Abstract: The practice of paying prisoners to for their participation in research has long been debated, and the controversy is reflected in the differing policies in the U.S. prison systems. Empirical...

Abstract: In the United States, final amendments to the Federal Policy for the Protection of Human Subjects (“the Common Rule”) were published on January 19, 2017, and they will take effect...

Abstract: Net-risk pediatric research encompasses interventions and studies that pose risks and do not offer a compensating potential for clinical benefit. These interventions and studies are central to efforts to improve...

Abstract: Given the numerous questions related to patient selection, surgical technique, and posttransplant care requiring evidence-based answers, transplantation programs should be conducting research with patients waiting to receive an organ...

Abstract: Surrogates’ decisions and advance directives currently offer the best opportunities for people to participate in research at times of decisional incapacity. We investigated which of these options better reflects an...

Abstract: Previous research has focused on the risks of research participation but has rarely considered possible benefits. For a study of family decision-making during pediatric bone marrow transplant, we conducted qualitative...

Abstract: Providing incentives is an accepted and common practice in human subjects research, including clinical HIV research. While we know that financial incentives among similar studies can greatly vary, surprisingly...

Abstract: Appropriate enrollment in early-phase clinical trials demands that potential research participants understand and appreciate critical study-related information, because discrepancies in understanding or appreciation can potentially invalidate informed consent to participate...

Abstract: While the use of nudges in public health initiatives and in obtaining informed consent to medical treatment recently has received considerable attention and support, there has been little consideration...

Abstract: We performed a content analysis of reliance agreement templates from 73 of the top U.S. research institutions ranked by research funding. Of the institutions in our sample, 67.1% used...

Abstract: Institutional review boards (IRBs) are tasked with reviewing language concerning reproductive risks in consent forms for clinical trials. Generally, pregnant women are excluded from clinical trials, and consent forms...

Abstract: In keeping with recent regulatory and policy requirements, a large proportion of multisite studies will be using a single institutional review board (IRB) of record. Further research is needed...

Abstract: In this set of invited commentaries, Rebecca Dresser, Stephanie Solomon Cargill, Nancy M. P. King, and Carl Elliott focus on the issue of giving research participants a voice in...

Although study subjects are often called partners in research, they actually have very little power in the research world. This ought to change. Subjects are the only people who know...

In the lead commentary in this issue of IRB: Ethics & Human Research, Rebecca Dresser advocates increased involvement of experienced research subjects in the design, conduct, and oversight of human...

While Rebecca Dresser, in this issue, provides a strong argument for the inclusion of experienced research participant voices in research ethics discussions, a major challenge to her argument lies in...

At the heart of the United States medical research enterprise is a tremendous injustice. Unlike virtually every other country in the developed world, the United States does not guarantee payment...

Abstract: Presurgical trials use a novel research design in which cancer patients receive an investigational drug in the interval between their diagnostic biopsy and their surgical resection. Such trials involve...

Abstract: The Patient-Centered Outcomes Research Institute (PCORI), the leading research institute in the United States for patient-centered outcomes research (PCOR), funded our multiyear mixed-methods project, the Patient Centered Outcomes Research...

Abstract: The Food and Drug Administration (FDA) requirements for pediatric research, “Additional Safeguards for Children in Clinical Investigations,” provide an ethical framework for whether and under what conditions children can...

For this theme issue, we invited leading experts and scholars in research ethics to identify and reflect on some of the important changes that the U.S. Department of Health and...

Abstract: The revised Common Rule contains several changes designed to reduce the time institutional review boards (IRBs) spend on overseeing low-risk studies, including an expansion of the categories of research...

Abstract: The revised Common Rule, published in January 2017, was the result of an arduous and lengthy process and of missed opportunities to rebalance foundational ethical principles and thereby to...

Abstract: Research consent forms provide important fodder for empirical analysis but can be difficult for those not running or participating in a particular study to access. Recognizing this problem, ClinicalTrials.gov...

Abstract: On January 19, 2017, the Office for Human Research Protections, released an updated “Common Rule” that was the product of a six-year administrative odyssey to modernize and improve the regulations...

