BACKGROUND

The importance attached to ethical practice and associated informed consent varies among health professionals and is further influenced by working environments, level of knowledge, experience and societal values and beliefs (¹).

Several studies have assessed the methodological/reporting quality of oral health (²-⁴) and examined important aspects related to conduct (⁵,⁶). Moreover, autonomy is a hugely important value, and the ability of the health professional to provide care also must be respected. This leads to the crux of the moral issues involved in setting limits to individual autonomy in health care (⁶-⁸).

One of the major challenges in bioethics has been research involving human volunteers. Historically, there was an “omission” of basic human rights, which resulted in the need for guidelines and norms on this kind of research (⁹).

In Brazil, guidelines and norms for research with human subjects were created. Initially, this was accomplished with Resolution 1/88 issued by the National Health Council (¹⁰) to the effect that studies should be conducted in such a way that scientific progress is not more important than people’s well-being and the protection of their rights. Later, Resolution 196/96 approved research guidelines and regulatory norms involving human subjects, and it was supported by international documents such as the Nuremberg Code and the Declaration of Helsinki, and incorporates the four basic principles of bioethics: autonomy, non-maleficence, beneficence and justice (¹¹,¹²). This last resolution was improved through Resolution 466/12.

Therefore, research subjects should know their participation is voluntary and they must understand what health researchers will do and decide whether or not to give their consent to participate in a study (⁸,¹²-¹⁶). Currently, many studies are conducted in educational institutions and the research subjects are patients who need the clinical services of those institutions. However, it is important to emphasize that the research volunteer and the patient are separate and have different needs. Research subjects contribute to science interests voluntarily and patients need treatment (¹,¹⁷).

Consequently, this study analyzed the ethical conduct of professors, undergraduates and graduate students through questionnaires applied to patients at the dental clinics of different dental schools.

METHODS

A questionnaire was prepared with 14 objective questions about signing informed consent, participation in scientific research, photos during treatment, requested saliva samples, requested tooth donation and information about tooth destination after removal. It was a descriptive and qualitative study carried out through data analysis.

Prior to the start of data collection, the research project was evaluated and approved by the Research Ethics Committee (CAAE nº 0043.0.138.000-09).

The research subjects were selected randomly (n=40) from three different dental schools at the University of São Paulo (the São Paulo Dental School, the Bauru Dental School and the Ribeirão Preto Dental School). The selection included patients who had finished treatment and those who were undergoing treated. In all, 120 volunteers were chosen. The participation of these research subjects was conditioned to a correct understanding of the goals and methods, as well as acceptance and signed of informed consent.

A frequency distribution (absolute and percentage values) was used for a statistical analysis of the data. The data were analyzed and distributed according to the patient’s response, as per the three different dental schools, then organized together. All the data were collected on one occasion only, because some patients finished their treatments shortly after answering the questions.

RESULTS

The results in terms of signed informed consent and participation in scientific research by patients are shown in Table 1.

Table 1 Signed Informed Consent to Treatment and Participation in Scientific Research 

The letter “N” refers to the number of patients who answered that part of the question.

Table 2 shows the patients who were photographed during dental treatment and gave their signed informed consent.

Table 2 Photos during Treatment and Signed Informed Consent 

The letter “N” refers to the number of patients who answered that part of the question.

In this table, “signed informed consent” applies to the patients who answered yes to the question about photographs.

Saliva sample requested and signed informed consent are shown in Table 3.

Table 3 Saliva Sample Requested and Signed Informed Consent 

The letter “N” refers to the number of patients who answered that part of the question.

In this table “signed informed consent” applies to the patients who said yes to the question about a saliva sample.

Table 4 shows tooth donations requested from the patients and the informed consent signed by them.

Table 4 Tooth Donation Requested and Signed Informed Consent 

The letter “N” refers to the number of patients who answered that part of the question.

In this table, “signed informed consent” applies to the patients who said yes to the question about tooth donation.

Finally, Table 5 shows tooth destination reported to patients, after removal, when donation was not requested.

Table 5 Tooth Destination after Removal, when Donation was not Requested 

The letter “N” refers to the number of patients who answered that part of the question.

