 Background
In September of 1996, the NIH Office of Extramural Research (OER) announced a special Request for Applications (RFA) focusing on Informed Consent Research Involving Human Participants. The goal of this initiative was to identify and validate methods for improving the informed consent process in scientific research. Coordinated by OER, this inter-departmental and trans- NIH program is being co-sponsored by a number of NIH components, including the National Cancer Institute (NCI), the National Human Genome Research Institute (NHGRI), the National Institute on Aging (NIA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Allergy and Infectious Diseases ((NIAID), the National Institute of Child Health and Human Development (NICHD), the National Institute on Drug Abuse (NIDA), the National Institute of Mental Health (NIMH), and the National Institute of Nursing Research (NINR). The Department of Energy (DOE) and the Department of Veterans Affairs ( VA) have joined with NIH in sponsoring this program, making this RFA the first interdepartmental and trans-NIH research funding program on informed consent.
The sponsoring organizations recognize that there is an ethical as well as a legal responsibility to ensure that individuals both consent to and understand their participation in research. For consent to participate in research to be truly informed, the information imparted to potential participants must clearly explain study procedures, distinguish research from treatment, realistically portray the potential for medical or other benefits from participation and the nature of potential benefit, carefully explain the potential for discomfort, toxicity, or other risks that may accompany participation in the research, and clearly delineate the participant's rights and limits regarding confidentiality and withdrawal from participation.
Intended to be responsive to the White House Committee on Human Radiation Experiments' concern about the process of obtaining informed consent in contemporary research (not limited to radiation), the RFA encouraged research on how to enhance the degree of understanding achieved by research participants on issues such as: developing innovative methods for clearly conveying consent information or for assessing comprehension and reasoning ability required to understand and consent to specific experimental procedures and risks (e.g., placebo controls, stored tissue); identifying the cognitive processes underlying complex decisions, or the determinants for participation, retention, and satisfaction in research; assessing the effect of including relatives, friends, or an ombudsman in the consent process; and identifying ways to address special issues related to patient records, specialized settings (e.g., emergency care, the workplace, the military, and prisons), or specialized populations (e.g., children, elderly, women of child bearing potential, drug abusers, HIV positive, mentally ill, institutionalized, terminally ill, or comatose individuals, and individuals with questionable competence).
The sponsoring organizations set aside a total of $2,250,000 annually to fund between 8 to 11 three-year research grants. Response to the RFA was remarkable, resulting in the submission of 82 applications by the March 11, 1997 deadline. These applications were reviewed in July. Based on the scientific review, a funding package was proposed by the co-sponsors which included the 11 top-rated applications. The applications were sent to the respective NIH advisory councils in September, for proposed funding before October 1, 1997. A twelfth project was paid directly by NHGRI (Miller), and others may be paid by outside agencies or the organizations co-sponsoring this RFA in fiscal year 1998. The grantees will meet annually throughout the three-year life of these projects in order to report progress, discuss problems, and share information related to the conduct of their grants.
An Experimental Study to Improve Risk/benefit Appraisal
Dr. James Sorenson
University of North Carolina
This research will develop, implement, and assess the effectiveness of a low cost component that involves participants in balancing the risk and benefits as a part of the consent process itself . A particular strength of the method is that it includes consideration of the risks and benefit to the participants' self-concept and values, as well as to other family members. Although the participants will be women deciding to accept or reject free hemophilia A carrier testing, the method is highly generalizable to all areas of medicine. This project is supported by the National Human Genome Research Institute.
Therapeutic Research Consent: Empirical/ethical Analysis
Dr. Laura Siminoff
Case Western Reserve University
This research will describe the disclosure and decision making process with three patient populations of potential subjects of Phase III clinical trials: Adult cancer patients, critically ill children, and Alzheimer's disease patients. Participants will be asked what they believe is important in making research participation decisions. Behavior decision analysis theory will be used to examine clinician -participant interactions to identify factors associated with better outcomes. This research is supported by the National Cancer Institute, the National Institute on Aging, the Department of Veterans Affairs, and the National Institute on Drug Abuse.
Dynamics of Informed Consent in AIDS Clinical Trials
Dr. Mary-Rose Mueller
UCSF
This qualitative study will identify and describe the social processes and dynamics of informed consent in public and privately funded AIDS clinical trial research, and analyze and compare how the organization and social context of AIDS research affects the approaches, interpretations, and decision-making practices of health professionals and patients. The project will give focused attention to how the various parties to the informed consent process coordinate their different (and sometimes conflicting) interests regarding clinical research trials. This grant is supported by the National Institute of Nursing Research.
Dementia Research: Informed, Proxy, and Advance Consent
Greg Sachs, MD
University of Chicago
This project will empirically study the feasibility and and effectiveness of different methods for facilitating ethical research on subjects with dementia. By combining the perspectives of several disciplines, and by using research vignettes and analysis of videotaped consent encounters, this project will answer practical questions about: the ability of dementia subjects to participate in research decision making despite their impairments; the utility of a multidisciplinary approach to yield a deeper understanding of informed consent and proxy consent for dementia research; and the effectiveness of an advance consent process involving dementia subject and proxy together. This research is supported by the National Institute on Aging, the National Institute of Mental Health, and the Veterans Administration.
