Demographics
In this study, demographic data were collected from 25 study participants (21 herbalists who underwent in-depth interviews and four herbalists' association leaders who were key informants). There were 15 females (median age of 54 years), and 14 had attained primary education only. Ten herbalists had more than 20 years of experience in their field. A summary of the demographics of the 21 in-depth interviewees is presented in Table 1. The association leaders of the four herbalists were all males aged 30 to 60 years. All four leaders held a bachelor's degree and had more than five years of working experience as herbalists.
Table 1
Sociodemographic characteristics of the IDI participants.
Population Demographics | Number (N = 21) |
Age 30–40 years | 2 |
41–50 years | 7 |
51–60 years | 5 |
61–70 years | 7 |
Gender Male | 6 |
Female | 15 |
Education status Primary education | 14 |
Secondary education | 6 |
Tertiary | 1 |
Experience working as a herbalist < 5 years | 1 |
5–10 years | 3 |
11–20 years | 7 |
> 20 years | 10 |
Analysis of the data yielded five themes: description of an herbalist and source of herbal medicine knowledge, attitudes of herbalists toward the IC, practices of obtaining IC, factors that prompted them to obtain IC, and barriers that hindered them from practicing IC adequately.
Description of the herbalist
The participants described herbalists in the following categories: (i) individuals who treat patients' diseases using naturally occurring plants, including their leaves, flowers, seeds, stems and roots; (ii) individuals who do not attend to patients but teach other people herbal medicines; and (iii) individuals who collect and process herbs from forests and gardens but do not directly attend to patients. These patients were further categorized into different specialties, such as traditional birth attendants, bone setters, and dispensers;
“I am looking at an herbalist as an individual who is approached by a patient, examines their health status and, depending on what the patient explains to them, picks certain herbs, roots, leaves, stems or any plant material, mix and prepare them to treat the patients’ ailment.” (KII_Male_4)
A ‘herbalist is one who treats diseases using naturally occurring elements such as trees and herbs that were created by God” (IDI_Female_04).
Source of knowledge regarding herbal medicine
The majority of participants reported acquiring herbal knowledge orally and informally from their relatives. They noted that herbalism has a robust foundation in traditional healing. Some participants had also undergone formal training in herbalism schools, learned from colleagues, and gained knowledge and experience through long-term use of various herbs for a range of diseases, such as malaria, skin diseases, diarrhea, and sexually transmitted diseases. Patients with chronic diseases also provided antenatal care services and managed the side effects of long-term drug medication.
‘’I got this knowledge from my grand-parents, then from my father who used to work with Nakalooli brothers in Kisubi.’’ (IDI_Male_12)
“There is a category of herbalists who have undergone training and been educated. They go to medical schools or natural chemotherapeutics, and they learn about the herbs; there are some who read from the internet and start practicing”. (KII_Male_4)
Herbalists’ attitudes toward informed consent
The majority of the study participants regarded ICs as essential for adequately disclosing information about the proposed treatment to the patient and for identifying the misconceptions people have about herbal medicine (safety and side effects). The authors suggested that disclosure should include treatment benefits, costs, dosage, and side effects.
"It is beneficial to inform the patient about the medicine's benefits, risks, and potential side effects to ensure they leave satisfied, confident, and well informed based on the explanation provided. Nevertheless, there are instances when withholding certain information becomes necessary, particularly if revealing everything might induce fear and panic in the patient, potentially exacerbating their problems." (IDI_Female_09)
“While there is a common belief that these herbs are entirely safe and natural, there are instances where improper consumption can lead to harm. Thus, it is essential to clarify to patients what they should anticipate after taking the medication. "(IDI_Female_05)
“It is very good practice to explain to the patient thoroughly what the treatment entails, such that they can make valid and informed decisions.” (IDI_Male_13)
However, there was nearly unanimous agreement among them that revealing information about alternative treatments and the specific components of herbal mixtures was not necessary for patients, and they believed it could have negative financial and professional implications for them.