Since 1998, the National Cancer Institute (NCI) has mandated that researchers use its consent form template in developing consent forms for their NCI-funded clinical trials. The template was substantially revised...

This study entailed conducting extensive qualitative interviews of mothers who had been invited to have their infants participate in the Kilimanjaro Intermittent Preventive Treatment of Malaria in Infants (Kili IPTi)...

In Silent Partners: Human Subjects and Research Ethics, Rebecca Dresser extends her work on research ethics and the experience of illness into fruitful new territory, arguing that experienced research subjects...

Offers of payment to research participants, though quite common, persist as a source of ethical controversy. U.S. regulations governing human subjects research do not specifically address offers of payment; yet,...

Understanding how patients decide whether to enroll in research can help improve educational materials, protocols, and recruitment rates. However, little is known about patients’ willingness to participate in research on...

The ethical review of research on adolescent sexual behavior is challenging. Investigators and institutional review boards (IRBs) alike struggle with pediatric risk categorizations for research on sexual health and other...

Quality improvement (QI) is now an important part of the health care delivery system, and health care systems have an obligation to evaluate QI initiatives. However, federal human research regulations...

Heightened global commitment to research on diseases such as HIV/AIDS, tuberculosis, and malaria has led to increased research over the past decade in many African countries, including Nigeria. This increase...

Pregnancy testing is often required for participation in clinical research, but little published literature addresses the special issues that arise when adolescents who are not legal adults are eligible to...

Research oversight bodies conducting for-cause investigations often fail to interview research subjects who have complaints of mistreatment. I argue that this failure is a mistake for three reasons. First, because...

This paper discusses the ethics review by one of the three research ethics committees that approved the Ebola vaccine trial carried out in the Republic of Guinea in 2015. It...

As reported elsewhere, we recently conducted a study—the Effective Delivery of Informed Consent (EDICT) study—designed to advance the use of shorter informed consent forms (ICFs) in clinical research. Previous research...

Death by suicide is a leading cause of fatality among individuals aged 15 to 44, but practical ethical challenges related to suicide are seldom discussed. We conducted a scoping review...

Activities such as continuous quality improvement, comparative effectiveness research, and electronic medical record review—collectively referred to as research on medical practices (ROMP)—are posing more and more challenges for meeting regulatory...

At the federal level in the United States, development of regulations is governed by the Administrative Procedure Act (APA), the statute by which Congress authorized various federal agencies to develop...

Abstract: Because children are presumed to have insufficient cognitive ability to consent to participate in research, pediatric research raises particular ethical and legal issues. For children who have not reached...

Abstract: The Office for Human Research Protections (OHRP) is responsible for overseeing compliance with the Department of Health and Human Services’ regulations governing research with human subjects. This article describes...

Abstract: Effective communication of informed consent is challenging for individuals with low health literacy. The existing literature in this field highlights that research participants often do not adequately comprehend informed...

In March 2015, the U.S. Food and Drug Administration (FDA) issued draft guidance specific to the use of electronic informed consent (eIC) in FDA-regulated clinical investigations. In an effort to...

Social psychological research has demonstrated that people are often unrealistically optimistic about their chances of experiencing future positive and negative outcomes. Past research has found significant levels of this bias...

Robert Klitzman’s provocatively titled book, The Ethics Police? The Struggle to Make Human Research Safe, explores the often contentious relationship between the scientists who conduct human subjects research and the...

Ten Veterans Affairs’ research facilities with institutional review board (IRB) continuing review lapse rates that were higher than the Veterans Affairs’ national average for three consecutive years, from 2011-2013, developed...

Employees who participate in employer-based research are vulnerable subjects, due to their susceptibility to coercion or undue influence in the work environment. Investigators, institutional review boards (IRBs), and employers should...

The primary objective of this study was to describe parents’ and children’s perceptions of the health benefits of research participation. We assessed 180 children ages 8 to 17 years who...

In a number of biomedical science fields, a lack of reproducibility of research results has caused alarm about wasted resources, both human and financial.1 The inability to replicate findings has...

