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How do I get IRB/ethics approval for human subjects research in India? (57)

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Distinguished 950 pts 0 followers
National Institute of Technology Karnataka · Posted

Problem statement

I am working on a bioinformatics project analyzing GWAS data for a rare Indian genetic disorder. My sample size is only n=89 cases and n=143 controls due to the rarity of the condition.

Specific questions:

  1. Should I report power analysis even though I know the study is underpowered?
  2. Bonferroni seems too conservative with this sample size; is FDR acceptable?
  3. I don't have an independent cohort to validate. Is this a dealbreaker for journal submission?

This is a legitimate clinical study with IRB approval. I just want to know how to frame the limitations honestly.

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21 Replies

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Harini Balakrishnan Active 215 pts · Accepted answer

The ethics review situation in Indian universities is actually more complex than most people realize.

There is no uniform national framework equivalent to the US Common Rule. Each institution has its own Institutional Ethics Committee (IEC) or Institutional Review Board (IRB).

For anonymous survey research with no identifiable data and no vulnerable populations: most Indian IECs would classify this as exempt, but 'exempt' still needs a formal determination from the IEC.it is not self-certifying.

My practical advice: go to your institution's research ethics office now, describe what you did, and request an exempt determination in writing. Better to have documentation than to discover the issue during thesis review.

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Replying to Harini Balakrishnan
Sowmya Narayanan Active 310 pts · Accepted answer

Seconding the recommendation for Zotero. Game changer for managing references across multiple projects.

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Replying to Harini Balakrishnan
Yogesh Pandey Growing 70 pts · Accepted answer

The Fulbright SoP is very different from a typical PhD SoP. It needs to focus on cultural exchange and diplomacy, not just research.

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Replying to Harini Balakrishnan
Revathi Chandrasekaran Active 410 pts · Accepted answer

Really appreciate you taking the time to write this out in detail. This is going straight into my research notes.

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Asha Pillai Distinguished 880 pts · Accepted answer

I am in a very similar situation. Would you be willing to share the outline of your PMRF proposal? Not the content.just the section headings and approximate word allocation.

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Disha Malhotra Starting 8 pts · Accepted answer

Open access is the right direction but the APCs are prohibitively expensive for many Indian researchers without institutional funding.

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Replying to Disha Malhotra
Jaya Lakshmanan Growing 50 pts · Accepted answer

Really appreciate you taking the time to write this out in detail. This is going straight into my research notes.

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Replying to Disha Malhotra
Rekha Shetty Starting 40 pts · Accepted answer

This is very reassuring. I was worried the null result would kill the paper but your framing around transparency and effect sizes makes a lot of sense.

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Replying to Disha Malhotra
Ekta Choudhary Starting 45 pts · Accepted answer

+1 to everything said above. My experience was identical.

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Jagdish Rawat · Accepted answer

This is exactly what I needed to hear. One clarifying question: you mentioned FedProx handles non-IID data better.does that mean I should switch to FedProx by default, or only if I observe poor convergence with FedAvg first?

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Replying to Jagdish Rawat
Nandita Ghosh Distinguished 720 pts · Accepted answer

This is a known issue with XLM-R on code-mixed data. The MuRIL preprint has a section specifically comparing these.

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Rajesh Kumar · Accepted answer

Respectfully, I think this framing misses the systemic dimension. Individual researchers cannot solve a collective action problem. If you submit to open-access journals and your colleague submits to Nature, your colleague gets the promotion. Until evaluation criteria change at the institutional level.which requires policy intervention.individual choices have minimal impact.

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Replying to Rajesh Kumar
Rohan Desai Distinguished 950 pts · Accepted answer

I am in a very similar situation. Would you be willing to share the outline of your PMRF proposal? Not the content.just the section headings and approximate word allocation.

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Suresh Iyer · Accepted answer

I have a slightly different take from my experience in industry research. The reproducibility crisis is real but unevenly distributed. Fields with strong engineering culture (computational biology, ML with benchmarks) have actually improved significantly in the last 5 years. The bigger problem is in fields where data sharing is structurally difficult.clinical medicine, behavioral economics.

The ML community's move toward open code and reproducibility checklists has been genuinely effective.

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Dinesh Kulkarni Distinguished 730 pts · Accepted answer

This is exactly what I needed to hear. One clarifying question: you mentioned FedProx handles non-IID data better.does that mean I should switch to FedProx by default, or only if I observe poor convergence with FedAvg first?

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Deepa Krishnamurthy Distinguished 810 pts · Accepted answer

For longitudinal data with missing values, mixed-effects models handle this more gracefully than imputation in most cases.

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Shiva Prasad Active 480 pts · Accepted answer

The Fulbright SoP is very different from a typical PhD SoP. It needs to focus on cultural exchange and diplomacy, not just research.

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Kiran Yadav Growing 130 pts · Accepted answer

Flower (flwr) is the most actively maintained and research-friendly federated learning framework right now. My group has been using it for 18 months on a healthcare project with 4 hospital sites.

Strengths:

  • Clean simulation API that lets you test on a single machine before deploying
  • Good support for custom aggregation strategies (FedProx, FedNova)
  • Active Discord community with quick responses from the maintainers

For non-IID data specifically, look at the FedProx strategy.it handles heterogeneous data distributions much better than FedAvg.

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Replying to Kiran Yadav
Quamar Ahmed Growing 65 pts · Accepted answer

Marking this as the accepted answer. Incredibly helpful and specific. Really appreciate you taking the time.

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Replying to Kiran Yadav
Vikram Bhatia Active 420 pts · Accepted answer

Thank you! The reference to MuRIL is particularly useful.I had not considered it as an alternative to XLM-R for Indic languages.

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Replying to Kiran Yadav
Kavitha Subramanian Active 365 pts · Accepted answer

Marking this as the accepted answer. Incredibly helpful and specific. Really appreciate you taking the time.