"Some individuals, upon learning about the herbs used in a formulation, may falsely claim to be herbalists without understanding the proper preparation, usage, dosage, and comprehensive applications. Subsequently, they may misinform others, attributing their newfound knowledge to the original herbalist. This is why I limit the information I share with patients to avoid potential harm to my profession and reputation from unqualified individuals misrepresenting themselves as herbalists. "’ (IDI_Female_005)
"I do not reveal the specific herbs I blend to create the formulation. Instead, I focus on preparing the most effective medicine tailored to treating the patient's specific ailment. This approach eliminates the need for the patient to seek alternative treatments, as I consistently provide the best treatment within my knowledge." (IDI_Female_007)
The study participants did not perceive it necessary to inquire whether patients voluntarily accepted or refused the suggested treatment. The patients' arrival at the herbalists' premises was automatically construed as their acceptance of the impending treatment. Consequently, the herbalists did not inquire about their patients' perspectives regarding the treatment offered by the herbalist.
“Only the herbalist is allowed to make decisions and not the patient; patients do not tell us what to do, and therefore, they take whatever we as herbalists choose (KII_ Male-1).
“A patient is not supposed to make any decisions because he or she does not have knowledge regarding the treatment. (IDI_Female_02)
Some herbalists emphasized the significance of shared decision-making between themselves and the patient because this approach allowed for mutual advice and education during discussions, and the herbalist did not possess an absolute right to make decisions for the patient.
“The herbalist should not assume to know everything and decide alone. Patients may possess knowledge that the herbalist lacks. We need to collaborate and engage in discussions, and I, as the herbalist, must inquire whether the patient accepts or rejects the suggested treatment. It is the herbalist's responsibility to educate the patient ensuring they are informed about their choices." (IDI_Female_04)
“You have to explain to the patient; you then give them a chance to decide for themselves either to accept or refuse the treatment.” (IDI_Female_09)
The participants did not believe that signing consent forms was necessary. Moreover, some herbalists were unable to write, making it impractical for them to sign such forms. The participants viewed signing consent forms as irrelevant to herbal medicine and time consuming and asserted that the significance of the consent forms was associated with the use of conventional medicine for administrative purposes.
‘The patients trust us; therefore, there is no need for the patient to sign anywhere because by the time they approach you for medicine, they trust you……. Usually, there is no time to ask much or even sign consent forms.’’ (IDI_Female_09)
Informed consent was obtained from the herbalists
The herbalists who disclosed information reported that they needed to disclose the information to patients since they regarded themselves as having more information and knowledge regarding treatment than did the patients. At times, the information shared was based on the kind of questions asked by the patients. The information shared by almost all study participants included common herbal side effects, the cost of medicine and the dosage of the formulation provided, dietary restrictions and any known drug interactions with the herbs provided.
“You clarify the risks linked to the formulation, emphasizing that some individuals erroneously believe herbal medicine is devoid of side effects or the possibility of overdosing, despite the reality that it does have both side effects and the potential for overdoses.” (IDI_Female_02)
“I tell the patient the cost of the treatment before I prepare the medicine, such that we can agree. I also tell them about the dosage, and I encourage them to first eat food before taking the medicine.” (IDI_Female_12)
“I further teach them about diet, encourage them to eat vegetables and roughage, not to drink sugar in case they are diabetic. I generally give them health education, and it is that which consumes most of our time.” (IDI_ Male_16)
Some participants refrained from disclosing the patient's diagnosis if they anticipated family conflict or increased stress. Additionally, for some illnesses perceived not as an individual’s burden but rather as a communal or family matter, the latter often take precedence in receiving information about the patient's diagnosis and making treatment decisions about the patients themselves.
Another consideration that hindered study participants from disclosing their diagnosis to them was the fear of self-medication following media advertisements about different herbs.
“Now, if we talk about informed consent from a communal perspective, in our culture and setting, illness is not an individual person’s issue but rather a community or family concern. The patient’s family asks you not to disclose information to the patient; rather, all the information and decisions are made by them.” (KII_Male_4)
In addition, herbalists considered a patient’s capacity to comprehend information to determine whether to initiate discussions, which in turn determined their decision-making practices. For instance, guardians or parents may engage in discussions and decision making for the child's treatment. Similarly, for very ill patients, a designated proxy, often a family member, was furnished with the information and assumed the responsibility of making decisions regarding the patient's treatment choices.