The informed consent process for clinical research is one that includes personal interactions, the informed consent document, and an individual’s decision about whether to participate in research. The intent is...

Some proponents of community-engaged research (CEnR) have suggested that federal regulations governing research with humans (the Common Rule) should be fundamentally altered and that institutional review boards (IRBs) should incorporate...

Human biospecimens are essential to uncovering the basis of human health and disease. Each year, millions of biospecimens are collected from both living and deceased donors for a variety of...

Clinical researchers struggle to meet subject recruitment goals, with one-third of studies underenrolled. Compounding this problem, ethnic and racial minorities are largely underrepresented in clinical research, limiting the ability of...

Recent discussions of the ethics of clinical research, and especially early phase cancer trials, have identified the optimistic bias, also known as “unrealistic optimism,” as a possible defect in the...

Is it ever ethical to conduct a randomized controlled trial (RCT) without consent?1This surprising question is increasingly being asked2owing to great interest in RCTs that compare widely used “standard” treatments...

This paper discusses findings of a study examining whether inmate participants in clinical research experience their participation as exploitative and what opinions they have regarding access to research in general....

Efforts to strengthen the capacity of research ethics committees in Africa to date have largely targeted their chairs and members, neglecting an explicit focus on research ethics committee administrators, who...

Few data exist pertaining to the perceived burdens or benefits experienced by medically ill children from participating in psychological research, particularly in outpatient pediatric settings. As part of a larger...

Preterm infants in the neonatal intensive care unit are a vulnerable population whose parents are frequently approached to have their infants involved in research. However, few studies have addressed the...

In July 2011 the U.S. Department of Health and Human Services (DHHS) published in theFederal Registeran Advance Notice of Proposed Rule Making (ANPRM) entitled “Human Subjects Research Protections: Enhancing Protections...

In the present paper, we revisit the minimal risk standard to identify an appropriate benchmark for the nature and magnitude of risk associated with incidental findings (IFs). We review the...

Medical researchers, institutional review boards, research ethicists, and other scholars have variously portrayed the relationship between researchers and participants as akin to donor, doctor-patient, commercial, legal, community-individual, or collaborative relationships....

It is often said that research participants fail to understand that the purpose of research is not primarily to benefit them, which is a sign of therapeutic misconception (TM). We...

Clinical research with human subjects is key to progress in understanding and improving human health. Research of this type that is supported by the U.S. government follows a system of...

Although pain is identified as a characteristic that makes potential research participants a vulnerable population requiring special protections, few studies have formally evaluated the decisional capacity of individuals in acute...

When health researchers conduct studies in low-resource settings, they sometimes anticipate or encounter ancillary-care needs that raise ethical questions about how they ought to respond. Ancillary care (AC) is health...

On July 26, 2011, the U.S. Department of Health and Human Services (HHS) published proposed changes to the Common Rule, the federal regulation that governs much of the federally funded...

Researchers who conduct electronic surveys are increasingly using lotteries to attract participants. These lotteries are permissible under federal regulations, but attitudes among bioethicists and institutional review board (IRB) members toward...

The use of biospecimens from biobanks raises a unique set of issues for researchers and institutional review boards (IRBs) that can complicate human subjects protections and may hinder the development...

The Federal Policy for the Protection of Human Subjects, also known as the Common Rule, requires that institutional review boards (IRBs) conduct continuing review of human research at intervals appropriate...

Multicenter clinical trials are necessary for translational science and commonplace for evaluating the effectiveness and generalizability of health care interventions; however, conducting them is cumbersome, time consuming, and labor intensive...

There has been little quantitative research on assessment of researchers’ satisfaction with their institutional review boards (IRBs) and of their compliance with regulatory and IRB requirements for research with humans....

Consent forms and processes have been proposed for biobanks with no discussion about the most effective means to provide the information to potential biobank participants to enhance their knowledge and...

Although attention has focused on whether participants actually derive better medical outcomes in research, the social benefits experienced in research have not been systematically examined. At regular follow-up visits during...

When institutional review boards (IRBs) review protocols for multisite studies, the default practice is for iterative, often sequential independent reviews to take place by an IRB at each site engaged...

