There are three sources of regulation that you must pass.

1) Governmental

2) Institutional

3) Publisher

If any one of these says "yes" then the ethical review board approval is mandatory. Obviously, you can circumvent all of these by moving to a country with fewer regulations, studying at an institution without an ethics review board, and submitting for publication to a journal that has no such rules.

The question really is how far are you willing to go to avoid the ethical review?

As an observational study you might need more guidance on how to answer some questions like "will all participants sign a consent form? Asking for consent might provide people with a hint that something is happening and this could influence their response.

If you do not go through the ethical review board, then I think you should be able to cite a specific clause in the review board documents that states that your research is exempt.

To be on the safer side, get an ethical clearance from the ethics committee of an institution you or your co-researcher is affiliated with.

Unlike in the past when ethical clearance was mostly about ensuring one’s research methods/procedures were appropriate and confidentiality protocol was up to standard, recent requirements include that the participants be given a consent form which has the contact info of the Ethics Committee, should in case they have any issue with the research(er)/methods so they can a channel or an authority to lodge a formal complaint.

Hi Sai

In the case of manifesting that the interest of the investigation is centered in the social dynamics, in the socioeconomic and / or community effects. Similarly, if projects designed as forms of social research use people as informants about social conditions of which they are a part and do not receive benefits related to research, it does not require an ethics certification to initiate research.

Even if the questionnaire does not request private or personal data, certification is not required either. The important thing in any case is to give a workshop on IRB to the researchers participating in the research in order to recognize the treatment that must be given both to the informant and to the data provided for the research.

However. If the survey on knowledge, attitudes and practices includes questions that seek data about individual privacy and whose information could be sensitive if it is publicized, then in this case the project must be evaluated by an authorized ethics committee.

To review the protocol to follow, it is important to note the official sources of the country or countries where the investigation will be carried out.

Jose Luis Da Silva Timothy A Ebert Mohammed M. Alhaji

Hello all,

I would like to thank all of you for putting your efforts in order to assist me with this specific question. It actually provided me with a great insight with regards to this question. Your valuable responses are highly appreciated.

Yes ethical review is safer for any research

Yes, I agree with you all. However, I just want to assess/deal with the perceptions, beliefs and opinions of certain well known familiar things/conditions among general public/students (but not the patients). As some of you mentioned to approach the particular university's HREB with a proposed study, but I wanted to conduct these studies out of my interest which are nothing related to the university though.

In a nutshell, I assume certain things such as ethical approvals might be a barrier to the researchers who are fascinated to carryout qualitative observational surveys among the native public.

The problem is that there have been cases of ethical violations in human research in the past and people would like to avoid such in the future.

You are potentially taking on a great deal of risk. If one of your subjects wants to take you to court, the university would help defend you if the research was approved and you were following agreed on protocols. If you do it on your own, then you assume all of the risk. Even if the lawsuit is eventually ruled baseless, you are still out the time (possibly expense) of defending yourself.

While your enthusiasm is admirable, I think your time would be better spent elsewhere. On the other hand, if you are doing this out of personal interest for only yourself (no publication, no presentation) then there is nothing we can do to stop you. Just realize that if the police get involved or a law firm then you are entirely on your own. I expect that the university will disown you faster than you can blink and possibly to the extent of kicking you out of the university.

If you want to publish your research in a good journal then you need IEC approval or else your manuscript will be rejected each time. A good research should reach its audience if it doesn't then all your efforts putted in it will to go waste and yes ethical approval is mandatory whenever you are involving an human participant in any study.

Hi Dr Sai

i agree with Jose Luis Da Silva ‘s answer

Hello Timothy A Ebert,

I appreciate your prompt response, in fact it was quite realistic though. As you mentioned the statement " If one of your subjects wants to take you to court..." with regards to this, I would let you know that the information which I would collect from the respondents would be De-identified and will not consist either of their sensitive data.

Secondly, I just want to let you know that I was/would like to take the informed consent from the participants by clearly providing them with the basic essence of the theme/rationale of the survey before they actually take part in the study. They were also told that they can withdraw from the survey responses at any point of time before officially reporting the survey results in any journal, it was de-identified though.

So, would this makes sense and allows me to carry such type of surveys without HREB/IEC approvals? (Yeah, though getting these approvals are safer)

Else everything make sense to me and I completely in accordance with you/your statements.

Thanks once again for your insights.

Hi Manik Chhabra,

Yeah, the answer by Jose Luis Da Silva completely makes sense to me as well.

But let's gather others opinion too on this.

Yes, ethical approval is safer for any research...........cheers

In the beginning it does not matter what you think or do. If one person complains to a lawyer and the lawyer thinks they can win or at least make money then you may be in trouble. In court, your actions may make a difference to the outcome but that depends on whether your lawyer or theirs is better at spinning the perceptions into something evil or benign. It is possible that my answer is biased by living in the United States and the legal system in your country is better.

Another option: say you run the survey and two days later my identity is stolen. Can you prove that the theft did not come from your computer? Do you follow all of the legal protocols for data security that would be standard at a university? Your system is hacked, or your computer stolen. Are you protected. Can you afford paying for identity protection for people who were in your system?

Ok, I agree. These are the worse case scenarios that I can think of. Most likely you will run your survey, satisfy your curiosity, and nothing else happens. However, the risk is yours alone in this task.

Hello Timothy A Ebert,

Again a big thanks for sharing your opinion on this question. I really appreciate your efforts in making me understand this.

Regards.

Yes. Generally all research involving human subjects requires ethics approval by an ethics review committee. Even where the risks to the participants is considered minimal, you still need to have ethics approval or a waiver by an ethics review committee.

The approval is helpful before, during and after the research. For instance, most journals will not publish papers from research that did not have ethics approval in the first instance.

Hi Sai Krishna Gudi

Usually yes. It is important to bear in mind that any questionnaire that looks for particular information of the person, and that could be published, even if statistically, should have certification, because it is necessary to comply with the IRB's own protocols.

Hello Nyawira Mwangi & Jose Luis Da Silva,

Thanks for your insights. I really appreciate it.