Rohtak PGIMS tightens norms for clinical trials sponsored by industry
Aims to enhance transparency, accountability and prevent conflicts of interest
Pt BD Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak, has issued comprehensive guidelines to regulate industry-sponsored clinical trials, making disclosure of foreign travel, hospitality and financial relationships with pharmaceutical companies mandatory for government doctors.
The guidelines, framed after examining clinical trial agreements from legal, administrative and ethical perspectives, aim to enhance transparency, accountability and prevent conflicts of interest. They take into account provisions of the Prevention of Corruption Act, the Haryana Civil Services (Conduct) Rules, government instructions on foreign visits by public servants, principles governing transparency in government medical institutions and liabilities arising from adverse incidents during clinical trials.
“Payments made by pharmaceutical companies for legitimate research activities may be permissible, but there is a risk that financial incentives could directly or indirectly influence patient recruitment, investigators’ neutrality, recommendations of sponsors’ products, and future procurement or prescribing behaviour. Therefore, clear guidelines were required,” said a PGIMS official.
The official said the institute found that some clinical trial agreements did not contain mandatory clauses requiring disclosure of foreign travel, participation in international conferences, accommodation, hospitality and other benefits extended to investigators or their family members. “This omission assumes significance as pharma and medical device companies frequently sponsor conferences, workshops and foreign visits connected with their products and studies. In the absence of mandatory disclosure provisions, such benefits may remain beyond the knowledge of higher authorities and audit bodies,” the official added.
The norms state that acceptance of undisclosed sponsorships or hospitality by government doctors could invite scrutiny under the Prevention of Corruption Act and may also amount to misconduct under the Haryana Civil Services (Conduct) Rules.
To safeguard institutional integrity, PGIMS has made several provisions mandatory for all future clinical trial agreements. These include compulsory disclosure of sponsor-funded foreign travel, conference participation, accommodation, hospitality benefits and sponsorships extended to family members. Prior approval from the competent authority will be required before accepting any sponsor-funded travel, air tickets, accommodation or conference sponsorship.
The institute has also made annual conflict-of-interest declarations mandatory, requiring investigators to disclose research grants, consultancy assignments, honoraria, travel sponsorships and other financial relationships with the industry.
All payments related to clinical studies will be routed through institutional accounts and subjected to audit. A vigilance monitoring mechanism will maintain records of industry-sponsored travel and other benefits to ensure greater transparency. PGIMS Director Dr SK Singhal confirmed the guidelines.
