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The dataset was not collected by the authors, but the study was conducted on a publicly available dataset. The source of the data is cited, but the source does not have an ethics statement itself. The data is heartbeat time series.

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  • Please specify ethics: in agreement to which moral values? of which culture?
    – EarlGrey
    Apr 26 '21 at 9:45
  • This is really a question about your local law. Did you consult your ethics committee coordinator? Consider adding your country. Apr 26 '21 at 10:50
  • 2
    Does your uni have an ethics council (or whatever it is locally called) that can help you? Could you retro-construct an ethics statement for the data? If it's a very benign study it may be easy. For example, if collecting the heartbeat info was from all informed volunteer subjects, involved no danger or harm to the subjects, and was entirely anonymous.
    – puppetsock
    Apr 26 '21 at 14:25
  • Can you give a link to the source? That might be helpful in giving a more precise answer.
    – Ben Bolker
    Apr 26 '21 at 23:51
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The following assumes that the analysis is being done as research (i.e., as a systematic investigation intended to contribute to generalizable knowledge) and that the intention is to publish the results of the analysis in a scientific journal.

There are two separate questions here.

What kind of ethics review is required when analyzing publicly available data about humans?

How should the ethical review of data about the analysis of publicly available data about humans be described when submitting a manuscript that reports the results of the analysis?

The answer to each question is complex. The answer to the first question would be modified by the specific requirements of the author’s institution as well as the local (country) context. The answer to the second question would depend on the specific requirements of any journal in which an attempt is made to publish the results of the analysis of the data.

You should clarify your institution’s requirements for review of publicly available data with an expert on these matters at your institution. They are likely to want to know a lot more about the data: when it was collected, how it was collected, whether the humans whose data are contained in the dataset consented to the data collection and to the use of the data for research, and, importantly in secondary analysis, whether there are elements of the data that could be used to identify or potentially identify a specific living human being.

Medical journals vary widely in what they require in an ethics statement. You should think about what journals might be interested in the results of your analysis and review their requirements for an ethics statement. A review of two or three journals that might be interested would give you an idea of the range of requirements.

A “fail-safe” method for assuring that an analysis of publicly available data about humans will not raise concerns about the ethics of use of the data at the journal submission stage (or worse, after publication) is to submit the plan for the analysis to the institutional entity charged with ethics review and have this entity determine what kind of review is required or deem that the analysis is not subject to (further) review. This sounds like (and is) quite bureaucratic but it also protects the analyst(s) from allegations that ethics were breached in analyzing the data.

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  • This is the best (safest/most practical) answer so far.
    – Ben Bolker
    Apr 26 '21 at 23:54
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You should not need ethics clearance at all. There is no ethical impediment to making inferences from publicly available data and reporting your results publicly.

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  • Example of past ethical issues: irishtimes.com/news/science/…
    – EarlGrey
    Apr 26 '21 at 7:27
  • Thanks for the link. An interesting case, but note that in that case the data is not yet public, and the ethics argument is over whether the data should be published, rather than whether a research can make inferences from published data.
    – Ben
    Apr 26 '21 at 9:06
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    This is dangerous advice; check your local laws and regulations. Not everything that is ethical is legal. Apr 26 '21 at 10:53
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    Can you suggest a possible law that could prohibit making and reporting inferences from publicly available datasets?
    – Ben
    Apr 26 '21 at 12:39
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    I just want to clarify for everyone that the OP is about analysis of a dataset that is already publicly available. Any ethical issues concerning publication of data, while interesting in other contexts, are not applicable here. Instead, the operative question is whether there is any ethical impediment to analysis of public data and publication of findings.
    – Ben
    Apr 28 '21 at 22:54
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In general you wouldn't need ethics approval to use this data set; it would be covered by the ethics statement from the original experiment. Presumably the original data collectors had one, even if it's not referenced; if you want to be extra-careful, you should try to find the peer-reviewed publication associated with the data set, and look there for the ethics statement.

More generally, it's hard to see how you could be causing harm by using a public, already collected data set; you didn't have any interaction at all with the subjects! The exception to this would be if you had reason to believe that the original data set might not have been ethically collected, in which there would be an argument for not using the data even though it has already been collected. Practically speaking, though, if these are data collected in the last few decades, it's likely that the researchers were required to undergo ethics approval before data collection.

There are lots of edge cases here:

If possible, you should be careful and follow @DianaPetitti's advice by checking with your university's research ethics board; hopefully they will tell you you're good to go. (Although I absolutely understand why it is so, ethics boards are often cautious to the point of [researcher] frustration even when the probability of harm is almost vanishingly small.)

Disclaimer: I am not an ethicist and have not been involved in dealing with ethics statements with the exception of a few surveys and student evaluation exercises.


Tracking the source of the data back we get to Greenwald, S.D. (1990). Improved detection and classification of arrhythmias in noise-corrupted electrocardiograms using contextual information. Thesis. Massachusetts Institute of Technology. https://dspace.mit.edu/handle/1721.1/29206

We established a test database of 35 half-hour ECG records ... [Some data] are from the MIT/BIH Arrhythmia Database ...
[Some other data] are from the AHA Arrhythmia Database ...
Tapes in the 800 series were collected for this research from long-term Holter records archived in the Beth Israel Hospital Arrhythmia Laboratory ...

This is admittedly a little disappointing; there's no evidence that informed consent was obtained, although from a practical standpoint it seems incredibly unlikely that these records could either be personally identified, or that any significant harm was caused in their collection. (This describes the data that are first presented in the thesis — for complete diligence you'd have to go back farther to the sources of the other two arrhythmia databases listed here and see what they say about sample collection ..)

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    It is NOT safe to assume that data collected in the last few decades are "safe". Example: ncbi.nlm.nih.gov/pmc/articles/PMC4132579
    – EarlGrey
    Apr 26 '21 at 9:40
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    This is dangerous advice; check your local laws and regulations. Not everything that is ethical is legal. Apr 26 '21 at 10:52
  • "it's hard to see how you could be causing harm by using an already collected data set; you didn't have any interaction at all with the subjects" This does not apply if the data is not public and is identifiable. Apr 26 '21 at 10:53
  • 'In general you wouldn't need ethics approval to use this data set; it would be covered by the ethics statement from the original experiment.' What if the original ethics statement hinges on the data being presented in anonymised form, then a new research project discovers hitherto-unsuspected subtle features in the published data set, from which the identities of the participants can be reconstructed? Apr 26 '21 at 11:40
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    @Ben: to be fair, an earlier version of my answer didn't include the qualifier "public". Also, DanielHatton says "hitherto-unsuspected subtle features in the published data set" make it identifiable. I think this is stretching a hypothetical point too far, but it's certainly possible
    – Ben Bolker
    Apr 28 '21 at 23:16
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I suggest to start your research for answers from expert in the field of ethics and data usage. For example:

https://www.ama-assn.org/delivering-care/ethics/release-data-unethical-experiments

Please avoid expecting a meaningful response for such kind of delicate questions.

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  • "the source does not have an ethics statement itself" ---> the data collection should be considered as unethical (on the basis of good practices not being respected). Thanks to the downvote(s) for considering not useful this answer.
    – EarlGrey
    Apr 26 '21 at 11:26
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    I think this answer would be more useful if you included some more of the information from the link.
    – Ben Bolker
    Apr 26 '21 at 23:38

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