IRB: Ethics & Human Research


Vol. 33, No. 5, September-October

Pediatric Magnetic Resonance Research and the Minimalrisk Standard
Magnetic resonance imaging (MRI) research combines powerful electromagnetic forces and sophisticated electronic technology to provide privileged glimpses into the human body. These features make the field a proving ground for ethical debate on research...
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The Merits of Procedure-Level Risk-Benefit Assessment
Medical research exposes research subjects to various procedures to gather data, and these procedures usually involve some risks. One of the central requirements for ethical medical research is that these risks are reasonable in relation to the potential...
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Researcher Experiences with IRBs: A Survey of Members of the American College of Neuropsychopharmacology
In recent years there has been growing frustration on the part of some researchers, research ethics experts, and others that the policies and practices of institutional review boards (IRBs) often create unnecessary barriers for the human research enterprise....
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Vol. 33, No. 4, July-August

Decisional Capacity and Consent for Schizophrenia Research
Concerns about the capacity of people with schizophrenia to provide informed consent to participate in research stem, in part, from worries that the associated cognitive deficits and/or psychotic symptoms of the disorder--delusions, hallucinations,...
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Justifying Research Risks in a Clinical Trial for Treatment of Multidrug-Resistant Tuberculosis
Investigators and ethics review committees must en sure the proper justification of risks to participants in clinical trials. (1) Despite the existence of a systematic framework for analyzing the ethical evaluation of research risks, (2) the literature...
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Vol. 33, No. 3, May-June

Broad Data Sharing in Genetic Research: Views of Institutional Review Board Professionals
Institutional review boards (IRBs) play a key role in J. ensuring that genetic research with humans meets ethical and regulatory standards. They are involved with issues such as how research participants will be informed about researchers' intent to...
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Off the Beaten Path: Conducting Ethical Pragmatic Trials with Marginalized Populations
In October 2009, the Mental Health Commission of Canada (MHCC) began recruiting participants for its At Home/Chez Soi (AHCS) project. The AHCS project is designed as a pragmatic trial intended "to provide policy relevant evidence [i.e., effectiveness...
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Parents' Understanding and Recall of Informed Consent Information for Neonatal Research
Numerous studies have shown that research participants often fail to understand important core requirements of informed consent: the purpose of the study, its risks and benefits, that participation is voluntary, and that they have the right to discontinue...
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Vol. 33, No. 2, March-April

(Mis)understanding Exploitation
The notion of exploitation frequently crops up in -A- discussions about the ethics of biomedical research. A standard concern about clinical trials is that they exploit research subjects for the benefit of future patients. This concern is particularly...
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Informed Consent Language and Parents' Willingness to Enroll Their Children in Research
Federal regulations governing research with humans require that specific information be provided to potential research participants in the informed consent process: 1) that the study involves research, with a description of its purpose, duration, and...
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Protecting Research Subjects: IRBs in a Changing Research Landscape
When the model for institutional review boards (IRBs) was codified in 1981 in federal regulations governing research with humans, biomedical research was primarily conducted at academic medical centers in large urban communities. Each academic center...
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Vol. 33, No. 1, January-February

Unrealistic Optimism in Early-Phase Oncology Trials
Early-phase oncology trials are vital for developing new and more effective therapies for treating cancers. While it is possible that some of these trials provide benefit to patient-subjects, (1) it is widely recognized that early-phase trials are...
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Consent for Future Genetic Research: The NHANES Experience in 2007-2008
The National Health and Nutrition Examination Survey (NHANES) is a program of studies conducted since the 1960s by the National Center for Health Statistics of the U.S. Centers for Disease Control and Prevention. Its purpose is to obtain information...
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Institutional Not-for-Cause Compliance Review Programs
Over the last few years, many academic institutions have begun to routinely audit ongoing research with human subjects to identify and mitigate risks to research participants, to ensure compliance with approved protocols, and to educate investigators...
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Vol. 32, No. 6, November-December

Research with Decisionally Incapacitated Older Adults: Practices of Canadian Research Ethics Boards
Although research has provided great insight into neurodegenerative disorders such as Alzheimer disease and other dementias, additional studies are needed to prevent these disorders, delay disease onset, reduce the caregiver burden, and develop more...
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Enhancing Research Ethics Decision-Making: An REB Decision Bank
In both common law and ethics, precedent shapes the deliberation of novel issues. (1) While new cases may challenge the sufficiency of existing laws and regulations, consideration and alignment with prior decisions nonetheless promotes consistent,...
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Ideal vs. Real: Revisiting Contraceptive Guidelines
We read, with interest, the lead article in the September-October 2010 issue of IRB: Ethics & Human Research. (1) We are grateful to Chris Kaposy and Frangoise Baylis for keeping the important issue of the ethical use of contraception in research...
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Vol. 32, No. 5, September-October

