Most journals are very particular about written consent. But is it necessary to take written consent in the descriptive studies? Sharing your knowledge and vision about this question will not only help me but also help other researchers.
In any study where human subjects are involved, a written informed consent must be obtained (regardless of the study design).
In the case you presented (phone interview) it could be acceptable a verbal consent if:
1) The protocol clearly defines the modality of which the verbal consent must be obtained
2) An IRB approve the study and the procedure outlined for the verbal consent obtainement
3) The entire consent process obtainement is DOCUMENTED (as Niamh said, it must be audio-recorded or conducted with an impartial witness and then transcribed)
4) Only the questions listed in the approved protocol, should be answered by the subject
In addition to this, you must be compliant with your specific country regulations about subjects data protection, and their integrity
Dear Brijesh
Scientific study, of whatever kind, is a subject of interest of the investigating researcher. Scientific study may require human volunteers for generation of data and evidence. Investigator has to ask the human volunteer for his/her willingness for registration in study to ensure volunteer's autonomy while registration. Willingness i.e. consent of selected human volunteers is required irrespective of the type of study i.e. descriptive, analytical or experimental. In my opinion the only difference between written and verbal consent is that written consent generates a record of consent which ensure the consent of particular volunteer. Few studies like retrospective secondary data based study, outbreak investigations are often exempted from consent seeking to the best of my knowledge. I will be thankful to the researchers who further enrich the subject.
Dear Dr. Anand thank you so much for the answer. Yes we will wait for other researchers answers those who knows how to do good and relevant scientific research like you.
Research that involves human subjects necessitates that the reasearcher seeks for consent from the respondents(informed vebal/written).However, there are instances where the consent will be assumed to have been given. For instance when mailed questionnaires are used in a survey, the respondent is taken as having consented when he/she fills in the questionnaire on the basis of the information in the cover letter. On the other hand incertain studies the researcher ensures that the respondent fills in a consent form before proceeding with the research, for instance when doing reserch that involves the elderly and children. This may differ from when say a researcher is doing a study that will use focus groups as a data collection tool. You may need to get verbal consent from each focus group after informing them of the objectives of the study and their right to remain / or opt out of the study if they feel uncomfortable.
Written concent should be required for any research involving human subjects, whether it is descriptive, an intervention, or what have you.
Written concent is required so that a) there is a permanent record of the participant's concent, b) the exact nature of what has been concented is documented, c) assurances as to participant safety and privacy can be spelled out, and d) a statement of the participant's right to refuse at any time during the study protocol. In addition to these four things, the written concent is a tool to assure that all of the participants have been concented in the same way.
Further: the concept of 'informed concent' is critical. The participant must be fully informed of what will be asked of him or her, and must able to understand those requirements. A person who cannot be informed and/or cannot understand what the researcher is asking of him or her cannot give informed concent. Examples; young children, persons under the influence of licit or illicit substances, persons with cognitive deficit.
Essays, articles, and entire book chapters have been written on the importance of concent, what constitues concent, and the ethics of concent.
In addition to @Mary and @Sindisiwe's comments, the key is informed consent. The subjects must be explained on the nature of the research and the potential risks involved in a language that he/she can understand/read in order for them to sign.
Hi Brijesh. First, as any lawyer will tell you the distinction you are concerned about is between written and oral consent. Verbal just means words, and so can be either oral (by mouth) or written. Sometimes only oral consent is possible if the subjects are not literate enough to participate in a written consent process. In such cases field researchers make a record of the time that the consent is given. Further, in the case of minors (usually under 18, but that migh vary), consent can't be given and is usually called assent, and consent is usually given by a parent or caregiver with the authority to consent. It is worth looking up standards, usually specific to a field, of what should be part of the informed consent. Generally, this includes the ability to stop participating at any time and to not answer any questiont. Various professional organizations have guiding principles that can help. In medicine, one thing to look at is the Declaration of Helsinki that defines rights of participants in medical studies. Although some principles may be universal, in practice simpler less invasive data collection methods generally have simpler informed consent statements. I think for a simple survey if participants know of their right to stop and especially of their right to not answer any question that is generally appropriate. Lengthy statements about potential harm from participation and so on possibly in themselves do harm by creating undue apprehension. Nonetheless, you may have to comply with the standards of the organization your represent, particularly if there is an institutional review board, and if you are an active member of a professional organization related to the work, you should consider complying with its standards as well; in fact, you membership agreement may require that. Bob
The signed informed consent document is necessary in scientific studies involving persons. This document should demonstrate that participants are willing to participate in the study, that they have received the information on the study (what and how is going to be done), that they will be able to withdrawn in any moment. The document also indicates who is responsible for the study and who takes the personal, medical or other information. The latter must also sign the document. Verbal consent could not be accepted in many estudies, unless you have registered the same information as in a written informed consent document.
