Hi everyone!
This post is intended to start a conversation on navigating regulatory requirements while planning and conducting international collaborative research. I know this may trigger painful memories for some and indeed is one of the perceived barriers to effective collaboration.
My take on it is slightly different- I do think that local regulations are intended to safeguard the interests of both the research participants and the researchers, and generally aimed at ensuring fair and equal efforts, contributions and outcomes for all parties.
So I can provide more context on the regulations in India, as I am familiar with those. All international collaborative research in India needs to be approved by the Health Ministry Screening Committee; this is the website were Indian PIs can apply: https://hmsc.dhr.gov.in/. Since late 2022, projects also need to be registered on the BioRRAP portal https://biorrap.gov.in/Home/Login before consideration at HMSC. Additionally, if the project is a clinical trial, prospective registration in the Clinical Trials Registry of India Clinical Trials Registry - India (CTRI) is mandatory. The responsibility to obtain these approvals rests with your Indian collaborator PI. Institute Ethics Committee approval for each center needs to be submitted while applying to these.
In general, 2 types of projects come within the ambit of HMSC approval- those planning data/ material sharing with foreign collaborators and those receiving foreign funding, even if there is no data sharing.
In my experience, the application process is relatively smooth and decisions are received within 2-3 months. One can apply while the project is under consideration for funding with the funding agency, so that approvals are in place soon after funding decisions.
The decisions are made on a case-to-case basis but general pointers are that requests for transfer of large number of biospecimens to foreign labs is unlikely to be approved. Generally, about 10% of the entire cohort maybe transferred for validation, QC etc. but the bulk of the work is to be carried out within Indian partners. In recent times, this is not a major challenge as there are several research as well as commercial labs with spectrum of NGS and other ancillary services available, and research plans that utilize these or offer avenues for capacity generation within India are likely to be successful. For transfer of biospecimens, a Material Transfer Agreement needs to be executed by both labs, formats are available on the HMSC website and the terms of the agreement are carefully reviewed by the HMSC- specifically regarding the number of samples, IP protection etc. Regarding data sharing, Indian guidelines do not allow sharing of identifiable raw data but sharing of anonymized/de-identified is permitted and also needs HMSC approval. Another aspect that the HMSC considers is that the institutes receiving foreign research funding, should be mandatorily cleared to do so under the Indian FCRA (Foreign Contribution Regulation Act).
So, this might seem a bit of a tedious and lengthy process but is not that difficult to execute in reality. It is best to be aware of these regulations at the planning stage and seek experienced partners to implement the project. There are many collaborative projects duly approved by HMSC and successfully implemented throughout India.
Apologies for such a lengthy post, just wanted to put out the resources here for those interested in a collaborative project with Indian partners. I would love to hear from others regarding the regulations at your respective countries!
PS: Happy to answer any further questions on this.
Thanks so much for sharing, @rooparajan. It’s really interesting to hear your perspective on this. One question I have is whether there are any regulations on using (as opposed to creating) shared datasets – for instance, are you able to access PPMI without jumping through any regulatory hoops?
I’m also curious whether folks from other countries, for instance @johanna.junker or @psaffie, have any similar experiences working around regulations, or whether it’s quite different? I’d love to hear other people’s experiences on regulatory requirements at different stages of your research.
Dear Roopa,
Thank you for sharing your experience with us! These are the important hurdles to overcome to make international collaborations realistic. Within the GP2 Monogenic Network, we have gained a lot of experience with overcoming these bureaucratic hurdles in different countries, and it is often not easy and very time-consuming.
Roopa, I wanted to ask you if you are interested in joining the GP2 Monogenic Network? The Monogenic Network is studying patients and families with Parkinson’s to identify causal gene mutations and discover new genes. Among other things, it aims to generate large data sets to address research questions about Parkinson’s disease. If you are interested, let me know. I can provide you with more information.