DISCUSSION

It is observed that most patients had given signed informed consent, which is very important information. The patient and his/her rights are being respected, as required by Resolution CNS 466/12 (11), since it is necessary to show all procedures, risks and benefits, which must be written in language that is accessible and understandable to the research subject (¹,¹³-¹⁶,¹⁸). It should be noted that the person’s autonomy should be respected so he/she can make decisions that might affect their life (¹,¹³,¹⁶,¹⁸).

Although more than half of the patients had given their signed informed consent, those who did not remember are a cause for concern. However, the bias in not remembering about signing informed consent can be explained by the fact that subjects might not understand the contents of the term (¹³,¹⁸-²⁰). Best practice already obliges researchers to comply with a range of legal and ethical obligations, with a particular focus on informed consent and research transparency (⁶,¹⁵,¹⁶,¹⁸,²¹).

Regarding participation in scientific research, despite the fact that only a few patients did not know if they had participated, it is something that should not happen. This must be explained to patients who are invited to participate in research voluntarily, including informed consent. If so, they would remember their decision to participate in research or their refusal to do so (⁶,¹²,¹³,¹⁸,²²).

The research subject is a person who agrees to attend voluntarily, to contribute to science interests, and to look for progress and an improvement in the research field. The patient is seen as a person who requires care and treatment, and this need must be satisfied by the responsible professional, regardless of acceptance to participate in scientific studies (¹⁴,¹⁷,¹⁸,²²).

The reasons for taking part (or not) in clinical trials have been reported in another study (²³). A major theme emerging from the analysis was the extent to which people said they took part because they anticipated some kind of personal benefit and this was their primary motivation. Others expressed more mixed reasoning, citing both personal benefits and helping others or medical science. In many of these cases, helping others was presented as a secondary reason, while a smaller number said it was their primary motivation and personal benefit was secondary. Very few people mentioned helping medical science or benefiting others as their only reason (²⁴).

The number of patients who were photographed during treatment and had not given their signed informed consent was very similar to those who had given their signed informed consent. In most parts of the developed world, written consent is usually obtained for medico-legal purposes prior to any medical procedure, including photography (²⁵). Patients need to be informed of the purpose for which their photographs are to be used (²⁶). In medical practice, privacy of the individual patient and confidentiality of patient information should never be violated. Indiscriminate use of patients’ photographs violates the ethical principle of ‘respect for persons’ (²⁵). A few patients had been requested to give a saliva sample and been asked for a tooth donation, and the majority of them had signed an authorization to that effect. This information is important because the patients had given a body part or a sample and had consented to do so, in writing, according to Resolution CNS 466/12 (¹¹,²⁷). A number of lawsuits concerning the use of human tissue in research emphasize the central importance of the donor’s informed consent (²¹,²⁸). The use of teeth and saliva as biological samples of human origin must comply with legislation and ethical rules (²⁷,²⁸,²⁹,³⁰). Acceptability, as measured by the proportion of samples collected, varied by sample type. Saliva was easily accessed and given by all participants after having given their informed consent in writing (³¹).

More than half of the patients did not know the destination of the tooth after removal, when donation is not requested. This probably occurs due to a lack of information about the tooth being considered an organ of the body (²⁷,²⁸,³⁰). Research transparency is relevant, since it means participants feel their autonomy is respected and their interests are being represented throughout the research process (²¹).

Another study considered it discouraging that, despite in-depth information sessions and the consent process, 4-12% of the participants, depending on the type of sample, gave it because they thought it was required. It is recommended that consent forms include a section where participants can indicate the sampling methods they consent to. Since the consent form is signed at the beginning of the study, verbal confirmation as to which samples the participant is agreeing to at each visit is also recommended. This should be documented, in writing, in clinical notes or other source documents. There currently is a clinical trial with these added precautions. The authors plan to compare participants’ reasons for agreeing to provide specimens and to determine if this additional step has improved their understanding of the study requirements (³¹).

CONCLUSIONS

The majority of the patients gave signed informed consent for treatment, photos, saliva samples and tooth donations. This demonstrates that professors, undergraduates and graduate students were working ethically in the dentist-patient relationship, which is very important for all the procedures done in dentistry.