Ethical, Evidence-Based Guidelines for Contraceptive Use in Research
Research ethics review committees commonly approve protocols that require women of childbearing potential to use one or two means of birth control while enrolled in clinical drug trials, and sometimes the means of birth control are specified (e.g.,...
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IRBs and Ethically Challenging Protocols: Views of IRB Chairs about Useful Resources
Institutional review boards (IRBs) often review research protocols that raise significant ethical issues. Such issues include informed consent for research with vulnerable populations, including those who may lack decision-making capacity; potential...
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Vol. 32, No. 4, July-August

Comprehension and Informed Consent: Assessing the Effect of a Short Consent Form
Although informed consent is a fundamental ethical requirement for research with humans, many studies indicate that research volunteers often do not understand critical aspects of the research in which they are participating, suggesting that the "informed"...
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Assessing the Readability of Non-English-Language Consent Forms: The Case of Kiswahili for Research Conducted in Kenya
One of the fundamental ethical requirements for research with humans is that individuals provide valid informed consent to participate in research studies. (1) A key issue regarding the validity of informed consent is whether individuals understand...
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Assessing the Quality of Human Research Protection Programs: The Experience at the Department of Veterans Affairs
In the late 1990s and early 2000s, federally supported research programs at a number of major academic institutions were temporarily suspended in response to persistent noncompliance with federal regulations governing research with humans. These suspensions...
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Vol. 32, No. 3, May-June

The Process Is the Product: A New Model for Multisite IRB Review of Data-Only Studies
Over the past decade, support for reexamining and reconsidering the U.S. model of ethics review for protocols involving research with humans has grown, (1) particularly for studies involving participants from multiple locales and organizations. This...
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The Evolution of Consent Forms for Research: A Quarter Century of Changes
The informed consent process in the research context typically relies heavily on information provided to potential research participants in a written consent form. Federal regulations governing research with humans list the elements of information...
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Canadian Research Ethics Boards and Multisite Research: Experiences from Two Minimal-Risk Studies
Numerous studies have identified the challenges researchers face when attempting to obtain ethics approval for multisite studies. For instance, Greene and Geiger have identified delays in achieving ethics approval across sites, excessive associated...
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Vol. 32, No. 2, March-April

OHRP Compliance Oversight Letters: An Update
In this article, we describe our review of 23 5 compliance oversight determination letters that the Office for Human Research Protections (OHRP) issued to 146 institutions between August 1, 2002, and August 31, 2007. Our previous review of 269 determination...
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Genetic Research with Stored Biological Materials: Ethics and Practice
Many biomedical advances--particularly advances involving genetics--have only been achieved through research with human biological materials. (1) Such research has been critical in identifying genes and gene changes associated with disease or disease...
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Vol. 32, No. 1, January-February

Genomic Research Data: Open vs. Restricted Access
The free and open exchange of information is an essential part of scientific methodology and ethics. Openness plays an important role in collaboration, accountability, replication, discovery, and debate in science, and helps to promote the development...
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Bipolar Mania and Capacity to Consent: Recommendations for Investigators and IRBs
In 1998 the National Bioethics Advisory Commission (NBAC) released a report entitled Research Involving Persons with Mental Disorders That May Affect Decision-Making Capacity. (1) The Commission expressed concern that certain mental disorders--including...
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Motivated by Money? the Impact of Financial Incentive for the Research Team on Study Recruitment
Biomedical research is a very competitive arena. Investigators not only compete for internal and external funding for their clinical trials, but also for healthy people or patients to enroll in their studies. Indeed, one of the largest obstacles investigators...
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Vol. 31, No. 6, November-December

Points to Consider: The Research Ethics Consultation Service and the IRB
Research ethics consultation was first mentioned in the published literature nearly 20 years ago when Singer and colleagues described a collaborative process between clinical investigators and ethicists to analyze the ethics of liver transplants using...
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Voluntariness of Consent to Research: A Preliminary Empirical Investigation
Providing informed consent to participate in research--a primary pillar of the ethical conduct of research--is based on three components: adequate information, a competent decision-maker, and a voluntary decision process. (1) Techniques have been developed...
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Vol. 31, No. 5, September-October