Dear Brijesh, The First part of the question is the difference between the written and verbal consent. The written consent is the willingness of the study subjects and understanding the study and implications of the research study by the subjects and singed in the consent form by the individual concerned and kept permanent record by the researcher. Suppose some times it is not possible to get the consent of the subject, but the same may be got by his words(verbal) with authentication of the legal heir or guardian or attender, the same may be considered as verbal consent. In medical research such verbal consent is inevitable in the occasions such bad condition of the patients and the data may be vital for the research. Regards
Interesting debate here. Stress on ethical issues is to gaurantee that the participant's interest in a research study is not exploited or neglected. Hence verbal consent is just an euphemism that scientist often use to by pass the procedure of informed-consent from the subject or his gaurdian. Illiteracy can not be an excuse, for the onus of explaining the purpose of research, procedures, its risks etc is on the investigator. The consent has to be documented and signed or a thumb- print taken.
In cases of interventional or major invasive procedures, it is in the investigator's interest to ensure that the documentation is proper by having it witnessed by a person not blonging to his team.
It depends on the type of study.
if you do a phone interview just the oral consent, however if you make a written questionnaire or you have the person in front of you, you need a consensus.
In Italy such consent is also linked to the management of personal information.
However, understood that you explain the purpose of the study.
Each country has specific legislation, so in dept legal considerations are necessary. General tendency is towards more stringent requirements. Just to resume a few major points, there are others:
1- consent must be given after documented information. Nobody can give a consent without having understood what he is consenting to, and the control of this understanding is under the responsability of the researcher. Italian Law states it as an "informed consent". So documentation of this information must be available.
2- the information must be given in such a way that the patient can understand it. Formal general fact sheets are nice, but do not go all the way. The researcher must give evidence, that he took care of the intellectual level of the patient. An illiterate's consent after having seen a written document, or a foreigner's consent on the base of a paper whose language he does not speak, is void. A good advice is to write always a few words by hand in adjunct to printed matter, to demonstrate personal relationship, for all major a dangerous procedures.
3- if the consent is not for procedures, but only for the release of personal data, a written supplement that states this in form a a release form, can be sufficient. It should be specifically signed.
4- If no written consent can be obtained, verbal consent has to be documented by a witness, which signs with the doctor and is unrelated to him and his work interests.
Many other subtile points are in this, but this may be a good start for now. Just take care that declaring an informed consent form not sufficient, given under psychological pressure or not fully understood, is the last and most active frontier in malpractice claims today. In case of a question, ask a lawyer or a doctor, expert in forensic medicine. It's cheaper.
In my country - Bulgaria signed informed consent is document containig information about reasons and conditions of in scientific studies involving persons. It is absolutely necessary and it is revised by ethical committees
As others have already said, each country have specific legislation dealing with "health data treatment for research", this implies also rules on informed consent. In general, the experience in Italy is that you definitely need a written consent for clinical trials and genetic data treatment,. No IRB will accept to approve such studies without a sound written informed consent, it is a mandatory element. But, in my experience, considering also the requirements of the legislation on health data treatment, it is important to administer, whenever possible, a written consent to participants, also when you are conducting a descriptive, non-invasive study. In other words, the written form is the best form to consider the consent "well documented". In this procedure you may also be sure that the participants receive a copy of the information note that has to be considered an integral part of the informed consent procedure. The information note may be consulted and remind participants about what has been accepted; the name, adress etc of the person in charge to cancel them and relative data from the study, in case of withdrawal. Last, but not least, biomedical andd also epidiemiological studies involving biobanking requires a well documented informed consent, taking into account the storage of biospecismens, future research not yet defined, communication of incidental findings etc. , at this purpose a written consent is the best to be used.
If You are in doubt ask your local Ethic Board as the legislation differ from country to country. Overall a oral consent is just as good as a written, but You save your self a lot of Q, if you get a written consent, and you need to store and keep it for years in a safe place. If you include children be aware of the legislation in your country. Children >= 16 can give full consent to participate and parents consents is not needed. Children 14-16 yr has to give consent + parents consent. Children 7-14 has to give assent (say yes) and of course parents has to consent. Children less than 7 yr does not have to give assent
I can only talk about my experience in the US doing social research. Consent is always needed to collect data from human subjects. Signed informed consent (I.e., written consent) is usually necessary for most studies including those which are descriptive only. The only justification for verbal consent is when the signature obtained may identify a subject whose identify must be kept hidden. Those subjects are usually very vulnerable, e.g., those who are at risk for arrest for illegal activities such as selling or using illegal drugs, and in order to protect them from arrest, prosecution or social stigma, signed consent is waived. In this and a few other select cases, verbal consent only is approved for the study.
Informed consent is necessary for any study involving human beings, including qualitative and quantitative studies and is an exigence of any ethical committee. Funding bodies request the agreement of ethical comittees to provide financial support for researchs on human beings as well a scientific journal to accept the publication of the results of research. Informed consent should be written and forms should be signed by every person involved in the research. A special attention should be paid to vulnerable populations such as prisoners.
In most journals with a peer review the written version is asked. So it seems to me to use always in good studies written informed consent .
When a research study involves human subjects, obtaining a written informed consent from them is a good practice to avoid legal problems. Even if you get a verbal consent, record it as a document with the full name, address and telephone numbers etc. lalitha kabilan
Whether informed consent is obtained in writing through a detailed consent form, by means of an informative statement, or verbally, depends on the nature of the research, the kind of data gathered, the data format and how the data will be used. Verbal consent might be appropriate for certain populations (including non-literate, politically vulnerable populations or elderly population who may get difficulties with a written consent procedure) and certain types of low risk research.
