The committee examined the current landscape of international privacy protection laws to see how they provide protection against privacy breaches and whether they would offer sufficient protection in an environment of increased transparency of clinical trial data. International laws protecting personal data—commonly referred to as data protection laws—regulate the collection and use of personal data and are commonly based on fair information practices Privacy International, In general, fair information practices help ensure that data are collected only for specified and legitimate purposes, that individuals are informed about data collection, that data are kept secure and accurate, and that appropriate remedies exist should data be breached Privacy International, In the case of personal health data, a variety of approaches to protection are taken across jurisdictions see Box International Protections for Health Data.
In Europe, protections for sensitive data—typically defined as including data on health or medical conditions—commonly require the consent of the subject prior to data access, use, or disclosure; more Data protection laws often apply only to identifiable data. For example, European data protection laws cover only information that relates directly or indirectly to an identified or identifiable individual Retzer et al.
As discussed in Chapter 5 , however, there are no uniform international standards for determining when data have been sufficiently anonymized or de-identified to be exempt from regulatory requirements.
Similarly, pseudonymized data—data for which personal identifiers have been replaced with a pseudonym or code—are subject to less onerous restrictions in some European countries and under HIPAA in the United States , but other countries apply the full range of data protection requirements even to such data Retzer et al.
As big data analytics becomes more widespread, even data that have been de-identified may lead to violations of privacy. Combining rich data from various sources into a data set increases the likelihood of being able to re-identify individuals in the data set or determine whether they belong to a subgroup with certain characteristics Barocas and Nissenbaum, For participants from vulnerable populations who historically were victims of unethical research, the possibility that if data sharing becomes obligatory their data will be used for purposes or by individuals or organizations they do not sanction IOM, may be a particular concern.
The history of human subjects research is sullied by several scandals in which vulnerable participants were enrolled in trials without their knowledge or ethically valid consent. In the United States, these scandals included the Tuskegee Syphilis Study, drug clinical trials carried out on prisoners, and research on institutionalized persons with mental disabilities or psychiatric illnesses. Many participants in these unethical trials were poor, poorly educated, or members of racial and cultural groups that suffer discrimination.
In the African American community, the Tuskegee study and other examples of unethical research have led to ongoing mistrust in research generally. Partly because of such mistrust, fewer African Americans than Caucasians enroll in clinical research.
In turn, this low participation rate results in a weaker evidence base to guide the clinical care of this population, potentially contributing to health disparities in the United States Corbie-Smith et al.
Internationally, violations of informed consent in clinical research involving vulnerable populations have created mistrust toward research sponsored or directed by entities from wealthy developed countries.
Recent examples include unethical research on sexually transmitted infections in Guatemala and alleged violations of consent in HIV prevention trials of pre-exposure prophylaxis with tenofovir Singh and Mills, Although this topic has not received extensive empirical study, this evidence of mistrust suggests that certain vulnerable populations—those that have been the victims of unethical research, are disadvantaged socially or economically, or have been discriminated against—might also mistrust sharing of clinical trial data.
This possibility might be addressed, strengthening engagement in clinical trials, if representatives of such vulnerable populations were included in the design and implementation of trials and if effective ways of helping participants understand the benefits of data sharing and protecting the subjects of trials were developed. Research Ethics Committees are tasked with reviewing, revising, and approving clinical investigations involving humans, with the goal of protecting research participants and ensuring they are treated ethically as a result of their participation.
One interpretation is that data sharing, even of individual participant data, is not prohibited. On the other hand, some might suggest that because ClinicalTrials. Research Ethics Committees play an important role in protecting research participants and giving due consideration to the interests and values of communities. For example, there is always some level of risk that individual participant data, even if de-identified, could be used to re-identify a research participant, particularly if other auxiliary information were linked with the clinical trial data set Dwork, In addition, using auxiliary information, it may be possible to infer or learn information about individuals in a research data set—for example, whether they have a sensitive condition such as alcoholism or mental illness—even without specifically re-identifying them Dwork, Chapter 5 examines these privacy challenges in greater detail, as well as appropriate protections and controls that reduce these risks.
Research Ethics Committees can establish policies that allow and promote responsible sharing of individual participant data in the clinical trials they review. To this end, they can ensure that investigators discuss with research participants during the informed consent process both the prospective benefits and the risks, including privacy risks, of sharing clinical trial data.