Competing Commitments in Clinical Trials
Scholars of the ethics of clinical trials have long recognized a tension between the therapeutic obligations (1) of clinicians (physician, nurses, and other health professionals) and the scientific demands of clinical trials. (2) The basis for this...
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An Approach to Evaluating the Therapeutic Misconception
A natural worry among bioethicists is that persons with severe neurological or psychiatric disorders may be so desperate for a cure that they are particularly vulnerable to exploitation in high-risk research studies because they are under a therapeutic...
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Factors That Influence Institutional Review Board Members' Commitment to Their Role Responsibilities
A growing body of empirical research exists on institutional review board (IRB) characteristics, (1) methods of review and decision-making practices, (2) and variability in methods among IRBs domestically and internationally. (3) However, there is...
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Vol. 31, No. 4, July-August

A Consent Form Template for Phase I Oncology Trials
The two primary components of the consent process A for research are a consent form and a discussion between the investigator and the potential research participant. Although empirical assessments of consent forms suggest that the majority contain...
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Canadian Research Ethics Boards, MRI Research Risks, and MRI Risk Classification
Magnetic resonance imaging (MRI) research has been increasingly conducted in recent years--a fact that parallels the growing pervasiveness of MRI examinations in the clinic. The optimism around the potential uses of MRI is not only tied to its ability...
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Struggling with the Dilemma of Exploitation in the Developing World
The nine essays on the topic of exploitation and clinical research in developing countries in this book originated from a seminar series on the topic at the Department of Clinical Bioethics of the National Institutes of Health in 2002. The editors...
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Vol. 31, No. 3, May-June

An Intervention to Improve Cancer Patients' Understanding of Early-Phase Clinical Trials
The consent process for human subjects research educates potential participants about research risks, benefits, and procedures so they can make an informed decision about whether to enroll in a clinical trial. Yet numerous studies demonstrate that...
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Problems with Minimal-Risk Research Oversight: A Threat to Academic Freedom?
Although criticism of a powerful bureaucratic body is expected, your local institutional review board (IRB) might deserve a touch of sympathy, having been subjected to withering critique in recent years for a long list of sins. The observed faults...
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Data-Sharing Dilemmas: Allowing Pharmaceutical Company Access to Research Data
Dilemmas sometimes arise in interactions between the organizations that conduct clinical research and the pharmaceutical companies that sponsor the trials and are interested in study participants' information. These dilemmas can occur when new uses...
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Vol. 31, No. 2, March-April

Reformed Consent: Adapting to New Media and Research Participant Preferences
The principle of respect for persons clearly demands that investigators communicate with potential research participants in a way that fosters comprehension of the information relevant to deciding whether to enroll in a particular study. (1) Federal...
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Research Ethics Consultation at the Johns Hopkins Bloomberg School of Public Health
Although many hospitals have long offered a clinical ethics consultation service to their physicians, patients, and allied health professionals, formal ethics consultation in the research setting is a relatively new development. (1) This article describes...
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Consent and Population Genomics: The Creation of Generic Tools
In recent years, the number of genomic databases or "biobanks" being created for use in research has grown significantly. While the term "biobank" has been used to describe many collections of samples and data, a "population biobank" has been defined...
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Vol. 31, No. 1, January-February

Including Persons with Alzheimer Disease in Research on Comorbid Conditions
Alzheimer disease is a progressive neurodegenerative condition that affects 4.5 million people in the United States, with the number expected to rise dramatically over the next fifty years due to the aging of the population. (1) The prevalence of Alzheimer...
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Community Hospital Oversight of Clinical Investigators' Financial Relationships
In response to growing concerns over conflicts of interest in clinical research, considerable attention has been paid in recent years to clinical investigators' financial interests in the studies they conduct. To date, most of this attention has focused...
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IRB Policies regarding Finder's Fees and Role Conflicts in Recruiting Research Participants
Conflicts of interest may arise during the recruitment of research subjects in several ways. Financial conflicts of interest may arise when research sponsors (or their agents) pay members of the research team or clinicians to identify potential participants...
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Vol. 30, No. 6, November-December

