Hello,
it’s my first topic in this forum so excuse if it’s in the wrong category.
My question is:
Does anybody know an option how to review a study, which I’m planning, if i don’t have acces to an ethical comittee at an university or something similar?
Best Regards Alexander Kessner
Hi @Alexander_Kessner, welcome to the forum 
Good question! Unfortunately there aren’t yet any well-established alternatives to IRBs.
Where are you based? If it’s the US then our friends at the Ronin Institute may be able to help, particularly if you are able to get by with an ethical review waiver.
This post from Helen Kara discusses ethical review for independent researchers and has a few other suggestions.
Thank You! Unfortenately I’m based in Europe (Germany)
Great Link, exactly what i searched for. 
In Sweden the review boards are government institutions. If your research can be said to have some connection to Sweden you might be able to use those.
The answers to this question on Research Gate may also be of interest.
Thank you! We now realised that the German Psychological Society (DGPs) has a ethical commission which we can use for relatively little money (125€). But nevertheless it’s interessting to see that there are more people with this problem and initiatives to found independent review boards.
Does anybody know of anything like this that might be valid for Italy or Europe in general? Has the conversation gone any further in these 2 years?
Hi @eleonora.marocchini! Thanks for reviving this conversation (I think @msundukova is also interested in this topic). The IGDORE board has spent a bit of time looking into this, but we have not been able to come up with any options for providing ethical review for studies on subjects outside of Sweden (where IGDORE is legally based). The guidance for the IGDORE Code of Research Conduct states:
adhere to the ethical codes for research activities in which human subjects and animals are involved;
Research subjects must be protected, and any harms should be balanced against the benefit the research is expected to provide. It is the responsibility of researchers to know the regulations for ethical review requirements in the country where their research is conducted and apply for ethical review if it is necessary for their work to comply with national legislation.
If an IGDORE researcher is conducting a study on participants outside of Sweden then we can provide a funder with a letter stating the ethical review of the study by IGDORE is not possible, and that we will require confirmation that ethical approval has been obtained (or is not required) in the participants’ country before approving expenditure from the grant.
Some other resources I have come across that provide context for the difficulty of ethical review for transnational studies:
http://www.eurecnet.org/information/index.html is a good reference point for the national ethics committees across Europe. Unfortunately, funder requirements for ethical review seem to be largely driven from the perspective of international multi-site medical studies, where there will be a local partner in the medical centre in each country who each submits an application to their local ethics committee. For instance, the Wellcome human research guidelines says:
Ethical approval
Before research begins, researchers must have in place:
- ethical approval in every country where any part of the research will be carried out (this includes approval from their administering organisation if it’s based in a different country and the organisation requires it)
- the relevant regulatory and ethical approvals for every site where research will be carried out
- appropriate governance mechanisms.
I saw similar requirements on the websites of a few different UK universities, so I think this is fairly standard. It seems reasonable in the case of medical studies, but might be excessive for low-risk social science studies. For instance, the article “Only Applies to Research Conducted in Sweden…”: Dilemmas in Gaining Ethics Approval in Transnational Qualitative Research describes two case studies where researchers in Sweden had real difficulties in meeting funder requirements to get ethical approvals to conduct transnational online surveys:
The national circumscription of the ethics approvals involved (“Only Applies to Research Conducted in Sweden…”) meant that both researchers were required to seek ethics approval in all the participant countries in which they were going to conduct their research.
Further, Ethical review procedures in international internet-based intervention studies describes the wide variability in national requirements for ethical review of a transnational study on an online mental health-based intervention:
the Association of Internet Researchers (AoIR), which incorporates an Ethics Working Committee of international ethicists and researchers aiming to ensure that ‘research on and about the Internet is conducted in an ethical and professional manner’ (Association of Internet Researchers, n.d.), does not provide information about the ethical approval procedures in case of international internet-based research. The European Network of Research Ethics Committees (EUREC) only provides information regarding EU legislation for onsite clinical trials on medicinal products for human use, stating that in a multinational multi-centre trial, an ethical opinion of a REC in each participating country would be required (European Network of Research Ethics Committee, 2012). A European initiative on other types of clinical research than clinical drug trials, such as observational, survey or psychosocial or behavioral intervention studies is lacking (Veerus et al., 2014).