Recruitment is a critical step in the process of implementing a study. We suggest that the process of participant recruitment is more than a procedural research step because it is...

Institutional review boards (IRBs) are repeatedly faced with the ethical dilemma of how to balance the inclusion of women of childbearing potential in clinical studies with protecting potential offspring from...

The At Home/Chez Soi (AHCS) project was a multisite pragmatic randomized controlled trial evaluating the effectiveness of providing housing and psychosocial support for individuals who were previously homeless and suffered...

Informal caregivers of orthopedic trauma patients, such as family members and friends who are not part of the medical team, provide a wide range of care and support through several...

Risk assessment is key to ethics review, yet we know little about how research participants experience risk in survey research. We tackle this deficit in this Canadian case study of...

When donating leftover biological samples to a biobank for use in medical research, people generally are asked to give a broad consent. This allows their samples and associated medical information...

We compared Human Research Protection Program quality indicator data among the Department of Veterans Affairs facilities with small (< 50 active human research protocols), medium (50-200), and large (> 200)...

The authors of this paper and others collaborated in conducting a randomized controlled trial of continuous positive airway pressure (CPAP) to support ventilation in children in four district hospitals in...

This paper describes how one set of HIV-TB prevention research studies put procedures in place to be responsive to these foundational ethical principles when interacting with communities in large population-based,...

Clinical trials that include research biopsies might present challenges for consent validity. An ethical framework for enrolling patients in studies that include a research biopsy rides heavily on informed consent....

Decisions about whether or not a study involves minimal risk structure critical procedural and substantive determinations by institutional review boards (IRBs). In particular, minimal risk is a necessary—though not a...

The Emergency Care Coordination Center within the Office of the Secretary for Preparedness and Response in the Department of Health and Human Services hosted a forum entitled Institutional Review Board...

Developing and implementing protections for research participants should be based, when possible, on relevant data that provide evidence of the need for and effectiveness of such protections. This is the...

This paper describes the implementation and refinement of a theory- and research-based Partnership of Consent Protocol that we used for two feeding skills studies involving patients with dementia conducted in...

Researchers conducting studies in which sensitive information about the participants is collected may apply to the National Institutes of Health (NIH) for a Certificate of Confidentiality to help safeguard participants’...

This article describes a set of procedures that the Veterans Health Administration (VHA) of the U.S. Department of Veterans Affairs established to help investigators, administrators, and institutional review boards at...

Federal research regulations require participants to be informed about whether medical care or compensation for injury is available in more than minimal risk studies, and the regulations prohibit language in...

Do U.S. Regulations Allow More than Minor Increase over Minimal Risk Pediatric Research? Should They? It is widely held that children should not participate in research that does not offer...

We have developed a Pregnancy Testing Policy for studies involving women of childbearing potential that describe pregnancy as an exclusion criterion. This policy is an effort to standardize pregnancy testing...

What mechanism should be used to conduct the review of quality improvement activities to ensure their ethical integrity? One important step toward an appropriate ethical review of quality improvement (QI)...

This article reports our findings from a study investigating the attitudes of IRB members toward compensation for participation in pediatric research. Payment to participate in research may have an important...

Research ethics boards need to be better resourced in terms of knowledge, expertise and practical tools to help them do their very important work, which includes being willing and able...

This paper reports data from a postal survey conducted among five groups of Canadians: community-dwelling adults aged 65 and over (n=679), informal caregivers of cognitively-impaired older adults (n=384), physicians (n=495),...

We replicated our 2003 study that showed that IRBs’ template text for informed consent forms fell short of the IRBs’ own readability standards. In view of national attention to the...

We appreciate the letter submitted by Zarin and Tse (“Clarification about ClnicalTrials.gov,” May-June 2013) in response to our article, “The Presidential Bioethics Commission’s Database of Human Subjects Research” (March-April 2013),...

In January 2009, the New York Times published on the front page an article about scientists conducting research on their own young children.1 Of the approximately 60 comments responding to the article, more...

Many questions exist concerning how IRBs view and respond to challenges posed by industry-funded studies. These studies may be designed to benefit the funder more than science or society more...