Assessment of patients’ understanding of the information given
Participants highlighted various methods for assessing patient understanding of provided information. This evaluation involved utilizing questions, interpreting body language, and conducting follow-up phone calls to gauge adherence to prescribed treatments. However, some participants neglected to employ any verification methods to confirm patient comprehension, placing less importance on whether patients understood the shared information, as long as discussions centered around treatment dosages.
“I rephrase a question... I paraphrase it again and ask it again to be sure that the patient has understood what I have told them.” (KII__Male_2)
‘I do not know how. I just explain and leave the rest to God, for him to have mercy on the patient and help him/her understand and remember whatever you have told them. “(IDI_Female_03)
Documentation of informed consent
Participants emphasized a practice founded on trust, honesty, and voluntarism. The majority of the studies solely recorded patients' personal details, medical history, and prescribed medication. Informal communication typically determines treatment acceptance or refusal. Patients did not sign any informed consent documents but provided implied consent through verbal agreement to take the medicine. Additionally, some herbalists lacking writing skills could not provide documented informed consent. A key informant mentioned that, despite being considered necessary in medical ethics, informed consent documentation is not applied in herbal medicine since neither the patient nor the herbalist deems it necessary.
“I have never let a patient sign anywhere. However, we agree verbally; they then take the medication…….and imply they have accepted.” (IDI _Female_02)
“Some of us don’t know how to write, and we also do not see the importance of making the patient sign those consent forms. I don’t know whether any herbalists practice written informed consent.” (KII_ Male_4)
“We have a registry book and referral forms; however, we do not have consent forms on which patients signed. It is usually a verbal consent.” (IDI_Female_05)
Notably, a few of the participants reported documenting consent for patients or relatives, especially for patients with a terminal illness such as cancer, to avoid blame in case the patient died. Finally, there is a need for evidence in case queries from relatives on the treatment presented at some point.
‘’Some patients arrive critically ill with cancer. After administering medication, they are at risk of succumbing, and if that occurs, accusations may arise linking their deaths to the prescribed medicine. To address such situations, consent forms are signed, and I keep a copy along with the patient's relative during this process.’ (KII_ Male_1):
“I document whether the patient accepted or declined the treatment, though the patient themselves does not sign or write anything. This practice ensures that when their relatives visit, I can promptly provide assistance. It also serves as confirmation that I provided treatment at my center.” (IDI_Female-20)
Factors that facilitate the practice of IC among herbalists
For participants who practiced and perceived informed consent to be important, this was because they perceived it to be a way to enhance the good relationship between the patient and the herbalist, to attract more patients, to portray trust and honesty, which enhanced the good relationship between the patient and the herbalist.
“It is very good as it enables you to establish a good relationship with the patient such that they can easily open up to you, create awareness of whatever is going on, avoid stressing the patient unnecessarily, and know that they have come to the right person and place.” (IDI_Female_18)
Some participants felt that IC would help them avoid blame and false accusations from patients or blame by the public and relatives if a sick person experienced harm after receiving medicine. In this case, documenting consent was considered a protective measure against potential liability.
The correct procedure would have been to document and sign informed consent forms (ICFs), but we have not been following it. The patient might accuse you of providing medication that caused harm, even if they had visited another herbalist who gave them the medicine that led to harm. With proper documentation, you are protected from false accusations and blame. (IDI_Male_11)
“Disclosure and discussion of side effects with the patients is the only thing that can protect the herbalist from being sued in court because they can clearly confirm that they informed the patients of the side effects before they dispensed it to them. (KII_ Male_02)
Most participants reported that sharing information and proper explanations during the consent process would help patients adhere to the treatment, restore hope and hence improve treatment outcomes.
“It helps a lot because the patient gets to know that you are honest and trustworthy, you understand what you are doing... such that they are confident about the treatment you give them that they will be well.” (IDI_Female_17)
Practicing IC was perceived as a sign of transparency and professionalism among providers and ethically added value to their job and ensured the safety of their patients.