…
Based on the guidelines and examples so far, it seems obvious for researchers to approach ethical review committees of participating institutes in international studies when physical activities are involved, such as providing study drugs or taking a blood sample. However, for international internet-based studies that take place solely online, it seems less obvious to apply for ethical review procedures in multiple countries.
Even the analysis of datasets in a transnational context can be difficult. A researcher analysing non-sensitive physiological data was unable to transfer a grant to IGDORE because we could not provide an ethical review as the data came from people outside of Sweden (even though ethical review had already been done during data collection, and possibly again for the analysis by the institution that hosted the grant initially). The article Ethics review for international data-intensive research notes:
research ethics committees (RECs) have been guided by ethical principles regarding human experimentation intended to protect participants from physical harms and to provide assurance as to their interests and welfare. But research that analyzes large aggregate data sets, possibly including detailed clinical and genomic information of individuals, may require different assessment. At the same time, growth in international data-sharing collaborations adds stress to a system already under fire for subjecting multisite research to replicate ethics reviews, which can inhibit research without improving the quality of human subjects’ protections
…
Data-intensive projects often raise ethical concerns for which RECs have little guidance. Data can be collected from consenting participants at one site but stored, analyzed, or linked with data sets elsewhere. Data are typically stored for long periods and can be reused and (re)linked. Particularly problematic is that perceived and legislated ownership of data and the responsibility to authorize data sharing varies across jurisdictions.
…
Ethics review for data-intensive international research should be founded on at least two principles. First, projects imposing similar risks on research participants should be subjected to similar levels of scrutiny by all RECs. Second, if we assume that procedural and regulatory alignment is in place, once an ethics review opinion has been provided, each jurisdiction should not require further de novo review.
Some new options for ethical review in low-risk settings are starting to take shape:
The ethics project aimed at non-medical researchers with a somewhat multinational focus that I know of is PRO-RES. My understanding is that this provides a collection of ethical codes and guidelines from across Europe, but I do think that it provides ethical review. @HelenKara wrote about her experience working on the project here: https://helenkara.com/2022/02/03/ethics-codes-and-guidelines/
The Social Research Association (UK based) also recently began offering an ethics appraisal service:
The service is designed for organisations and individuals who wish to have an independent ethical review of their research proposals, and can’t access this another way
Although they stress:
This service is not a REC (Research Ethics Committee) and does not ‘approve’ research - it offers expert advice and consultancy on a key aspect of research practice. Clients are welcome to cite their use of this service, but must not misrepresent it as a REC, or as having given approval.
(The Aotearoa Research Ethics Committee provides a similar service based in New Zealand)
Finally, our friends at the Ronin Institute (US based) recently developed a Human Subjects Research Policy and I believe that they have can provide exemptions for low-risk research (@arika.virapongse - is this exemption limited to studies done on subjects in the US?).
It occurs to me that rather than aiming to find an organization to provide an ethical review service in a transnational context, it could be helpful just to assemble a list of national ethical boards/committees that can conduct ethical reviews for researchers without a traditional academic affiliation in that country (some of these may already be in EUREC). Would anybody be interested in contributing to such a project?
Just to point out that (at least in the EU), ethics committees are heavily regulated. Depending on the type of study (e.g. medical research with humans), it is very clear which EC is competent to review your study. In these cases, any feedback from any of the ECs mentioned above almost certainly does not suffice.
Yeah, I agree that for medical research, it’s usually clear which ethics board should review the study. But I think many independent researchers are in the situation where they want to do low-risk social science studies (i.e. run an online survey or do some zoom interviews, potentially with participants from a different country in which they reside), and in these cases, it is often unclear if there is any ethics board that will review their work.
