Is it necessary to have tripartite legal clinical trial agreement between sponsor, investigator, and representative from institute?
Dr Sreevatsa
The agreement between the sponsor, the investigator, and the institution is to ensure that the investigator and the institution conduct the trial in compliance with GCP, with the applicable regulatory requirement(s) and with the protocol agreed to by the sponsor and given approval/favourable opinion by the IRB/IEC.
The GCP responsibilities of the investigator are similar in most of the situations. However, in some situations the investigator must inform the institution e.g. SAE report to the Head of the Institution. Also, in case the investigator leaves the institution, institution would be responsible for GCP compliance. Even if the head of the institute is the investigator, the responsibilities for both these roles for regulatory compliance are different. So, it is desirable that there are two signatories from the hospital – the investigator and the head of the institute. If there is another person from the institution authorized to sign legal agreements, he/she could be the second signatory.
Indian GCP definition of contract mentions investigator and institution separately:
• Contract: A written, dated, and signed document describing the agreement between two or more parties involved in a biomedical study, namely Investigator, Sponsor, Institution. Typically, a contract sets out delegation/distribution of responsibilities, financial arrangements, and other pertinent terms. The “Protocol” may form the basis of “Contract”.
See also finance and insurance which mentions institution and the investigator separately.
• 2.3.1.12. Finance and insurance.
c. The financial arrangement between the sponsor, the individual researcher(s)/manufacturer involved, institution and the investigator(s) in case such information is not stated explicitly.
e. The liability of the involved parties (investigator, sponsor /manufacturer, institution(s) etc.) must be clearly agreed and stated before the start of the study.
We are looking use, implement the participant recruitment website as a recruitment tool in India. Is this something can be implemented in India with getting all necessary approvals? What India regulations says about this?
Vishal Barge
There are no Indian regulatory guidelines on this issue. There are critical ethical issues to be considered e. g. privacy, confidentiality, vulnerability. The issues are more challenging for a pharmaceutical company /clinical research organisation (CRO) wanting to set up a participant recruitment website.
Websites, along with print and broadcast advertisements, are commonly used by investigators and institutions to recruit research subjects. In some cases, the information provided on these websites may constitute the earliest components of the informed consent process. IRB review of informed consent, all recruitment materials, and plans for protecting the confidentiality of that information is essential.
US National Institutes of Health has a Guidance Regarding Social Media Tools for employees, contractors, or partners who are engaged in Office of Intramural Research recruitment of patients to clinical trials. This guidance is focused on social media tools and technologies that allow people to exchange information in real (or delayed time) on platforms that are public - including but not limited to - social networks (such as Facebook), micro blogs (such as Twitter), automated feeds (such as RSS), image/video sharing sites (such as YouTube), social bookmarking services, blogs, forums and other emerging technologies with the purpose of social interaction. In the social media environment, the movement and placement, context, and content of information, may all be manipulated. Also, audiences may be highly-targeted without individuals in those audiences self-selecting to be reached.
To fulfil the responsibilities in using new and social media for recruiting research participants, the Investigators should consider the following questions:
• Have I considered the full implications of privacy in this new and less-controlled environment?
• I need to carefully consider how my materials will be used.
• Have I controlled my informational data in a locked format?
• Have I made the contact for further information site protected for the privacy of interested individuals?
• Do I clearly understand that the interactive nature of social media escalates the speed of interaction, allowing for greater opportunities for errors in protecting private information?
• Have I planned to obviate those errors?
• Have I accounted for problems related to the portability and secure handling of information, including the encryption of all government laptops, the encryption of sensitive information during transport, including but not limited to transport across the network or on portable media, and the reporting of unintended breaches of sensitive personal information in the government’s possession?
• Have I included my complete strategy for use of the social media and my strategies for protection of privacy and strategies for informed consent explicitly in my proposal to the IRB?
• Have my team and I clearly understood the invasive nature of joining groups (i.e., support groups, disease groups, advocacy groups, etc.) for the purpose of recruitment?
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
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