Research Ethics Consultation: The Stanford Experience
Although bioethicists and institutions have long provided ethics consultations on an individual basis, research ethics consultation is still a relatively new concept (1) as an institutionalized service and has been limited primarily to consultation...
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Oncology Consent Forms: Failure to Disclose Off-Site Treatment Availability
Many research studies investigate new uses of medications that are commercially available. (1) For example, cancer researchers often conduct studies to determine whether a chemotherapy agent approved by the Food and Drug Administration (FDA) to...
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The Antidepressant Debate and Ethically Defensible Placebo-Controlled Trials
A basic tenet of biological psychiatry is that placebo-controlled, randomized drug trials under double blind have shown that antidepressants exert pharmacological efficacy--in other words, that they induce specific and measurable drug effects on...
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Vol. 30, No. 5, September-October

Knowledge of Regulations Governing Pediatric Research: A Pilot Study
A growing awareness of the paucity of evidence for most treatments in pediatric medicine (1) has led to a rapid increase in the number of clinical trials involving children. (2) This means that some Institutional Review Boards (IRBs) are increasingly...
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Nonscientist IRB Members at the NIH
A fundamental stipulation of the federal regulations governing research with humans is that Institutional Review Boards (IRBs) have a membership diverse in race, gender, and cultural backgrounds and be sensitive to issues such as community attitudes....
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Identifying the Human Research Subject in Cluster Randomized Controlled Trials
A cluster randomized controlled trial (RCT) is a research design in which organizational, social, or geographically-defined units rather than individuals are randomized between or among comparator interventions. They are also referred to as group-controlled...
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Improving the Quality of Informed Consent to Research
A substantial body of work has demonstrated that many research subjects have significant misunderstandings about the clinical trials in which they agreed to participate, despite lengthy informed consent documents and detailed explanation of the research...
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Vol. 30, No. 4, July-August

How Should We Communicate the Likelihood of Risks to Inform Decisions about Consent?
A longstanding concern in research ethics is whether prospective research participants are given adequate information about the potential risks of research participation during the informed consent process. (1) This review of some of the literature...
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The Research and Family Liaison: Enhancing Informed Consent
The advancement of medical diagnosis and treatment requires scientifically sound and ethically appropriate research involving human participants. The inclusion of children in research necessitates assuring adequate protection for a population that...
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International Perspectives on the Collection, Storage, and Testing of Human Biospecimens in HIV Research
Biomedical research that seeks to advance health knowledge and medical practice is an overall social good. However, there is a wide range of professional and lay perspectives regarding the distribution of benefit from research involving human biospecimens....
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Vol. 30, No. 3, May-June

Marginalized Populations and Drug Addiction Research: Realism, Mistrust, and Misconception
Making a reasoned decision to participate in a randomized controlled trial requires, among other factors, understanding of the uncertain efficacy and risks of the experimental treatment, random assignment to interventions, and the use of placebos or...
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Continuing Ethics Review Practices by Canadian Research Ethics Boards
The main role of research ethics boards (REBs) is to review proposed research studies to determine if they meet ethical and regulatory requirements governing research with humans. This review includes assessing the risk of potential harms to research...
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How Independent Are IRBs?
What does it mean to say that ethics committees that provide prospective review of research involving human beings are "independent"? Independent of what or whom? Independent in what way or ways? And can they ever be truly independent? Most international...
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Vol. 30, No. 2, March-April

Research Benefits for Hypothetical HIV Vaccine Trials: The Views of Ugandans in the Rakai District
Collaborative, multinational clinical research is complicated by thorny ethical issues, especially when sponsored by developed world entities and conducted in the developing world. An overarching ethical concern in all research is the possible exploitation...
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Effective Use of Consent Forms and Interactive Questions in the Consent Process
As noted by the U.S. Department of Health and Human Services' Office for Human Research Protections (OHRP), "Informed consent is a process, not just a form.... The procedures used in obtaining informed consent should be designed to educate the subject...
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Clinical Research in Low-Literacy Populations: Using Teach-Back to Assess Comprehension of Informed Consent and Privacy Information
Ensuring informed consent of participants in clinical research is a significant challenge. (1) During the consent process, prospective participants must be provided with adequate information in order to make an educated decision about whether to enroll...
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Vol. 30, No. 1, January-February

