National Cancer Institute (NCI)

The National Cancer Institute (NCI) coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.

The National Cancer Institute is interested in supporting research that fills gaps in our knowledge and understanding of the many complex ethical issues facing investigators, IRBs and participants in research. General topics of interest include: 1) novel approaches to informed consent and assessment of the understanding of research participants; 2) development of strategies for advance consent for specimen collection; 3) evaluations to better understand the weighing of risks and harms, in particular for children in early phase clinical trials; 4) assessment of methods to ensure the privacy and confidentiality of research information while conducting research, including assessment of understanding and provision of new information to participants; 5) evaluation of the new challenges in conducting population-based research including community and privacy issues; 6) strategies that will enhance the effectiveness and efficiency of the IRB system; and 7) development of strategies that will promote the ethical inclusion of minorities and special populations in clinical research.

National Heart, Lung, and Blood Institute (NHLBI)

The National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, fosters, and supports research, clinical investigations and trials, observational studies, and demonstration and education projects in diseases of the heart, blood vessels, lung, and blood; sleep disorders; and the clinical use of blood and blood resources, and transfusion medicine. Since October 1997, the NHLBI has also had administrative responsibility for the NIH Woman's Health Initiative. For health professionals and the public, the NHLBI conducts educational activities, including development and dissemination of materials in the above areas, with an emphasis on prevention.

The NHLBI seeks to fund research in bioethics and medical research ethics that addresses:

• Emerging technologies with the potential for clinical applications, for example, cell-based therapies;



• Traditional bioethical issues that may need reassessment in light of changing societal, cultural and political norms, for example informed decision-making and the process leading to informed consent; children as research subjects in clinical trials; the role of industry in research and conflict of interest; research with communities and with socially disadvantaged populations; and



• Issues related to advances in medicine and technology, for example the speed of translational research from the lab to beside and clinic; the use of repository specimens for future tests of genetic mutations; data confidentiality and privacy, especially for data on phenotype-genotype correlations; the social constructs of race and ethnicity in relation to genetics; and adverse event reporting.

The NHLBI welcomes other lines of bioethical inquiry that are consistent with NHLBI’s scientific research mission.

National Human Genome Research Institute (NIHGRI)

The NHGRI, along with several other federal and private national and international organizations, is currently engaged in a research effort known as the Human Genome Project (HGP). This project’s primary goal is to map and sequence the entire human genome. The HGP currently has several interrelated goals, among them, the identification and analysis of the ethical, legal, and social implications of this research. The Ethical, Legal, and Social Implications (ELSI) Research Program of NHGRI is charged with administering program activities related to this goal and as such has a number of related program announcements. They can be viewed by touching the "Funding Opportunities button at: http://www.nhgri.nih.gov:80/About_NHGRI/Der/Elsi/ .

With regard to this Program Announcement, the NHGRI is interested in funding a broad range of ethics issues research related to genetic topics. Examples of research topics of interest are:

• How to design and conduct genetic and genomic research in an ethical manner, taking into consideration issues of special concern to individuals from diverse communities who traditionally have not been involved in this type of research, or who may have been adversely affected in the past by genetic types of research;

• How best to provide information during the informed consent process for participation in genetics research, particularly since many of the research topics are complex, confusing, and not well understood. Further, this process may be made more complicated by the fact that there may be no words into which certain genetic research terms or concepts can be translated;

• How best to minimize potential risks associated with genetics research, particularly when some of the research risks may remain unknown; and



• How best to protect the privacy and confidentiality of individuals, families, and groups who participate in genetics research.

Inquiries about this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome.

National Institute on Aging (NIA)

The NIA’s research mission is to support and conduct high quality research on aging processes, age-related diseases, and special problems and needs of the aged. Examples of research of ethical issues of interest to the NIA include, but are not limited to:

• decision making and consent process in older persons
• end of life decisions
• comprehension of information necessary for informed consent in light of impaired cognitive functioning and executive functions in some older persons
• impact of degree and type of cognitive impairment on decision making
• development of methods and instruments for assessing capacity to comprehend and appreciate participation in research in older individuals with and without diminished cognitive abilities
• education interventions for improving ability of investigators to assess competency to give consent
• issues surrounding surrogate decision-makers for frail elderly or older individuals with cognitive impairment

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) supports and conducts biomedical and behavioral research on the causes, consequences, treatment, and prevention of alcoholism and alcohol-related problems. NIAAA also provides leadership in the national effort to reduce the severe and often fatal consequences of these problems.