Key words/concepts: Human subjects research, human research ethics, research regulation and oversight, regulations and guidelines for human subjects research, research review boards and committees, institutional review board (IRB), research ethics...

Groman and Sugarman’s commentary “The Presidential Bioethics Commission’s Database of Human Subjects Research” (March-April 2013) reviews the findings of the U.S. Presidential Commission for the Study of Bioethical Issues 2012...

The gambler’s fallacy is a cognitive error that presents itself in a variety of forms. It undermines a gambler’s understanding and fosters the belief that a win is more certain...

Renewed concerns regarding the possible harm of deceptive methods in psychological research have led to increased attention to this topic, with some IRBs placing significant restrictions on the implementation of...

Ethical review of the use of incentives in recruiting research participants appears haphazard across U.S. institutions, and little is known about comparable practices at institutions outside the United States. Ethics...

In its recent report, Moral Science: Protecting Participants in Human Subjects Research, the U.S. Presidential Commission for the Study of Bioethical Issues highlighted a blind spot regarding human subjects research supported by...

We conducted a systematic review of empirical studies that examined the effectiveness of multimedia tools to enhance the research consent process. Consent procedures that used multimedia aids resulted in significantly...

A growing number of clinical trials use invasive research procedures to obtain tissue for disease screening and to monitor the effects of drugs. These procedures can be ethically contentious because...

Researchers increasingly use electronic survey instruments to collect data in minimal-risk protocols involving human subjects. This study reports the results from a survey with 52 contact officers of institutional review...

As an international IRB collaboration project, we set out to develop an approach to enhance the understanding of issues related to the conduct of human research with an international partner....

Pregnant women and their interests have been underrepresented in health research. Little is known about issues relevant to women considering research participation during pregnancy. We performed in-depth interviews with 22...

We examined institutional review board (IRB) policies from the top U.S. research universities to determine how many have policies that define or provide examples of what constitutes a “minor change”...

Institutional review boards (IRBs) are almost universally considered to be overworked and understaffed. They also require substantial commitments of time and resources from their members. Although some surveys report average...

Recruiting research participants based on genetic information generated about them in a prior study is a potentially powerful way to study the functional significance of human genetic variation, but it...

The inauguration of Michigan’s BioTrust for Health, a research biobank for leftover neonatal blood spots, posed several novel questions for the state’s Department of Community Health institutional review board. The...

In 2011, the U.S. Department of Health and Human Services (HHS) proposed changes to its regulations governing research with humans (the Common Rule), which apply to all federally funded research....

In many research studies, tumor biopsies are an unavoidable requirement for achieving key scientific aims. Yet some commentators view mandatory research biopsies as coercive and suggest they should be optional,...

In a commentary published in 2009 inNaturemagazine, Kim and colleagues1argued that the federal regulations governing research with humans (known as the Common Rule2) should be changed to exempt minimal-risk research...

Although there is great concern about protecting those who participate in research, little if any concern has been expressed in the literature about protecting “decliners”—individuals who were invited to participate,...

A letter to the editor from Erik Malmqvist in response to the recent letter from Howard Brody, David Buchanan, and Franklin G. Miller (“Misunderstanding, Period,” Sept-Oct 2011) concerning his article (“(Mis)Understanding...

Researchers nearly always offer money to healthy individuals—and increasingly to individuals who are ill—as an incentive to enroll in research studies and as compensation for research participation.1Yet there is a...

The complexity of biobank research raises concerns about individuals’ understanding of the information conveyed in the consent process for such research.. We report the results of a qualitative, cognitive interview...

In research involving pregnant women and fetuses, a number of questions arise concerning the balancing of risks and benefits. In research that holds out a prospect of direct benefit for...

This study assessed parents’ perspectives about a written versus a verbal consent approach for minimal-risk pediatric research. We conducted a survey of 161 parents of hospitalized children. Eighty-one percent of...

Researchers want to conduct an online survey to determine respondents’ attitudes toward and concerns about uses of deidentified tissue in research biobanks to see whether their concerns affect their willingness...

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...