Dear Maria Alvarado:
Informed consent plays a pivotal role in human research. It serves as a marker for the subject's comprehension of all the pertinent elements of the study. It is also a pledge by the investigator that during the study including household surveys, the rights and safety of the subject will be protected. Informed consent attempts to ensure that ethical behavior will be upheld throughout the study (i.e. household surveys). A discussion of the research and expectations, and a signed letter of consent should precede any interaction between researchers and participants that yields data, whether structured and formal or unstructured and conversational. Researchers seeking informed consent need to make clear to their subjects what material they will collect and how material about them and/or from them will be used. In the United States Code of Federal Regulations, the law mandates that researchers obtain informed consent to do the following: protect human subjects/volunteers; ensure that potential study subjects clearly understand the benefits and risks associated with their participation in a study; and provide the potential study subjects with all information needed to reach a decision on whether or not to participate in a research study.
Informed Consent is an integral part of any research which is human related. In sub-saharan Africa most countries have developed IRBs and Research committees to evaluate and authorise any proposals, and a major component is the Ethics part of it. A written informed consent form is the best way to go especially in developing countries as the general public would not want to participate in any survey. Furthermore in some countries translating the consent forms and questionnaires to the local languages is a must and every participant should be given an option on the best language to use to communicate information properly.
Informed consent should be included in any protocol in which human beings participate. It is one of the criteria that IRB evaluate. I think that when the ethic risk is minimal (studies exploring satisfaction with a topic or an opinion ) we can use a verbal Informed consent. It should be previously explained in the protocol
Maybe my publicatio: The informed consent for surgery. Update for Belgium in 2008.
F J M P Somville, M von Stritzky Dept. of Epidemiology and Community Medicine, Wilrijk, Belgium.Acta chirurgica Belgica (impact factor: 0.43). 12/2012; 108(5):487-91.
can give you more information who we do it in Belgium , still this days.
I believe that a written consent and documentation is a must when you involve the subject necessarily for the research eg, clinical trial..etc
A verbal consent may be sufficient when you are doing a survey on behalf of the govt., or when your subject needs it eg a CT scan/MRI for diagnosis
In fact any patient in the first step of his/her treatment should be informed about the treatment protocol already possible, and risks associated with each option. In this case you must inform the patient and he/she then sign informed consent to ensure you in a case of therapeutic misadventure.
when you only emphasis on verbal consent, some problems may be in doubt about incomplete comunication between you and your patient.
I guess written consent involves where invasive procedures are involved for treatment/research and verbal vice versa.For instance where few ml. of blood are taken for research purpose or to study the details of disease in question then verbal consent of the patient should be taken
What about getting verbal consent where your study population is visually impaired? Does the giving of consent need to be witnessed by a third individual? Any thoughts?
If the study population is visually impaired then their ward or person taking care of them should be asked for consent
For publication of research results in scientific journal is necessary obtaining a consent from de respondents.
Hi,
I am probably a bit late on the topic, but anyway. The major difference between verbal and written consent is similar to the one between a verbal and a written contract: the agreement in writing is much more explicit. The major point is the information, as Sindisiwe and others have pointed out.
See the very good volume by Faden, beauchamp, and King on the topic of informed consent in general:
http://www.amazon.com/A-History-Theory-Informed-Consent/dp/0195036867
The MANTRA portal at the Edina, Edinbugh, offers a module on data protection, rights, and access:
http://datalib.edina.ac.uk/mantra/
Yours,
Oliver.
Isn't verbal consent enough in surveys? I mean, if people don't agree that their data would be used in your study, then they wouldn't have participated in it in the first place. If they participate, the consent is implied assuming that you explained the purpose of the study to the participants.
I think the study design, the population of interest (e.g., adults versus children) and the research question are all important in considering if verbal consent or written consent will be required. In community-based studies seeking to understand interaction in naturalistic social settings to explore the social determinants of health, participant observation is often used to developed rich descriptions of the interaction and dialogue in field notes prior to interviewing individual study participants. For this type of study design (e.g. critical ethnography), verbal consent for observations are often accepted by an REB as long as participants can give an informed consent verbally based on having adequate information about the study (e.g., a study information sheet at an appropriate level of literacy). In settings where children are present with adults, parents would need to provide verbal consent for their children to be observed.
Most of the IRBs require consent , that are written in the language of the respondents to be part of the material of data collection package in primary studies. Verbal consent are used in telephone survey, and other research where there is no requirement for the written one. Children must give ascent, and the guardians must consent for them.
An informed and signed consent is the norm in research. but in cases where there is need for interviewing thousands of people (social research), it can be replaced by a verbal informed consent.
Difference between verbal and written consent
When two parties discussed something verbally and no records have been generated. A written consent is when the two parties review and signed a document to prove that they agree to the terms and conditions of what the two parties have discussed.
i.e. before a doctor performs any medical and surgical procedure an any patient or clinical trial on a specific drug, the doctor or the researchers need to explain the whole procedure and then have them signed the consent consent form for record. Then this signed document become a legal and biding document to cover all the three parties: the hospital, the doctors and the patient.
