METHODOLOGY AND MEASUREMENT IN THE BEHAVIORAL AND SOCIAL SCIENCES Release Date: February 25, 1998 PA NUMBER: PA-98-031 P.T. National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Cancer Institute National Institute of Child Health and Human Development National Institute of Dental Research National Institute on Drug Abuse National Institute of Mental Health National Institute of Nursing Research National Heart, Lung, and Blood Institute Office of Behavioral and Social Sciences Research Office of Alternative Medicine PURPOSE The National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Cancer Institute (NCI), National Institute of Child Health and Human Development (NICHD), National Institute of Dental Research (NIDR), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute of Nursing Research (NINR), National Heart, Lung, and Blood Institute (NHLBI), Office of Behavioral and Social Science Research (OBSSR), and Office of Alternative Medicine (OAM) invite qualified researchers to submit research grant applications on methodology and measurement in the behavioral and social sciences. Methodology and measurement issues in the behavioral and social sciences include the processes that underlie self reports, research design, data collection techniques, measurement, data analysis techniques, and ethical issues in the above topics. The goal of this program announcement is to encourage research that will improve the quality and scientific power of data collected in the behavioral and social sciences, relevant to the missions of the NIH Institutes and Centers. Research that addresses methodology and measurement issues in diverse populations, issues in studying sensitive behaviors, and issues in developing multidisciplinary and multimethod approaches to behavioral and social science research is particularly encouraged. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity for setting priority areas. This PA is related to the priority areas of alcohol and other drugs, nutrition, tobacco, physical activity and fitness, family planning, heart disease and stroke, oral health, cancer, HIV infection, sexually transmitted diseases, and immunization and infectious diseases. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402- 9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The mechanisms of support will be the investigator-initiated research project grant (R01). Applicants may consult with program staff listed under INQUIRIES regarding other mechanisms and relevant announcements on topics related to this program announcement. RESEARCH OBJECTIVES In all areas of science, advances in methodology and measurement go hand in hand with advances in substantive knowledge. This program announcement invites research to improve the quality and scientific power of behavioral and social science data relevant to the missions of the sponsoring institutes. These missions encompass a broad range of scientific questions related to the health and well-being of our nation"s people. The National Institute on Aging supports behavioral and social research on the aging processes and on the diseases and other special problems and needs of older people. The National Institute on Alcohol Abuse and Alcoholism supports basic and applied research on the effects of alcohol on biobehavioral processes, research on the processes leading to pathological drinking, and research to develop improved diagnosis, prevention and treatment. The National Cancer Institute supports social and behavioral research related to the distribution, etiology, natural history, and prevention of human cancer. The National Institute of Child Health and Human Development supports behavioral and social research related to reproduction and population change, perinatal and infant health, nutrition, child development and behavior, mental retardation and developmental disabilities, Acquired Immunodeficiency Syndrome (AIDS), and medical rehabilitation. The National Institute of Dental Research supports behavioral and social research related to oral health promotion and the prevention, etiology, diagnosis, and treatment of oral diseases or systematic diseases influence by oral health. The National Institute on Drug Abuse supports research related to the epidemiology, etiology, assessment, treatment, and prevention of drug abuse, as well as the role of drug abuse in AIDS. The National Institute of Mental Health supports research on mental illness and mental health, including studies of the brain, behavior, and mental health services. 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 and the promotion of healthy lifestyles. The National Heart, Lung and Blood Institute supports behavioral and social research relating to the causes, prevention, diagnosis and treatment of heart, blood vessel, lung, and blood diseases and blood resources. The Office of Behavioral and Social Sciences Research provides leadership and direction in increasing the scope and support of research on the role of human behavior and social processes in the promotion of health and prevention of disease. The Office of Alternative Medicine supports behavioral and social science research on topics (e.g., mind-body medicine) that fall outside of mainstream medicine. Further information about the missions of participating institutes is available from the contacts identified at the end of this announcement, or from the National Institutes of Health web site (http://www.nih.gov). This program announcement encourages applications in six general areas of methodology and measurement research. These areas, discussed in detail below, include the processes that underlie self reports, research design, data collection techniques, measurement, data analysis techniques, and related ethical issues. Within the broad spectrum of research defined by these areas, applicants are particularly encouraged (but are not required) to consider studies that address one or more of the following key issues: Methodology and measurement issues in research relating to diverse populations, for