For each research protocol that they review, institutional review boards must assess whether the risks of the protocol are acceptable in relation to the potential direct benefits to study participants...

In order to characterize the impact of institutional review boards on neuropsychiatric investigations, we conducted a Web-based survey among members of the American College of Neuropsychopharmacology (ACNP), which is dedicated...

A letter to the editor from Howard Brody, David Buchanan, and Franklin G. Miller in response to the recent article by Erik Malmqvist “(Mis)Understanding Exploitation,” March-April 2011). Key words/concepts: human...

Despite substantial research on overall decision-making capacity levels in schizophrenia, the factors that cause individuals to make errors when making decisions regarding research participation or treatment are relatively unknown. We...

Investigators and ethics review committees must ensure the proper justification of risks to participants in clinical trials.1Despite the existence of a systematic framework for analyzing the ethical evaluation of research...

Institutional review boards (IRBs) play a key role in ensuring that genetic research with humans meets ethical and regulatory standards. They are involved with issues such as how research participants...

The At Home/Chez Soi project is a pragmatic trial that is intended to test the effectiveness of providing persons who are homeless and mentally ill with housing and support for...

In an effort to improve parents’ understanding of key information during the informed consent process for neonatal research, we developed an enhanced consent process to measure parents’ understanding and recall...

The notion of exploitation frequently crops up in discussions about the ethics of biomedical research. A standard concern about clinical trials is that they exploit research subjects for the benefit...

Decisions to enroll in research must be voluntary and should be based on an unbiased presentation of all information required to reasonably assess risks, benefits, and procedures involved. This means...

Given the many changes in the research environment since the model for the institutional review board (IRB) was codified in 1981, tensions may arise as IRBs try to fulfill their...

A letter to the editor from Françoise Baylis and Chris Kaposy concerning the recent commentary by Toby Schonfeld and colleagues (“Ideal vs. Real: Revisiting Contraceptive Guidelines,” Nov-Dec 2010), which was...

Unrealistic optimism is a bias that leads people to believe, with respect to a specific event or hazard, that they are more likely to experience positive outcomes and/or less likely...

We analyzed the characteristics of consenting individuals participating in the 2007–2008 data cycle of the National Health and Nutrition Examination Survey, a nationally representative survey of the U.S. population, to...

Use of routine, not-for-cause research study review programs to determine and mitigate risks to research participants has markedly increased in recent years, yet no guidance on the topic is currently...

Research ethics is often said to have been born of scandal. The field is regularly accused of having developed in response to particular cases and transgressions. Whether or not this...

Older adults who are incapable of giving informed consent to participate in dementia research require special regulatory protection. We investigated the practices of Canadian research ethics boards (REBs) regarding research...

In both law and ethics, precedent shapes the deliberation of novel issues. Despite the interconnection between new and old decisions, few research ethics boards (REBs) have an explicit mechanism for...

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 Françoise Baylis for keeping the important issue of the...

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...

We interviewed 85 institutional review board chairs from a national sample of IRBs that review mental health research, asking them to rate the helpfulness of various resources that might be...

A letter from Alan Meisel on “The Evolution of Consent Forms for Research: A Quarter Century of Changes,” by Ilene Albala, Margaret Doyle, and Paul S. Appelbaum (May-Jun 2010). “When...

The objective of this study—a substudy to a phase I bioequivalence study—was to compare the effect of standard and concise consent forms on research volunteers’ comprehension of and satisfaction with...

One of the fundamental ethical requirements for research with humans is that individuals provide valid informed consent to participate in research studies.1A key issue regarding the validity of informed consent...

Considerable efforts have been made in recent years to improve the safety of human subjects who participate in research. However, there are no data to demonstrate that we have made...

Over the past decade, support for reexamining and reconsidering the U.S. model of ethics review for protocols involving research with humans has grown, particularly for studies involving participants from multiple...

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...

Canada’s Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) mandates that all research involving human subjects be reviewed and approved by a research ethics board (REB). We have...

In this article, we describe our review of 235 compliance oversight determination letters that the Office for Human Research Protections (OHRP) issued to 146 institutions between August 1, 2002, and...

