REB Study Identifiers, logs, key files

AC-AER-020
REB Study Identifiers, logs, key files
DepartmentApplied Educational Research
Creation DateMay 24, 2011
Approval DateMay 24, 2011
Effective DateMay 24, 2011

Organizational Scope

This policy pertains to all staff, faculty, students or external persons intending to participate in or carry out research at and/or in collaboration with the Michener Institute.

Purpose

In the interest of protecting the privacy and confidentiality of research participants, this policy describes the requirements for assigning identifiers to study participants’ data and the creation, use and storage of key files and logs.

Definitions

Confidentiality: is “an ethical and/or legal responsibility of individuals or organizations to safeguard information entrusted to them, from unauthorized access, use, disclosure, modification, loss or theft.1 Confidentiality answers the question: What information about another person(s) am I obliged to keep secure?

Identifiable or ‘Personal’ Information: “Information that may reasonably be expected to identify an individual, alone or in combination with other available information. “1

Directly identifying information-information identifies a specific individual through direct identifiers (e.g. name, address, telephone number, email address)

Indirectly identifying information-information can be reasonably expected to identify an individual through a combination of indirect identifiers (e.g. department, sex, personal characteristics)

De-identified information-any information that identifies and individual is removed. (De-identified information may be coded or anonymized)

Coded information-direct identifiers are removed and replaced with a code. (code can be linked to an identifying key for re-identification)

Anonymized information-information is irrevocably stripped of direct identifiers (there is no possibility of re-linkage)

Anonymous information-information never had identifiers.

Unique Study Identifier (Code): a unique combination of numbers and/or letters and/or symbols such as an alpha-numeric code used to identify a study participant.

Key file: a means of linking a unique study identifier with any information that identifies an individual.

Privacy:individual’s right to be free from intrusion or interference by others.”1. Privacy answers the question: What information about myself do I have a right to keep secure?

Security: “Measures taken to protect information. It includes physical, administrative and technical safeguards.”1

 

Policy

The Study Investigator and/or sponsor is responsible for protecting the privacy and confidentiality of participant data. Study identifiers, logs and key files are created and used to support this mandate.

 Responsibility

This policy applies to the Chair, members of the Research Office and/or administration, REB, Study Investigators and Sponsors.

The Investigator and/or sponsor is charged with the responsibility of protecting the privacy and confidentiality, and the security of the research data both within the Institution and while being transported and/or stored elsewhere.

Procedures

2.1         Identifiable Data-Randomization Schedules, Key Files, Consent Forms and Screening logs

2.1.1      Investigators will limit the collection of personal data to that which is necessary to achieve the research objectives only;

2.1.2      Randomization schedules, key files, consent forms and screening logs provide identifiable participant data and must be diligently protected;

2.1.3      Randomization schedules, key files, consent forms and screening logs will not leave The Michener Institute unless for the sake of long-term storage or when approved by the REB;

2.1.4                      Randomization schedules, key files, consent forms and screening logs will be encrypted or stored on a secured server and kept separately from other research data that could potentially link the two;

2.1.5      Hard copy randomization schedules, key files, consent forms and screening logs will be stored in locked cabinets in locked offices and kept separately from other research data that could potentially link the two;

2.1.6      Access to randomization schedules, key files, consent forms and screening logs is restricted to appropriately designated members of the research team.

 2.2         Non-identifiable Data-Unique Study Identifiers

2.2.1      All study-related documentation (except those listed in 2.1) will contain NO information that would allow the participant to be identified;

2.2.2      Unique study identifiers (such as alpha-numeric codes) will be used to collect and store research participant data;

2.2.3      Electronic data files of data with unique study identifiers will be encrypted or stored on a secured server;

2.1.4      Hard copy files of data with unique study identifiers will be stored in locked cabinets in locked offices;

2.1.5      A unique study identifier is NOT derived from or related to any personal identifier of the participant such as:

  1. Name, initials, reverse initials, first or last three letters of the participant’s name;
  2. DOB (in full or in part);

iii.   Address, phone number, email address;

  1. Student number, health card number, driver’s licence number, social insurance number.

2.3         Data Security

2.3.1      Access to study data is restricted to appropriately designated members of the research team;

2.3.2      The Principal Investigator will designate in writing who has access to study data;

2.3.3      All data leaving Michener will be de-identified and only contain a unique study identifier.

References

  1. Tri-Council Policy Statement (TCPS 2). Ethical Conduct for Research Involving Humans, Medical research Council of Canada 2010. Chapter 5.

http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/

  1. ICH Harmonized Tripartite Guideline. Good Clinical Practice: Consolidated Guideline (E6)1996.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php

  1. CIHR Best Practices for Protecting Privacy in Health Research (2005)

http://www.cihr-irsc.gc.ca/e/29072.html