What about getting verbal consent where your study population is visually impaired? Does the giving of consent need to be witnessed by a third individual? Any thoughts?
Hello Gary Dix,
If your study population is visually impaired a third party which has to be a relative, a lawyer of someone appointed by the court need to be present to sign any legal document because these individuals are not capable to see and read what is written.
I believe that for all LEGAL purposes Researchers need to take a SIGNED consent rather than a verbal consent
I think that culture may play a role here. Informed consent is vital, written consent is much stronger than verbal, but verbal consent can be utilized in some cases. Also, some researchers use witnessed verbal consent.
I am involved in conducting many qualitative telephone interviews so the consent process is verbal, but it is very clear and specific (a series of questions read out and answered by the participant) and it is audio-recorded so there is a record there.
I think written consent should be sought if possible. But in cultural setting like that of Nepal where people are skeptical about signing any document because they think it could potentially have some legal or financial misuse, it is difficult to obtain a written consent, and hence, only verbal consent is often obtained. Lower literacy rate could also be a factor. Besides, when a good rapport has been built between the interviewer and the interviewee at the beginning of the survey, sometimes it can even become awkward or embarrassing to seek a written consent.
Written consent is most import for various aspect. However, written consent is not always possible. It depends upon your subjects and context. If you will take verbal consent instead of written consent, you must have to give rational why should you take verbal consent. It will prevent your further difficulties.
In any study where human subjects are involved, a written informed consent must be obtained (regardless of the study design).
In the case you presented (phone interview) it could be acceptable a verbal consent if:
1) The protocol clearly defines the modality of which the verbal consent must be obtained
2) An IRB approve the study and the procedure outlined for the verbal consent obtainement
3) The entire consent process obtainement is DOCUMENTED (as Niamh said, it must be audio-recorded or conducted with an impartial witness and then transcribed)
4) Only the questions listed in the approved protocol, should be answered by the subject
In addition to this, you must be compliant with your specific country regulations about subjects data protection, and their integrity
I agree with Emanuela Marchesi: the informed consent should always be required when human beings are involved in the study for any reason. In the experimental studies (clinical trials, case-control, etc. ) the informed consent must protect the enrolled patients from potential risks related to exposure to experimental treatment. In observational studies the consent protects the sensitive patient information, ensures privacy and defines the purpose of the use of the data collected and the time in which can be used. In my mind, the written consent is preferable to the oral. However, when it is not possible to request written consent it is important to be sure that the person to whom you ask consent he understood the reason for the request to participate in the study. Of course, the interviewer must read an informed consent form that has been approved by the IRB and must not put pressure to get an answer quickly.
Written consent should be the norm in any study, however in some countries due to social and cultural factor "verbal" consent must suffice
While taking informed/ written consent it is also vital that the patients be assured that their identity would be protected and under any circumstances be not exposed except for the individuals involved in the study. Sometimes language barrier also prevents in understanding the importance of studies undertaken.Hence it mandatory to explain to the patients in their own native language either through interpreter or through consent form in their own language to understand well
Informed consent is of great importance and should be obtained in all studies with human subjects. However, it should not be seen as an unnecessary, but legally essential, stage which slows down research.
Instead it is an opportunity to summarise all the issues involved, almost certainly in an information sheet which can inform subjects about all essential parts of the study and enable them to ask their own questions. They may provide insights which can benefit the whole research project.
Now, research carried out by the same medical team that is involved in treatment of a patient is a particular case. Patients will feel dependent on that team and might fear that if they do not participate in the research, they will be less favoured and disadvantaged from the viewpoint of treatment. Also, if the patient has a good relationship with their doctor, they may feel unable to say that they do not wish to take part. For example, cancer patients may be especially vulnerable and may hope for a cure and believe that it is only by taking part in (any) research that they will have a chance. That means that although the team may be carying out the research, it should be someone separate from the main therapeutic team who actually broaches the issue of taking part with the patient and obtains incormed consent.
I believe too, that only if a patient knows that he/she is already receiving the best treatment in terms of all available evidence (e.g. in a country which has a well-organised National Health Service) can they really weigh up the pros and cons of whether they should participate.
As a person who has done population surveys with well over 200000 people now, I can assure you that as long as the person is informed that the survey is voluntary and that they may refuse to answer questions or stop at any time, if they consent to proceed that is sufficient consent. Not one person has complained about this procedure. We do sent brochures out to anyone who has an address and we do offer to send brochures to all the people who consent to recontacted (over 90%) and to have their data linked to administrative datasets (80%). BUT if the study is more invasive and has more possible personal consequences for participants, then written consent is a must as is ethics approval for the study (which all of our surveys have). Hope that this helps,
Agree with Alison Daly: if the person is informed that the survey is voluntary, option to opt-out of any question, and survey responses will be de-identified (including sociodemographic information, with results reported in aggregate, then it seems no written informed consent document is necessary (unless a specific government law or regulation states otherwise).
Many of the contributors have indicated the level of literacy and cultural factors as determinants of choice of consent and I agree with that. Written or verbal, consent must be informed and without coercion. Reading this article may also be helpful.Emanuel, J. E., Wendler, D., Killen, J., & Grady, C. (2004). What Makes Clinical Research In Developing Countries Ethical? The Benchmarks of Ethical Research. JID, 189(1 March), 930-937.
