Research that involves human subjects is more complicated, from an ethical standpoint, than other types of biomedical and life sciences research. Because it is so important to protect the rights of human subjects, researchers consult with an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) to ensure that proper steps are taken to preserve patient welfare.
During clinical trials, the principal investigator (PI) is primarily responsible for ensuring compliance with IRB/IEC procedures or requirements. But those involved with any aspect of quality control at any stage also have an interest in understanding IRB procedures. All parties from buyers to suppliers should take steps to protect patient rights in clinical trials.
If your grasp of IRB meaning and why institutional review is so crucial to participant safety is a little rusty, the following offers a quick refresher.
A Brief History of IRB’s in the U.S.
To fully understand the role of IRB’s in clinical trials, we need to take a look back at the history of IRB clinical trials. These formal review procedures were originally developed in response to research abuses of the 20th century. Among the most infamous abuses of human subjects in the name of clinical research are the experiments of Nazi physicians during World War II, the Tuskegee Syphilis Study conducted between 1932 and 1972, and numerous human radiation experiments taking place during the Cold War.
The public outcry regarding such abuses resulted in the National Research Act of 1974 and the Belmont Report, which outline ethical principles to protect the rights of human subjects. According to these guidelines, an IRB can only approve research for which the risks to subjects are balanced against the potential benefits to society. These pieces of legislation also created the framework for obtaining informed consent from research participants.
What is an Institutional Review Board (aka IRB)?
An Institutional Review Board (IRB) refers to any appropriately constituted group designated to review and monitor biomedical research involving human subjects. An IRB is an administrative body established to protect patient rights during all stages of research. When human subjects are recruited for clinical trials or to participate in other research activities, the IRB is charged with the responsibility of reviewing all research plans prior to the initiation of work.
The purpose of IRB’s is to protect patient rights in clinical trials and its main concern is with protecting the welfare and privacy of all human subjects. As such and in accordance with FDA regulations, IRB’s have the authority to approve, disapprove, monitor, and require modifications to all research that falls within its jurisdiction as determined by federal regulations and institutional policy. The most effective IRB’s are composed of members (usually five) with varying backgrounds handpicked to provide adequate review of the institutional, legal, scientific, and social implications of proposed research.
Institutions such as hospitals and universities, that regularly engage in research involving human beings often establish their own IRB’s. However, there is no specific federal regulation requiring institutions to form their own and there are many established independent IRB’s that can serve as “outside” reviewers.
What does this all mean for me?
As members of the scientific community, we all have the responsibility to look out for those being recruited for clinical trials. This is a crucial feature of a successful clinical trial. All those involved with IRB clinical trials can take steps to ensure that human subjects understand their risks prior to agreeing to participate in the study and to protect personal data collected from subjects.
5 Steps to help patients understand their risks:
- If you suspect human research subjects are not being adequately informed of the risks and benefits of research participation and the procedures involved, speak to those overseeing the clinical trial about your concerns.
- Look for evidence that informed consent is obtained from all human subjects in advance of initiation of research and is being appropriately documented. This may include ensuring appropriate translations of all original clinical trial documents not in participants’ native languages.
- Push for adequate monitoring of the data being collected to ensure the safety of human research subjects.
- Take appropriate steps to protect the privacy and maintain the confidentiality of patient data.
- If the clinical trial involves subjects who are especially vulnerable to coercion or undue influence (e.g., children, prisoners, pregnant women, cognitively impaired persons, or members of economically or educationally disadvantaged groups), ensure that appropriate additional safeguards have been applied.
Helping participants understand their risks includes, but is not limited to, ensuring that all information is provided at an appropriate educational level and in the native language of all participants. To protect rights of human subjects to the fullest extent, there’s no substitute for strong, timely, effective, and accurate communication.
7 Ways to safeguard participant data:
In addition to ensuring that research subjects understand their rights and risks before agreeing to participate in a clinical trial, evaluators must also have a plan for protecting the information they gather.
Below are examples of policies often used to protect patients’ personal data:
- Assign study participant identification numbers for all instruments, questionnaires, surveys, etc. Keep a list with identifying information (e.g., names, ages, addresses, social security numbers, etc.) in a separate location with restricted access. Only those with appropriate training should have access to personal data.
- Encrypt all electronic transmissions over the internet (including by email), file transfers, or other data transfer modalities.
- Remove all cover sheets containing identifiers (e.g., names, ages, and addresses) from survey instruments containing data after receiving them from study participants.
- When the study concludes and you are no longer required to keep the data, properly dispose of, destroy, or delete study data and all documents. (Keep in mind, simply deleting data from a computer is not sufficient. Additional steps must be taken to permanently remove it from the hard drive).
- Securely store sensitive documents within locked locations and/or assign security codes to digital records.
- If the data will be stored on a multi-user server, the specific server name and IP address should be included with the protocol. Also, include who has access to the server and detail the security of the server.
- No data containing sensitive patient information may be stored in external organization storage, such as Google Docs, unless the organization has appropriate legal documentation approved in advance to do so.
What happens if despite your best efforts to protect the data, a breach occurs? Any loss of or breach of security relating to research data must be reported to the IRB as an Unanticipated Problem Involving Risks to Subjects or Others and also to the study Sponsor (if applicable).
Protection of study data must be prioritized at all stages of research using the methods described above. Be aware that the above list only contains examples of ways to guard against threats to both privacy and confidentiality. Every study is different and may require different protocols to protect the rights of human subjects.
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