|
Can an optometrist be the PI and or co-investigator in an in-house clinical trial/research study? What should be their qualification? Is it necessary to have a clinician in the research team where all investigators are optometrists.
Dr Sreevatsa
As per Indian GCP the investigator or co-investigator should be a medical person. See the relevant excerpt:
Qualifications
The investigator should be qualified by education, training and experience to assume responsibility for the proper conduct of the study and should have qualifications prescribed by the Medical Council of India (MCI).
Co-investigator
A person legally qualified to be an investigator, to whom the investigator delegates a part of his responsibilities.
So, an optometrist can’t become investigator or co-investigator in a trial in India.
Are there any local regulation in India which allow sponsor to donate the equipment to the sites at study end/early termination stage?
Vijay Barve
WHO has published Guidelines for Health Care Equipment Donations in 2000, which recommends following:
Donors should always respect the four core principles:
1) a donation should benefit the recipient to the maximum extent possible;
2) a donation should respect the wishes of the recipient and their authority within the health system;
3) there should be no double standards in quality;
4) there should be maximum communication between donor and recipient. Donors should also respect the national guidelines for health care equipment donations and respond to the priority needs indicated by the recipient. Although they are a reality of life, unsolicited donations should be discouraged as much as possible.
However, neither ICMR guidelines nor NDCTR19 provide any guidance about donation of equipment to the sites at study end/early termination stage.
Sponsors considering equipment donations should be aware of the following ethical issues:
Assess potential conflicts of interest: Ensure that the donation does not influence the impartiality of current or future trials the site.
Seek ethical approval: Obtain approval from ethics committees to ensure the donation aligns with ethical standards.
Document transparently: Maintain clear records of the donation process, including agreements and communications with the recipient site.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
|