Consent Guidelines Research Articles

A critical review of thyroidectomy consent in the UK.

In 2015-16, the National Health Service (NHS) Litigation Authority received 10,965 claims for clinical negligence, with surgery having the highest number of claims. Currently a sum amounting to 25% of the annual NHS budget has been ring-fenced to meet extant claims. Claims made on a basis of inadequate informed consent are increasingly seen with many achieving a successful plaintiff outcome. There are presently no UK guidelines for thyroidectomy consent. A prospective study was performed to investigate current consent practice among the British Association of Endocrine and Thyroid Surgeons (BAETS) membership and patients having previously undergone thyroidectomy. For surgeons, the Bolam legal test applied where surgeons declared what risks and complications they routinely consented for during their practice. A study was also undertaken in patients who had previously undergone thyroidectomy for cancer applying the rule of Montgomery. Consent practice from 193 surgeons and data from 415 patients was analysed. In total thyroidectomy for cancer, 95% of surgeons consent for Recurrent Laryngeal Nerve (RLN) injury and temporary or permanent voice change. 70% specifically consent for External Laryngeal Nerve (ELN) injury, 50% for tracheostomy and 55% for general anaesthetic associated complications. Analysis of patient data showed they would like to be consented for far more risks than they are presently informed about in general medical practice. There was significant variation in the consenting practice in BAETS surgeons. A BAETS approved consensus guideline to standardise UK consent practice would be appropriate. This may reduce complaints, litigation claims and guide expert witnesses.

Barriers and pathways to informed consent for ionising radiation imaging examinations: A qualitative study

IntroductionInformed consent for ionising radiation medical imaging examinations represents a recent change to medical imaging practice. This practice has not had a definitive and authoritative integration into clinical practice, and lack of direction has caused many health care professionals to be unsure of an appropriate consent methodology. Consent practices have been undertaken inconsistently and sometimes poorly. This research sought to investigate what barriers exist to meaningful informed consent, and what pathways are suggested to overcome these barriers. These views are then discussed in the context of practical health care consent practices. MethodsA semi-structured interview explored the views of radiographers and radiologists on the practice of disclosing the ionising radiation risk of a clinical medical imaging examination. Qualitative data was analysed using a nominal method of quantitative transformation. Responses were reviewed, and a set of definitive themes constructed. Participants considered the influences, logistics and barriers to the informed consent process. Participants were then asked what pathways might be developed that would improve the process. ResultsTwenty-one (21) radiographer participants and nine (9) radiologists were interviewed. The barriers to consent identified issues of time constraints, lack of a unified message, and patient presentations. Pathways suggested included limiting the scope of the consent practice, sharing the consent responsibility, and formulation of definitive consent guidelines. ConclusionA unified, definitive series of guidelines for informed consent for ionising radiation examinations would alleviate many of the identified barriers. Having the consent process consistently begin with the referring doctor would facilitate more meaningful consent.

Behind the Screens: Informed Consent and Digital Literacy in Art Therapy

Art therapists face challenges of implementing digital or new media art practices due to concerns for privacy, confidentiality, and unfamiliarity with legal standards and best practices. This article discusses the ethical challenges of digital media use in art therapy, illustrated with case vignettes. The authors present informed consent guidelines to guide practice and to identify potential ethical concerns, and highlight the importance of digital literacy as it relates to cultural humility. Recommendations are offered for more effectively navigating the complexities of digital media in art therapy.

Biological material collection to advance translational research and treatment of children with CNS tumours: position paper from the SIOPE Brain Tumour Group

Paediatric CNS tumours are the most common cause of childhood cancer-related morbidity and mortality, and improvements in their diagnosis and treatment are needed. New genetic and epigenetic information about paediatric CNS tumours is transforming the field dramatically. For most paediatric CNS tumour entities, subgroups with distinct biological characteristics have been identified, and these characteristics are increasingly used to facilitate accurate diagnoses and therapeutic recommendations. Future treatments will be further tailored to specific molecular subtypes of disease, specific tumour predisposition syndromes, and other biological criteria. Successful biomaterial collection is a key requirement for the application of contemporary methodologies for the validation of candidate prognostic factors, the discovery of new biomarkers, the establishment of appropriate preclinical research models for targeted agents, a quicker clinical implementation of precision medicine, and for other therapeutic uses (eg, for immunotherapies). However, deficits in organisational structures and interdisciplinary cooperation are impeding the collection of high-quality biomaterial from CNS tumours in most centres. Practical, legal, and ethical guidelines for consent, storage, material transfer, biobanking, data sharing, and funding should be established by research consortia and local institutions to allow optimal collection of primary and subsequent tumour tissue, body fluids, and normal tissue. Procedures for the collection and storage of biomaterials and related data should be implemented according to the individual and organisational structures of the local institutions.