As most mentioned in above answers, written consent should be signed if possible no matter what type of study is investigated. However, if verbal consent is the only way, make sure the participant fully understand the consent and record the conversation between explainer and participants.
In research we are told 'if it is not documented it was not done', so in an ideal world all consent should be written.As much as possible consent should be written in the language best understood and read by the study participants-literacy is not only in English!Very rarely will a verbal consent suffice-as mentioned above maybe a phone interview.
Written consent is required in all researches on human subjects. In any case, the consent could be informed for descriptive studies where there are no invasive steps to undertake. The written signed consent is appropriate for studies that require sampling,followup, intervention/experiments,...etc. consent is always to be written down and administered 'verbally' or 'in signed' forms.
The signed informed consent is required in study involving human subjects.
it should be informative and with witness. if this the requirement, it is clear that the verbal one will not suffice ! or the let us think the other way How the investigators will ensure that they actually take the consent if it is verbal? or the patient himself/herself will deny it
Best Regards
Written consents assure formal committment of all involved parts in research. They are necessary even to safeguard that researched persons that eventually disagree with the paths of research (as the research is goes on) can step back on their former consent.Written consent, therefore, are a type of ethical monitoring of research involving human beings and animals. Verbal consents are weak and do not give any assurance to researcher, their institution, and to involved people. Any type of research that embraces health (physical, social, mental) shall be done under written consent and undergo Ethical Research Committee of University or institution that sponsor the research.
Approaching this question from both a good governance and also a health and development research perspective, I feel really encouraged by the many strong arguments in responses above that research involving human subjects should be based on informed consent. While there are arguments to be made about at which level of intrusion informed consent is really required (e.g. monitoring traffic (pedestrian or vehicular) pattens or building a research database from regular patient consultations is often done without any information to those monitored), the question usually comes down to a balance between practicality and ethics. For instance, counting people crossing a street in order to see if a traffic light is required is usually unlikely to need any sort of individual consent.
However, as soon as one asks a question of those individuals then the issue of informed consent becomes actual, since a response may have personal/social/ political consequences. Once in this area, written consent is the ethical basis from which authoritative findings and recommendations can be made. If the questions are over the telephone or raised with people who are not literate (i.e. must have the information read out to them) then an audio recording is likely to be sufficient (with or without a witness). This should be agreed with an ethics committee in advance and obviously people need to have given oral consent to the recording in the first place!
Thus the ethical question is when should informed consent be obtained then the question of oral versus written consent is largely 'technical'. In any sort of liberal democracy, informed consent provides the basis for consitutional law. Regrettably, transparency (for/in authoritative sources) still seems controversial in most countries. Since the scientific project aims towards the bettement of not only human knowledge but the human condition, academic research should lead the way in both transparency and ethical data management.
We can get a little "precious" about this issue. In practical terms, in a household survey where a written questionnaire is used, the participant's consent is implied by his/her completion and returning of the questionnaire. End of story. Having to get a signed consent form as well is just needless bureaucracy, and we have enough of that in our health systems already. Let's be sensible here, folks!
Answering to Sathian´s question about written and verbal conset in descriptive studies, in my opinion it depends on the populatin under investigation. If doing research on special population (e.g. down syndrome, mentally retarded, children exposed to HIV) written consent must be obtained, on the other hand if doing research on adult population to determine opinion, knowledge, attitude a verbal consent might be enough..
In answer to William, I agree that practical issues are also important. E.g. One reason that answering postal, online or on-street interviews is taken to imply consent is that asking people to send in a separate written consent form lowers recruitment/response rates (survey fatigue, time costs). This can result in non-response bias (and affect any goals for statistical power in quantiative studies). It also costs more (postage, data handling).
On the other hand, funders, ethics committees and publishers tend to view written consent as an audit trail which may provide some insurance that the respondents being counted
a) exist
b) have read or heard the info on the study purposes
c) agree to questions and other activities
d) agree to the researchers proposals/promises for how their data will be handled before, during and after the study, including for publication purposes.
Worth bearing in mind, 'written' consent may be as minimal as 'ticking the box', signing the interview protocl or oral equivalent and that this audit trail can add value to any descriptive study that does more than count traffic in terms of credibility (assuming no other bias or error issues) and longevity. Irrespective, once a study collects personal data (name, address, etc) the issue is subject to legal (IP, data protection, privacy) requirements in many countries where research publishers look for audience. Therefore, it seems eminently sensible to prepare one's study design to meet the highest ethical standards suitable to the project that one can afford,
Although filling in an sending back a questionnaire can be taken as consent, it cannot be taken as informed consent. It is not evidence that the participant knows the purpose to which their data will be put or the risks and benefits of participation. The crucial evidence required is that the participant was correctly and fully informed, and this is not provided by a signed form, or by the return of a questionnaire.
Study design does pose an issue. Written consent is difficult to obtain in phone interviews, in studies where people are afraid that signing on a form may expose them (for example sexual workers, illegal migrants, undertrails, criminals), or when study is about sensitive issues like HIV/AIDS sexual behaviour. In such cases when ppl are not educated enuf to understand the written process, verbal consent can be obtained but this deviation should be noted and communicated to IRB.
