There are pros and cons to everything and that includes oversight and regulations. There are state, federal, and company regulations this also includes regulations for clinical research. First, we will look at the pros of the oversight or regulations of clinical research. The pros to having oversight are to ensure mistakes get fixed and lessons are learned. For example, let’s say I documented the refrigerator thermostat incorrectly. The ranges for the refrigerator are 2°C-8°C and I document that the refrigerator ranges are current: 6°C, low: 3°C, and high 7°C. Yes, that 3°C is in the range, however, the actual low range was -3°C which is in the red zone for the appropriate low range.

            Now, let’s get into the pros of the oversight in this scenario. Without having someone perform oversight the accidental documentation would not be fixed accordingly. Because of the oversight and people (or person) checking behind me, the issues can be fixed, and corrective action can be performed. The corrective could also include replacing the thermostat and/or the refrigerator. If the issue is not corrected, then the research could end up with faulty results and inaccurate results as well. I would also like to point out that not all inaccurate results are created on purpose to make research look good or to get a human subject into a clinical trial. Human mistakes do happen especially when things get chaotic even just for a moment, things can get missed and that is why I think of oversight as a pro for not just everyday jobs but also for clinical research.

            We are now going to look at a few published examples of the pros of having oversight in clinical research. “The role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects.” (Office of the Secretary. 1979, April 18. The Belmont Report. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html ). When it comes to oversight with informed consent, a lot of people suggested that the requirements adopted by HHS were a lot better and clearer in understanding, so the FDA agreed to adopt those informed consent requirements as well. This is great because it helps with understanding the different informed consent when it comes to FDA-regulated products and HHS-funded research. Now, let’s focus on the ethical issues with the Henrietta Lacks case and why there should have been oversight. Henrietta Lacks was diagnosed with very aggressive cervical cancer. The hospital that operated on Henrietta Lacks and collected her cervical cancer cells without her consent was Johns Hopkins Hospital in Baltimore, Maryland. She originally went there for medical help on her abnormal heavy vaginal bleeding and there ended up being a cancerous tumor. The doctor that collected the cells was Dr. George Otto Gey, cancer and virus researcher. Dr. Gey named her cells HeLa cells, and this was inspired by the first two letters of her first name and the first two letters of her last name. Yes, her cells were named after her, however, she received no credit or recognition, or even compensation for her cells. This is important because, in my opinion, it’s important to understand where the beginning of something so scientifically changing started and how it got to where it is today. Her family also lived in poverty and the compensation would have been great for them. Lacks did receive treatment for her condition, but she still ended up passing away at the age of 31 on October 4, 1951. Unfortunately, Johns Hopkins Hospital held a press conference to announce their findings on the HeLa cells. Not only did they unethically collect Lacks’ cells, but they held the press release on the day she passed away. Her cells were massed produced in many labs around the world.

            Now, let’s look at the cons when it comes to an oversight in clinical research. Clinical research can be a bit tricky and absolutely overwhelming so yes, having someone check behind you at the end of the day can be great and keep the research in check, however, it can also have possible risks. “In some studies, you may receive a placebo.” (National Heart, Lung, and Blood Institute. 2022, March 22. Benefits, Risks, and Safety Measures. Retrieved from https://www.nhlbi.nih.gov/research/clinical-trials/safety-benefits-risks ). With this quote, it’s important to note that there are placebos in clinical trials and with that, there can be mistakes with oversight because if the person who is overlooking the clinical trial doesn’t know that the human subject is receiving a placebo then there can be risks. Human mistakes are common, even when it comes to someone in compliance and regulations. Also, regulations can make clinical researchers have less access to certain actions or even use specific materials. Let’s say, for example, there is a regulation in a research study on you can only use a dark lavender EDTA tube with a grey port and not a full purple top with a purple port. Well, the researcher runs out of the dark purple EDTA tube with the grey port, so they use the light purple EDTA tube with the purple port. Yes, results are different depending on the port top but because they ran out of the grey port, they had no other choice but to use the purple port top. The regulations are created for the reason of accurate results, however, on a day that material is running low or out of it can create limits and run out of research time depending on the due date of the research. However, to help the results be understood with a different mindset and open mind, it is very critical to document everything during those moments when you must use an alternative route for the clinical trial/research.

Resources

·      Office of the Secretary. 1979, April 18. The Belmont Report. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

·      Food and Drug Administration. 1981, January 27. Protection of Human Subjects; Informed Consent. Retrieved from https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/protection-human-subjects-informed-consent

·      Franklin County Public Health. 2022, February 16. Henrietta Lacks: The Mother of Modern Medicine. Retrieved from https://myfcph.org/henrietta-lacks-the-mother-of-modern-medicine/

·      National Heart, Lung, and Blood Institute. 2022, March 22. Benefits, Risks, and Safety Measures. Retrieved from https://www.nhlbi.nih.gov/research/clinical-trials/safety-benefits-risks

·      McMahon, Alex, Conway, David, and Gordon, McInnes. 2009, November 06. The Unintended Consequences of Clinical Trials Regulations. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2768793/