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Institutional Ethics Committee (IEC)
Institutional Ethics Committee (IEC)
Pi Health Cancer Hospital has an Institutional Ethics Committee (IEC) that consists of medical, non-medical, scientific and non-scientific members who are independent and competent. The IEC’s role is to protect the rights, safety and well-being of human subjects who participate in clinical trials conducted by the hospital or its affiliates. The IEC does this by reviewing, approving, and monitoring the trial protocols and amendments, as well as ensuring compliance with ethical and scientific standards.
The IEC follows the guidelines and regulations of the Drug Controller General of India (DCGI), the National Accreditation Board for Hospitals and Healthcare providers (NABH), and other relevant authorities. The IEC also supports the development and education of a research community that is responsive to local health care needs.
The IEC was established in May 2023 and is registered with the DCGI. The registration number is ECR/1844/Inst/TG/2023 and is renewed periodically.
Institutional Ethics Committe
3rd Floor, Pi Health Cancer Hospital
survey no 110, phase IV, plot 184, HIG-B, DLF Rd, Gachibowli, Telangana 500032
IEC Review Process
Investigators who wish to conduct clinical trials at Pi Health Cancer Hospital or its affiliates must submit their documents to the IEC at least three weeks before the scheduled IEC meeting. The IEC Secretariat will verify the completeness and validity of the Project Application Proforma and the signatures of the Principal Investigator.
The IEC members will evaluate the study protocol based on the following criteria:
- Risks to participants are minimized and proportional to the expected benefits.
- Participants are selected fairly and inclusively.
- Informed consent is clear, comprehensive and well-documented.
- The research plan provides adequate monitoring of the data collected to ensure the safety of participants, where appropriate.
- There are sufficient measures to protect the privacy of participants and to maintain the confidentiality of data, where appropriate.
- Special safeguards are included to protect vulnerable participants.
- The advertisements regarding the research project do not mislead or coerce the participants to join the clinical trials and that the Research doctor has a recruitment policy to ensure unbiased selection of adequate number of suitable subjects according to the protocol.