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What are the requirements regarding sharing of intellectual properties coming out of exploratory research (leveraging human genetic resources) in India? In case of multisite investigator initiated trial and real-world evidence research in India who is the IP owner of the genetic data coming out of the research? Is there any regulation on human genetic related data export in India?
Dr Partha Gokhale
ICMR 2017 National Ethical Guidelines for Biomedical and Health Research involving human participants describes intellectual property rights (IPR) in several sections:
Ethical considerations in collaborative research
• The participating centres should function as partners with the collaborator(s) and sponsor(s) in terms of ownership of samples and data, analysis, dissemination, publication and IPR as appropriate. There must be free flow of knowledge and capacity at bilateral/multilateral levels.
International collaboration
• Indian participating centres should function as partners with the collaborator(s) and sponsor(s) in terms of ownership of samples and data, analysis, dissemination, publication and IPR related to research in India, as may be considered appropriate.
• Any research involving exchange of biological material/specimens with collaborating institution(s) outside India must sign an MTA (Material Transfer Agreement) justifying the purpose and quantity of the sample being collected and addressing issues related to confidentiality, sharing of data, joint publication policy, IPR and benefit sharing, post analysis handling of the leftover biological materials, safety norms, etc.
Handling IPRs related to gene patenting and development of newer technologies for commercial gains should follow the applicable national policy/regulations.
In addition to the general contents specified in Section 5, the consent form for genetic testing for research may have explanations/details on the following elements:
• Issues related to ownership rights, IPR concerns, commercialization aspects and benefit sharing.
Ownership of biological samples and data
The participant owns the biological sample and data collected from her/him and therefore, could withdraw both the biological material donated to the biobank and the related data unless the latter is required for outcome measurement and is so mentioned in the initial informed consent document. Complete anonymization would practically make the original donor lose the right of ownership. Biobanks/institutes are the custodians or trustees of the samples and data through their ECs as their present and future use would be done under supervision of the respective ECs. Researchers have no claim for either ownership or custodianship. Existing guidelines on international collaboration for biological samples, data and intellectual property including publication related issues will be applicable.
National guidelines for stem cell research 2017 recommend the cell lines/products may also undergo genetic manipulation and have the potential for commercialization. In the latter event, the IPR of the biological material will not vest with the donor. However, if commercialization brings any benefits, say financial, efforts should be made to pass on the same to the donor/community wherever possible.
IPR and social responsibility
Outcome of research on stem cells/lines and/or application of their products/derivatives may have commercial value. The option of sharing IPR should be indicated in the informed consent form. It is expected that a proportion of the benefit accruing from commercial use of donated tissue/cells will be returned to the community (the word “community” here refers to all potential beneficiaries including patient/s, which has directly or indirectly contributed to the product) as per the norms.
Is there any regulation on human genetic related data export in India?
Dr Partha Gokhale
ICMR Guidelines for international collaboration/research projects in health research recommend sharing of raw data by Indian PI (principal investigator) with the foreign agency in any form is not permitted. Only de-identified/anonymized/analysed data can be shared.
Can an EC conduct an impromptu audit without principal investigator’s knowledge on investigational product related issues?
Ninad Satam
If the Ethics Committee has received a complaint about the investigator in relation to investigational product use and accountability, the committee can conduct an impromptu audit without informing principal investigator.
Dr Arun Bhatt is a Consultant - Clinical Research & Development, Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
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