When reviewing trials, Research Ethics Committees also can ensure that the risks of data sharing are minimized and that they are acceptable in light of the anticipated benefits. Initially, the DMC reviews the trial protocol to gain familiarity with the details but generally not to approve it. During the conduct of the trial, the DMC typically reviews a detailed report on interim data by intervention arm, usually unblinded to intervention assignment.
This review encompasses recruitment progress, baseline data describing the participants' characteristics, comparison of baseline data, concomitant medications or interventions, adverse event data, serious adverse events, primary outcome data, secondary outcome data, and a small list of prespecified subgroups.
In addition, DMCs typically request additional analyses motivated by trends in interim data. Interim DMC reports are strictly confidential until the trial is completed. Throughout the conduct of the trail, DMCs are on the alert for signals regarding inadequacies in data integrity and data quality and may ask for specific follow-up reports to clarify or rectify these inadequacies. DMCs usually complete their work with the last participant's last visit and may be asked by the sponsor and investigators to share their view or interpretation of the results when the data files are absolutely complete and locked down.
However, their role is not to review or approve papers presenting final results, although their input is often solicited. DMCs indirectly facilitate data sharing because they commonly ask the trial's data management and biostatistics teams to modify their presentation of data in interim reports so as to make the data clearer and more comprehensible.
The DMCs' directions likely lead to improvements in data organization and presentation that are helpful not only to the clinical trial team but also to other investigators who later analyze shared data sets. Although DMCs are likely to be strongly in favor of data sharing, they are not in a position to enforce that practice any more than they can enforce registration of trials on ClinicalTrials. To give DMCs any responsibility for enforcing data sharing would substantially increase their responsibilities and require them to remain operational for some time beyond completion of a trial.
Disease advocacy organizations are groups of individuals with a common condition or disease that share resources and knowledge to support clinical research, patient education, and clinical care. These organizations are active in the United States e. Traditionally, disease advocacy organizations have been involved primarily in promoting and facilitating participation in clinical trials and raising money to fund research. More recently, their roles have expanded to encompass.
Furthermore, disease advocacy organizations, through online networks, have acted as a conduit for the expression of participant frustrations regarding the lack of data sharing by investigators. In many online forums, participants often express frustration about the lack of communication from investigators at the conclusion of a clinical trial Terry and Terry, A recent study in the cancer community Ramers-Verhoeven et al.
According to the authors,. Unfortunately, this feeling of being special in many cases vanished when participation was over. Although all participants were appreciative of the care they received during the trial, there was a very clear sense of feeling that they were no longer a priority when the trial ended. This is the major problem I had with it. Many participants also expressed frustration at never being told the results of the clinical trial in which they participated:.
The clinical trial experience was similar to how I had imagined it, but I was surprised that I didn't get more information about it all as it progressed and when I was withdrawn. Will the results of the clinical trial be provided? That's what preoccupied me the most. Disease advocacy organizations are uniquely positioned to address these frustrations—both as a conduit for the expression of concerns and as a potential partner with investigators to create frameworks for continual engagement with trial participants.
An increasing number of patient groups have responded to this frustration by bypassing traditional investigator- or company-initiated clinical trials and organizing themselves to conduct their own trials of experimental agents.
For example amyotrophic lateral sclerosis ALS patients have banded together to develop homemade versions of an experimental agent and test it on themselves Marcus, When acting in this capacity, disease advocacy organizations share many of the same concerns, roles, and responsibilities as those of other nonprofit funders and sponsors of clinical trials with regard to data sharing.
Whether through direct financial support either alone or as part of a funding syndicate or other forms of assistance e. These efforts give these organizations an opportunity to influence policies and strategies so as to encourage responsible sharing of clinical trial data.
Both funders and sponsors of clinical trials have significant leverage to set standards and to encourage data sharing for the trials they fund. When considering data sharing, however, it is important to consider the context for each clinical trial in terms of the remit of the organization that has funded the work and the type of organization or institution that is the sponsor of the trial.
Public and nonprofit organizations e. The recipient organization is required to take on the role of sponsor or may delegate this role to an appropriate organization or group that has the capacity to act as sponsor. The trial sponsor is defined by ICH GCP as the organization that has specific responsibilities for trial conduct, such as ensuring that the trial is scientifically robust, that its conduct and procedures comply with safety and ethical standards, and that participants will be compensated for any harm that may result from their participation ICH, Sponsors also are required to ensure that the trial is listed on a recognized clinical trial registry.