The discussion shows that we should distinguish at least two different kinds of research when talking about informed consent:
(1) social research using general population surveys, and
(2) human subject research in psychology and medicine.
I agree that a patient or a person that is part of a clinical trial need to be treated with special care. A patient undergoing surgery will go through a full anamnesis and will be fully informed e.g. that the intervention might lead to his or her death. There is no alternative to a written consent form with a valid signature of this person.
It is quite a different thing - and this has been mentioned a number of times already - if you conduct a general social survey with one, two or three thousand respondents via telephone. A major point here is that the data collected can be anonymized (e.g. in a first step by deleting direct identifiers) since statistical analysis does regularly not aim at individuals. Participation in a survey is voluntary and conduct implies an intent, if I get the legal term right in English.
Right. I absolutely agree. This would be something like barrier-free consent. We have just seen this in an international survey GESIS helped to conduct in which the needs of disabled individuals had to be taken into account - concerning the interviewing as well as the consent.
Dear Brijesh Sathian,
The term 'verbal consent' does not exist in the European laws and rules governing research with human beings. So, we have to obtain 'written consent' always. Likely, you have to demonstrate consent in case authorities monitor or audit a study. It is not possible having 'verbal consent'.
Descriptive studies do not fall under the (European) laws and rules of research with human beings. Studies influencing human beings physically, or mentally, are subject of these laws and rules only. We call this commonly an 'intervention'. We do, however, also have privacy laws and rules. So, in case of descriptive studies, you need (written) consent of the participants doing prospective research. You do not need it retrospectively although you need to use the data carefully still.
I am less familiar with the legislation outside Europe. I, however, feel it is similar so far legislation exists at all. I did not encounter the term 'verbal consent' in the international scientific literature yet.
In Englan in the university setting we have ethical committees which will tell us categorically whether we written consent (either in NHS setting with NHS ethics or university ethics for non-NHS settings) - in my studies I have used both - for survey's we don't ask for written consent but make it clear that the participant doesn't have to take part and they don't leave their name or any other identifiable information so the questionnaire will not be able to be identifiable to a single person. For intervention studies, or studies where I am collecting identifiable information I ALWAYS get written consent and wouldn't be able to do my study without it (rightly so).
I would say they both are informed consent and you should obtain written consent for any study dealing with human subjects, however, in some studies e.g. online surveys where you don't breach any ethical issues you can use verbal consent (in this case verbal refer to the acceptance to fill the questionnaire)
In Australia we are guided by the National Statement on Ethical Conduct in Human Research 2007 - Updated May 2013 Chapter 2.2.5 Consent may be expressed orally, in writing or by some other means (for example, return of a survey, or conduct implying consent), depending on:
(a) the nature, complexity and level of risk of the research; and
(b) the participant’s personal and cultural circumstances.
http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e72_national_statement_130813.pdf
In addition to what others have answered, I would like to add that we use "Verbal Consent" in India and neighboring countries where a large segment of rural population is illiterate. We read out the informed consent script and take their verbal approval before starting the survey. In case the respondent is ready to give a thumb impression, we also encourage them to put the thumb impression in the place for signature.
History of research is replete with many unethical practices . We therefore illiteracy cannot be a justification for conducting research involving human participants without a written informed consent . In research anything not documented is not done. Written informed consent can be obtained from low literates by having an impartial witness observe the consenting process. The witness ensures that the consent information is explained to the participant in language and way they understand . S/He also onfirms comprehension by asking checking questions. The witness thereafter signs the signature page after the low literate participants append his or her thumb print.
I accept that this may vary vary from country to country but when in doubt contact your Institutional Review Board or Ethics Committee
I think written consent is mainly used to cover the researcher's back especially in case of complications during clinical interventions (e.g. testing a new drug), because in studies based on data collection like surveys or polls, if a person doesn't agree to participate to a study they will simply not answer the question. In these cases a verbal consent is enough, given that the purpose of the study was thoroughly explained to the participants; and even so they can choose to not answer certain questions if they are not comfortable with them.
Oliver, I agree with your description of the best practices. But one can seek IRB approval for modifications to the standard procedures when the research involves "minimal risk" and involves only demographic/psychographic data gathering from the respondents, and when the research does not involve "vulnerable populations" (pregnant women, children and other vulnerable sections). Even then it is important to maintain complete confidentiality of personal identifiers and use the social research data for statistical analysis only.
There are distinct differences between written and verbal consent. Written consent is a form of approval/permission that shows that a participant is willing and happy to participate in a study or research. This is done on paper and signature of the participant appended and dated. It is in many instances needed when clinical trials involving human subjects are being carried out. Verbal consent on the other hand is the same as oral consent, this can be documented through audio system or other means but written consent is more important when carrying out drug/clinical trials on human subjects because participant need to know what role they will play in the study, how the study will affect them, what they stand to gain e.t.c. and ethic review board require such consent and want to know
that human subjects are happy to participate in the study.