• The ethics of administering alcohol as part of NIH-sponsored research, to what patient groups and for how long:
• Is it ethical to give alcohol to alcoholics for the purpose of research, and if so, under what circumstances?
• How much and for how long can alcohol be given to non-alcoholics?
• Informed consent issues:
• What types of consent procedures are needed for alcoholics who are impaired due to current intoxication, withdrawal symptoms, or medically related cognitive impairments?
• Appropriate procedures to inform alcoholics that insurance companies and other agents may seek release of their medical records and may deny insurance with out such a release.
• Research with minors:
• Under specific situations, IRB’s can waive the requirements to obtain active parental consent. What aspects of research with children and adolescents influence decisions about waiving active parental consent?
• Whether providing information on safer ways to drink (harm reduction) inadvertently increases the risk that youth will engage in drinking (illegal behavior).
• Whether a strictly abstinence message increases youth vulnerability to engage in drinking and other high-risk behaviors.
• Can one allow an alcoholic to continue their usual drinking pattern while being studied or must treatment be given immediately?
• In genetic research, if genes that put people at risk for alcohol problems are identified, then later statements about the population of people who have those genetic factors may result in the stigmatization of persons who never gave informed consent to participate in the study.
• What are the ethical issues pertaining to the design, development, and application of summary measures of population health?
• Questions regarding the relationship of domestic violence to alcohol consumption and protecting the privacy of both victims and perpetrators so that treatment can be offered and research can be conducted.
• Financial compensation of alcoholics, particularly homeless and poverty-stricken persons, for participation in research.
• What are appropriate levels of protection for subjects and researchers when tissue is obtained for genetic studies?
• Ethical considerations in the treatment of HIV infected alcohol abusers.

National Institute on Allergy and Infectious Diseases (NIAID)

NIAID provides the major support for scientists conducting research aimed at developing better ways to diagnose, treat and prevent the many infectious, immunologic and allergic diseases that afflict people worldwide. Examples include gene transfer research, xenotransplantation, and HIV vaccine trials. These advances in biomedical and behavioral research by NIAID and their application to medicine have highlighted the importance of ethical issues in these areas.  Thus, NIAID encourages research of an operational nature, such as development of tools to demonstrate that research participants are in fact informed when they consent, or analysis of ethical obligations when basic principles differ between sponsor and host country or other subject areas germane to NIAID's mission.

Lawrence J. Prograis, Jr., M.D.
DAIT
NIAID
6700 B Rockledge, Room 5134
Bethesda, MD  20892
Telephone:  (301) 496-1886
FAX: (301) 402-2571
Email: LPROGRAIS@niaid.nih.gov

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases, the training of basic and clinical scientists to carry out this research, and the dissemination of information on research progress in these diseases.

NIAMS is aware of the many complex ethical issues encompassing clinical research. In order to enhance our knowledge and understanding, we are interested in supporting research that addresses these issues. Examples include: 1) informed consent; 2) advance consent for specimen collection and long term storage/use; 3) assessment of comprehension and by participants; 4) assessment of methods to ensure the privacy and confidentiality of research information; 5) IRB-related issues; and 6) development of strategies that will promote the ethical inclusion of minorities and children in clinical research.

The National Institute of Child Health and Human Development (NICHD)

The National Institute of Child Health and Human Development (NICHD) has dedicated its research to understanding the dynamic biological, behavioral, and social processes that dictate physical, emotional, and cognitive growth. The NICHD seeks the knowledge to understand the complex interplay of processes that transform cells into healthy functioning individuals, free of disease and disabilities. When this goal is not achieved, or achieved unequally by different groups, the NICHD mission is to understand why, and to develop remedies to ensure the healthy functioning of all infants, children, youth, and families.

NICHD has interest in supporting research that will increase our understanding of the complex ethical issues and potential risks and benefits that are involved when research protocols include children, pregnant females, couples or individuals attempting to conceive as participants, or individuals with developmental disabilities.

