Women and Health Research

Women and Health Research
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 286
Release: 1994-02-01
Genre: Medical
ISBN: 030904992X

In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues. Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies. Leading experts present general principles for the ethical conduct of research on womenâ€"principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research. Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research. The book addresses present-day challenges to equity in four areas: Scientificâ€"Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics. Social and Ethicalâ€"The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants. Legalâ€"Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases. Riskâ€"The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed. This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 103
Release: 2020-01-27
Genre: Medical
ISBN: 0309498511

To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

Sharing Publication-Related Data and Materials

Sharing Publication-Related Data and Materials
Author: National Research Council
Publisher: National Academies Press
Total Pages: 240
Release: 2003-04-17
Genre: Science
ISBN: 0309168503

Biologists communicate to the research community and document their scientific accomplishments by publishing in scholarly journals. This report explores the responsibilities of authors to share data, software, and materials related to their publications. In addition to describing the principles that support community standards for sharing different kinds of data and materials, the report makes recommendations for ways to facilitate sharing in the future.

Guidance for the Description of Animal Research in Scientific Publications

Guidance for the Description of Animal Research in Scientific Publications
Author: National Research Council
Publisher: National Academies Press
Total Pages: 42
Release: 2011-09-16
Genre: Science
ISBN: 030921954X

The publication of research articles involving animal studies is central to many disciplines in science and biomedicine. Effective descriptions in such publications enable researchers to interpret the data, evaluate and replicate findings, and move the science forward. Analyses of published studies with research animals have demonstrated numerous deficiencies in the reporting of details in research methods for animal studies. Considerable variation in the amount of information required by scientific publications and reported by authors undermines this basic scientific principle and results in the unnecessary use of animals and other resources in failed efforts to reproduce study results. Guidance for the Description of Animal Research in Scientific Publications outlines the information that should be included in scientific papers regarding the animal studies to ensure that the study can be replicated. The report urges journal editors to actively promote effective and ethical research by encouraging the provision of sufficient information. Examples of this information include: conditions of housing and husbandry, genetic nomenclature, microbial status, detailed experimental manipulations, and handling and use of pharmaceuticals. Inclusion of this information will enable assessment and interpretation of research findings and advancement of knowledge based on reproducible results.

Sharing Clinical Trial Data

Sharing Clinical Trial Data
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 236
Release: 2015-04-20
Genre: Medical
ISBN: 0309316324

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.

Beyond the HIPAA Privacy Rule

Beyond the HIPAA Privacy Rule
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 334
Release: 2009-03-24
Genre: Computers
ISBN: 0309124999

In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

The Prevention and Treatment of Missing Data in Clinical Trials

The Prevention and Treatment of Missing Data in Clinical Trials
Author: National Research Council
Publisher: National Academies Press
Total Pages: 163
Release: 2010-12-21
Genre: Medical
ISBN: 030918651X

Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.