This study examined how research conducted at several federally funded institutions designated as Clinical Research Centers (CRCs, general and pediatric) or Specialized Programs of Research Excellence (SPOREs) addressed the issues...

Those involved in research with humans confront a host of ethical issues and a maze of regulations. James M. DuBois’s Ethics in Mental Health Research: Principles, Guidance, and Cases is...

Openness is one of science’s fundamental ethical norms, but it should not take precedence over the obligation to protect the confidentiality of data. Deidentifying the data obtained from human genomic...

There is little guidance to help investigators and institutional review boards determine what safeguards should be in place to ensure that individuals with bipolar disorder have adequate capacity to consent...

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...

Research ethics consultation is increasingly recognized as a potentially valuable mechanism for addressing the depth and breadth of ethical issues that arise in research related to human health and well-being....

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...

Scholars of the ethics of clinical trials have long recognized a tension between the therapeutic obligations1 of clinicians (physician, nurses, and other health professionals) and the scientific demands of clinical...

Subjects enrolled in studies testing high risk interventions for incurable or progressive brain diseases may be vulnerable to deficiencies in informed consent, such as the therapeutic misconception. However, the definition...

Because many institutions struggle to determine how best to support their institutional review board programs, we conducted an exploratory study to identify the individual, group, and institutional factors that may...

Download Consent Form Template (Spanish) The two primary components of the consent process for research are a consent form and a discussion between the investigator and the potential research participant....

In order to illuminate the potential harms of MRI research, we present data obtained by examining MRI research proposal files that had been submitted for review to several Canadian Research...

Researchers appear to take unfair advantage of those who live in the developing world by using placebo-controlled trials to test the efficacy of drugs. This type of trial would not...

“Financial Conflicts and Clinical Research’”: a letter from Karin Meyers about “Community Hospital Oversight of Clinical Investigators’ Financial Relationships” (January-February 2009).

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...

A subcommittee of the American Association of University Professors (AAUP) has published a report, “Research on Human Subjects: Academic Freedom and the Institutional Review Board” (AAUP, 2006), which argues that...

Pharmaceutical companies can dramatically improve their understanding of how certain drugs work by having access to data from prospective research participants and those enrolled in clinical trials. Yet can data...

A letter from Howard C. Berkowitz about “Impact of a Clinical Trials Information Handbook on Patient Knowledge, Perceptions, and Likelihood of Participation” (January-February 2008)

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...

Although many hospitals have long offered a clinical ethics consultation to their physicians, patients, and allied health professionals, formal ethics consultation in the research setting is a relatively new development....

There has been an increase in the creation of population biobanks and large-scale genomic cohort studies over the last few years. These resources collect samples and associated data in an...

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 considerable attention to financial interests in clinical research has focused mostly on academic medical centers, even though the majority of clinical research is conducted in community practice settings. To...

IRB policies at 121 U.S. medical schools obtained from relevant Web sites were examined to determine whether the policies addressed matters involving investigator finders’s fees and role conflicts in recruiting...

Emerging biomedical technologies often raise new research ethics questions that have the potential to impact not just patients and families, but society as a whole. At the Stanford Center for...

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...

The expert clinical community is split about whether the difference between antidepressant treatment and treatment with placebos stems from the efficacy of the drug or from subjects’ heightened expectancy enhanced...

A growing awareness of the paucity of evidence for most treatments in pediatric medicine1 has led to a rapid increase in the number of clinical trials involving children.2 This means...

The Code of Federal Regulations for the protection of human research subjects (45 CFR 46) stipulates that institutional review boards have a diverse membership that is sensitive to issues such...

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. Interventions are...

In order to facilitate the informed consent process, we suggest recording it. If investigators routinely recorded the consent process—including subsequent testing of participants’ comprehension and reeducation efforts—they could monitor the...

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...

To explore how international communities view the collection, storage, and testing of human biospecimens we held a structured discussion on the topic at the annual meeting of a global HIV...

Providing understandable information about risks of participation in research is required for informed consent. However, there are no evidence-based guidelines for investigators and members of institutional review boards on how...