• Investigate the conditions, which influence children and adolescents to participate in research with focus on the child’s relationship with parent(s,) developmental stage, physical health or health history, communication with peers, and life experiences.
• Investigate children's or families’ of individuals with development disabilities understanding of research risks, the value of research, and the consent process as it influences their participation in research.
• Investigate the practices and consequences of obtaining "assent" from children or individuals with developmental disabilities.
• Investigate pregnant female’s understanding of research risks to her fetus, the value of research to her and her fetus and the consent process as it influences her participation in research. At what point do potential research benefits outweigh potential risks and how much risk is too much risk for a pregnant female and her fetus.
• Investigate the understanding of the risks and benefits of fertility research on the part of couples attempting to conceive. Investigate the practices and consequences of obtaining "assent" for fertility research from couples or individuals attempting to conceive.
• Investigate ethical issues surrounding the potential conflict between cultural norms in countries where we do research and US research policies.
• Investigate the concept of "community" in the context of research. Identify optimal ways in which: (a) a community could be consulted when considered the sampling frame of a research protocol; (b) researchers can determine who represents the interests of a community and how to obtain input from community representatives; (c) researchers can minimize group harms that may result as a consequence of the study.
• Research the challenges in the ethical design and conduct of cross-cultural studies, especially research conducted in low- and middle- income nations, with an emphasis on translating ethical procedures to local environments such as risk/benefit assessment, informed consent, privacy and confidentiality, and appropriate material inducements; considerations arising from the methodological design and conduct of cross-cultural protocols, such as placebo control and randomization; community involvement at different levels of study design, conduct and recruitment; and broader issues of "distributive justice" including clinical obligations to the study participants and allocation of intellectual property and other benefits.
• Apply existing knowledge from cognitive, behavioral, social, and educational fields to develop practical, reliable, valid, and efficient methods and instruments for assessing capacity to comprehend, appreciate and/or reason in a research setting, especially when individuals with cognitive, psychiatric, and developmental disorders are involved; the focus should be on functional abilities rather than on clinical diagnosis.

National Institute on Deafness and Other Communication Disorders (NIDCD)

The NIDCD supports biomedical and behavioral research and research training in the normal and disordered processes of hearing, balance, smell, taste, voice, speech, and language. The Institute also conducts and supports research and research training related to disease prevention and health promotion; addresses special biomedical and behavioral problems associated with people who have communication impairments or disorders; and supports efforts to create devices which substitute for lost and impaired sensory and communication function.

The NIDCD in interested in supporting research related to ethical issues in research in human communication for all individuals, whether the primary communication mode is spoken, signed, or an augmentative/alternative device.

These include:

• Novel approaches to informed consent and assessment of the understanding of research participants with deafness/hearing impairment; strategies to better promote the ethical inclusion of children and minorities in research studies; issues related to conflicts of interest and study outcomes; and understanding how health care delivery policies or practices have an impact on research in NIDCD mission areas.

• Issues specific to advances in genetics. These include: the development of adequate informed consent procedures about the use of DNA specimens for genetic testing related to hearing impairment; advance consent/reconsenting for the use of repository specimens for future genetic studies; novel approaches to facilitate comprehension of genetic information and subsequent informed decision making for various cultural groups as well as for individuals with hearing impairment; and, novel ways to include individuals with hearing impairment and individuals who are deaf, as well as related organizations representing the spectrum of communities of deaf or hearing impaired people, in the research enterprise.

National Institute of Dental and Craniofacial Research (NIDCR)

The mission of the NIDCR is to promote general health through supporting research to improve oral, dental, and craniofacial health. Prevention, diagnosis, and treatment of conditions such as inherited and acquired craniofacial deformities, salivary disorders, acute and chronic orofacial pain conditions, oral infectious diseases including dental caries and periodontal diseases, and oral aspects of systemic diseases all fall with the scope of NIDCR’s interests. Studies addressing ethical issues related to oral/craniofacial conditions, oral-systemic disease linkages, and public health or health care delivery policies or practices influencing oral health are of specific interest to NIDCR.

