Returning Individual Research Results to Participants - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Returning Individual Research Results to Participants write by National Academies of Sciences, Engineering, and Medicine. This book was released on 2018-09-23. Returning Individual Research Results to Participants available in PDF, EPUB and Kindle. When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.
Returning Individual Research Results to Participants
Returning Individual Research Results to Participants - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Returning Individual Research Results to Participants write by National Academies of Sciences, Engineering, and Medicine (U.S.). Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories. This book was released on 2018. Returning Individual Research Results to Participants available in PDF, EPUB and Kindle. "There is a long-standing tension in biomedical research arising from a conflict in core values--the desire to respect the interests and desires of research participants by communicating results contrasted with the responsibility to protect participants from uncertain, perhaps poorly validated information. Traditionally, the balance has been tipped toward the latter resulting in what has been termed "helicopter research." The notion here is that investigators drop into communities or people's lives, engage with them in often very personal ways, and then take off, never to be heard from again. Yet people are curious about themselves, particularly about their health and their family's health, leaving a sense of frustration and loss when investigators take but do not share"--Page ix.
Returning Individual Research Results to Participants
Returning Individual Research Results to Participants - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Returning Individual Research Results to Participants write by National Academies of Sciences, Engineering, and Medicine. This book was released on 2018-08-23. Returning Individual Research Results to Participants available in PDF, EPUB and Kindle. When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.
Sharing Clinical Trial Data
Sharing Clinical Trial Data - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Sharing Clinical Trial Data write by Institute of Medicine. This book was released on 2015-04-20. Sharing Clinical Trial Data available in PDF, EPUB and Kindle. Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Informed Consent and Health Literacy
Informed Consent and Health Literacy - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Informed Consent and Health Literacy write by Institute of Medicine. This book was released on 2015-03-04. Informed Consent and Health Literacy available in PDF, EPUB and Kindle. Informed consent - the process of communication between a patient or research subject and a physician or researcher that results in the explicit agreement to undergo a specific medical intervention - is an ethical concept based on the principle that all patients and research subjects should understand and agree to the potential consequences of the clinical care they receive. Regulations that govern the attainment of informed consent for treatment and research are crucial to ensuring that medical care and research are conducted in an ethical manner and with the utmost respect for individual preferences and dignity. These regulations, however, often require - or are perceived to require - that informed consent documents and related materials contain language that is beyond the comprehension level of most patients and study participants. To explore what actions can be taken to help close the gap between what is required in the informed consent process and communicating it in a health-literate and meaningful manner to individuals, the Institute of Medicine's Roundtable on Health Literacy convened a one-day public workshop featuring presentations and discussions that examine the implications of health literacy for informed consent for both research involving human subjects and treatment of patients. Topics covered in this workshop included an overview of the ethical imperative to gain informed consent from patients and research participants, a review of the current state and best practices for informed consent in research and treatment, the connection between poor informed consent processes and minority underrepresentation in research, new approaches to informed consent that reflect principles of health literacy, and the future of informed consent in the treatment and research settings. Informed Consent and Health Literacy is the summary of the presentations and discussion of the workshop.