Ethics in Telerehabilitation: Looking Ahead

Given the fast-paced growth of telerehabilitation, an updated integrated analysis of the ethical codes and ramifications for telerehabilitation practice is warranted. This article sensitizes rehabilitation counselors to ethical issues associated with providing telerehabilitation services and provides suggestions for safeguards and resources for addressing ethical challenges. Recent publications of the American Counseling Association (ACA, 2014), the Commission on Rehabilitation Counselor Certification (2017), and the National Board for Certified Counselors (NBCC, 2016a) highlight ethical issues such as privacy, security, informed consent, and social media guidelines. Suggestions for practitioners to address ethical challenges include acquiring compliant software, receiving training, setting clear boundaries with clients through an informed consent procedure, and using an ethical decision-making model.

PRIVATE SURGEONS’ ATTITUDE TOWARDS INFORMED CONSENT, KUWAIT

Background: Surgeons ’ role in informed consent is crucial and should know the basic principle of informed consent in collecting and providing information to patients. Surgeons’ attitudes toward informed consent depends on the knowledge they possess . Objectives: Surgeons should become aware of the informed consent guidelines. New guidelines for consent have resulted in changes in health care environment that surgeons must adhere to. This study aims to highlight the way the surgeons in private hospitals view the informed consent for surgery processes. Methods: This study is a cross-sectional survey that was conducted from January to June 2016 in two private hospitals. The sampling unit used in this survey was private hospitals in Kuwait. A custom designed questionnaire about informed consent for surgery was completed by surgeons working at private hospitals in Kuwait. The questionnaire was developed to examine the surgeons' attitudes towards informed consent. The participants, who were surgeons and working in the various surgical specialties in the two hospitals, were made aware that the emphasis was on the verbal or written information about the operation they provide their patients with and not merely about the signing of the consent form which could take place at the same time or later. They were asked to respond to each question by Yes (agreeing) or No (disagreeing) or Unsure. The responses of the surgeons to each statement were calculated, using Statistical analysis SPSS version 21. Results: A high proportion 98.1% of private surgeons considered informed consent routinely achieved in their current practice. They thought that all surgeons should receive formal training on informed consent 81.6%. They have been received formal training on informed consent 76.7%. On the other hand, private surgeons thought that written information leaflets should be provided for patients during informed consent46.6%. However, only 30.1% of private surgeons provide their patients with leaflets during informed consent. A high proportion of private surgeons 86.4% thought that the main purpose of informed consent is to provide the surgeon with greater protection against litigation. Furthermore, 95.1% of private surgeons thought that the main purpose of informed consent is to respect the patient’s right of autonomy. The majority of private surgeons 94.3% thought that the main purpose of informed consent is to improve the doctor patient relationship, and 83.5% of private thought that the main purpose of informed consent is to improve the patient’s compliance with medical care. On other hand, lower percentages 42.7% of private surgeons thought that informed consent may be unnecessary because most patients depend on their doctor to make the decision for them, and 62.1% of private surgeons thought that the doctor who is going to perform the operation, who should do the informed consent. Also, more private surgeons thought that the patients age, complexity and duration of surgery, gender, the patient social class, the timing of surgery, and the need for referral to another doctor or hospital affects the amount of information given during informed consent. Conclusion: Surgeons in private should be more aware of the informed consent guidelines and they should adhere to them. Training on informed consent in both hospitals are recommended, and to provide more leaflet for patient during informed consent is required and important. Keywords: Informed consent, surgical risk, private.

Open Availability of Patient Medical Photographs in Google Images Search Results: Cross-Sectional Study of Transgender Research.

