Informed Consent and the Clinician-Client Relationship [English and Spanish versions]

A Spanish translation of this publication is available to download under Additional Files below. Informed consent creates a continuing dialogue and promotes a clinician-client relationship that fosters mutual respect, shared decision-making and client autonomy. Informed consent done correctly involves clinicians providing clients with the information necessary to make informed decisions about their treatment

Central IRBs: Enhanced Protections for Research Participants [English and Spanish versions]

A Spanish translation of this publication is available for download under Additional Files below. Institutional Review Boards (IRBs) play a critical role in research, and assure safety and fairness to participants enrolled in research studies. Multisite studies are often reviewed by multiple IRBs (an IRB review at each site participating in the study), which can slow down study approval, result in duplication of effort, and occasionally produce contradictory decisions by different IRBs. To address these problems, the federal government has promoted the use of single IRBs (referred to as Central IRBs or CIRBs), where a single IRB is responsible for the review of all sites where the research study is conducted. The National Institutes of Health (NIH) has recently announced that beginning in 2017 all research conducted at multiple sites must be reviewed by a CIRB. This CIRB process is new and requires careful study to understand its pitfalls and benefits. As such, UMass Medical School and Columbia University received a (NIH) grant to study how different institutions conduct reviews of research involving multiple sites

How We Got a 75.4% Response Rate on an Internet Survey

Presentation on how to receive a high survey response rate using the Dillon Method, Survey Monkey and various contact steps

Single IRBs in Multisite Trials: Questions Posed by the New NIH Policy

Of all the issues raised by the NIH single-IRB policy, the relationship between the single IRB and the participating sites is possibly the most complex. There are 3 critical aspects that academic institutions, researchers, and policy makers will have to resolve before implementation of the new policy: (1) the relationship between the single IRB and the local institutions, including the local IRBs; (2) the collection and incorporation of local knowledge in the single-IRB review; and (3) the relationship between the single IRB and local researchers. These issues involve fundamental legal, ethical, institutional, and policy tensions that will profoundly shape the costs and effectiveness of future multisite research involving human research participants

Protecting Research Participants: How Can We Reduce “Therapeutic Misconception in Clinical Research Trials? [English and Spanish versions]

A Spanish translation of this publication is available to download under Additional Files below. Therapeutic Misconception and Scientific Reframing is a National Institute of Mental Health funded study led by Charles Lidz, Ph.D. The study’s goals are to: (1) Develop an innovative procedure that educates participants about clinical research trials to reduce Therapeutic Misconception (TM); and (2) Test this innovative procedure in a hypothetical clinical research trial to reduce TM without reducing study enrollment rates

Voluntariness of Consent to Research: A Conceptual Model

A good deal of policy and practice in human subjects research aims to ensure that when subjects consent to research, they do so voluntarily. To date, however, voluntariness and its impairment have been poorly conceptualized and studied. The legal doctrine of informed consent could provide a useful model