Dealing with participants / Patients requests and complaints

16.1 Purpose:

The IRB considers protection of the rights and welfare of the human subjects participating in a biomedical research approved by the IRB as its primary responsibility. Informed consent documents reviewed by the IRB contains the statement, questions regarding rights of a participant/patient may be addressed to the IRB secretariat, with the IRB address and phone number.

This procedure provides guidelines for dealing with and accommodating requests by participants/ patients regarding their rights as a participant or to resolve their complaints in any approved research study.

16.2 Scope:

This SOP applies to all requests concerning the rights and well-being of the research participants participating in studies approved by the IRB.

16.3 Responsibility:

It is the responsibility of the IRB secretariat for providing required information to the research participants in case of queries received from research participants.

It is the responsibility of the chairperson to initiate a process to give information to the participants or to identify and address any injustice that has occurred, if complaints are received from research participants.

16.4 Detailed instructions:

  • The IRB member/ administrative staff receive an inquiry or request from research participant / patient.
  • The secretariat will inform the chairperson about the query / complaint received from the research participant.
  • The chairperson / members designated by the chairperson will provide information required by the research participant.
  • In case of complaint received from a research participant, the chairperson initiates a process to identify and address any injustice that may have occurred.
  • The chairperson will direct the member secretary to consider the matter for discussion at a IRB meeting or to call an emergency meeting of 2 or more IRB members for discussion or to appoint a subcommittee of 2 or more IRB members for enquiry in order to resolve the matter.
  • The chairperson / member secretary / designated IRB members will assess the situation and mediate a dialogue between the research participant and the investigator in an attempt to resolve the matter.
  • The IRB will insist on factual details to determine reality between truth and individual perception.
  • The final decision will be informed to the research participant by the secretariat.
  • The IRB members are informed about the action taken and the outcomes in the forthcoming IRB meeting.

16.5 Filing the request document:

  • The request from research participant / patient is filed in the “response” file by the Member Secretary / administrative staff.
  • A copy of the same is kept in the study file.
  • The file is stored in a secured place.