G3P : good privacy protection practice in clinical research : principles of pseudonymization and anonymization / Karl-Heinz Schriever, Markus Schröder.

Format:

Book

Author/Creator:

Schriever, K.-H., 1948- author.

Schröder, Markus, 1960- author.

Language:

English

Subjects (All):

Clinical trials--Research.

Clinical trials.

Data protection.

Medical care--Research.

Medical care.

Medical records--Access control.

Medical records.

Privacy, Right of.

Physical Description:

1 online resource (210 p.)

Edition:

1st ed.

Place of Publication:

Berlin ; New York : De Gruyter, [2014]

Language Note:

English

Summary:

Establishing ethical and privacy protection aspects in scientific research, especially in medical research, has a long history. Medical data are usually more sensible than other personal data and require therefore an even higher degree of protection than other personal data. In recent research projects genetic evaluations become more and more important and trigger thereby new and continuing activities in the context of data protection. Genetic data as a subset of medical data are the most sensible category of personal data and require therefore the highest degree of data protection.The book provides a systematic and itemized approach to data protection in clinical research including the handling of genetic material, genetic samples as well as derived genetic data and the subsequent secure storage of them. The set up of different kinds of clinical trials having in addition a genetic part, the concept of a genetic informed consent as well as collection schemes of samples are described in detail. Technical requirements and aspects of data protection including pseudonymization and anonymization procedures taking into account ethics committees requirements as well as the underlying legal framework are also presented.Without any exception, all principles and methods presented are best practices, repeatedly applied in different clinical environments and by no means theoretical considerations.

Contents:

Study modes

Protection masks and procedures

Coding methods for de-identified samples/data

Relationships among the protection masks

Data types

Anonymization

Validation : a brief introduction

Request management

Legal requirements & regulations

Informed consent

Selected data protection & medical sites

Impact of external services on data protection

Practical approach to clinical trials with supplementary genetic parts.

Notes:

Description based upon print version of record.

Includes bibliographical references (pages [191]-196) and index.

Description based on print version record.

ISBN:

9783110283280

311028328X

9783110381597

3110381591

OCLC:

898769669