Starting point should be ... if the research involves data collection from human participants then research ethics approval is required. I would ask if your pedestrian example was research at all. If it isn't research then research ethics approval might not be required. Might this be market research (which isn't research), an audit or even an evaluation?

First off every researcher ought to think through the ethical implications of their research, after all it is the researcher's responsibility to conduct ethical research. The requirement for ethics committee approval will depend on who the researcher is (their job and who they work for), and the specific legal and regulatory sytems in operation. It is not ethics committee approval that renders research ethical (in the substantive sense) but the approval process contributes to the 'bench-marking' of the research. Some research 'legally' requires ethics committee approval e.g. in the UK a clinical trial, or research involving adults who cannot consent. There are many instances when research involving humans can be conducted without the specific approval of an ethics committee and you give a possible example, another might be market research, also some kinds of project involving human tissues might not need a specific ethics committee approval (though usually these are conducted under a wider approval). I would suggest that all research involving humans requires some level of ethical reflection and justification, some might need the approval of an ethics committee. However, speaking pragmatically, if a journal requires it then it is de facto necessary!

I believe it depends on what the purpose of the experiment is. In the UK the National Research Ethics service published a guide "Does my project require review by a research ethics committee?". If the experiment is really an audit or a service evaluation no review is required. The define research and service evaluation as well as clinical audit. Sometimes the distinctions may be grey rather than absolute. Another category involves experiments on yourselves and fellow staff, provided there is no element of coercion or advantage for taking part. Bear in mind that the acquisition of the same knowledge may be achieved by two similar techniques whose difference is only in the title of the investigation. If it involves something that is not something you would normally do to a patient it should be reviewed by an ethics committee. This is not always the case. For example introducing a software package to facilitate prescribing on the wards may represent a significant advantage in terms of removing legibility errors, drug interactions dosage errors etc. The same software introduced into an operating theatre environment may represent a major source of distraction for an anaesthetist. This enforced distraction is not something one would normally countenance let alone be mandatory and yet few would insist that this should be passed before an ethics committee despite the time critical errors that may be induced being significantly more lethal than the errors the software is designed to eliminate. Here is a useful reference source. Anaesthesia; vol. 68' no. 6. June 2013 pp 551- 557

Hm, to do research on your fellow staff might easily evoke ethical concerns, for example if a senior staff member asks juniors to take part, then junior staff might be considered vulnerable, and thus in need of special protection (including an ethical review). Vulnerable because being dependent on the senior.

Just to answer the question, typically observational research in the social sciences are exempt. Most countries would have interventional research, research involving the processing of personal data, or research on vulnerable populations subject to review.

First, I should note that the following are my opinions and should not be construed as official statements of my institution. Generally speaking, this is a two-tiered question, as noted above. First, is IRB/REC approval (or, at least, review) necessary; then, given the necessity of that review, whether informed consent from the participants/subjects is necessary. This varies from jurisdiction to jurisdiction, and from institution to institution, so you have to check with the statutes in your country and the policies at your university.

However, in general, there are only a few cases where research may be exempt from IRB/REC review - usually, these involve cases of observational research on de-identified subjects (although the need for IRB approval in these cases seems to vary a great deal); survey research where the research team does not have access to identifying information about the subjects; research on human biospecimens/tissue/data which is de-identified; and emergency (usually public health) research. It should be noted that in most of these cases one still needs to check with the IRB/REC/institution to get their official stamp of approval that this research is indeed exempt, and there may be other approvals needed (especially in the case of using de-identified human specimens or data). And again, none of these are universal - these are just some general situations where review may not be necessary, but there are always exceptions.

Two things should be noted - 1) at least within the US, some of this is in policy limbo right now (anticipated changes are coming to the Common Rule, although I have no idea what those might be); 2) a lot of this is being ethically debated and remains controversial. For example, the use of de-identified specimens has often constituted "not human subjects research" in many cases, but the possibility of re-identification of subjects from the genomic data has re-opened this debate.

