Institutional Review Boards

The role of the governments is to represent and protect the people. This applies when scientific research is being conducted as well. In that regard the most important role of government is to make sure that people’s lives are safe and human dignity respected. To protect human life and dignity the government requires that purposefully created bodies called Institutional Review Boards (IRB) approve the scientific research and written informed consent is obtained from people that will be subject of the study.

Informed consent is required to make sure that those patients that will be subjects of the study know all the benefits and risks as well as the costs that they may incur when participating in the study. In the field of medicine this will allow patient to be aware of the nature of the treatments, available alternative treatments, and risks and benefits related to such treatments. The client or patient must fully understand the treatment before the informed consent to have validity. Within the topic of ethics privacy and conflicts of interest are the most debated area in medical research. (1)

Without such approvals the research using human subjects cannot be conducted even though expected results may constitute breakthroughs in medicine that can save many lives. This is the case in USA and other developed countries. In general people in other countries agree with, support and even demand that their governments carry out the majority of these roles. In other cases especially in developing world where people are not fully aware and knowledgeable about their rights or where there are no institutions to protect human rights, conflicts of interests may prevail leading to research projects without the informed consent and IRB approvals.

These concepts have evolved with time and IRB and informed consents have not been know or honored before even in USA. Henrietta Lacks (1920-1951) is a patient of John Hopkins hospital who lived at a time when informed consent was simply a concept in its path to development and a time where IRBs were not present in governing and approving research protocols. In absence of informed consent and IRBs, there was a breach of confidentiality when Dr. Gey gave samples of Henrietta Lacks’ cells to any doctor or researcher who asked for. When Dr. Gey, Mrs. Lacks’ doctor discovered that her cancer cells didn’t die, he knew that her cells, the HeLa cell line would be instrumental to scientific breakthroughs and discoveries. He was right because for 60 years her cells provided the opportunity for scientists and researchers to make these discoveries.

Mrs. Lacks, however, was never told that her cells were being researched on or why her cells were taken at all. It is clear that this was a different era in medicine where permission to take a patient’s tissue sample for biomedical research purposes, and an informed consent, were non-existent. Henrietta Lacks serves as an example of a time before the protection of human subjects within studies. During this time period, though, many other patients never knew that their tissues were being used after they were cared for by doctors. (2)
Things are different nowadays, as patients are asked to sign an informed consent agreeing that the hospital owns the samples. It is important to keep in mind that Informed consent and IRB communities along with their guidelines are still evolving and improving. (3) Institutional review board committees or IRBs must find a balance between the protection of human ethical rights and encouraging innovative research that will benefit people in the future. (4) Without institutions like IRB committees and informed consent people would become fearful that they too can be used as a mere tool in biomedical research along with other studies. Mrs. Lacks’ story shows how important informed consent and IRBs are.

Unfortunately, people are still becoming victims of similar ethical violations. These individuals consist of the underprivileged and the medically illiterate.  Poor communication between the patient and doctor as well as low confidence levels of medical establishments are two key elements that lead to deficiency of an informed consent. Many underprivileged are suspicious of traditional medicine.

There is much controversy over IRBs because some believe that it restricts research and slows down progress of new medical discoveries or other possible forms of advances. Others believe that IRBs are necessary in protecting individuals from different forms of harm from the services they provide in helping researchers. When having access to an original consent, researchers argue whether a second or third consent is needed. There are individuals who strongly believe that donors should give a valid informed consent while others do not think that it is necessary if the samples are kept anonymous.

However, it is extremely important that people realize that IRBs are beneficial to both researchers and the participants in studies.  If it wasn’t for the existence of IRBs, the majority of the research that needs to be conducted with human subjects for medical discoveries would not happen because the government would not jeopardize the lives of humans to conduct a research that might not have any beneficial medical discoveries or the ‘possibility of a cure’. If IRBs were not in existence there would be some other form of restriction among studies. There has always been and will always be some challenge that researchers will have to overcome in order to complete their research. The IRBs were created so that scientists could conduct studies in order to make new medical discoveries while keeping people’s mental and physical health a main priority.   If researchers make it possible for their human subjects in developing countries or in US, to understand the reason for the study with its details along with the benefits of conducting the study then the subjects might be more helpful and willing during the procedure of donating.

The complications of such research include the need for awareness of local risks in the area, the presence of locals who understand the ethics and protocols of the research being conducted, and above all having the support of official researchers who are willing to abide by IRBs decisions and guidelines.


Satisfying both IRB (which includes ethical guidelines on human research) and the local, cultural, and socioeconomic factors of the developing country is very important because it can not only lead to an easier time conducting the research and having more people become donors but it could also lead to future opportunities to work with that developing country. If the US IRB shows respect for the developing country’s culture and traditions, making the human subjects the number one priority, then the research can gain a larger number of subjects and greater access to the resources they might need during the treatment.

1. http://fyb.umd.edu/2011/informed.html
2. http://www.hopkinsmedicine.org/news/publications/hopkins_medicine_magazine/hopkins_medicine_magazine_spring_summer_2011/web_extra_honoring_the_henrietta_lacks_legacy_at_hopkins
3. http://blog.acpinternist.org/2011/05/hela-hipaa-and-ethics-of-informed.html

http://www.hhs.gov/ohrp/assurances/irb/
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