The ability to manipulate atoms and molecules at the nanoscale has catalyzed the emerging field of nanomedicine. While many biological phenomena occur at the nanoscale, "nanomedicine" denotes material fabricated at the scale of 1-100 nanometers (nm) to take advantage of novel properties (biological, optical, thermal, chemical, and mechanical) that manifest at the nanoscale. A focal area of development is nanodiagnostics and nanotherapeutics.

This project explores whether the current regulations for protecting research subjects will provide adequate protections and guidance for future research involving human prenatal gene therapy. It seeks to determine whether additions or other revisions to the regulations are needed to deal with the ethical issues that will be raised in protecting human subjects in such research. Examples of issues that will need to be addressed include the following: 1) The current regulations do not specify how risks and benefits should be balanced between the fetus and pregnant woman.

Most discussion of the ethical challenges raised by the growth of research biobanks relies on the assumption that the only ethically relevant interests are those that concern risks to subjects' welfare or well-being. Once materials have been collected, and any further risks have been reduced to near-zero by de-identification, it follows that no further protection of the interests of research subjects is required.

This research project will collect and analyze qualitative and quantitative data about US biobanks, exploring how organizational strategies, features, and attributes affect both framing and response to ELSI and policy choices. We argue that a biobank's organizational features impact 1) policy choices directly, and 2) members' framing and response to ELSI which in turn impact policy choices.

The proposed research seeks to contribute to an emerging literature that assesses the philosophical implications of the ecological concepts, metaphors, and analogies that are beginning both to frame our understanding of the human microbiome and to challenge entrenched mechanistic concepts of the human body and the human being -- entrenched concepts that not only include the "blueprint" analogies of the Human Genome Project but stretch back at least to the discovery of the circulation of the blood.

Two major forces in clinical medicine on the horizon are expected to change the paradigm of clinical care. One is personalized genomic medicine (PGM), which seeks to harness knowledge about the genetic endowment of the individual to individually tailor specific medical therapies. The second driving force in healthcare today is to conduct comparative effectiveness research (CER) to directly compare the effectiveness, and sometimes the cost, of alternative therapies or diagnostic modalities for the same disease or condition.

Genomic data, including findings incidental to the purpose for which a study is undertaken, can contain information of use and importance to research subjects related to their health, lifestyle, and reproductive choices. A growing consensus of expert groups is that at least some information from genomic studies should be available to participants. It seems clear that return of results from genomic studies should and will require the informed consent of research subjects.

Personal genetic and genomic information is becoming more widely available and affordable, generating increased discussions on the merits and dangers of direct-to-consumer (DTC) genetic testing and appropriateness of using personal genetic information in various contexts (e.g. clinics, research laboratories, courtrooms, and classrooms). While attention has focused predominately on health-related testing, conversations about DTC genetic ancestry testing and information are intensifying as well.

Recent progress in genomic science has been accompanied by great expectations that we are on the verge of a medical revolution where genetic knowledge of the complex interaction between multiple genes and the environmental/behavioral factors impacting their expression, will redefine illness and health, guiding risk prediction, disease diagnosis and treatment strategies. As yet, with a few notable exceptions, the promise of genetically driven diagnoses and treatment remains largely theoretical.

H3Africa provides an unprecedented opportunity to study genetic and genomic technologies into research, diagnosis, intervention, and treatment for sickle cell disease (SCD) in Africa. As such, involving a few African Centers already involved in the forefront of Sickle Cell Disease Research in Africa with moderate expertise on psychosocial research (Cameroon), newborn screening (Ghana) or genomics studies (Tanzania) could serves as a reservoir for rigorous examination of a wide range of accompanying ethical, psychosocial, cultural, and policy issues.