Some IRBs ask as part of their routine to add an ICF (informed consent form) for respondents? Is this mandatory or in other words is this part of the state-of-the-art practice for such studies or it is an internal decision from the local IRB?
Any study on human subjects requires an IRB approval. If you intend to publish in a medical/ health sciences journal, you'll need one. In most institutions, you'll get a waiver for questionnaire-based research especially if it doesn't involve patients. Sometimes IRB dont phrase it as a straightforward waiver, just that it does not need approval. It would be OK with most journals.
for all scientific human study inform concern and ethical clearance is necessary
No Brasil, todo estudo envolvendo seres humanos precisa de um Termo de Consentimento Livre e Esclarecido. O Comitê de Ética avalia os riscos e benefícios da pesquisa, algo mais amplo do que somente observar se o pesquisador cumpriu com questões burocráticas em pesquisa. As perguntas e as possíveis conclusões de seu estudo sobre a população estudada merecem apreciação ética. Logo, por aqui, temos que desenvolver pesquisas sempre com Termo de Consentimento. Ademais, se quiser publicar os resultados da pesquisa ou divulgar de qualquer outra forma, os meios de comunicação, como as revistas científicas, solicitam a aprovação nos Comitês de Ética, e isto somente se dá com a elaboração do Termo de Consentimento como uma das etapas.
If the satisfaction survey is being conducted for research, IRB approval and informed consent are required. If the researcher is partnering with the employer to administer the survey, the employer must inform its employees that the results of the satisfaction survey will be used for research purposes.
If the researcher is using secondary data from employee satisfaction surveys that have been previously administered, consent may not be required if the research falls within the realm of "compatible use." The data must also be deidentified. Depending on the nature of the research, your IRB MAY require informed consent for use of secondary data.
If this is not research and the questions are addressed to the staff it should not require official inform-consent. Employers do have the right ( and the duty ) to ask their employees about their satisfaction.
As per as my understanding all the research carried out human should required Institute ethical committee clearance . I suggesting that you can write letter to institute ethical committee regarding wavering inform consent and wait for the comments from IEC.
however permission from organisation is must before starting the study.
I agree with a couple of the answers given already that if the staff satisfaction survey is being done for operations, then no IRB approval and no specific informed consent need be sought or obtained. If, however, you are planning to publish your results, then your IRB should be consulted. Many have an expedited procedure and will waive formal informed consent if you are going to publish only group results and not those of specific individuals. Finally, it is easy to put out a brief consent form with a staff satisfaction survey in which you explain the purpose of the survey, how the data will be handled - ideally de-identified, etc, and ask the respondent to sign, guaranteeing to the respondent that the consent (signed) will be separated from the survey before analysis, etc.
If the survey is specific to process improvement, an IRB is not needed. However, if the data might be used in publication or is specific to a research question- then it is subject to an IRB for human subject protection.
The key question is PURPOSE: quality improvement or research.
Of course, de-identification of subjects should also be included.
Whenever a human research is done is necessary to make an informed consent and participants decide whether or not to participate. Is ethically correct potential participants tell which is the aim of the research indicate that it is voluntary, ensure anonymity.
If it is a study (whether going to publish or not), informed written consent is needed
But if it's part of the routine quality improvement exercise (that means, we are not going to use this data for research publication), consent is not mandatory
However I would suggest to take consent in either case
Informed consent is always required, but from my experience, a verbal consent might be acceptable in some situations. To be on the safe side its always better to consider a written consent though.
Best regards
Informed consent implies your respondents have been given a rationale for the study and it depends on the context in which you work. If you were doing a staff survey in England, there are all sorts of guidelines and restrictions - so you need to work within the constraints of your own institution/country's ethical requirements and guidelines. As Muna suggests, safety will protect you, even if it seems cumbersome.
If you have submitted an application to an IRB then you think what you are doing is research. As such informed consent is always required. If you are calling it a study then it is research so informed consent is always needed.
Depending upon the assessment method you may or may not need a separate consent form. If it is a paper and pencil or computer administered survey, respondents are consenting by completing the survey and a separate form is not needed. You may however still want to include a place for respondents to state that they agree to participate at the end of the explanation of the survey. It is important that you clearly state that their participation is voluntary. You also need to inform the respondent that their refusal to participate will not result in any negative consequences and that individual results will not be provided to the employer.
As someone stated before you may be able to use oral consent if you are conducting interviews or face-to-face surveys. In this case the interviewer should mark that the respondent was informed of their right to not participate without any negative consequences and that the respondent consented.
Regardless of the aim of the study, agreement of participate to take part is necessary. The approval of the ethical committee(s) is also necessary. Research in general is an institutional work and researchers need to comply with regulations and safety. Also they need to protect themselves.
When you are doing research, you have take your staff as a study participants, not the general staff or friends, workmates etc. This is mandatory. We can debate on 'verbal' or 'Written'. Both types of informed consent have opportunities and challenges. The study participants should know about your study/research and they have rights to say, 'NO'.
The answer essentially boils down to whether it is 'research' or a corporate evaluation activity or quality assurance activity. So it goes to the heart of the definition of research. And to make it a bit more complicated: quality assurance and corporate evaluation activities might morph into or become research activities; and will be certainly research activities if involve approaches that may pose risks for participants (such as being outed etc).
A good illustration you find for this continuum on
http://www.orei.qut.edu.au/human/guidance/qa.jsp
My advice: in doubt consult with your Ethics Committee.
The ethical principle for informed consent is to guarantee the voluntariness of the participants, since they have the right to say NO. However, in a survey the invitation can act as consent if it contemplates the objective of the study, which was evaluated and approved by an ethics committee, that the person is free to refuse to participate and that confidentiality is ensured, among other elements.
If you are doing a research and your participants are the staffs, yes, informed consent is a must. The research should get through the ethics committee.
Informed consent is required if it is research. It is not required if you are doing a quality improvement survey.
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