Once this issue is resolved with your research, then comes the question of whether informed consent is required. IRB/RECs may grant "waivers" of informed consent in certain cases, usually case-by-case involving use of specimens for scientifically compelling reasons, social science research, or other cases. This is also ethically debated - especially whether observational research on de-identified subjects should still necessitate informed consent, whether such research can constitute deception if it otherwise manipulates the subject's environment, etc.

In general, *risk* to subjects is a broad term and often constitutes not just physical risks (which may often be low in many cases) but also privacy risks, psychological risks (having been deceived; having unwittingly participated in research that leads to conclusions that harm one's social group, etc.), and other risks.

Again, these are all just my opinions. Hopefully helpful though.

Read carefully J. Lowenthal's comments.His comments are a good foundation for understanding. The basic rule is - whenever humans are involved it required review. That is not to say that the reviewing group such an Institutional Review Board or Ethics Committee does not have the ability to exempt it from continuing review based on several reasons. The study you describe could likely be considered exempt.

I am a chaplain of a hospital that serves as the spirtual voice on our ethics committee. WITHOUT EXCEPTION, if we enage the patiernt OR their family in any discussion of possiblle procedures deemed experimental by our senior medical staff , WE MUST get approval for that discussion PRIOR to it from the hospital ethics committee. It is also true if we collect information on a patient that is not necessarily part of the medical record but may be still sanctioned by JACHO for collection. The reason I know is because I document my encounters with patients pursuant to JACHO standards pf practice and still had to defend that to the ethics committee and secure their approval prior to even beginning the process.

While human subject research review is required at the University of California, an ethical review honors human subject research. A person, regardless of age or gender, possesses the highest value simply by being human. In addition to possessing self-reflection, consciousness of life and a desire to protect the vulnerable, humankind has a highly complex body and mind--from the macro as socio-political beings to the micro of genetic chemistry.

There is an entire class of research activities involving human subjects classified as "Exempt" from IRB review under the applicable regulations in the US, (Title 45 Code of Federal Regulations Part 46). There are also several types of human research activities considered to involve "no greater than minimal risk" that can may be approved by an expedited review process that does not require review by a fully convened ethics committee. Guidance on these issues is avaialble from the Office for Human Research Protections website.

Speaking strictly to the technical part of your question: We have also noticed publishers more frequently requiring IRB review of activities involving living individuals EVEN if the IRB determination is "Not Human Subjects Research". For these situations, we have a streamlined submission process for researchers who believe their activities do not meet DHHS/OHRP regulatory definition of "research involving human subjects" but who require a concurring statement from our IRB. When it is clearly documented by the researcher that the activities are NOT a "systematic investigation” includ[ing] development, testing and evaluation" or NOT “develop[ing] or contribute[ing] to generalizable knowledge” or the investigator (whether professional or student) conducting research is NOT "obtain[ing]: data through intervention or interaction with the individual, or identifiable private information" the statement by our IRB to that effect has been accepted by publishers. SPECIAL NOTE: Just like protocols which ARE determined to be "research involving human subjects", these "Not HSR" statements only apply to the reviewed submission. Should the proposed activities evolve after IRB review, it is the researcher's responsibility to re-confirm that the activities still do not meet DHHS/OHRP regulatory definition of "research involving human subjects" by submitting a change request just as they would for a "research involving human subjects" protocol.

When one involves humans as the objects of research, whether in biomedical or in social sciences research, the investigator must analyze the benefits and the risks for the participants. Risks can be psychological (emotional) or physical or absent. Once the researcher identifies the possible risks, someone has to decide whether the researcher has proposed adequate measures to minimize these risks or to agree that in fact, the research poses no risk. The researcher CANNOT make this decision because it is an obvious conflict of interests (hence scientific misconduct). In countries where national regulations concerning human research exist, this evaluation has to be carried out by a research ethics committee. In countries without regulations, international guidelines must be used--- and all suggest that an ethics committee should review the proposal.

To use humans and animals as our research subjects is a privilege. And this entails the responsibility of respecting them. Ethics committees had to be created in order to ensure that researchers respect the dignity and welfare of those being studied.

Going back to the spirit of my question: are there any experiments that are so trivial that it is generally accepted that no ethics approval is needed? For example, we do market research on humans, we get humans to complete surveys, we give them tests and questions....none of these appear to require an ethics approval. However, what about trivial non-contact measurements such as looking at human crowd behaviour or body motion? Or counting eye colour types in a group? Or measuring people's heights? Where are the exceptions and what are the principles behind that?