National Institute of Diabetes and Digestive Kidney Diseases (NIDDK)

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts and supports research encompassing a broad spectrum of metabolic diseases such as diabetes, inborn errors of metabolism, endocrine disorders, mineral metabolism, digestive diseases, nutrition, obesity, urology and renal disease, and hematology. The NIDDK is interested in supporting research that will enhance the knowledge and understanding of the many complex ethical issues facing investigators, IRBs and participants in research. General topics of interest include: 1) development of methodology to assure research subjects possess the cognitive ability to differentiate between research and standard treatment and to distinguish between discretionary and obligatory activities; 2) investigation of factors that would lead individuals to participate in studies that present significant risk with little or no prospect of direct benefit; 3) definition, measurement, and understanding of social harms that might be associated with research participation; 4) assessment of methods to ensure the privacy and confidentiality of research information while conducting research, including provision of new information to participants and future access to medical records; 5) study the challenges in the ethical design and conduct of cross-cultural studies, especially research conducted in low- and middle- income nations; 6) development of strategies associated with re-consenting patients to allow for extended storage of blood and tissue samples in repositories for use at a later time and for presently unidentified studies; 7) strategies in the ethical design and conduct of studies involving special populations such as the homeless and drug abuse populations; 8) development of methodologies for ensuring informed consent and confidentiality with internet or web based questionnaires or computer driven questionnaires; 9) development of novel strategies for obtaining and evaluating alternate methods of informed consent such as the use of videos and interactive computer prompts in the informed consent process.

National Institute on Drug Abuse (NIDA)

NIDA’s mission is to lead the nation in bringing the power of science to bear on drug abuse and addiction. This charge has two critical components: The first is the strategic support and conduct of research across a broad range of disciplines. The second is to ensure the rapid and effective dissemination and use of the results of that research to significantly improve drug abuse and addiction prevention, treatment, and policy.

NIDA supports research of ethical issues related to the definition, measurement, and understanding of social harms that might be associated with participation in drug abuse and addiction research. Examples of such issues include, but are not limited to, the following:

• Discrimination by insurance companies or employers that may results from participation in HIV/AIDS or drug abuse studies;
• Vaccine research;
• Genetic research using identifiable tissue samples;
• Novel re-contact or opt-out strategies;
• Certificates of confidentiality.

Other ethical issues related to drug abuse research will also be considered.

National Institute of Environmental Health Sciences (NIEHS)

The National Institute of Environmental Health Sciences is interested in supporting research and educational efforts that promote public understanding of the social, ethical, and legal implications of conducting environmental health research involving human subjects in areas such as gene-environment interactions, environmental health hazards, disease susceptibility, and social stressors. Specifically, NIEHS is interested in those research and education projects that involve translational research endeavors that foster community-university partnerships and also address:

• Developing innovative methods for obtaining informed consent, especially in minority and at-risk communities.
• Limitations of proxy consent, especially for children, physically and mentally challenged or incapacitated individuals.
• Methods of communicating issues relating to risk and benefits to the individual and the community of participation in research projects.
• Individual, family and community rights in access to information and the materials generated from the research. Role of certificates of confidentiality.
• Challenges in researching and identifying environmental hazards long before effective and acceptable medical, ecological, or policy interventions are available.
• Issues relating to confidentiality, such as, limitations and challenges of reusing the data or information (stored data, banked samples) by other researchers/ communities.
• Issues relating to conflict of interest, benefits of the process and outcome of research and interventions.
• Challenges and guidelines for ensuring equal representation or selection of participants and communities.
• Methods of disseminating or creating greater public awareness on consent procedures, role of IRBs, and the process of voluntary disclosures.
• Ownership of the data. The role of the community in community based participatory research programs.
• Challenges in developing and conducting community, institutional and societal level interventions.
• Issues relating to stigmatization, discrimination in employment and health care, and in community.

National Institute of General Medical Sciences (NIGMS)

NIGMS supports research in Genetics, Pharmacogenetics, Clinical Pharmacology, Anesthesia, and Trauma and Burn Injury.

Genetic studies are aimed at understanding the fundamental mechanisms of inheritance and development including chromosome organization and mechanics, control of gene expression, developmental genetics, extrachromosomal inheritance, mechanisms of mutagenesis, neurogenetics and the genetics of behavior; population genetics, evolution, and the genetics of complex traits, including SNPs and haplotypes. NIGMS supports a focus in pharmacogenetics on understanding individual variations in drug responses and identifying the responsible receptors and enzymes, as well as discovering variants and their altered functions; the emphasis is on linking phenotype to genotype in humans. Studies in clinical pharmacology and anesthesiology include the effects of drugs on the body and the body's effects on drugs, such as absorption, transport, distribution, metabolism, and excretion, as well as drug interactions with receptors, signal transduction mechanisms, and drug delivery strategies. Studies in trauma and burn injury are directed towards an improved understanding of the physiological responses to injury, including shock, compensatory mechanisms, adverse consequences (including sepsis and multiple organ failure), and restoration of tissue integrity.

