ICH E6 Update: What do you need to know? (PowerPoint)
This webinar was presented on 16 May 2018 by Dr Sophie Mepham SMGCP.
Principal Investigator: Clinical Trial Letter of Agreement
This document summarises the roles and responsibilities under ICH GCP of a PI who is nominated to conduct a Clinical Trial on behalf of an institution. Elements can be added or deleted as appropriate to an organisation or institutions needs.
Service Level Agreement Template for the inclusion of third party service providers in a Clinical Trial
DOC - 88 KB
This template helps to demonstrate the inclusions that should be considered when including third party providers such as Radiology providers or other ancillary services such as non core laboratories for the conduct of a clinical trial in line with protocol requirements. These documents may help with meeting local institutional governance requirements, noting they should be amended as appropriate to align with institutional requirements and do not serve to replace agreements already mandated by institutions who have similar documents in place. We always suggest you discuss this with your Research Governance Office or Research Office first.
Pragmatic Tools for Sharing Genomic Research Results with the Relatives of Living and Deceased Research Participants
PDF - 889 KB
The goal of this paper is to offer pragmatic guidance and implementation tools to facilitate the ethical return of genomic research results to family members. Because the issue of sharing research results with relatives arises in ethically and legally complex scenarios and in a wide variety of research studies, these tools provide a much-needed starting point and source of guidance for researchers, IRBs, biobanks, and research institutions. This toolkit will help them to anticipate family requests for research results and facilitate orderly return of results without overburdening the research institution.
Informed Consent in Translational Genomics: Insufficient Without Trustworthy Governance
PDF - 122 KB
Should researchers prioritize the use of limited research resources to return only those results that require medical intervention in the near term to avert serious disease, or also those that could potentially inform medical action in the future? Should researchers consider offering results intended to motivate a healthier lifestyle — e.g., results indicating a higher risk of diabetes or coronary heart disease — given that the recommended lifestyle measures would be appropriate for everyone and data suggest such risk information is rarely motivating?Do results unrelated to the participant’s own health but potentially relevant to reproductive decision making, such as information about carrier status, merit return?.
Capacity, Vulnerability, and Informed Consent for Research
PDF - 304 KB
This paper will discuss decisional capacity and vulnerabilities and how these characteristics must be recognized and addressed in the clinical research process. It reviews the concept of informed consent, especially in light of decisional capacity and vulnerability, and also describes the limitations of the current informed consent processes from the standpoint of the clinician researcher. Finally, it advances a theoretical model to stimulate further consideration of the effectiveness of the informed consent process under certain clinical circumstances.
The Ethics of Using Complementary Medicine in Pediatric Oncology Trials: Reconciling Challenges
PDF - 153 KB
For childhood cancer patients, the process of medication reconciliation frequently reveals substances being administered by parents that are not approved by the FDA, including vitamins, herbal supplements, homeopathic agents, probiotics, and cannabis. Patients and parents choose to use complementary medicine not only for symptom and side-effect relief — including pain, nausea, pruritis, fatigue, and anxiety — but also with the hope that the patient’s overall health status will improve or the medications may even help cure the malignancy.
Avoiding Exploitation in Phase I Clinical Trials: More than (Un)Just Compensation
PDF - 150 KB
Subjects in Phase I trials must often check into a clinical trial site for several weeks, where their diet, vital signs, and health status will be closely monitored as they are given an experimental drug. Sometimes they must undergo invasive procedures, such as endoscopies or lumbar punctures. Although most Phase I trials are relatively safe, some of them have resulted in disaster, such as the notorious TeGenero TGN1412 study at NorthWick Park Hospital in England, which sent six healthy, paid volunteers into multisystem organ failure in 2006. Since subjects in Phase I trials get no medical benefit from the studies, their primary motivation for enrolling is the payment. IRBs typically attempt to keep payment to subjects low, on the grounds that money might unduly influence the subjects, yet the subjects themselves naturally feel they deserve to be paid well.
Personal Experiences with Tribal IRBs, Hidden Hegemony of Researchers, and the Need for an Inter-cultural Approach: Views from an American Indian Researcher
PDF - 107 KB
This brief article constitutes a reality-based, first-hand report on selected aspects of researcher-IRB dynamics. Much of the literature written in the scholarly model is silent on the items that the author bring forward here, and highlights those here precisely because they are little discussed. Moreover, the complexity of American Indian and Alaska Native culture, cultural dynamics, and cultural expressions across tribes (including the intra-group variations of a given population) make acknowledgement of the nearly infinite variations across and within tribes impossible to specify.
Seeing Beyond the Margins: Challenges to Informed Inclusion of Vulnerable Populations in Research
PDF - 171 KB
The paper begins by providing the rationale for including racial/ethnic minorities and those of low socioeconomic status or educational attainment under the “vulnerable population” rubric. In the remainder of the paper, the authors describe the underrepresentation of these vulnerable populations in research, the harms that can result from exclusion, and finally describe recent strategies to improve informed consent. Throughout, they address two distinct but interrelated issues: underrepresentation and informed consent. Identifying and addressing the barriers to participation in research is related to the need to ensure informed consent, since informed consent is ethically necessary before participation can occur. As such, ensuring that vulnerable groups are given the opportunity to take part in research by eliminating structural barriers is a necessary first step to informed consent.