Surely there are some non-invasive things that are regarded as trivial?

The problem is who decides whether they are trivial-- the researcher cannot decide because there is an obvious bias. So somebody else has to make that decision.

Good question. Taking your term experiment broadly to include observational research with no video or participation by the researcher you are exempt from IRB review. If you have any doubts, you can get what is called an expedited review by the IRB, but you will not be required to use consent forms. In my experience, journals are happy to know that you had an expedited review.

Not every country has regulations concerning what research is exempt from IRB review--- and none of the international guidelines (CIOMS, Helsinki 2008 etc) mention exempt research. Researchers have to abide by national regulations first. So if you are carrying out research in the US there is the possibility that the IRB will tell you your work is exempt (that is not expedited review, by the way). However ,in several countries in South America this is not the case. So one must become familiar with the national regulations concerning research subjects when carrying out collaborative research in other countries. Title 45 CFR Part 46 concerning exempt research is an exception rather than the rule.

Even a "trivial" project involving living individuals as participants or their personally identifiable private information CAN meet the federal definition of "research involving human subjects" if it is designed in such a way that it is both a "systematic investigation” includ[ing] development, testing and evaluation" AND “develop[ing] or contribute[ing] to generalizable knowledge”. So the inverse is also true. Any project, "trivial" or "complex", which is NOT designed as a "systematic investigation" OR NOT intended to "develop or contribute to generalizable knowledge" does not require IRB review. Some projects which typically do not meet the federal definition of "research involving human subjects" are standard (traditional) oral histories, program (quality) improvement activities, and research (student) practicum. However, if an oral historian or program evaluator or student researcher designs a project in such a way that it is BOTH a "systematic investigation” includ[ing] development, testing and evaluation" AND “develop[ing] or contribute[ing] to generalizable knowledge” then IRB review is required. Even economists must submit their research projects for IRB review if the data they're analyzing is personally identifiable private information AND they've designed a project which meets the federal definition of "research involving human subjects".

The magic phrase of the question is "human experiment". Any true human experiment, which by definition always includes a randomized intervention in a part of the research subjects, requires necessarily an informed consent both experimental as control group. All studies of this type, including a psychological or sociological research, requires review by an ethics committee. Naturally, is not the case of the observational research, as the observation of the people movement or the frecuencies of eyes color, for example.

Yes - anonymous data of an innocuous nature e.g. "do you prefer this chocolate to that chocolate?"

I think any research where impact of the treatments, disclosure and publication of personal data may affect the human subjects, needs informed consent and approval. But experiment where humans subjects are not directly affected by the treatments given to them in the experiment or disclosure of their privacy is not involved does not need ethical approval. For example experiments on average age of a locality, average height in some population, literacy rate in a locality, IQ level of different age groups may not need ethical approval in my personal opinion.

When we get information from the farmers regarding their farming and to improve their livelihood, I feel it is not necessary to get ethical clearance to obtain the data related to this. I strongly believe when our investigation or data mining affect the farming community in any way we should get the ethical clearance.

In our country (argentina) epidemiological studies without intervention dont need the approval of ethics comittee. We only need to send a letter to inform the comittee but no need of approval.

No, all human experiments for which ethics committee approval is needed.

If you can recognize an individual person in the results or diacussion, you should require approval bu the ethic committe and informed consent from participants

It's OK if you do not record any identifiable features of the pedestrians.

Experiments that do not have an ability to harm humans; which is virtually none.

Observational studies only, if not harmful.

Observing pedestrian movements is observational research, is not harmful, so is a good example of research not requiring ethical clearance. Just remember to put a fuzzy filter over each identifiable face in your films before publishing them.

What is the definition of an experiment, thus a human experiment? If people are observing others in controlled or uncontrolled conditions, some might name it an experiment, others not. The impact on who is observed is individual-dependent. Some like to be observed, others not..... . Ethical rules also differ across geographic regions, perhaps culture-dependent, as you know.