example, populations that are distinctive by virtue of age, gender, sexual orientation, ethnicity, culture, literacy, or disability. Issues in studying sensitive behaviors, such as drug use, sexual behavior, abortion, abuse and violence, and other covert or illegal behaviors, and Development of multidisciplinary and multimethod approaches to behavioral and social science research. Even where explicitly multidisciplinary and multimethod approaches are not considered, potential applicants are encouraged to explore the ideas and methods developed in social science and behavioral fields other than their own. Consulting relevant literature and collaborating with colleagues from other disciplines may provide important opportunities for cross-fertilization in developing improved methodology and measurement. A. PROCESSES UNDERLYING SELF-REPORTS Self-reports are a primary source of information in a wide range of clinical and research settings. For example, recent investigations have begun to analyze the cognitive processes that underlie self-reports of events, beliefs, feelings, preferences, attitudes, and symptoms. Such processes include the comprehension of questions, the retrieval of information from memory, and the use of heuristics and prior beliefs in formulating responses. By understanding these processes, and the biological, social, and cultural influences upon them, techniques for improving the validity and reliability of self-reports can be developed. Topics for new research on the processes underlying self-reports include, but are not limited to: 1. Basic issues in cognition, including perception, attention, memory, reasoning, decision-making, and communication, with particular focus on those processes that contribute significantly to self-report behavior (e.g., temporal perception and memory, comprehension, and decision processes that underlie survey responses). 2. Basic issues in the sensory, motor, social, cultural, and other psychological processes that underlie self report. 3. Development of the processes that underlie self-reports across the lifespan. 4. Influences of arousal and affective states upon self-reports. 5. Gender- and culture-related differences upon self-reports. 6. Effects of physical and social context on self-report validity and reliability. 7. Effects of sensory, motor, cognitive, and psychiatric limitations or disorders upon the processes that underlie self-reports, including effects of alcohol and drugs. 8. Construction of survey and interview instruments, including issues of format, medium, and wording of instructions and items. B. RESEARCH DESIGN The study of diverse populations, sensitive behaviors and the incorporation of multi-disciplinary frameworks and methods involves a number of challenges to behavioral research design. Broadly, research design determines how well a research plan can accomplish stated purposes and test hypotheses. Research design encompasses many decisions including the sampling plan, selection of appropriate study designs, methods, procedures and measures, and, assuring confidence in the study’s internal and external validity. An innovative sample design and/or sampling frame can be the centerpiece of a research design. Examples of questions on research design are, but are not limited to the following: 1. Methodological research to improve the design of survey research. 2. Conceptual design issues in studying culture and self-identification of race- ethnicity. 3. Designs to improve causal inference from non-experimental research. 4. Research to improve the design of research studies, including multi-wave longitudinal designs. 5. Methods for improving the design of community-based intervention trials (e.g., health promotion/disease prevention programs). 6. Conceptual and methodological issues in designing studies that use different sources of information, for example, studies comparing self and proxy reports (from surrogates family or friends -- and professional providers of care), validation studies using biological markers and record sources, studies comparing report data with data obtained by observing behavior, for example, patient ratings of pain versus family ratings of patient pain, client report of symptoms versus findings from clinical examination. C. MEASUREMENT ISSUES Developing and validating research instruments and questions are vitally important for collecting accurate information, and have an obvious impact on data validity and reliability. For example, health care practitioners must collect accurate reports of symptoms from their patients in order to accurately diagnose disease. Data collection instruments and questions developed for a particular age, gender, or cultural group may not be valid for other groups. For example, a dietary history questionnaire developed for Americans of European descent may not contain the foods commonly eaten by Americans of African, Asian, or South American descent. Continued improvement and innovation in validating data collection instruments is important for all types of research settings, ranging from the clinical interview to the observational study and the survey interview. Examples of measurement issues include, but are not limited to the following: 1. Development and refinement of measures used in behavioral and social science research. Topics include, but are not limited to: preferences for outcomes (health states), outcomes worse than death, perceptions of risks and benefits of treatments, perceptions of risks of diseases, desired role in medical decision-making, impact of disease on families (caregiver burden) and on patients, self-efficacy/fatalism about health outcomes (self-care and care-seeking behaviors are related to this belief structure, dental pain and anxiety about dental treatment), social support, socioeconomic status, and stress, and techniques for measuring social context or environment. 