Vulnerability and Informed Consent in Clinical Research
Dr. Laura Roberts
University of New Mexico
This study seeks to clarify the subjective responses of patients to informed consent in clinical research and to determine whether an educational intervention for clinical researchers enhances their awareness of the consent process. This study includes two components. The first component involves interviews with patients who have psychiatric disorders (schizophrenia, major depression, PTSD), lung cancer, AIDS, and healthy controls. This component will examine attitudes, motivations, and perceptions of different patient populations towards research. The hypothesis is that patients with different clinical syndromes will exhibit diagnostic-specific differences with respect to subjective aspects of informed consent. The second component involves an educational intervention targeted toward researchers, to examine the effectiveness of the intervention in enhancing the researchers' sensitivity to the subjective experiences of clinical populations. This research is supported by the National Institute of Mental Health and the National Institute on Drug Abuse.
Improving Understanding in Early Phase Clinical Trials
Dr. Nancy Kass
Johns Hopkins University
Baltimore, MD
This project focuses on using an intervention to enhance understanding of the nature of early phase clinical research in patients eligible for such trials in HIV and oncology at the Johns Hopkins Hospital and Duke University Medical Center respectively. The intervention uses a patient activation component which is intended to "activate" or "empower" a patient to negotiate differently with their health care provider. This intervention has been used effectively in the health education arena, but has never been tested in early clinical trials. The National Institute of Allergy and Infectious Diseases is supporting this project.
Enhancing Autonomy of Vulnerable Subjects of Research
Dr. Laurence McCullough
Baylor College of Medicine
Houston, TX
This research aims to identify and remove the barriers to autonomy of four populations of vulnerable subjects of research: adolescent patients; patients with HIV infection; patients with mental illness; and geriatric patients. The projects consists of two interrelated objectives: 1) to use focus group research to identify barriers to the exercise of autonomy among these populations, and to design a trial of interventions to remove these barriers and 2) to develop and validate instruments to measure intentionality, understanding, non-control, and the perception of barriers to autonomy. This application is supported by the National Institute of Nursing Research, the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Aging, and the Department of Veterans Affairs.
Improving the Consent Process for Low-Literacy Parents
Dr. Frances Campbell
University of North Carolina
Chapel Hill, NC
Consent forms serve to guarantee that human beings participating in research are fully informed of their rights and of the procedures, risks, and benefits of any studies they agree to join. One significant problem accruing to the process of obtaining informed consent concerns the presentation of the necessary information. The research proposed by Dr. Campbell is designed to (a) examine the readability and comprehensibility of currently employed consent forms, and (b) examine the media through which information is communicated to low-literacy subjects, represented by the parents of Head Start children. The research will include the development of materials in alternative media (such as videotape enhancement, and interactive multimedia presentations). It will also include the testing of subjects' comprehension of information presented, and their willingness to consent to their children's participation in research as a function of these various media. This project is supported by the National Institute of Child Health and Human Development and the National Institute of Mental Health.
Minors at Risk of Future Disease: Their Role in Research
Dr. Gail Geller
Johns Hopkins University
Baltimore, MD
This study will explore the process by which families at increased risk of adult-onset disease decide to involve their children in research on genetic susceptibility. Through interviews with parents at increased risk for heart disease and breast cancer, their children between the ages of 10 and 17, and the physicians they identify as influential, the investigators will explore perceptions about the motivations and barriers to participation of children in research on genetic susceptibility to these two diseases. In addition, the study will compare families from different cultural backgrounds (African-American, Jewish and Caucasian non-Jewish) and children at different stages of cognitive development. This study is supported by to the National Institute of Child Health and Human Development , the National Human Genome Research Institute, the National Institute on Drug Abuse, and the National Cancer Institute.
Evaluating Informed Consent in BRCA1 and BRCA2 Screening
Dr. James Gribble
Research Triangle Institute
Research Triangle, NC.
Acknowledging and responding to cultural differences is an important factor in our diverse society. This is no less true when discussing cancer risk information. This project will develop and validate alternative methods for administering informed consent in clinical trials to diverse populations of women at increased risk for breast cancer. It will also standardize the instruments used to evaluate the effect. The information which this study will provide is supported by the National Cancer Institute, the National Human Genome Research Institute, the National Institute on Drug Abuse, and the Office of Behavioral and Social Sciences Research.
Informed Consent to DNA Banking for Research
Jon Frederick Merz, MBA
Unversity of Pennsylvania
This project will develop and assess a model consent process for General Clinical Research Center patients being asked to donate blood to a DNA bank. The study will make extensive use of focus groups to further refine the consent form, and then test the use of vignettes against a traditional consent form, using a brief questionnaire to assess knowledge and attitudes. This study is supported by the National Human Genome Research Institute, the Department of Energy, and the National Institute of Allergy and Infectious Diseases.
Facilitating Well-Informed Decisions for BRCA Testing
Dr. Suzanne Miller
Fox Chase Cancer Center
Philadelphia, PA
This project is designed to develop and assess a core intervention, based on the state-of-the-art theory and research in order to facilitate well-informed decisions for BRCA1/2 testing. In a randomized controlled trial, it will compare the Cognitive-Affective Preparation (CAP) procedure with General Health Information (GHI) serving as the control condition. In addition, the study will explore the influence of characteristic individual differences in styles of coping with health threats, focusing on the impact of high monitoring (e.g. scanning for cancer-related cues) vs. low monitoring (e.g. distraction from cancer-related cues) on information processing, on the genetic testing decision, and on adaptation to the consequences. The research carried out in this project is of particular interest to the National Human Genome Research Institute.
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