Written consent is mandatory in case of drug/clinical trials and for material source obtained through invasive procedure for the experiments.But in case of biological material obtained through non invasive methods such as urine/stool/sputum etc verbal consent may be sufficient
All medical research must adhere to the principles of the Declaration of Helsinki. The relevant section of this document, for the purposes of this discussion, is in Paragraph 26: "After ensuring that the potential subject has understood the information" (referred to earlier in the paragraph) "the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed."
In the UK all medical research involving patients requires approval from a Research Ethics Committee (REC). The REC will expect the recording of written consent, on a standard consent form that explains (for example) the right of participants to withdraw at any time, without any negative consequences for the patients medical care. However, if the applicants make a case for obtaining verbal consent, that the REC considers justified, then this would generally be accepted. However, the obtaining of verbal consent must be formally documented by the researcher, and should be witnessed for the procedure to be compliant with the declaration.
The legislative framework governing medical research, and possibly research in other disciplines too, will vary between countries. The Declaration of Helsinki makes clear that although individual nations may impose stricter requirements than those in the Declaration, none of the requirements therein can be over-ridden.
In many areas of social research, where the Declaration of Helsinki does not hold the same status (though many of its principles will still apply), verbal consent is commonly accepted, though still requires documentation, but consent is considered an ongoing process, rather than a one-off event. My view is that this is very sensible and should be more widely applied where participants' involvement in the research is extended over time, rather than being a one-off event.
There is also passive consent and active consent. Passive consent is a situation where consent is assumed to be in place unless the patient (or consent-giver) actively opts to revoke or deny it. Active consent is where consent must be given; i.e., it is assumed consent is not present unless they actively give their consent. My experience in America is that you should not seek active consent if consent is already implied for the data you have; i.e., don't give them too much rope or they'll hang you with it (and it can delay your study by a year). The more anonymous (de-identified) the data is, the less consent is needed, generally speaking. Many public health records and hospital records have consent implied when the data is gathered from the patient. But of course, follow the ethics. You can ask the Institutional Review Board of your institution, if you have one. Many journals require a statement that IRB approval and/or informed consent was given before they'll publish an article.
It depends on the research scenario it has nothing to with study design. You need verbal consent and written consent depending upon your reseach objective; for same study design some time you need informed consent and sometime informed written consent. Informed written consent are required where researcher wants to intervene in study.
Both are necessary , especially in a clinical trial, a written consent must be signed by the patient under going the study. But in some studies, both are necessary. Because the type of intervention and risks should be explained to the subjects.
Without reading all the answers above (Sorry for being lazy), we have a study looking at scabies in nursing homes. Many of the patients have dementia and thus cannot consent for themselves, so after assessing their capacity to consent, we may contact the next of kin, or another 'consultee' for their permission to include the patient in our study.
The verbal consent over the phone is sufficient to allow us to include them in the study (since this is an outbreak situation, you need consent pretty much 'there and then'). We then follow up with a hard-copy signed consent form from the consultee.
This method of working has gained ethical approval in our study, and indeed we copied and adapted it from another study looking at acute episodes of pain in dementia patients, who also gained ethical approval.
No idea if that's helpful to anyone, but there you go!
Interesting - so did you go through the telephone consent route on the basis the vision impairment fluctuates and thus you preferred approval there and then?
Actually, whilst our study has now just started, might be some value in finding out more - can you drop me an email on [email protected], would be interesting to see your study protocol etc if you're happy to share them. And I suspect the project leads of our scabies work would be happy to do similar in return.
We really struggled to get a workable solution to the consent issues, and it was another UCL study looking at acute episodes of pain in patients lacking capacity who were finally able to help us and show a way forward. Shows there is a real need for some good networking across disciplines to solve the problem sometimes. We've got a paper written (invited to revise, though the journal's revisions were beyond what we could do, so may have to resubmit elsewhere) which will outline our experiences in the hope that may help others in time.
We did telephone interviews on one project and simply asked at the beginning of the interview if they consent to participate. We told them that they are not required to participate and that not participating wouldn't affect their future medical care at the institution in any way. This was interviews of former cancer patients. The IRB approved this verbal process, which is common for interview studies.
On another project, we used school records as sources of data. This was considered "passive consent"; i.e., consent is assumed to be already there unless the parents actively refused it. I believe for that study we sent a notice to parents saying their children's records would be used unless they didn't want them used. In another part of that study, no consent was obtained at all: the school records were assumed to be something that could be studied and the data was totally de-identified by those abstracting it from the records.
Most journals merely require a statement that the IRB approved the research. Sometimes in clearly clinical studies they require affirmation that consent was obtained, for example in clinical trials. Some ethicists and others go overboard in claiming that written consent is necessary for everything; but it is not. FERPA guidelines allow studies of school records without consent, and NIH national guidelines exempt most psychology and educational research from the consent process completely. Probably every American university requires an IRB submission, however. And as others have pointed out, consent even for clinical studies is sometimes difficult or impossible, for example trials of emergency room cases where there is a head injury and the patient is unconscious. IRBs take a good look at those, though.
Our IRB generally allows for verbal consent in, for example, key informant interviews. The introductory script for the interview makes clear that the person is not obligated to participate in the interview, and that if any question makes them uncomfortable they have no obligation to respond. We also make clear that we will not quote them personally unless we review it with them ahead of time. A final concern is that we do not interview people with their supervisors in the room.
