Informed Consent in International Research: The Rationale for Different Approaches

Informed consent is one of the main pillars of human subject protection in research. But the process is not an easy task, particularly in the context of international research.  So far the informed consent process in the developing countries has been approached from a developed country perspective. In their article, Informed Consent in International Research: The Rationale for Different Approaches, Krogstad and his colleagues compared the process of informed consent between developed and developing countries.

For example, in the developed countries, autonomy of an individual is the foundation for decision making during the informed consent process. Autonomy is deeply rooted in the western culture and dates back to Greek philosophers as Plato and Socrates.  On the other hand, communal decision making prevails in many communities of the developing world. The research is typically introduced to the chief and village council before the matter is discussed at a family level by heads of households and elderly. Research subjects could be the last in the list to give their agreement to participating in research.

Another challenge in the informed consent is the high illiteracy rate in the developing countries. In developed countries, informed consent forms are long and contain complex language primarily designed to protect the institution, sponsors and researchers from any liabilities.  But, when  translated to local languages  there is a fear that much of the vital information necessary to understand the research is lost.   Another issue involves written documentation of consent, as informed consent is only valid when signed/ thumb printed by research participants. However, the requirement of a signature generates distrust in the developing world, as the use of a signature is usually associated with closure of business transactions that in the past, have resulted in bad outcomes for many vulnerable subjects in the developing world.

Finally,  introducing new concepts such as randomization and the right to refusal is challenging in developing countries. The research subjects are mostly unaware of the rationale behind randomization and having to explain such term requires basic knowledge of statistics.

Besides the issues of the informed consent process itself, there are concerns with the IRBs in developing countries. IRBs lack experience, resources and expertise particularly in up to the minute topics such as bioinformatics and genomics. Furthermore, the industry sponsored research usually provides financial incentives and the promise of career advancement for investigators in both developed and developing countries. However, these incentives are more attractive to low paid researchers in the developing countries.  These incentives may pose as conflict of interest that local IRB s are ill-prepared to handle..

At the end of article, the authors set forth 7 recommendations to resolve some of the aforementioned challenges. They are:

“(1) IRBs should be responsible only for the rights of participants and the integrity of the consent process (not for institutional liability).

(2) IRBs should consider the customs and cultural nuances of the host country when making recommendations to investigators.

(3) Medical expenses for injuries incurred during health research should be covered by liability insurance (when available) to protect study participants from potential financial hardship.

(4) Community leaders should participate in the consent process when appropriate to ensure that participants understand the research proposed and its potential risks and benefits when they provide their consent.

(5) Strategies consistent with the cultural practices and traditions of the communities in which studies are performed should be developed to present those studies to illiterate participants without using written documents (e.g., presentation of a study in the local language on videotape with demonstrations of the procedures involved in the study).

(6) Informed consent should likewise be obtained without the use of written documents (e.g., by videotaping the consent transaction between the participant and a representative of the study [oral consent that is videotaped]).

(7) The understanding of potential participants should be assessed orally before they are permitted to enroll or participate in clinical studies”

The proposed recommendations are food for thought. They are all relevant to the Arab region. But in my opinion,  they are not enough to resolve all concerns regarding informed consent that currently occurs in our countries. For example, there are concerns that there are deficiencies with the implementation of the informed consent process, as many investigators take the issue lightly, especially in the absence of adequate monitoring.  Furthermore, since obtaining informed consent is not widespread in clinical medicine, investigators might neglect to obtain informed consent in the research setting.   I think more efforts are needed to optimize the informed consent process when studies are performed in the Arab region.