Alternatively, a private company e. Currently, NIH supports more than 3, open trials 10 percent of all open trials registered on ClinicalTrials.
Currently, however, the results of only 46 percent of NIH-funded trials are published within 30 months of trial completion Ross et al. As the primary funder of translational and clinical science, NIH has been a crucial force behind major innovations designed to transform and restructure research.
First, during the Human Genome Project, NIH was a key driver of researchers' sharing of genome sequencing data soon after they discovered the sequence so that other scientists could benefit from this knowledge to make further discoveries NIH issues genomic data sharing policy , The U. Obtain, reproduce, publish, or otherwise use the data first produced under an award;.
Authorize others to receive, reproduce, publish or otherwise use such data for Federal purposes. In line with this regulation, NIH on numerous occasions has adopted policies requiring investigators working on large-scale genome projects to deposit the data they have generated. Second, to promote broader dissemination of the results of the trials it sponsors, NIH requires investigators applying for new funding to link the publications in their biosketch to the ID number in PubMed Central or similar platforms for sharing articles NIH, c.
The FDAAA originally required that summary-level results of trials of FDA-approved products including demographic and other baseline participant characteristics, primary and secondary outcomes, and adverse events be shared on the ClinicalTrials. The proposed rule extends the requirement to register and share summary-level results so that it covers trials of unapproved products.
Also in November , NIH proposed a draft policy to require registration and summary results reporting of all interventional clinical trials i. To facilitate such reporting of results, ClinicalTrials. NIH also is taking timely reporting of clinical trial results into account during the review of subsequent funding applications. NIH could be a driver for the sharing of clinical trial data by making it a requirement in the grant approval process and funding stipulations.
NIH's experience with the legal and policy justification for requirements to share publicly funded genomic data has implications for the sharing of clinical trial data. In the context of human genome data, NIH has sometimes implemented controlled access to accommodate concerns about participant privacy and informed consent. This experience with policies on genomic data could inform policies that NIH and other agencies adopt with respect to publicly funded clinical trial data.
Resolution of the issue of whether and how NIH might enforce data deposition requirements against violators similarly could be informed by the experience with genomic data. For its policies regarding genomic data deposition, NIH generally has refrained from articulating legal enforcement mechanisms.
Such sanctions include withholding of future research awards and even suspension of an entire institution from receipt of federal funding. The Wellcome Trust is a charitable foundation based in the United Kingdom that provides funding for research in the United Kingdom and low- and middle-income countries The Wellcome Trust, a.
The foundation supports increased transparency and sharing of clinical trial data from the research it funds by 1 requiring a data management and data sharing plan for all applications for funding, regardless of whether the investigation is taking place in a resource-poor country or the United Kingdom; 2 requiring any research papers published in peer-reviewed journals to be made available through PubMed Central PMC and Europe PubMed Central Europe PMC within 6 months of publication and providing funding to cover open access charges; and 3 requiring authors and publishers that receive open access payments to license research papers to be freely copied and reused with proper attribution to the original authors, using the Creative Commons Attribution license CC-BY The Wellcome Trust, b.
In addition, the foundation supports a number of major initiatives that promote data sharing, such as MalariaGEN—the Malaria Genomic Epidemiology Network, a community established in comprising more than 20 countries and researchers. MalariaGEN serves as the main driver of collaborative research and genomic data sharing for malaria research, both of which play a crucial role in researchers' efforts to work to develop and improve tools for controlling this disease MalariaGen, a.
It has joined the International Aid Transparency Initiative IATI , which works to improve the transparency of aid, development, and humanitarian resources by establishing a common standard for the publication of aid information and providing an online repository for all raw data published to the IATI standard.
Starting in January , the Gates Foundation will require grantees to make publications, and the underlying data sets, available for free immediately upon publication and with no restrictions on use. The foundation will pay open access fees for publication. In the past, the culture of clinical research in industry did not include proactively sharing clinical trial data.
There are several reasons for this culture, including concerns about incorrect or conflicting analyses generated by secondary users; concerns about participant privacy; and the desire to allow participating researchers and investigators the unique opportunity to publish data from trials in which they participated, which is important for their careers. Moreover, clinical research generated in support of marketing applications generally was considered to be commercially confidential information.
Sponsors spend significant time and effort in developing drugs, clinical and regulatory strategies, and clinical research protocols and analysis plans. These plans and documents may include considerations based on confidential interactions with regulatory authorities and internal scientific expertise and on strategic ideas.
Access to this information could give competitors a significant competitive advantage. Thus, sharing clinical trial data could shorten the time between the marketing of a first-in-class product and the marketing of similar products. Further decreases could discourage future investment in new product development. Appendix C provides additional legal analysis, conducted by the committee, of industry intellectual property concerns.
This legal analysis focuses on small molecules and biologics. Of course, clinical trial data also are generated in medical device trials. With medical devices, however, issues regarding data exclusivity, even in jurisdictions like the United States, are less clear-cut. Indeed, according to a submission to this committee from the trade group AdvaMed, release of data associated with receiving FDA clearance through the expensive premarket approval process could facilitate market entry for competitors using the so-called k pathway for approval AdvaMed, Proving substantial equivalence requires showing that the new device has the same intended use and technological characteristics as the predicate.
Some companies had procedures and review committees for external proposals Rosenblatt, , while others did not. Independent researchers who have obtained clinical study reports CSRs 8 and individual participant data from industry-sponsored trials have identified significant problems with underreporting of negative results and serious adverse events and with failure to publish results of negative trials for widely prescribed therapies and a vaccine Doshi et al.
These claims, however, have been disputed by sponsors. In several cases, the ensuing scientific and public debate has led to changes in labeling and marketing of drugs, legal settlements, and further clinical trials to address contested clinical hypotheses see Table The results of these additional trials have shown a more complex and nuanced picture than did either the original clinical trial results or the first independent analyses.
This back-and-forth debate is part of the scientific method, which leads to ongoing clarification of scientific issues. Although complex and sometimes confusing to the public, this process illustrates how scientific knowledge generally progresses through debate, new data and analyses, and further debate. Cases in which requests for access by independent investigators were repeatedly denied or delayed have sparked calls for a more systematic and transparent approach to the sharing of industry clinical trial data.
In addition, as discussed in the section below on regulatory agencies, the European Medicines Agency EMA has generated a great deal of discussion on its mandate to share clinical trial data after marketing approval EMA, In parallel with these discussions, recent HIPAA guidance has led to increased comfort with sharing de-identified clinical trial data for scientifically important analyses HHS, Thus, over the past several years, the culture in industry has been changing, so that, as noted in Chapter 1 , industry now is often leading data sharing initiatives.
Several new initiatives launched by pharmaceutical companies and two device companies have significantly changed the paradigm for sharing of clinical trial data see Appendix D Krumholz et al.
Currently, the costs of sharing clinical trial data see Box are borne by trial sponsors that agree to share the data. A substantial portion of this cost is for redacting commercially confidential information and participant identifiers from the data manually—for example, handwritten notes in CSRs that identify participants or reveal a company's strategy for future research or for interactions with regulators Shoulson, Costs of Sharing Clinical Trial Data.
Costs associated with current data sharing activities among private sponsors of clinical trials may include the following: Protections for privacy, including de-identification of data. Small companies that account for a significant proportion of new therapeutic discoveries have stated that they currently do not have the revenue to support sharing clinical trial data. There are precedents for reducing fees for small companies. Sharing clinical trial data may be an analogous situation in which small companies should not pay the same costs as large companies.
Submission of clinical trial data to regulatory authorities to gain approval for a new product or indication is an important consideration in the sharing of clinical trial data. Although health authorities exist around the world, 9 this section focuses primarily on the EMA and the FDA because many other countries worldwide rely on those agencies' review of products instead of conducting their own.
The EMA has been a pioneer in the sharing of clinical trial data; its plan for sharing data submitted to it and its engagement with stakeholders and the public on the issue have stimulated international discussions of data sharing. They should provide robust processes and deliver compliant outputs. They should have experience or knowledge on preparation of regulatory documents or dossiers.
They need to continually implement guidelines and identify ways to deliver better returns to the clients. They should be informed and updated on current legislative guidelines, local and global regulatory procedures, policies and trends since they play an important role in submission of dossier, processing trial application and reporting trial results in accordance with regulatory requirement.
They should have basic understanding of technical development and scientific research of healthcare products. The skills and competencies of regulatory affair professionals include comprehensive writing; computation and communicating skills; thorough understanding of the drug development process; sound knowledge of ICH-GCP guidelines; multi-tasking ability; teamwork culture; ability to work independently; foresee and mitigate risks; global business acumen; understanding business context of projects and regulatory services.
Positions in regulatory affairs provide opportunities in regulatory information or document management, submission or publishing and offer excellent job security. The need to meet the demand of insufficient experience in regulatory affairs, continuously improving standards of regulatory agencies and delivery of quality regulatory documents pertaining to clinical trials has increased the number of institutes providing courses and training programs in this field.
A fixed-dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio. The investigator must ensure that clinical trials are conducted as per the rules outlined below[ 13 ].
Investigators and Administrators of Academic Institutes should ensure that their Institutional Ethics Committees IECs are registered with the central licensing authority and the registration renewed at the end of 3 years. A recent regulatory change with respect to IISs is that academicians who carry out trials with 'new drugs' no longer need approval from the DCGI for the conduct of the trial and IEC approval would suffice.
This is provided that these studies are not intended for generating data to make a regulatory submission. In the event that the IEC feels that there could be a potential overlap between the academic and regulatory purposes of the trial, they should notify the office of the DCGI.
If the IEC does not hear from the DCGI within 30 days, it should be presumed that no permission is needed from the licensing authority. Institutional Ethics Committees function according to standard operating procedures [SOPS] that are usually available on their websites. Projects submitted essentially undergo two broad types of review- Full board or full committee review [for all projects that present more than minimal risk] or expedited review [for projects that pose no more than minimal risk; e.
The CTRI[ 16 , 17 ] is a free, online portal that allows both investigator-initiated and regulatory studies to be registered. It is recommended that all studies are registered at a public portal. Registration is important from a publication standpoint point as editors of many Biomedical Journals will not accept papers that have interventional studies not registered with a Clinical Trials Registry.
Investigators must ensure that written, informed consent is obtained from all participants in a clinical trial. For trials that involve vulnerable participants children or mentally challenged patients for example and involve a new chemical entity or a new molecular entity, the investigators in addition have to ensure audio visual recording of the informed consent process gazette notification dated 19 th November, An SAE is defined as an untoward medical occurrence during a clinical trial that is associated with death, in patient hospitalisation if the study was done on outpatient basis , prolongation of hospitalisation if the study was conducted on in-patient basis , persistent or significant disability or incapacity, a congenital anomaly or birth defect or is otherwise life-threatening.
In addition, send to Chairman of IEC and the Head of the institution where the trial has been conducted within 14 calendar days of occurrence of the event. Compensation in a clinical trial is needed both when death occurs or when there is clinical trial-related injury. The formulae for compensation for both are described below. Compensation for birth defect or congenital anomaly: Medical care to be provided as long as required and a lumpsum amount to be kept in a fixed deposit that would bring in a monthly interest equal to half of the minimum wage of an unskilled worker in Delhi.
For institutes that do not have them, this would be a good committee to constitute. Since clinical trial related injury or death is equally possible both with pharmaceutical industry and investigator-initiated academic studies, budgetary provisions need to be in place at the institutional level for the medical management of adverse events [AEs], SAEs and provision of insurance to trial participants.
Understand that the regulator can inspect the site at any time and that he can cancel the trial permission and discontinue the study. Therefore preparedness of the study site at all times must be ensured. Per this notification, medical devices are broadly classified as investigational medical devices and registered or approved medical devices. Chapter VII of this notification states that clinical trials with the former need both IEC and DCGI approval, while academic studies [studies not intended for manufacturing or marketing the device] with the latter, need only IEC approval.
Table 2 covers must know and good to know aspects of clinical trial research. Several governmental and non-governmental organisations within the country fund academic research and the academician needs to make an application to them with application formats and timelines being available on their home pages.
In addition, several pharmaceutical companies in the country also fund investigator initiated research. The funding from the industry could be by way of provision of drug supplies or monetary support or both. The control of the study including its conception, conduct and analysis remains exclusively with the investigator in these studies and would need a clear memorandum of understanding with the industry funder. ClinRegs does not control the quality or accuracy of translated content and may result in unexpected and unpredictable degradation of portions of text, images and the general appearance on translated pages.
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Subchapter V, Part A, Sec. Subpart A Transition Provision. Also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist. Treatment INDs - Submitted for experimental drugs showing potential to address serious or immediately life-threatening conditions while the final clinical work is completed and the FDA review takes place.
III C. Definitions and Policy. Part C, Subpart 2 g and h. Foreword, Introduction, 1. IV and V. Definitions, Assurance Process. Further, the RevisedCommonRule modifies what constitutes research to specifically exclude the following types of research: Scholarly and journalistic activities Public health surveillance activities authorized by a public health authority to assess onsets of disease outbreaks or conditions of public health importance Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for criminal investigative activities Authorized operational activities in support of intelligence, homeland security, defense, or other national security missions.
Due to varying institutional EC schedules, specific timeline review schedules are not available. Foreword, 1. III F. Overview Many institutional ethics committees ECs referred to as institutional review boards IRBs in the United States US charge fees to review research proposals submitted by industry-sponsored research or other for-profit entities. Subpart B Subpart E I and II. II and IV. EC Requirements Each EC has its own application form and clearance requirements, which can differ significantly regarding the number of copies supplied and application format requirements.
Sections I and III. Form FDA Subparts A, B, and C. Data and Safety Monitoring. Per 21CFR and the G-IND-Safety , the sponsor must also report the following: Any findings from epidemiological studies, pooled analyses of multiple studies, or clinical studies other than those reported in the safety report , whether or not conducted under an IND, and whether or not conducted by the sponsor, that suggest a significant risk in humans exposed to the drug Any findings from animal or in vitro testing, whether or not conducted by the sponsor, that suggest a significant risk in humans exposed to the drug Any clinically important increase in the rate of an SSAR over that listed in the protocol or IB In each safety report, the sponsor must identify all safety reports previously submitted to the FDA concerning a similar SAR, and must analyze the significance of the SAR in light of previous, similar reports, or any other relevant information.
Subparts A Form A and Form Results Information. The report must contain the following information for each study: Title, purpose, description of patient population, and current status Summary of the participants screened e.
The results information must include data on the following: Participant flow Demographic and baseline characteristics Outcomes and statistical analysis Adverse events The protocol and statistical analysis plan Administrative information See 42CFR11 for more detailed requirements. Subpart C. NIH Policy and Purpose. Overview The United States US regulations do not require compensation for trial participants either for participation in a trial or in the event of trial-related injuries or death.
Overview Per the US-ICH-GCPs , the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results.
Multicenter Studies In the event of multicenter clinical studies, also known as cooperative research studies, which are required to comply with the RevisedCommonRule , all federally-funded or sponsored institutions that are located in the US and engaged in multicenter research must use a single EC to review that study, known as the EC policy.
Subpart D Overview As set forth in 21CFR and the US-ICH-GCPs , the sponsor is responsible for selecting the investigator s and the institution s for the clinical trial and for ensuring that the investigator s are qualified by training and experience.
Data Safety and Monitoring Board Although not specified as a sponsor requirement, the US-ICH-GCPs states that a Data and Safety Monitoring Board may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.
Foreign Sponsor Responsibilities No applicable regulatory requirements. Per the CommonRule and the RevisedCommonRule , the EC may waive the requirement to obtain a signed ICF if it finds any of the following: The ICF would risk a breach of confidentiality by linking the participant to the study The research presents minimal risk and involves no procedures for which written consent is required outside of the study The RevisedCommonRule also adds that the EC may waive the requirements to obtain a signed ICF if the participants are part of a distinct cultural group or community in which signing the form is not the norm, the research presents minimal risk, and there is an alternative approach to document informed consent.
Subparts B-D. Non-English Speaking Subjects. What are the basic elements of informed consent? Waiver of Subject's Rights. The Right to Privacy and Confidentiality As per 21CFR50 , the CommonRule , and the RevisedCommonRule , participants should be given a statement describing the extent, if any, to which confidentiality of records identifying them will be maintained. Introduction, 1. Waiver or Alteration of Consent The CommonRule , the RevisedCommonRule , and G-MinRiskWaiver specify that although voluntary informed consent is always a requirement for every trial, the EC may approve a waiver or alteration of consent if the study involves a public benefit and service program conducted by or subject to the approval of state or local officials and could not be carried out without the waiver or alteration.
II 20 and V III Is it possible to obtain legally effective informed consent to research in an urgent or emergency care setting?
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