BackgroundThis paper focuses on the collision of three factors: a growing emphasis on sharing research through open access publication, an increasing awareness of big data and its potential uses, and an engaged public interested in the privacy and confidentiality of their personal health information. One conceptual space where this collision is brought into sharp relief is with the open availability of patient medical photographs from peer-reviewed journal articles in the search results of online image databases such as Google Images.ObjectiveThe aim of this study was to assess the availability of patient medical photographs from published journal articles in Google Images search results and the factors impacting this availability.MethodsWe conducted a cross-sectional study using data from an evidence map of research with transgender, gender non-binary, and other gender diverse (trans) participants. For the original evidence map, a comprehensive search of 15 academic databases was developed in collaboration with a health sciences librarian. Initial search results produced 25,230 references after duplicates were removed. Eligibility criteria were established to include empirical research of any design that included trans participants or their personal information and that was published in English in peer-reviewed journals. We identified all articles published between 2008 and 2015 with medical photographs of trans participants. For each reference, images were individually numbered in order to track the total number of medical photographs. We used odds ratios (OR) to assess the association between availability of the clinical photograph on Google Images and the following factors: whether the article was openly available online (open access, Researchgate.net, or Academia.edu), whether the article included genital images, if the photographs were published in color, and whether the photographs were located on the journal article landing page.ResultsWe identified 94 articles with medical photographs of trans participants, including a total of 605 photographs. Of the 94 publications, 35 (37%) included at least one medical photograph that was found on Google Images. The ability to locate the article freely online contributes to the availability of at least one image from the article on Google Images (OR 2.99, 95% CI 1.20-7.45).ConclusionsThis is the first study to document the existence of medical photographs from peer-reviewed journals appearing in Google Images search results. Almost all of the images we searched for included sensitive photographs of patient genitals, chests, or breasts. Given that it is unlikely that patients consented to sharing their personal health information in these ways, this constitutes a risk to patient privacy. Based on the impact of current practices, revisions to informed consent policies and guidelines are required.

Consulting Dr. Google: Quality of Online Resources About Tympanostomy Tube Placement.

Tympanostomy tube (TT) placement is common in children; however, family-centeredness and utility of online information used for decision making and understanding is unknown. We evaluate the quality of leading Internet resources describing TT placement. Cross-sectional descriptive design. We performed a Google (Menlo Park, CA) search for terms related to TTs. We defined quality using scaled readability measures (Flesch Reading Ease and Flesch-Kincaid Grade-Level), understandability and actionability (Patient Education Materials Assessment Tool), shared decision-making centrality (Center for Medicare and Medicaid Services informed consent guidelines), and clinical practice guideline (CPG) compatibility. Three reviewers coded each measure. Fleiss κ interrater reliability analysis was performed. Ten most frequently encountered websites were analyzed. One of 10 met national health literacy standards (mean 10th-grade level reading, median 9th, range 6-15th). All sites were understandable (mean understandability 81.9%, range 73%-92%). Most had low actionability scores (7 of 10, median 47%, mean 44.6%, range 0-80). Shared decision-making centrality was high (mean 5, range 4-6), but most did not list alternative treatment options. Although CPG compatibility was high (mean 3.4, range 1-4), many websites contained inconsistent recommendations about tube duration, follow-up, and water precautions. There was inter-rater agreement for understandability scoring (κ = 0.20; P = 0.02). Internet resources about TT placement vary in quality pertaining to health literacy, principles of shared decision making, and consistency with practice guidelines. With growing emphasis on patient-/family-centered engagement in healthcare decision making, standardization of content and improved usability of educational materials for common surgical procedures in children such as tympanostomy tube placement should be a public health priority. NA. Laryngoscope, 128:496-501, 2018.

"At our age, we would like to do things the way we want: " a qualitative study of adolescent HIV testing services in Kenya.

Adolescents in Africa have low HIV testing rates. Better understanding of adolescent, provider, and caregiver experiences in high-burden countries such as Kenya could improve adolescent HIV testing programs. We conducted 16 qualitative interviews with HIV-positive and HIV-negative adolescents (13-18 years) and six focus group discussions with Healthcare workers (HCWs) and caregivers of adolescents in Nairobi, Kenya. Semi-structured interviews and focus groups were recorded and transcribed. Analysis employed a modified constant comparative approach to triangulate findings and identify themes influencing testing experiences and practices. All groups identified that supportive interactions during testing were essential to the adolescent's positive testing experience. HCWs were a primary source of support during testing. HCWs who acted respectful and informed helped adolescents accept results, link to care, or return for repeat testing, whereas HCWs who acted dismissive or judgmental discouraged adolescent testing. Caregivers universally supported adolescent testing, including testing with the adolescent to demonstrate support. Caregivers relied on HCWs to inform and encourage adolescents. Although peers played less significant roles during testing, all groups agreed that school-based outreach could increase peer demand and counteract stigma. All groups recognized tensions around adolescent autonomy in the absence of clear consent guidelines. Adolescents valued support people during testing but wanted autonomy over testing and disclosure decisions. HCWs felt pressured to defer consent to caregivers. Caregivers wanted to know results regardless of adolescents' wishes. Findings indicate that strengthening HCW, caregiver, and peer capacities to support adolescents while respecting their autonomy may facilitate attaining '90-90-90' targets for adolescents.

