The pre-conference program of this year’s AER conference held in Boston in November 2015 included IRB 101. This workshop discussed the functions of Institutional Review Boards (IRBs), otherwise known as Research Ethics Committees (REC). The workshop also included a presentation regarding the history of IRBs, as well as the new challenges facing IRBs during the review process of protocols.
The presentation tracing the history and the development of research ethics started with a nice quote from George Santayanna “Those who cannot remember the past are condemned to repeat it”. It is always helpful to remind people of the importance of research ethics. The atrocious Nazi experiments, the Milgram obedience study, the Willowbrook study, the Tearoom Trade study, the Tuskegee study and many other studies are all examples of research ethics violations that motivated research ethics guidelines that evolved thought history: Nuremberg’s code, Belmont report, Helsinki Declaration, CIOMS and last but not least: the U.S. regulations (45 CFR 46), otherwise known as the Common Rule. These regulations include additional protections for vulnerable populations and also define different research categories that can qualify for exempt or expedited review.
The presentation also emphasized the main principles of research ethics: respect for persons, beneficence and justice and the role of IRBs in the application of these principles. Thus IRBs are responsible for insuring: proper assessment of benefits/risks, minimization of risks to subjects, existence of a process for informed consent, equitable selection of subjects, adequate provision for data monitoring and adequate provisions for maintenance of confidentiality.
The informed consent process was also one the topics discussed in this pre-conference. This presentation discussed the essentials informational elements of informed consent and also discussed that a valid informed consent must include: full disclosure of these informational elements, adequate comprehension by the potential research participant, the ability to make a decision, and the participant’s voluntary choice (that is, no coercion or undue inducement).
One of the most interesting segments of this workshop was an example of the ethical review of a protocol that was based on the Harry Potter books. The study to be reviewed involved a double blind placebo controlled trial for Snapeacillium. The drug was developed to treat MuGL gene mutation. The sponsor is Gryffindor and the principle investigator is Dr Rowling. The 60 participants included in the study must have prior magical abilities documented by the Ministry of Magic and screen positive for the MuGL gene mutation performed at the Hogsmeade clinical laboratory. The review process of this protocol included, the identifications of the risks, the assessment of risks/benefits, appropriate study monitoring and confidentiality/ privacy provisions.
What’s new in human subject research protection? That is what the last presentation discussed. We have witnessed an increase of research conducted on the internet, the use of mobile device research and an increase in social media research. These types of studies raise issues about data security and the assurance of privacy and confidentiality. The data security issue requires: an institutional policy for securing data, the IRB’s use of consultants with expertise in security and the protocols need to include details about the collection, the transfer, and storage of data that protects confidentiality.