Anyone in any of the health professions will necessarily be aware of, and often intensely involved with, the results of scientific studies. Systemic investigations in the hard sciences include research development, testing, and evaluation that hopefully will contribute to the general pool of knowledge for the benefit of everyone.

How often do we think about what is really behind the numerous studies that must be completed in order for a drug or other treatment to eventually become acceptable to and accessible by the general public? Observing a caged rodent is a whole different proposition from keeping tabs on a human being. What behavior of the human subject will be observed? Will they be following their natural, normal course and recording it? Or dealing with something different being done to the natural course, like taking a different medication?

Any objections?

To track the trajectory of a planet is one thing. To convince a person to, for instance, meticulously record every particle of matter that goes into them and comes out of them is a whole different situation. Even with the most cooperative subject, in the most meticulously conducted experiment, there will be times when the person just wants out.

On other occasions, it might be that the professionals doing the research will decide to end a subject’s participation. In either case, there are plenty of guidelines and multiple strict rules, declared by different agencies, concerning any possible circumstance.

For the benefit of scientists connected with the Marshfield Clinic, MarshfieldResearch.org turned its attention to research itself in a document by Lori A. Scheller titled “Withdrawal of Subjects from Research.” In some instances, the participation of a human subject consists of interaction and/or intervention with the research team.

Or, it might be that their identifiable personal information is used, whether that information consists of data only, or specimens obtained from them. A whole set of rules defines what is considered individually identifying information. This is one of the circumstances that can lead to the involvement of lawyers.

A person might discontinue participation in a research study through voluntary withdrawal, and the federal government requires that human subjects retain the right to withdraw their informed consent at any time. In other cases, the Principal Investigator (PI) might end someone’s participation, for the good of the project. Of course, in any case where the PI withdraws a subject, it is strongly urged that the reasons be explained to that individual.

To prevent trouble, regulations demand that any prospective research participant (or parent of a participating minor) must be fully informed of their rights before they sign anything. The information about withdrawal, voluntary or otherwise, includes…

[…] statements that participation in the research is voluntary, that participation may be discontinued at any time without penalty or loss of benefits to which the subject is otherwise entitled, a description of any circumstances whereby an investigator may terminate a subject’s participation, consequences of withdrawal, and procedures for orderly withdrawal.

Then, there will be another whole set of rules about what happens to the data already generated by their previous involvement. For instance,

According to the guidance, a biological specimen collected but not analyzed prior to a subject’s withdrawal may not be analyzed following a subject’s complete withdrawal from a study…

The guidance states that an institution may choose to honor a subject’s request that his or her data be destroyed or excluded from further analysis at withdrawal, but only with agreement from the funding agency, and only if the research is not FDA-regulated.

Where the Food and Drug Administration is involved, however, there is a requirement for “all data collected on withdrawing subjects to remain as part of the study database or records after withdrawal.” This “ensures clinical study validity and prevents unreasonable risks to enrolled subjects, future subjects, and eventual users of marketed products”:

The FDA describes its concern that subjects who withdraw from research are more likely to have experienced adverse events or a failure of efficacy, and allowing exclusion of their data would increase the probability of introducing bias, and would negatively impact the scientific validity of the research.

What happens when a PI has to cope with a lot of the subjects quitting, or with the necessity to “withdraw” them through executive action? In that case, it might be time to fall back and regroup:

He or she should re-evaluate the protocol and determine whether changes are necessary to facilitate subject retention without weakening the scientific integrity of the research.

Your responses and feedback are welcome!

Source: “Withdrawal of Subjects from Research,” MarshieldResearch.org, 09/11/15
Image by Steve Jurvetson/Attribution 2.0 Generic

The post Of Mice and Men and Women first appeared on Childhood Obesity News.



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