A Study to Evaluate the Effect of Investigator Attendance on the Efficiency of IRB Review
Institutional Review Boards (IRBs) are challenged to review increasing volumes of proposed research studies while meeting high ethical and regulatory standards. (1) A growing literature has documented concerns about the IRB review process, including...
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Impact of a Clinical Trials Information Handbook on Patient Knowledge, Perceptions, and Likelihood of Participation
If evidence-based medicine is the backbone of modern medical practice, clinical trial results are the vertebrae. Appropriately designed randomized clinical trials provide valid assessments of the safety and efficacy of treatments, diagnostics, and...
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Disclosure of Information to Potential Subjects on Research Recruitment Web Sites
Recruitment practices in clinical research may be changing rapidly as use of the Internet grows. Last year, 73% of Americans were reported to be using the Internet. (1) Yet despite the developing influence of the Internet as a tool for reaching...
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Vol. 29, No. 6, November-December

Maintaining Informed Consent Validity during Lengthy Research Protocols
Valid informed consent is a cornerstone of ethical clinical research. A great deal of work has been undertaken to improve the informed consent process for clinical research, largely targeting the adequacy of consent at the time of a subject's enrollment...
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How to Make Consent Informed: Possible Lessons from Tibet
The informed consent process is an essential component of ethical clinical research. (1) Despite the growing emphasis on the use of simple, nontechnical language and clear explanations, (2) researchers and ethicists are concerned that many individuals,...
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Vol. 29, No. 5, September-October

Ethical Review of Interpretive Research: Problems and Solutions
Since prior review and approval of human subject research became standard some thirty years ago, social scientists have voiced concern about the ways in which the rules and regulations that structure ethics review may affect their research practices....
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Moving beyond Compliance: Measuring Ethical Quality to Enhance the Oversight of Human Subjects Research
The procedural requirements of the U.S. federal regulations designed to protect human subjects are now well institutionalized. (1) These requirements include the mandate that an Institutional Review Board (IRB) review and approve research studies before...
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Are the New EPA Regulations concerning Intentional Exposure Studies Involving Children Overprotective?
On February 6, 2006, the Environmental Protection Agency (EPA) adopted new regulations regarding research with human subjects, after an eight-year battle among environmental groups and pesticide companies concerning human pesticide testing. (1) The...
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Clear Recommendations to Reform Pediatric Research
The nature of medical research involving children has evolved in the United States and abroad as the need to protect this vulnerable population has become more widely recognized. Changes include increased scientific and public awareness of pediatric...
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Vol. 29, No. 4, July-August

Who Should Go First in Trials with Scarce Agents? the Views of Potential Participants
Demands from AIDS activists in the 1980s for access to drugs not approved by the U.S. Food and Drug Administration (FDA) resulted in multiple programs to increase access, including single-patient treatment Investigational New Drug (IND) applications,...
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Informed Consent for Dementia Research: The Study Enrollment Encounter
Dementia is a major public health problem that affects about 4.5 million elders in the United States. (1) The prevalence of Alzheimer disease (AD)--one of several types of dementia--is expected to nearly quadruple in the next 40 years. (2) The need...
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Does Size Matter? Salience of Follow-Up Payments in Drug Abuse Research
Clinical outcomes studies frequently provide payment incentives to research participants for completing follow-up assessments. The payments are intended to compensate participants for their time and effort and to encourage those who might otherwise...
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Vol. 29, No. 3, May-June

Third-Party Risks in Research: Should IRBs Address Them?
In addition to risks to individual research subjects, scientific research poses risks to third parties and to groups. Genetic research presents such significant third-party risks to groups that the National Human Genome Research Institute at the National...
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The Many Ways of Saying Yes and No: Reflections on the Research Coordinator's Role in Recruiting Research Participants and Obtaining Informed Consent
It is now common to read in the clinical research literature that informed consent is more than the act of signing a consent form--rather, it is a process that extends throughout the research subject's clinical trial experience. (1) Various studies...
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Monitoring Reportable Events and Unanticipated Problems: The PHAROS and PREDICT Studies of Huntington Disease
The continual discovery of human genes linked to disease has led to increasing numbers of longitudinal studies. These types of studies observe healthy individuals identified by family history or genetic testing to be at high risk for the disease phenotype....
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First Impressions: The Experiences of a Community Member on a Research Ethics Committee
Two years ago, a friend of mine on the research ethics committee at the Sir Mortimer B. Davis Jewish General Hospital suggested I join as a community representative. I thought it over and decided to give it a try. I sent a CV to the research ethics...
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