2. Research to develop self ratings of quality of life for clinical trials, to include the determination of the cognitive and other factors that underlie self reports of subjective well-being and quality of life. 3. Measurement issues in communication between health practitioners and patients/clients to include diagnostic interviews, to include the impact of time per patient on communicative strategies and effectiveness, and techniques that may improve the conduct of diagnostic interviews. 4. Age, gender, and cultural differences in instrument design, instrument design issues in studying age, gender and culture, including methods of studying culture and self identification of race/ethnicity. 5. Calibration of instruments and methods with different population subgroups. 6. Psychometric studies of data collection instruments. 7. Assessment techniques of individuals and organizations, including methods such as q-sorts. 8. Measurement issues in collecting data on organizational processes. 9. Studies of what levels of precision are required in behavioral and social research. 10. Measurement issues in using technology such as computer assisted data collection. D. DATA COLLECTION TECHNIQUES Data collection techniques are the tools and procedures scientists use for implementing research designs and obtaining measurements. Methodologies for collecting research data have an important impact on data validity and reliability. For example, studies of mode effects have suggested that use of self-administered instruments can facilitate the reporting of sensitive or illegal behaviors. Innovative methodologies can also open the door to the collection of new or more complex types of data by behavioral scientists. For example, recent developments in computer-assisted interviewing have permitted more complex question sequences in survey research, and the development of hand- held "beepers" programmed for data entry have permitted the collection of time- specific data on activities such as cigarette smoking. Continued improvement and innovation in data collection methodologies is important for all types of research settings, ranging from the clinical interview to the observational study and the survey interview. In addition, more research is needed to understand how methodologies work in diverse populations, and how they can be modified to address the specific needs of populations. Potential topics for research include, but are not limited to: 1. Methodologies to improve data collection in surveys, ethnographic and other qualitative studies, and multi-method studies, this may include new approaches to instrument design and manipulation of mode, length, setting, and interpersonal factors in data collection exchanges, new methodologies for qualitative research, and techniques that facilitate integration of qualitative and quantitative measurement. 2. Methodologies to reduce nonresponse bias in research studies, including techniques to improve the coverage of relevant populations in household surveys, to increase the voluntary participation of eligible subjects, and to reduce attrition in longitudinal studies and clinical trials. 3. Techniques for collecting contextual data (e.g,. neighborhood composition, peer group characteristics) and for operationalizing the boundaries of particular social contexts. 4. Innovative technologies for data collection and their impact on response quality in a variety of populations and substantive areas. 5. Data collection techniques that address the needs of special populations (e.g., physically or mentally disabled, nonliterate populations, the homeless and incarcerated, children and the elderly) and that study the impact of methodologies on data quality and completeness across diverse populations. E. ANALYTIC METHODS Analytic methods encompass the concepts and techniques used in analyzing data and interpreting and reporting results. The goal of new and improved analytic methods is to help make estimation, hypothesis testing, and causal modeling based on scientific data as sound as possible. Challenges include developing techniques that distinguish underlying regularities from the noise created by variability and imprecise measurement, developing causal inferences from observational data, improving both the internal validity and external validity (generalizability) of studies, and developing appropriate analytic techniques for use with new kinds of data and new approaches to behavioral and social science research. Examples of areas of interest include, but are not limited to: 1. Research to improve the analysis of longitudinal studies (in particular, the analysis of correlated data and modeling of different sources of error and of missing data). 2. Methods for improving the analysis of community-based intervention trials (e.g., health promotion/disease prevention programs). 3. Methodological research to improve the analysis of complex survey data, including the statistical modeling of nonresponse and other survey errors. 4. Analytic issues in and innovative techniques for improving causal inference from non-experimental research. 5. Multidimensional scaling approaches. 6. Analytic methods for integrating evidence from qualitative and quantitative research. Research to examine and account for the complex relationships among multiple sources of information on a single construct, such as self and proxy reports, clinical examinations and testing, laboratory tests, and other record sources. For example, patient ratings of pain versus family ratings of patient pain, client report of symptoms versus findings from clinical examination. 7. Analytic methods that model social structures and social processes, such as social networks, social influence, diffusion, and contextual effects. 8. Methods to model and adjust for biases in choice-based samples (e.g., clinic patients, program participants) in drawing inferences about larger populations. 