Safeguarding confidentiality

[Guest guest]

Hello Everybody,

Moving ahead with the discussion let’s discuss about the need to protect the research participant’s confidentiality.

Safeguarding confidentiality:

Research participants should have their privacy protected and their well being monitored. The investigator must establish secure safeguards to ensure the confidentiality of participants’ research data. If the information collected and stored could cause harm or distress when disclosed to a third party, the investigator should arrange to protect the confidentiality of such information; for example, by omitting information that might lead to identification of individual participants, limiting access to the information, anonymizing data or by other means.

Research protocols should contain the following, and they should be considered by review committees:

A full description of people who will have access to personal data of the research participants, including medical records and biological samples.

The measures proposed to ensure confidentiality and security of personal information concerning participants.

A description of any plans to make the study product available to the research participants following the research.

The measures taken to inform research participants about information that becomes available during the course of research, which is relevant to their participation (including their rights, safety, and well being), and

The measures proposed to inform participants of study results when appropriate.

Data of individual participants can be disclosed under the following circumstances :

Only in a court of law under the orders of the presiding judge

If there is threat to a person’s life

In cases of severe adverse reaction may be required to communicate to drug registration authority

If there is risk to public health it takes precedence over personal right to privacy and may have to be communicated to health authority.

Therefore, the limitations in maintaining the confidentiality of data should be anticipated and assessed and communicated to appropriate individuals or authorities as the case may be.

Dr.Smita

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