I had to administer informed consent for my film shoot in UK. For shooting on streets, placards with information were placed. As for the people involved within the shoot, I got them to sign a consent form.

It depends on the subjects of your study. Informed consent should be communicated in a way that fits with the understanding of the subjects. If the subjects are illiterate then reading aloud would be appropriate. But reading aloud might be inappropriate if subjects are highly educated professionals.

Great and thanks for your feedback on this

Whatever way ........ Research participants must understand what they have being asked for and what rights they will in that particular study

Rightly said Kamlesh, the intention is to communicate and take permission regardless of the way.

I have to mostly agree with David, yet, when I am servicing a group of people I read the consent form out loud so as not to offend anyone that cannot read or presume that everyone can. But gaging the education level of your participants is important because you don't want to seem to belittle those that can read and have a high comprehension level.

It depends on the nature of the study and the population itself. In some way, participants (assuming basic literacy skills) should receive a written copy of the consent. If they have reasonable literacy, it is permissible to ask them to review the paper copy and then touch on the highlights. There are also variations for in-person written consent as opposed to consent done over the telephone or on a web-version of a survey. Your IRB should have details available about how to do this.

Thanks again for your feedback on this very important issue. Am in agreement that we should avoid jargon and depending on your respondents, assess the need to read out a loud or just provide them with a copy to read through.

Rhoune,

Informed consent entails disclosing, with honesty and without coercing, the risks and benefits of a procedure (surgery, treatment, etc.). After having exhausted the topic without bias, the patient should be left to make his own or her decision.

Thanks,

Ben Olwe,

Alumni, Walden University

Ultimately, this is a research question in need of an answer. I will focus on higher risks studies like studies of newly developed prescription medicine and invasive medical or surgical procedures.

The question is not simply one of the manner in which the disclosure is made to an individual considering study participation, but how any answers that individual may have that will need to be answered in a neutral manner. Approaches that need to be considered include the following:

(1) neutral third-party observers who are trained to provide information in a neutral manner as possible. This is recognized in the concept of "therapeutic misconception" in which an individual does not believe that his or her physician or the researchers to whom his or physician referred them to would allow them to participate in a research study in which the individual may not benefit and may sustain risks, including death, in high-risk studies.

(2) well-designed computer programs that are developed by groups that are highly knowledgeable in presenting information in a neutral fashion. The concept of "neutrality" of information disclosure is aimed at minimizing framing and like effects in presented information.

(3) bookets or books made available to individuals considering research participation that explain the notions of the framework that underlies informed consent in research. For example, in the United States, in clinical care of patients, there are two main standards used in judging informed consent, the professional standard held in about 50% of the states and the reasonable person standard in about 50%. However, in the U.S., the Belmont Report specifies that neither of these two clinical standards is sufficient in research informed consent. The writers of the Belmont Report developed what they call a "reasonable volunteer" standard to take into account in the research circumstance that individuals do not seek out research participation, rather they are recruited into research studies. In clinical care, individuals seek out physicians for care.

Also, note that the concept of "neutrality" in communicating information to individuals asked to consider research participation also needs to be developed and researched in terms of its benefits and harms to individuals and society.

Dennis

Dennis J. Mazur

References

1. Belmont Report.

Accessed on April 4, 2014.

2. Mazur DJ. Influence of the law on risk and informed consent.

British Medical Journal 2003;327:731. Available on ResearchGate (free PMC article).

3. Neuhauser, L., Paul, J., “Readability, Comprehension, and Usability.” In B. Fischhoff, N.T. Brewer, J.S. Downs (eds.). Communicating Risks and Benefits: An Evidence-Based User’s Guide. Washington, D.C.: Food and Drug Administration (FDA), US Department of Health and Human Services, August 2011.

Accessed on April 4, 2014.

The way we usually approach informed consent is by first allowing the participant to read the information leaflet which is in lay terms, and gives an overall idea about the study. Once they have read it they can ask questions to which the research assistant provides answers to. Once they have fully understood the study we hand them a separate consent form, the purpose if which is explained to them and then participants fill it out and sign it them selves.

If the participants are illiterate, a family member or friend is asked to read the information leaflet and consent form and help explain it to the participant, any questions will once again be answered by the research assistant.

This method ensures that the participant has fully understood on his own without the use of fancy jargon what the study is about and why he should or should not participate in the study.

The above commentary generates a new set of questions:

1,  To what extent is competency assumed versus to what extent is competency to be judged in a research informed consent session?

2.  What are the basic criteria to be used in judging competency to participate in a researh study?

3.  To what extent has a research assistant been trained to make judgments about completency and what has does this training consist of?

4.  In the case of an illiterate person, to what extent can a family member's or friend's participation in the informed cosent session say anything about whether the person being approached for participation is competent or whether he or she understands the information sufficiently?

Dennis Mazur

Dear Dennis,

Yes, an important set of questions. I am NOT an expert in bioethics, but have used the methods I previously described for obtaining informed consent in studies.

In the field it is the research assistant’s ability to determine competency for consent. It is practically quite a difficult task in certain situations because one has to know where to draw the line. Let’s say for example if a participant is suffering from a mild mental illness what criteria should we use to judge that the participant was competent enough to give consent? Research assistants should be trained to detect verbal and non-verbal signs such as confusion and nervousness (just a few of many), these may show that the participant has either not understood or is not willing to take part in the study. In such cases it would be best to get advice from a senior or more experienced member of the study team to assess for competence before proceeding.

When conducting large scale researchstudies in low and middle income countries in resource poor settings it is difficult to find research assistants with very high qualifications. This means that the study PI’s or coordinators must wisely choose research assistants who are also competent enough to obtain informed consent in an ethical manner, and then train them in basic ethics and informed consent using role playing and lectures.

Ultimately it all boils down to obtaining genuine consent.

Kaush