SES-0608791) on “Evaluating Oversight Models for Active Nanostructures and Nanosystems: Learning from Past Technologies in a Societal Context” (Susan M. Wolf, Principal Investigator (PI); Co-PIs: Efrosini Kokkoli, Jennifer Kuzma, Jordan Paradise, Gurumurthy Ramachandran). The goal of this project was to develop oversight recommendations for nanobiotechnology grounded in historical analysis and evaluation of oversight approaches to five cognate technologies: drugs, devices, human gene transfer research (“gene therapy”), chemicals in the workplace, and genetically modified organisms in the food supply. The investigators utilized expert elicitation and literature analysis to develop a structured survey to aid analysis of the successes and failures of these prior oversight regimes. The methodology is presented in the symposium and described in depth in additional team publications cited here. The survey instrument devised represents a significant new tool for evaluating science and technology oversight, including regulatory regimes. This symposium publishes the five historical case studies plus commentaries, an article co-authored by the investigators comparing across the five case studies to derive overarching lessons for nanobio oversight, and seven articles on cross-cutting ideas including nanobio governance and oversight, risk communication, and approaches to expert elicitation. The symposium includes the work of 30 authors and breaks new ground on policy approaches to emerging science and technology.

Decoding the research exemption

While debate continues as to whether genetic sequences, which many argue represent natural phenomena rather than inventions, should be subject to standard patent protections, issuance of patents that claim DNA sequences remains common practice. In an attempt to insulate researchers from patent claims that could hinder scientific progress, many countries have provided general exemptions for scientific research. However, there is no international consensus about the extent of required protections, and even existing exemptions vary widely in clarity and are limited in practical application. We believe that gene patents raise several unique issues that are inadequately handled by the current research exemptions.

Patient advocacy group collaboration in genetic research and the scope of joint inventorship under US patent law

Patent systems have traditionally operated to reward scientific innovation and discovery rather than the level and type of contribution of raw materials and other support. As U.S. and international patient advocacy groups continue to launch efforts to organize patients, collect and bank genetic material, and interface with researchers to find cures for diseases, there is need for critical examination of the scope of inventorship as constructed both in the U.S. patent law and abroad. In recently naming a non-scientist advocate a co-inventor on a patent covering a disease gene, the United States Patent & Trademark Office has determined that collaboration with researchers in providing banked genetic samples and participating in the laboratory rises to the level of inventorship. This article will review case law and U.S. patent law and discuss recent patient advocacy collaborative efforts. It will conclude with some considerations for fostering continued collaborative efforts in genetics research.