NIGMS’ interests in research on ethical issues includes:

• Issues associated with sharing stored samples

• Strategies for posting clinical data to web sites
• Issues related to the content of informed consents
• Conveying benefits to groups that participate in research
• Giving indirect consent when incapacitated
• Promoting dialogue with communities and giving feedback to research participants
• Maintaining privacy of individuals and groups for stored data

National Institute of Mental Health (NIMH)

The mission of the National Institute of Mental Health (NIMH) is to reduce the burden of mental illness through research on the mind, brain, and behavior. NIMH supports the scientific investigation of various topics related to research ethics, including the ongoing process of informed consent in studies involving research participants with mental disorders, the use of surrogate decision-makers (legally authorized representatives), and factors that influence IRB decisions regarding additional safeguards for participants in research on mental disorders, symptoms, and related disability. Of particular interest are empirical studies that apply the theories, findings, and methods of basic behavioral and neuroscience research to understand (a) research subjects’ "capacity" to understand relevant information, to appreciate the nature and consequences of participation options, to manipulate information rationally while making decisions, and to employ means for improving such decisions; (b) ethical decision-making (consideration of risks, benefits, and alternatives) by investigators studying mental disorders; and (c) IRB reviews of applications that involve participants with mental disorders.

National Institute of Neurological Disorders and Stroke (NINDS)

The National Institute of Neurological Disorders and Stroke encourages submission of research proposals addressing ways of meeting the ethical challenges encountered in performing well-controlled clinical studies of neurological and cerebrovascular disorders. Examples of topics of interest to NINDS include:

• Ethical issues associated with the use of placebo treatment, with or without standard care, in studies of acute and chronic neurological conditions: New, alternative research designs are needed to reconcile conflicting scientific and ethical requirements.



• Consent issues: To date, little is known about the extent to which patients with acute or chronic neurological disorders can provide informed consent. There is an urgent need to develop instruments for assessment of decision-making capacity in these vulnerable patients, and to develop methods of assisting such patients or their caretakers in decision-making concerning clinical trial enrollment decisions. There is a need for continued research on waiver-of-consent issues for studies on decisionally-impaired patients with traumatic brain injuries and other neurological disorders.



• Withdrawal of treatment issues: Clinical trials on neurological disorders often employ symptomatic treatment withdrawal in order to ascertain the "natural" state of the disease. The withdrawal of treatment is not well tolerated by patients, and its safety has not been established. In order to minimize discomfort and risk to patients, investigators curtail the withdrawal period, to the extent that the ascertainment of the natural state of the disease may not be valid. A question arises: how can novel treatments of neurological disorders be evaluated while addressing these ethical and methodological concerns?



• Issues associated with genetic risk studies: Linkage disequilibrium studies can lead to identification of disease genes towards a goal of helping to ameliorate or cure those diseases. Conversely, these studies can be used to characterize individuals, or even entire populations, in terms of their ultimate risk for developing disease, with potential, adverse consequences to those involved. Consequently, linkage disequilibrium studies pose numerous ethical challenges. Studies are needed to identify the risks posed by this research and the methods of minimizing those risks. While those kinds of risks are not unique to genetic studies of neurological disorders, the late onset of some neurological disorders leads to some special ethical issues.

National Institute of Nursing Research (NINR)

The National Institute of Nursing Research supports clinical and basic research to establish a scientific basis for the care of individuals across the life span-from management of patients during illness and recovery to the reduction of risks for disease and disability, the promotion of healthy lifestyles, promoting quality of life in those with chronic illness, and care for individuals at the end of life.

NINR is interested in research that addresses the ethical conduct of research. Ethical issues of interest to NINR include studies to improve the understanding of the informed consent process and to determine when secondary gains may become coercive (i.e., amount of remuneration, free health care). The factors that influence the decision making process in clinical trials with varying risks and benefits needs to be identified. Studies are needed to determine the capacity of consent in vulnerable populations (i.e., cognitively impaired, severely mentally ill, low literacy), and to identify cultural and ethnic factors that influence the recruitment, consent process and the participation in research studies. NINR is interested in the best practices of the participation of children in clinical trials, of patient and family considerations for participating in genetic studies and organ transplantation. Interventions are needed to improve the patients’ comprehension of participation in a clinical research trial and to enhance autonomy in the informed consent process of all populations. Lastly, NINR is interested in studies investigating ethical issues surrounding end of life research.