“Investigator Attendance”: a letter from Christopher S. von Bartheld about “A Study to Evaluate the Effect of Investigator Attendance on the Efficiency of IRB Review” (January-February 2008); and “Missing Subjects”:...

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,...

This study examined Canadian Research Ethics Board (REB) practices concerning continuing ethics review of approved studies. A mail-out questionnaire was used to elicit information from Canadian REB representatives about whether...

What does it mean to say that ethics committees that provide prospective review of research involving human beings should be “independent”? In the United States, IRBs—which are typically located within...

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...

Although written consent forms are standard in clinical research, there is little regulatory or empirical guidance regarding how to most effectively review consent forms with potential participants. We developed an...

To promote research subjects’ comprehension of study information, experts recommend simplifying consent documents, providing verbal information and visual aids, and asking patients to “teach-back” main points. We implemented these guidelines...

Institutional Review Boards (IRBs) are challenged to review increasing volumes of proposed research studies while meeting high ethical and regulatory standards.1A growing literature has documented concerns about the IRB review...

Researchers at the New Mexico Veterans’ Affairs Health Care System and the University of New Mexico Hospital developed a clinical trials information handbook for patients and conducted a study to...

Despite the developing influence of the Internet as a tool for reaching potential subjects, little empirical information exits on how individuals are recruited to participate in clinical research via the...

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...

We wanted to develop an informed consent document and process that would be culturally acceptable and comprehensible to women with little or no formal schooling in Lhasa, Tibet, where the...

What the Doctor Didn’t Say: The Hidden Truth About Medical Research, by Jerry Menikoff (with Edward Richards), is an insightful, clear, and engaging overview of some of the ethical and...

 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...

A robust measure of whether local oversight of human subjects research is achieving the ethical goals of research oversight (protecting the welfare of subjects, promoting respect, and attending to justice...

The Environmental Protection Agency has adopted new regulations that prevent the agency from conducting or funding intentional exposure research involving children, pregnant women, or fetuses.  I argue that these regulations...

In Children in Medical Research: Access Versus Protection, Lainie Friedman Ross presents a number of recommendations to increase protections for the vulnerable pediatric population—even if achieving this goal comes at the...

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...

The basic elements of informed consent are well known in the research community, but how they are discussed during the consent process for persons with dementia is seldom examined.  We...

Prior research has shown that providing higher cash payments increased follow-up rates in a treatment-outcome study without influencing participants’ perceptions of coercion or their relapse into drug use. Our study...

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...

Although essential elements of the informed consent process rest on the practical skills of the research coordinators who solicit potential research participants, little attention has been paid to the practical...

We describe a process developed to anticipate and identify new potential risks of harm to research participants who are at risk for Huntington disease but have not developed symptoms.  An...

My first two years as a community representative on a research ethics committee have given me a challenging, rewarding, and sometimes confusing acquaintance with the medical world.  My role in...

Relatively little attention has been paid to cancer chemoprevention research in the research ethics literature, especially compared to the ethical analyses of oncology treatment trials. Cancer chemoprevention trials test the...

We developed a survey instrument to estimate the true cost of operating an institutional review board and used it to collect information on resources used by academic IRBs in the...

A single-blind run-in phase is often employed in randomized controlled trials.  During these types of trials, all participants are given a placebo but are not informed of this fact.  In...

Two different but useful guidebooks—Working With and Within IRBs: A Practical Guide for Investigators, Sponsors, and IRB Members, by Eileen Hilton and Deirdre Hall, andInstitutional Review Board: Management and Function,...

Growing concern over financial interests in clinical research has provoked greater efforts to identify effective management strategies.1 Among the strategies discussed is the disclosure of financial interests to potential research...

We conducted this study to determine whether medical schools address conflicts of interest among their IRB members and staff, and, if so, in what ways.  We analyzed the conflict of...

This study examined the opinions of Dutch institutional review board members about the assessment of the risk-benefit ratio in phase II and phase III clinical cancer trials.  We conducted interviews...

Surgeons are generally free to make changes in operative procedures—from minor to major—without any need for approval from the Food and Drug Administration.  This raises a host of fascinating issues...