“If you don’t tell them, you will have done injustice to them. You need to tell the patient because some women come in while pregnant; this means that there are certain kinds of herbs you cannot give them, as they may lead to miscarriages. You have to tell the patient exactly what to take and not take to ensure their safety.” (IDI_Female_04)
Factors that hindered herbalists from providing informed consent.
Various structural challenges also hinder herbalists from implementing IC processes, such as limited time at the premises of the herbalist. A unique aspect of this finding was that most female patients visited herbalist practices without their husbands' permission, necessitating a quick return home. In view of such short visits, the women received information only about the use and dosage of medicines.
“Occasionally, patients arrive in a rush, leaving little time for extensive information about the treatment. In such cases, they are mainly interested in knowing the dosage and how to take it. A significant portion of these hurried patients are often married women who leave their homes without their husbands' approval, necessitating a prompt return home. (IDI_Female_02)
Most participants said they lacked the knowledge, skills, and self-efficacy to practice IC and that they had not had any form of training or had heard of the IC concept or its value and obligations.
“...therefore, the question of providing adequate information has to be informed by systematic training that would lead to someone somewhere formulating an herbal product that would come with information regarding effectiveness, safety, and contraindications, which will now guide this person going to use it to inform the other user” (KII_Female_03).
Some participants did not see the meaning or importance of signing IC forms or patients having choices as to whether they accepted or refused the herbalist’s treatment. The perception that IC should be used only for very risky health procedures, such as surgery-hindered IC practices by herbalists since they do not perform major surgeries:
“Written consent is obtained in most cases when major surgeries are going to be conducted like operations...for us in herbal medicine, we do not sign these forms because we do not perform major surgeries.” (KII_ Male_04)
Few participants disclosed much information to the patients because they feared losing the market for their medicines. Patients may notice that the drugs are readily available and accessible in the environment.
“If we disclose all that information to the patient, we will not attract a market for our medicines. Once we have shared all the details they need to know about their treatment, there's little incentive for them to return to us when they can access the information on their own.” (IDI_Female_17)
Some participants said that patients are generally not educated and have poor literacy; moreover, they do not know their rights or, thus, what to ask or expect from the herbalist.
“The majority of herbal medicine consumers lack education on what they should request or expect. However, if they were mentored, they would be more inclined to ask. Unfortunately, it would be problematic if the patient were to inquire when the herbalist lacks the knowledge to provide an answer.” (KII_Female_03)
Support needs that herbalists reported that could enable them to effectively practice informed consent
The participants also suggested the following ways to help motivate them to implement IC in their practice: receiving training in aspects of IC and strengthening collaboration with conventional medical practitioners.
“In case the herbalists are trained on what to do, they can implement the IC practice very well because it is very good practice. (IDI-Male-19)
Participants also requested that the government strengthen intellectual property protection for herbalists’ property rights and innovations. They need to assure that their knowledge will not be stolen or misused, especially after information disclosure about the herbs to the patients.
“There is also another law that handles intellectual property. Once somebody gets to know the benefit, then they share more, knowing that their knowledge can be protected... Therefore, it is all about giving confidence regarding intellectual property to the herbalists.” (KII_ Female_3)
Although adopting IC was suggested by some participants, there were concerns, on the other hand, that there is a need for it to be contextualized into our African cultural context.
“Now, in light of informed consent, I think there is need to be much more contextualized into our African setting. We should not import the Western concept to the traditional African way of living”. (KII_ Male_4)
The introduction of the law in Uganda that prompts herbalists to obtain IC from their patients and build their capacity to do so would promote this practice. Participants reported that if the law obligates the practice of IC, they would abide by it if they were skilled enough and would know what to do.
“The government should enact laws that guide the practice of traditional medicine and aims to uplift and enhance the capacity of herbalists. The existence of these laws is crucial, as some individuals enter the field by emulating others without proper training. The government's support in regulating and building the capacity of herbalists will help maintain standards in the practice.” (KII_ Female_03)