I realized I had already seen a document that covered something like this: The International Compilation of Human Research Standards from the U.S. Department of Health and Human Services. This is a compilation of standards, but the listing of key organisations may be a helpful starting point when looking for ethical boards operating in a country of interest.
(at the time of posting the 2022 version on the HHS site seems to be down, but an archive of the 2019 version of the compilation is available here [quote below if from the 2019 version])
The International Compilation of Human Research Standards enumerates over 1,000 laws, regulations, and guidelines (collectively referred to as “standards”) that govern human subject protections in 131 countries, as well as standards from a number of international and regional organizations. First published in 2005, the Compilation was developed for use by researchers, IRBs/Research Ethics Committees, sponsors, and others who are involved in human subjects research protections around the world. Content experts from around the world, listed at the end of the Compilation, provided updates (or confirmations of prior listings), which are reflected in the hundreds of changes entered into this Edition. One new country is featured in the 2019 Edition: El Salvador.
For each country, the standards are categorized by row as:
- General, i.e., applicable to most or all types of human subjects research
- Drugs, Biologics, and Devices
- Clinical Trial Registries
- Research Injury
- Social-Behavioral Research (also see Description and Analysis of Social-Behavioral Research Standards: https://www.hhs.gov/ohrp/international/socialbehavioral-research-standards/index.html)
- Privacy/Data Protection (also see Privacy International reports: https://www.privacyinternational.org/reports)
- Human Biological Materials
- Genetic (also see the HumGen International database: http://www.humgen.umontreal.ca/int/)
- Embryos, Stem Cells, and Cloning
These nine categories often overlap, so it may be necessary to review the other standards to obtain an accurate understanding of the country’s requirements. The information is then organized into four columns:
- Key Organizations – include those groups that issue regulations or guidelines, or serve in a national oversight role for human subjects research.
- Legislation – encompasses statutes, statutory instruments, and legislative decrees, as well as any pertinent constitutional provisions.
- Regulations – refer to instruments that are created and issued in the name of governmental administrative bodies.
- Guidelines – pertain to non-binding instruments.
Unfortunately, recent policy changes at the Swedish Ethical Approval Authority mean that applications are only accepted from researchers affiliated with a Swedish University, and it is no longer possible to apply for ethical review through IGDORE.
IREC is the UK’s only Independent Research Ethics Committee, and was set up to provide full ethical review for proposed research projects. Our approach is guided by seven principles: intersectionality, justice, dignity, respect, fairness, honesty, and care. We have designed our application process for maximum flexibility and minimum bureaucracy. Your application will be reviewed by four ethics experts with experience from a range of research settings. They will consider the ethical aspects of your project from start to finish.
Exciting news for independent researchers needing ethical review. Great work @HelenKara 
Just for clarity: as far as I can see, this IREC is not an official Research Ethics Committee (REC) within the UK. So their positive opinion does not allow you to actually conduct (at least medical) research within the UK.
Hi Jelle, yes, I am also not sure about the official legal position of the IREC. I hope that their opinion will at least be sufficient to legally conduct low-risk activities like surveys, although I agree that medical research is likely to be outside their intended (and legal) scope.
However, as noted on the IREC website, they aim for their review process to provide a more complete ethical evaluation than is usually done by institutional research ethics committees. So it is possible that a researcher who wanted their work to follow the IREC’s principles of intersectionality, justice, dignity, respect, fairness, honesty, and care, might feel that the (legally sufficient) ethical review performed by their institution’s own REC did not consider some (or all) of those principles in sufficient detail. In that case, I assume that they could apply to the IREC for a second opinion on their research, which they may find more ethically informative, even if the IREC’s opinion is not legally necessary to conduct the research.
This IRB is used by many international organizations and the fees are not outrageous (at least for exempt or expedited reviews). Thanks for the h/t @Enrico.Fucci