Usually research is only considered experimental if the treatment (or independent variable) is under the control of the researcher. However, even when research is not experimental, such as purely observational research, it still may require ethical review. Some IRBs do not require ethical review for surveys.

Observation research includes aspects related to privacy (ignored in wildlife studies), copy rights (ignored in wildlife studies).....

And in some cities/countries there are public cameras, not in other....

If in your publication (or to a lesser extent in the accompanying cover letter) you can justify why you feel you did not need to request the approval of a suitable ethics board, then perhaps an editor will accept it. But, if a researcher is confident that their research does not encroach on privacy issues, then it should not be a problem to submit it to review by an ethics board in any case. The only disadvantage is that it may take some extra time to get approval, and there is the added advantage of having peers review your research proposal and having some extra feedback on your approach. Not wanting to submit a proposal to an ethics board perhaps suggests that there could be some privacy issues and the researcher just does not want the complication of adapting their approach to limit them.

Not all observations are ethically neutral. Observing human behaviour by the use of hidden cameras might involve the observation of violence or abuse. The use to which this kind of observation is put is also relevant. While it might in many cases not be necessary to obtain an ethics approval from some appointed guardian of right and wrong the observer/ experimenter should consider the potential harm of their work.

In reply to all above on the issue of experimental controls, observation exercises are notorious for 'observer bias' and all data collected this way should be closely scrutinised for this.

We educated sophisticates should remember that 'observational studies' on human behaviour have led to some of the most appalling atrocities in history. The right and wrong in any study does not end with the publication of the results. In the worst case this is where the trouble commences.

Often, a quick phone call to your institution's ethics committee administrator, explaining the general nature of your research, will serve to clarify whether the ethics committee needs to review your research proposal. I see you are in Australia, so a first port of call would be the NH&MRC National Statement on Ethical conduct in Human Research. As Richard Hessler commented, an expedited review may be applicable if there is low risk. Always better to clarify requirements with administrator before beginning research, than to find oneself in a bind as the research progresses.

My hunch is that ethics approval "should" be required regardless of the "de-identification." Here's why - there is a crucial distinction in research (involving human subjects) between what is "compliant with regulations" and what is "morally acceptable." It may very well be that you could conduct such research within the guidelines of an ethics committee, but that fact alone does not make it morally permissible to do so. The distinction hinges, for me anyway, on the autonomous consent of the individuals studied to have their "behavioral tendencies" interpreted by a third party. If they have not granted such consent, then it seems to me unethical to do so.

The research you describe would appear to be "exempt" from the requirement to obtain prospective IRB approval based on the criteria at 45 CR 46 101(b)(2): "Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

Check out today's WSJ, Page B1. "Facebook Study Spurs Ethical Questions"

One of the most (over) used samples of human participants in research is college students.  

For this sample there can be special conditions that allow for experimental pedagogic research to be carried out without IRB approval.  This is the case if the 'experiment' is considered a normal part of educational practice.

For example a cohort study where the mode of delivery (PBL,  lectures,  online) changed with cohort, perhaps in a crossover design,  would be an experimental study that would not require IRB approval.   The changes would be considered part of improving educational practice, and would presumably be approved by a departmental curriculum committee etc.

My first thought is what ethics govern your discipline?  Outside of that, as a long-term chair of IRB, I would suggest a simple chat with the chair to see if one is needed.  Observational research can be quite tricky and can easily move from not needing consent or IRB approval to, "oh, my, we have a problem Houston."  For example, I am interesting in observing shopping patterns in a store.  As long as I am not interfering with the trade in the business and I am merely observing in the naturalistic environment, I am fine.  IRB would send me on my way.  But, suppose I begin to notice that shoppers who try on several items in the store are more apt to buy at least one.  Then, I may decide I need to know if there is ceiling effect and I need to count how many items someone tries on compared to whether or not they purchase something.  This requires me to become at a minimum a dressing room vulture so I can count their discards vs. the purchases.  Now, I have invaded private space; the dressing room.  This becomes labor intensive and sometimes I don't get everything counted so I decide to start recording people.  Hopefully, with this fanciful example, you can see how a seemingly innocent project becomes such an ethical landmine that the last thing you would worry about is could I get it published.