The document discusses principles for maintaining confidentiality in clinical trials, including: 1. Privacy, confidentiality, and anonymity of participant data should be protected according to regulatory requirements. 2. Personally identifiable participant data is kept confidential via informed consent agreements. 3. Breaches of confidentiality pose risks to participants and only essential information should be collected with consent.

1. Confidentiality of Clinical
Trial Participant Records
Dr Rajiv Ranjan Das
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3. 1. ETHICAL PRINCIPLES
2. RISK VERSUS BENEFITS
3. RIGHTS , SAFETY , WELL BEING OF SUBJECTS
4. NON CLINICAL AND CLINICAL DATA SHOULD SUPPORT STUDY
5. SCIENTIFIC , VALID PROTOCOL
6. IEC/IRB APPROVAL
7. MEDICAL CARE
8. TRAINING AND EXPERIENCE
9. FREE INFORMED CONSENT
10.RECORDING, HANDLING
11.CONFIDENTIALITY
12.GMP
13.QAAND QC
Summary… 13 ICH GCP PRINCIPLES
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4. 2.11 The confidentiality of records that could identify
subjects should be protected , respecting the privacy and
confidentiality rules in accordance with the applicable
regulatory requirements
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5. Important consideration for protecting human research
participants
1. Privacy
2. Confidentiality
3. Anonymity
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6. • It means protecting the individual’s right to access to their
participation in study
• The investigator must carefully consider how to approach an
individual
• The appropriate circumstances and setting where participants might
be contacted and where participant information will be collected
• For example a participant should not be asked for personal or
sensitive information in a public setting
Privacy
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7. Confidentiality
• It means protecting the participants personally identifiable data
• It represents an agreement that is formed between the researcher and
participant via the informed consent process that ensures the participants
identity, personal information , responses etc. will not be disclosed to
anyone outside the research team
• Breach of confidentiality is a potential risk to participants in research
• Only that information which is essential for research purposes be collected
,which should be done only after informed consent has been obtained
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8. Anonymity
• It means that no member of the research team collect any personal
identifiers, direct or indirect, that would link responses to a specific
individual
• Data collected in person is not anonymous even if key codes are used
instead of participant names or other identifiers
• If a study is being conducted with a population where a combination
of indirect identifiers (i.e., gender, ethnicity, age, class) are collected
and may be used to identify a specific individual, then the study is not
anonymous
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9. https://www.purdue.edu/research/dimensions/important-considerations-for-protecting-human-research-
participants/#:~:text=One%20of%20the%20key%20aspects,the%20participant%20to%20remain%20anonymous.
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11. It is significant to note that by enactment of the Information Technology Act, 2000,
the Indian Parliament provided a new legal idiom to data protection and privacy
The main principles on data protection and privacy enumerated under the
Information Technology Act, 2000 are:
(i) defining data, computer database, information, electronic form, originator,
addressee etc
(ii) creating civil liability if any person accesses or secures access to computer,
computer system or computer network
Breach of privacy and Confidentiality under
Information Technology Act, 2000
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12. (iii) creating criminal liability if any person accesses or secures access to
computer, computer system or computer network
(iv) declaring any computer, computer system or computer network as a
protected system
(v) imposing penalty for breach of confidentiality and privacy
(vi) setting up of hierarchy of regulatory authorities, namely adjudicating
officers, the Cyber Regulations Appellate Tribunal etc
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13. Section 72 of the Act relates to any person who, in pursuance of any of the
powers conferred by the Act or its allied rules and regulations has secured
access to any:
i) Electronic record,
ii) book,
iii) Register,
iv) Correspondence,
v) Information,
vi) Document,
or vii) Other material
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14. If such person discloses such
electronic record, book, register, correspondence,
information, document or other material to any other
person,
he will be punished with imprisonment for a term,
which may extend to two years, or with fine, which
may extend to two years, or with fine, which may
extend to one lakh rupees, or with both
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15. How to maintain confidentiality??
• Researchers employ a number of methods to keep their
subjects identity confidential
• Foremost , they keep their records secure through the
use of
•Password protected files
•Encryption when sending information over the
internet
•Old fashioned locked doors and drawers
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