National Center for Complementary and Alternative Medicine (NCCAM)

NCCAM is interested in supporting research regarding the ethical treatment of human subjects who participate in studies that utilize complementary and alternative medical practices. Studies of CAM practices share the same challenges as all clinical trials, but there are unique additional issues that incur potential ethical risks, issues than when well studied and better understood will considerably elevate the quality of future CAM research. CAM practices, by definition, are unproven and often poorly characterized or standardized. Thus, for example, NCCAM is interested in studies of informed consent regarding the choices research subjects might face in considering whether to receive a CAM treatment instead of, or in addition to, a proven conventional treatment. In developing nations, the only widely available practices might involve traditional healing methods. Thus, NCCAM is interested in ethical issues raised by studies that explore ancient local healing practices in populations that have no usual access to proven medications and who are unaccustomed to being research subjects.

Fogarty International Center (FIC)

The Fogarty International Center is primarily interested in supporting international bioethics research related to performing research on acute and chronic diseases in

low- and middle-income nations. Studies should focus on the internationally relevant aspects of the ethical, legal and social principles guiding the responsible conduct of research in developing countries, particularly on scientific integrity and the protection of the interests of research participants. Research areas may include ethical perspectives on the use of human biological materials in research, the ethics of designing clinical research protocols and ethical considerations in performing research in vulnerable populations with an emphasis on culturally relevant research. Other topics may include the impact of international codes, laws and guidelines and ethical issues related to informed consent, intellectual property, collaborative agreements between host and sponsor countries, the role of ethics review committees in the developing world and in cross-cultural research and ethnographic research.

Office of Behavioral and Social Sciences Research (OBSSR)

One mission of the Office of Behavioral and Social Sciences Research (OBSSR) is to promote research regarding the ethical treatment of human subjects in the behavioral and social sciences. In this mission we work with the various Institutes and Centers at NIH to insure that such research is appreciated and supported. While OBSSR provides no direct funding to applicants for ethics research, we do serve as a potential sounding board for applicants with interests in ethics topics in the behavioral and social sciences – with an interest in directing such applicants to the appropriate NIH Institute or Center. As such, we encourage applicants with questions regarding behavioral and social science ethics topics to contact OBBSR.

Office of Research on Women’s Health (ORWH)

The mission of the Office of Research on Women's Health (ORWH) is to: (a) advise the NIH Director and staff on matters relating to research on women's health; (b) strengthen and enhance research related to diseases, disorders, and conditions that affect women; (c) ensure that research conducted and supported by NIH adequately addresses issues regarding women's health; (d) ensure that women are appropriately represented in biomedical and biobehavioral research studies supported by NIH; (e) develop opportunities for and supports recruitment, retention, re-entry, and advancement of women in biomedical careers; and (f) support research on women's health issues. ORWH works in partnership with the NIH institutes and centers to ensure that women's health research is part of the scientific framework at NIH and throughout the scientific community.

ORWH is interested in ethical issues surrounding the inclusion of women in clinical studies and women as subjects in research studies, including the role and scope of IRBs. While ORWH provides no direct funding to applicants for ethics research, we do serve as a potential sounding board for applicants with interests in ethics topics in the issues related to women with an interest in directing such applicants to the appropriate NIH Institute or Center. ORWH is interested in research to identify the best strategies for explaining immediate and longer-term risks and benefits for women participating in research, particularly research involving screening (e.g., genetic screening, or screening for evidence of disease.) In addition, ORWH is interested in ethical issues surrounding inclusion of all populations of women in clinical trials and, especially women of reproductive age and pregnant women, the elderly. Priorities include:

• Ethical issues in recruitment and retention, defining usual care, issues of privacy, cognitively impaired patients,
• Ramifications of pregnant women in research enrollment,
• Enrollment of non-English speaking minorities,
• Enrollment of minorities in percentages appropriate for the disease being studied,
• Use of cognitively impaired women as in those with dementia,
• Use of incarcerated women, women under the influence of licit and illicit psychoactive agents,
• Enrollment of women in experimental therapies - risk-benefit issues.
• Use of tissue specimens from surgical and/or autopsy for research such as genetic basis for breast cancer and other cancers.
• Direct your questions about scientific/research issues to: