Regulatory Express_June 2018

Summary:

The US FDA has published an update to the Payment for Research   Subjects: Information Sheet.  The update clarifies that   reimbursement for travel expenses to and from the clinical trial site and   associated costs such as airfare, parking, and lodging are acceptable under   current practices. 

概要：

美国FDA就受试者报酬的相关信息做了更新。更新的内容阐明了根据目前惯例，对受试者往返研究中心的旅费及相关费用，例如机票费，停车费及住宿，提供报销是可以接受的。

OECD   Advisory Guidance

http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2018)6&doclanguage=en

(OECD issued on 19 April 2018)

Summary:

The OECD   Advisory Guidance provides   clarity for test facilities on the expectations of national Good Laboratory   Practice (GLP) compliance monitoring authorities on how test items are   transported, received, identified, labelled, sampled, handled, stored,   characterised, archived and disposed.  Scope of test items includes, but   is not limited to, agrochemicals, industrial chemicals, pharmaceuticals   (human and veterinary), cosmetics products, food/feed additives and medical   devices. The document consolidates existing OECD guidance on test items that   are used in studies conducted in compliance with the Principles of GLP.    It also aims to promote a consistent approach that is appropriate to   the objective of the study and the nature of the test item.

(The   Organisation for Economic Co-operation and Development (OECD) is an intergovernmental   organisation in which representatives of 35 industrialised countries in North   and South America, Europe and the Asia and Pacific region, as well as the   European Commission, meet to co-ordinate and harmonise policies, discuss   issues of mutual concern, and work together to respond to international   problems.)

概要：

“OECD咨询指导”    就国家GLP合规监督机构对于试验装置的期待提供了明晰的阐述，如检测样本(受试物和对照品)的运输、接收、确认、标签、取样、处理、保存、理化性质或生物特性、存储和处置。检测项目的范围包括但不限于农用化学品，化工原料，医药品（人用和兽用），化妆品，食品/饲料添加剂和医疗器械。文件整合了目前针对用于研究且需要遵循GLP原则的检测项目的OECD指南。其目的在于促进采取一致的、适合于研究目的和检测项目性质的方法。

（“经济合作与发展组织“（OECD）是一个政府间的组织，来自北美、南美、欧洲、亚太地区和欧盟的35个工业化国家的代表会面以统筹和协调政策，讨论共同关心的问题，以及共同应对国际问题。）

Clinical   Trial Imaging Endpoint Process Standards

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM268555.pdf

(US FDA   issued in Apr 2018)

Summary:

The FDA has released a final guidance entitled: Clinical   Trial Imaging Endpoint Process Standards.  Imaging process   standards help sponsors ensure that imaging data are obtained in a manner   that complies with a trial’s protocol, that the quality of imaging data is   maintained within and among clinical sites, and that a verifiable record of   the imaging process is created.

The guidance:

·          Focuses on imaging acquisition, display, archiving, and   interpretation process standards that FDA regards as important when imaging   is used to assess a trial’s primary endpoint or a component of that endpoint

·          Assists sponsors in optimizing the quality of imaging data   obtained in clinical trials intended to support approval of drugs and   biological products

·          Addresses the background considerations for determining the   role of imaging in a clinical trial as well as the major considerations in   the development of an imaging charter that describes the trial’s imaging   methods

·          Describes the minimum standards a sponsor should use to help   ensure that clinical trial imaging data are obtained in a manner that   complies with a trial’s protocol, maintains imaging data quality, and   provides a verifiable record of the imaging process

·          Specifically addresses the technical components of a charter’s   description of the image acquisition, image interpretation, and image data   development methods

概要：

美国FDA发布的题为“临床试验影像终点流程标准”的终版指南。影像流程标准帮助申办方确保影像数据的获取方式遵循试验方案，在研究中心及各研究中心之间保持影像数据的质量，以及创建一个可验证的成像过程记录。

该指南：

·          关注影像的获取、显示、存档和解释流程标准。美国FDA认为当影像是临床试验的主要终点指标或其组成部分的时候，上述流程标准至关重要

·          帮助申办方优化临床试验中获取的、用于支持药品和生物制品获批的影像数据的质量

·          针对明确影像在临床试验中的作用时需考虑的背景信息以及撰写试验成像方法文件时的主要考虑点

·          描述申办方确保影像数据的获取方式遵循试验方案、保持影像数据质量、并创建一个可验证的成像过程记录应采用的最低标准

·          具体说明一份描述影像获取、影像解释和影像数据开发方法的文件的技术要素

Guidelines   on Consent under Regulation 2016/679 (WP259) 

http://ec.europa.eu/newsroom/article29/item-detail.cfm?item_id=623051

(European Commission As last Revised and Adopted on 10   April 2018)

Summary:

European Commission (Advisory Body) issued Guidelines   on Consent under Regulation 2016/679 (WP259)  which provides   final guidelines on the requirements for valid consent under the EU’s General   Data Protection Regulation (the “GDPR”). A portion of the Final Guidelines   addresses the use of consent as a basis for processing personal data in   connection with scientific (including medical or clinical) research.    Consent remains one of six lawful bases to process personal data, as listed   in Article 6 of the GDPR. 

The Guidance Document:

• Provides further clarification and        specification of the requirements for obtaining consent

• Elements of valid consent

• Analyses to what extent the consent        forms must be updated to ensure compliance with the GDPR

• Provides Minimum content        requirements for consent to be ‘informed’

• Consenting of children

概要：

欧盟发布的“依据法规 2016/679的知情同意指南”，就欧盟“数据保护通则”（GDPR）下的有效知情同意要求提供了最终指导原则。该指导原则的一部分阐述了科学（包括医学或临床）研究中使用知情同意作为处理个人数据的基础。GDPR第六条中罗列的处理个人数据的6个法律基础中，知情同意是其中之一。

该指南文件：

• 进一步明确和规范了获得知情同意的要求

• 有效知情同意的要素

• 分析在多大程度上必须更新知情同意书，以确保遵循GDPR

• 提供了知情同意中需要告知的最低内容要求

• 儿童的知情同意

Guidance   for Researchers and Study Coordinators on Implications of the General Data   Protection Regulation (GDPR) for the Delivery of Research in the UK

https://www.hra.nhs.uk/about-us/news-updates/gdpr-guidance-researchers/

(MHRA updated on 24 May 2018)

Summary:

The   General Data Protection Regulation (GDPR) comes into force on 25 May 2018,   bringing with it increased expectations of organisations processing   personal data. Organisations need to be lawful, fair and transparent when   processing or controlling the processing of personal data. However, the new   legislation does not impede research. This guidance is aimed specifically at   researchers, sites and sponsors managing individual research projects.

Consent:

Ø  For the   purposes of the GDPR, the legal basis for processing data for health and   social care research is not “consent”. This means that requirements in the   GDPR relating to consent do not apply to health and care research. 

Ø  For   health and social care research, the legal basis is determined by the type of   organization:

n  for   universities, NHS organizations or Research Council institutes the processing   of personal data for research will be a ‘task in the public interest’

n  for   commercial companies and charitable research organizations the processing of   personal data for research will be undertaken within ‘legitimate interests’.

Ø  Even   though consent is not the legal basis for processing personal data for   research, the common law duty of confidentiality is not changing, so consent   is still needed to access and use confidential patient information for   research, unless you have support under the Health Service (Control of   Patient Information Regulations) 2002 (‘section 251 support’) applying via   the Confidentiality Advisory Group in England and Wales or equivalent arrangements   elsewhere in the UK. 

Transparency:

Ø  Under   the GDPR, transparency relates to providing information to people about the   processing of their personal data. (Participant data where the participant   cannot be identified directly or indirectly is no longer personal data, and   the GDPR transparency requirements do not apply.) 

Ø  Under   GDPR, in most cases you will need to provide transparency information about   your legal basis and other details of processing personal data in relation to   both the site and the sponsor from 25 May 2018 onward. 

Safeguard

Ø  Under   GDPR, there is a greater emphasis on implementing safeguards for research.   This means that you should give consideration to the arrangements for   security and storage of data, and ensure that data are pseudonymised or   anonymised wherever possible, and that personal data are only collected when   needed (known as ‘data minimisation’). If you can undertake some or all of   your research activities without using identifiable personal data, you should   make arrangements to do so.

Data subject right

Ø  The   GDPR incorporates a range of exemptions from data subject rights for health   research, to take account of particular aspects of research. In general these   exemptions are similar to those under previous legislation, and mean that   normally there will be no right for research participants to access their   data, rectify it or have their data erased. However, it is likely that under   national policy patients in England will still have a right to opt out of use   of their data for research.

Ø  The   research exemptions to data subject rights are not automatic, but should be   considered on a case by case basis. It is important, therefore, not to offer   or limit the rights available to research participants in the Participant   Information Sheet, without taking account of the relevance of the rights to a   particular project.

概要：

“数据保护通则”（GDPR）于2018年5月25日正式开始实施，与之而来的是增加了对组织/机构处理个人数据时的期望。组织/机构在处理或控制个人数据处理时，需要做到守法、公平和透明。然而，新的法规并不阻碍研究的开展。本指南特别针对管理各自研究项目的研究者，研究中心和申办方。

知情同意

Ø  就GDPR的目的而言，GDPR界定的在卫生和社会关怀研究中处理数据的法律依据并不是“知情同意”。这意味着GDPR有关知情同意的要求并不适用于上述研究。

Ø  对于卫生和社会关怀研究，法律依据由组织/机构的类别决定：

n  大学、英国国家医疗服务体系（NHS）机构或研究理事会机构，研究中处理个人数据的法律依据是为了公共利益

n  商业公司和慈善研究机构，研究中处理个人数据的法律依据是在其合法利益范围之内进行

Ø  尽管知情同意不是研究中处理个人数据的法律依据，保密作为通用法律责任并没有改变，所以当出于研究目的需要访问使用患者的个人保密信息时仍需获得知情同意，除非有英国相关法律条款支持

透明：

Ø  根据GDPR，透明是指告知人们将如何处理他们的个人数据（当参与者的数据无法被直接或间接地识别时，则不属于个人数据，不适用于GDPR中关于透明的要求。）

Ø  根据GDPR，自2018年5月25日，应提供与研究中心以及申办方有关的处理个人数据的法律依据和其他细节的信息

保护措施

Ø  根据GDPR，非常强调研究中采取保护措施。这意味着对于数据安全和保存应有充分的考虑，确保在可能的情况下对数据采用假名或匿名化，且只在需要时收集个人数据（公认的“数据最少化“）。如果研究中可以不使用或仅部分使用具有标识身份的个人数据，应安排这样做。

数据主体权

Ø  基于研究特定方面的考虑，GDPR包含了卫生研究中数据主体权利豁免范围。总的来说，这些豁免与之前的法规类似，意味着通常情况下研究参与者没有权利访问他们的数据，修改或删除数据。然而，在国家政策下，在英国的研究参与者有权选择不参加需要使用他们数据的研究。

Ø  研究并非自动获得数据主体权利豁免，而应具体情况具体分析。因此，在没有考虑该特定研究项目的权利相关性时，不应在参与者信息告知材料中即提供或限制研究参与者的权利。

Institutional   Review Board (IRB) Written Procedures: Guidance for Institutions and   IRBs. 

https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm512761.pdf

(US   FDA issued in May 2018)

Summary:

The US FDA has released a guidance entitled “Institutional   Review Board (IRB) Written Procedures: Guidance for Institutions and   IRBs.”  The guidance announced in this notice finalizes the   draft guidance of the same title dated August 2016. 

The guidance is intended for institutions and IRBs responsible   for review and oversight of human subject research under the Department of   Health and Human Services (HHS) and FDA regulations. The purpose of this   guidance is to assist staff at institutions and IRBs who are responsible for   preparing and maintaining written procedures.  The Written Procedures   Checklist in the guidance was designed to prompt a thorough evaluation of   written procedures that help to ensure the protection of human research   subjects.

The checklist:

• Incorporates the HHS and FDA        regulatory requirements in 45 CFR 46.103(b)(4) and (5) and 21 CFR        56.108(a) and (b) for written procedures for the IRB and recommendations        about operational details to include to support each of these        requirements.

• Identifies some additional topics        the institution/IRB may consider when developing comprehensive        procedures.

概要：

美国FDA发布的题为“伦理委员会书面程序指南”。该指南是2016年8月发布的同名草案的最终版。

该指南是为根据卫生及公共服务部（HHS）和FDA法规要求，为负责审查和监督涉及人的研究的机构和伦理委员会而制定的。旨在帮助机构和伦理委员会负责制定和维护书面程序的职员。指南中的书面程序清单有助于快速而彻底评估书面程序，以帮助确保对研究受试者的保护。

该清单：

• 包含了HHS和FDA在45 CFR        46.103(b)(4)和(5)以及21CFR56.108(a)和(b)中对于伦理委员会书面程序的法规要求和支持上述法规要求的操作细节的建议

• 指出了伦理委员会在制定综合程序时需考虑的额外内容