Abstract 5946: Universal consent for biospecimens: A novel electronic/video consent

Abstract Background: Developing innovative, efficient and institutionally scalable bio-specimen consent for remnant tissue that meets the NIH consent guidelines for genomic and molecular analysis is essential for precision medicine efforts in cancer. Solutions in this arena need to satisfy the needs of patients, researchers, ethicists, IRB and compliance leadership, while fitting as seamlessly as possible into existing clinical workflows. Methods: UCLA developed a video-application kiosk-based approach for providing universal consent to repurpose clinical remnant bio-specimen for research. The process was designed to be self-service, comprehensive yet fast (mean shorter than 5 minute for completion). The consent additionally asked the patient if they were willing to be contacted directly for future research projects. This approach was piloted with 474 patients who were coming in for routine services in laboratory medicine, radiology, oncology, and hospital admissions. Of the pilot population, 175 individuals had targeted surveys to evaluate drivers for opting-in or opting-out of the consent for allowing the collection and use of their remnant tissue for research. The cognitive survey was online and presented immediately after the consent process was completed. Results: The opt-in rate for the pilot was 90.7%, and 56% agreed to direct contact for future research. Only 7% needed help navigating the online consent process. Of the subgroup of pilot population who completed the targeted survey, there was no difference between individuals who opted in and out regarding ease of use, of the consent application with about 75% stating it provided mostly or very useful information, 90% stating it was mostly or very easy to understand, and 85% stating they trusted the information. However, there were significant differences between those that opted-in and opted-out in their beliefs concerning usefulness of tissue, trusting researchers, importance of contributing to science and privacy risk with those opting in strongly supporting these beliefs (>90%) compared to those that opted out (<40%), p<0.001. Conclusions: Video-application approach for allowing individuals to consent for remnant specimens to be collected and used for research, including cancer research, can be efficient, patient-centric and meet the NIH requirements. This method could increase the availability of blood and tissue for cancer research and should be tested for scalability as an enterprise solution. Citation Format: Arash Naeim, Neil Wenger, Antonia Petruse, Liliana Sanchez, Azita Sharif, Sarah Dry. Universal consent for biospecimens: A novel electronic/video consent [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 5946. doi:10.1158/1538-7445.AM2017-5946

Cushing’s Syndrome Complicating Pregnancy

To reveal Cushing’s syndrome in pregnancy is difficult since there are no worldwide consent guidelines for making a definitive diagnosis. Some advocate using urine free cortisol as more than four times the upper limit of normal or salivary cortisol is two to three times above. It is also difficult to evaluate the optimal time of surgical intervention because most cases are diagnosed at or beyond their second trimester. In the case describe below, the disease was being suspected because there was a lost circadian variation of serum cortisol, which could be a reasonable initiate test for clinical suspicious cases in our further practice.

Guidelines for documentation and consent for nonclinical, nonresearch MRI in human subjects.

1 J. Magn. Reson. Imaging 2017;45:36-41.

Participant understanding and recall of informed consent for induced pluripotent stem cell biobanking.

The ability to generate human induced pluripotent stem cells (iPSCs) has opened new avenues for human disease modelling and therapy. The aim of our study was to determine research participants' understanding of the information given when donating skin biopsies for the generation of patient-specific iPSCs. A customised 35-item questionnaire based on previous iPSC consent guidelines was sent to participants who had previously donated samples for iPSC research. The questionnaire asked pertinent demographic details, participants' motivation to take part in iPSC research and their attitudes towards related ethical issues. 234 participants were contacted with 141 (60.3%) complete responses received. The median duration between recruitment and follow-up questioning was 313days (range 10-573days). The majority of participants (n=129, 91.5%) believed they understood what a stem cell was; however, only 22 (16.1%) correctly answered questions related to basic stem cell properties. We found no statistically significant difference in responses from participants with different levels of education, or those with a health sciences background. The poor understanding amongst participants of iPSC research is unlikely to be unique to our study and may impact future research if not improved. As such, there is a need to develop an easily understood yet comprehensive consent process to ensure ongoing ethical progress of iPSC biobanking.

Disclosure of insurability risks in research and clinical consent forms

ABSTRACTGenetic testing results and research findings raise concerns about access to genetic information by insurers. Recently, the Canadian Life and Health Insurance Association reaffirmed its prerogative to request, for underwriting purposes, the disclosure of clinical and research genetic test results if the participant/patient or his physician has knowledge of the results. Studies have shown that access to genetic information to determine insurability can, in limited instances, lead to actual, or fear of, genetic discrimination, result in individuals refusing to undergo testing or declining participation in genomic research, and being asked to pay higher premiums or denied access to certain types of insurance. Obtaining informed consent for genetic testing and genomic research is crucial and should take into account the potential need to disclose possible insurability risks to patients and participants. Our study analyzed clinical and research consent forms, templates and guidelines from Quebec to investigate two questions: (1) whether consent forms include clauses providing information on potential insurability risks and (2) when such potential risks are included, what information is provided and how it is formulated. Our findings show that current information on insurability risks in Quebec’s forms/guidelines lack coherence, potentially resulting in patients/participants receiving inconsistent information.

Issues Concerning Clinical Research Using Human Pathologic Bioresources in the Biobank Era

Biobanks storing human pathologic resources have recently emerged as critical research platforms throughout the world for the discovery of biomarkers. Pathologists have not yet established policy consensus, regulations, or informed consent (IC) guidelines for the clinical use of archival pathologic resources. Obtaining broad consent from donors for biobanks in Japan is based on the expression of passive consent to use the remaining resources after pathologic diagnosis. However, genetic and proteomic studies using pathologic formaldehyde-fixed paraffin-embedded blocks (FFPE) have been developed re- cently and IC for the use of FFPE has become critical. In the current paper, we reviewed the Japanese guidelines for the use of human resources and discuss medical ethics criteria pertaining to IC for the use of FFPE and other formats when IC is not possible because of difficulties in contacting relatives of deceased donors. We propose the use of archival FFPE could be possible after providing official notification of its general use for clinical studies through a webpage or other information technology platform. Furthermore, we also suggest that access to samples over a sufficient term, i.e., greater than several years, is necessary. In conclusion, it is important to establish a common consent form for these institutions.

A Trust-Based Pact in Research Biobanks. From Theory to Practice.

Traditional Informed Consent is becoming increasingly inadequate, especially in the context of research biobanks. How much information is needed by patients for their consent to be truly informed? How does the quality of the information they receive match up to the quality of the information they ought to receive? How can information be conveyed fairly about future, non-predictable lines of research? To circumvent these difficulties, some scholars have proposed that current consent guidelines should be reassessed, with trust being used as a guiding principle instead of information. Here, we analyse one of these proposals, based on a Participation Pact, which is already being offered to patients at the Istituto Europeo di Oncologia, a comprehensive cancer hospital in Milan, Italy.

Accounting for personal and professional choices for pandemic influenza vaccination amongst English healthcare workers

BackgroundHealthcare workers (HCWs) are encouraged to get vaccinated during influenza pandemics to reduce their own, and patients’, risk of infection, and to encourage their patients to get immunised. Despite extensive research on HCWs’ receipt of vaccination, little is known about how HCWs articulate pandemic influenza vaccination advice to patients. AimsTo explore HCWs’ uptake of the A/H1N1 vaccine during the pandemic of 2009–2010, their recommendations to patients at the time, and their anticipated choices around influenza vaccination under different pandemic scenarios. MethodWe conducted semi-structured interviews and focus groups with eight vaccinated and seventeen non-vaccinated HCWs from primary care practices in England. The data was analysed using thematic analysis. ResultsThe HCWs constructed their receipt of vaccination as a personal choice informed by personal health history and perceptions of vaccine safety, while they viewed patients’ vaccination as choices made following informed consent and medical guidelines. Some HCWs received the A/H1N1 vaccine under the influence of their local practice organizational norms and values. While non-vaccinated HCWs regarded patients’ vaccination as patients’ choice, some vaccinated HCWs saw it also as a public health issue. The non-vaccinated HCWs emphasised that they would not allow their personal choices to influence the advice they gave to patients, whereas some vaccinated HCWs believed that by getting vaccinated themselves they could provide a reassuring example to patients, particularly those who have concerns about influenza vaccination. All HCWs indicated they would accept vaccination under the severe pandemic scenario. However, most non-vaccinated HCWs expressed reticence to vaccinate under the mild pandemic scenario. ConclusionsProviding evidence-based arguments about the safety of new vaccines and the priority of public health over personal choice, and creating strong social norms for influenza vaccination as part of the organizational culture, should increase uptake of influenza vaccination among primary care HCWs and their patients.