I am aware of a study in which the goal is to determine the best first responder treatment for cardiac arrest patients. There was a campaign to inform that if you should go into cardiac arrest in King County, you would be automatically randomized to the current standard, or the newer protocol A description of the treatments as well as a way to get more information was provided In an impressive collection of languages. There was a phone number to call if you wished to opt out, in which case, you would be listed for the standard protocol if you ended up becoming a participant. I thought that was a pretty good way to go, given the impossibility of consent at the moment of need.
I also am in the position to give consent for my older sister who is developmentally disabled. I didn't understand her situation until our parents passed away. As an adult, she is her own person, but unable to make decisions for herself, she is technically a ward of the state. At the same time, the organization that provides for my sister respects my concern for her. I am made aware of any changes to her health and well being, and sign consent for all non emergency medical care. I recently signed consent for a dental exam that is part of a study of the dental needs of developmentally disabled adults in state care. Of course in reality, if there is a medical need, she will get care without my consent, but she would not be placed into a research study without my consent.
Most of the research studies involving human subjects needs written consent,the IRB and the ethical approval should normally be given unless and until there is a written consent, the question of verbal consent only is literally is very weak and should be subject to various controversy in the case of any disputes and conflicts.
we should always seek informed written consent. The client/patient is often disrespected and treated as a means to an end. If it were not for participants we could not research. Opt in opt out is not appropriate...it is not the gold bench mark of obtaining consent, despite what many researchers wish.
The requirement to have written consent for use of any individual level data can not be applied in all study designs. If this was an absolute rule, then epidemiologists could not link datasets (e.g. census with death certificates) and could not use retrospective data on subjects who have died or are otherwise no longer able to give consent. It seems sensible that there is proportionate safeguards around use of data depending upon (a) the burden that is placed upon any human subject through exposure to new therapies, responding to new questions or sharing of existing information (b) the risk of harms arising from participation in research or disclosure of identifiable data. In the UK it is possible for caldicott guardian's to judge use of existing data without individual consent to be appropriate where obtaining consent would not be feasible, and it is in public interest (e.g. for retrospective epidemiological studies reporting population statistics). This said the concerns in England about data-sharing from primary care reflect public unease about potential commercial use of data and need for strict boundaries to safeguard confidentiality.
Hi Timothy
I agree with you point on retrospective studies on the dead, who have no legal rights. However, I have a problem with living sentient beings being 'opted in' without written consent. Whilst the rationale for using opt in is that the information is de-identified for say registers. However, it appears that even tissue samples can be placed on the register. I consider this an invasion of a persons body, which is by law inviolable.
Absolutely a written consent is a necessity when the human subjects are involved in the study, otherwise it can be either written or verbal consent depending on the protocol of the study, subject to the IRB approval.
Dear Helen and Sultan,
I can only speak from my understanding of UK, but right to confidentiality does exist after death (it would be unethical for a clinician to disclose information to a relative from confidential medical records for instance). As Alder Hay underlined, storage of physical tissues should be with clear consent - that is very different from a population level genetotype register (e.g. OMIM) which may use information gained from physical samples. It is important to be clear that in those situations where individual consent for use of data may not be necessary it is not that either researcher or those responsible for safeguarding data are disregarding the rights of participants. As Lorinne Du Toit states, the issue is around practicality and necessity of obtaining consent.
I don't think anyone would consider it ethical to have participants in an RCT of an experimental therapy without explicit consent. Should the same standards of seeking consent apply to a researcher investigating links between pre-term birth registrations and socio-economic status using national registers? Not only would this be entirely impractical (N = millions), it would be disproportionate. The data used are already gathered so no inconvenience arises from participation. Secondly, the risk of harm to any individual is, in comparison to taking a new therapy, so small as to negligible.
The main risks might be breach of confidentiality (hence need for governance around data security/management) and improper/harmful/commercial use (hence controls such as Caldicott Guardian). Data-linkage can be performed securely in authorised (e.g. university) data safe-havens, and in such a way that the research team only ever handles entirely anonymised data. Reporting is at an aggregate population level and so long as the condition is not rare this means it is impossible to identify individuals in papers.
A practical solution is to describe to the population how and why certain limited data may be used, and allow time for consensus to be gained (this is what is happening in England now). Scotland already has excellent systems for data collection / secure sharing at national scale, and this can have major benefits to population health. Rights are only defensible if they do not undermine the rights of others to similar freedoms. If data on my health/service use could help others at practically no risk to myself at all, refusing access on principal is taking my right to anonymity to an unhealthy extreme. We need to be careful not to apply a "one size fits all" approach to different scientific investigations.
It is an interesting topic. A written consent seems to be the most appropriate but as some other colleagues mention there are some situations where is is not feasible such as telephone surveys, in some communities and with some study subjects it is not possible to obtain the person signature (illiteracy, physical disability or other limiting condition) and verbal consent is an alternative, having witnesses and other evidences (all these possibilities included in the protocol). However it is important to remember studies with minors (young children) when a double procedure is needed: parents consent and children assent, and written/verbal consents is required from both individuals and witnesses if required. It is important to have this situation in mind
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