9. Methods for handling missing data. F. RESEARCH ETHICS IN METHODOLOGY AND MEASUREMENT Laboratory and community-based researchers face an array of ethical dilemmas when asking volunteers to report about their behavior or experiences, especially when the behaviors are illegal or stigmatized. These ethical difficulties are not simply centered on the informed consent process and confidentiality issues, but may involve virtually every stage of the research, including design, data collection, and analysis and dissemination. Applications may explore the perspective not only of researchers, but also the perspective of research volunteers, survey respondents, and their families. Potential legal issues such as mandatory reporting to criminal justice authorities when behaviors such as child abuse are disclosed may also be a legitimate area of investigation. Examples of areas of interest include, but are not limited to: 1. Ethical issues in self report such as how to respond when suicidal ideation is or the respondent becomes upset during an interview. 2. Ethical issues in the use of record sources as data or data validation. 3. Methodological techniques for protecting confidentiality of data shared for secondary analysis. 4. Issues concerning how to obtain and maintain genuinely informed consent from research participants throughout the course of a study. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register, March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies of the policy from the program staff listed under INQUIRIES or from the Internet at http://www.med.nyu.edu. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, email: [email protected]. The title and number of the program announcement must be typed in line 2 on the face page of the application. The completed original application and five legible copies must delivered to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by appropriate review committees of NIH, in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written review, comments on the following aspects of the application will be made in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in the assignment of the overall score. o Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? o Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? o Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? o Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that Institute/Center (IC). The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Jared B. Jobe, Ph.D. Behavioral and Social Research National Institute on Aging 7201 Wisconsin Avenue, Suite 533, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-3137 FAX: (301) 402-0051 Email: [email protected] Kendall J. Bryant, Ph.D. Program Officer for Prevention Methodology Development National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 Bethesda, MD 20892-7003 Telephone: (301) 443-1677 FAX: (301) 443-8774 Email: [email protected] Frances Stillman, Ed.D. Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Boulevard, Room 241 Rockville, MD 20852 Telephone: (301) 496-0274 FAX: (301) 496-8675 Email: [email protected] Christine A. Bachrach, Ph.D. Demographic and Behavioral Sciences Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B13, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1174 FAX: (301) 496-0962 Email: [email protected] Patricia Bryant, Ph.D. Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-24E Bethesda, MD 20892-6500 Telephone: (301) 594-2095 FAX: (301) 480-8318 Email: [email protected] Bennett Fletcher, Ph.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A30 Rockville, MD 20857 Telephone: (301) 443-4060 FAX: (301) 443-6185 Email: [email protected] William E. Narrow, M.D., M.P.H. Epidemiology Program National Institute of Mental Health 5600 Fishers Lane, Room 18C-14 Rockville, MD 20857 Telephone: (301) 443-1636 FAX: (301) 443-4611 Email: [email protected] Carole I. Hudgings, Ph.D., R.N. Division of Extramural Activities National Institute of Nursing Research 45 Center Drive, Room 3AN-12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5976 FAX: (301) 480-8260 Email: [email protected] Carolyn Voorhees, Ph.D. Behavioral Medicine Research Group National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7936 Bethesda, MD 20892-7936 Telephone: (301) 435-0435 FAX: (301) 480-1773 Email: [email protected] Virginia S. Cain, Ph.D. Office of Behavioral and Social Sciences Research National Institutes of Health 1 Center Drive, Room 326 Bethesda, MD 20892-1146 Telephone: (301) 402-1146 FAX: (301) 402-1150 Email: [email protected] Richard Nahin, M.P.H., Ph.D. Office of Alternative Medicine National Institutes of Health 9000 Rockville Pike, Room 5B-36 Bethesda, MD 20892 Telephone: (301) 496-4792 FAX: (301) 480-3519 Email: [email protected] Direct inquiries regarding fiscal matters to: Mr. Joseph Ellis Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: [email protected] Mr. Edward B. Ellis Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 504 Bethesda, MD 20892-7003 Telephone: (301) 443-4706 FAX: (301) 443-3891 Email: [email protected] Ms. Melinda Nelson Grants Management Branch National Institute of Child Health and Human Development Building 61E, Room 8A17 Bethesda, MD 20892 Telephone: (301) 496-5481 FAX: (301) 402-0915 Email: [email protected] Mr. Martin R. Rubinstein Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-44A Bethesda, MD 20892-6402 Telephone: (301) 594-4800 FAX: (301) 402-1517 Email: [email protected] Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: [email protected] Mr. Bruce L. Ringler Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-2811 FAX: (301) 443-6885 Email: [email protected] Mr. Jeff Carow Grants Management Officer National Institute of Nursing Research 45 Center Drive, Room 3AN-12, MSC 6301 Bethesda, MD 20892-6301 Telephone: (301) 594-6869 FAX: (301) 480-8260 Email: [email protected] Ms. Jane R. Davis Grants Operations Branch Division of Extramural Activities National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0166 FAX: (301) 480-3310 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.866, 93.399, 93.273, 93.393, 93.396, 93.399, 93.242, 93.865, 93.361, and 93.837, 93.121. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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