Content, accuracy and completeness of patient consent in a regional vascular surgery unit.

Although the General Medical Council has published guidelines for procedural consent, there is evidence to suggest that deficiencies still occur in completion demographics, documentation of procedural risks and information regarding alternative therapies. We assessed the accuracy and completeness of vascular consent within our unit. A retrospective review of patients undergoing vascular intervention between February 2010 and 2011 was performed. Patient chart examination included the analysis of consenting doctors' grade, responsible vascular consultant, completeness of procedural entry, documentation of correct side, use of abbreviations, discussion of benefits and complications, additional information and overall legibility. 323 patient consent forms were reviewed (male 203, mean age 68.0 years, elective surgery 241) including 50 AAA repairs, 27 carotid endarterectomies, 88 peripheral arterial reconstructions, 96 amputations and 69 elective varicose vein surgeries. 294 (91%) consent forms were completed by a specialist registrar or above with 286 (88.5%) forms having the responsible consultant documented. 85.4% of patients were consented within 48 h of surgery. 245 (75.9%) consent forms had legible printed names. However, only 75 (23.2%) had a legible signature. 306 (94.7%) consent forms had the procedure documented in full but 165 (51.0%) had used abbreviations. 103 (31.9%) had documentation of the intended benefits of surgery whilst 293 (90.7%) had documentation of potential complications. Three patients had documented evidence of receiving written information and one patient received a copy of the consent form. Of those surveyed, procedural mortality was discussed in 62.5% of open and 47.3% of endovascular AAA repairs. Stroke was documented in 96.3% of consent forms for carotid endarterectomy. Scarring was included most commonly in patients undergoing venous procedures. Vascular consent is a complex process involving a number of discussions and meetings with patients. Our unit has demonstrated compliance of nearly 90% for all consent-related processes and remains consistent with current GMC guidance. However, further improvement including the documentation of intended benefits, provision of additional written information whilst reducing the use of abbreviations is desired.

Genetic Counseling Practice in Next Generation Sequencing Research: Implications for the Ethical Oversight of the Informed Consent Process

The potential for next generation sequencing research (NGS) to generate individual genetic results could have implications for the informed consent process and the provision of genetic counseling. We undertook a content analysis of informed consent templates and guidelines produced by Canadian institutional review boards, purposively sampling documents used by researchers to obtain consent from participants in genetics studies. Our goal was to examine the extent to which the informed consent documents addressed genetic counseling and the return of individual genetic results. Our analysis reveals that the majority of informed consent documents did not mention genetic counseling while several did not mention the return of results. We found differences in the ways in which documents addressed availability of counseling, eligibility criteria for referral to a genetic counselor, genetic counselor involvement, provision of services to family members of participants and incidental findings. From an ethical standpoint, consent documents should provide appropriate information so that participants may make an informed decision about their participation in research. The need to ensure adequate counseling for study populations in an NGS research context will necessarily involve adapting values that underlie care in genetic counseling practice. If the interests of research participants are to be truly promoted, the drafting and review of informed consent documents should give proper due to genetic counseling.

Developing effective and efficient study specific training to enable rapid study start up

Study specific training is an essential but often understated component of the study set up process for individual site personnel. One of the many challenges for the trial manager is to ensure study staff are appropriately trained without compromising rapid study start-up, quality of training, ethical compliance, GCP, running costs. A variety of training methods exist with different studies employing one or more different training options. On site, centre specific (Site Initiation Visit (SIV/SV)), central, multi-centre (Investigator Meeting (IM)) or ‘virtual' IM training methods are often employed during start-up to enable in-depth protocol, safety, laboratory, informed consent and CRF completion guidelines and training. This ensures standardisation of study procedures across sites and that all site staff are informed of the procedures for conduct of the study. GCP and research governance guidelines state all study personnel are ‘qualified by education, training and experience'. Training should be proportionate and tailored to the specific needs of the site/study personnel. It should promote GCP but not replace formal GCP training. Experience from setting up a large UK multi-centre RCT (Vault or Uterine prolapse surgery Evaluatioin, VUE) indicates study sites appreciate the networking and open discussion opportunities provided by a central IM, but prefer the one to one site specific training that a SIV provides, and are particularly motivated by personal study training/information packs. This presentation will discuss essential components of study training and different training methods to promote rapid trial start up as well as feedback from site personnel exposed to different training methods.