Letters to the editor

July 1, 2002

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-07-01-2002,

Readers respond to articles and editorials.

Decision to consent

The best way to think about participation in clinical trials would be: informed decision and consent to participate.

This assures that the patients or subjects have been educated about this aspect of their care, and after this information was presented, they decided to participate in the clinical trial. A little wordy perhaps, but it embodies the philosophy of how patients should make their decisions about participation in a clinical trial.

Pamela J. Elliott, CRCResearch Department
Cancer Center of Santa Barbara
Santa Barbara, CA

Legal consent
I was under the impression that informed consent is a term with legal meanings and implications. Informed consent already implies that the subject was as fully informed as possible and agreed to participate. It is more important to focus on improving actual practices, not changing the terms used.

Jennifer L. Jones, RN, MS, CCRC

Research nurses, drugs
During a recent GCP course given in Virgina by the Association of Clinical Research Professionals (ACRP), one speaker stated, Nurses cannot dispense or administer study drugs. This was something neither I nor the other nurses in the room knew or understood. After all, drug administration occurs in hospitals, nursing homes, private duty, and doctors offices every day.

After a heated debate over the questions of administering drugs in hospitals, nursing homes, and private home care, the speaker said, You must check with your own state licensing board, as the law may be different with research in different states. For example, Florida has a provision that states, Nurses (RN, LPN) may administer study drugs.

After spending five days searching, I found someone in the know at the New York State Department of Professional Licensing Services. He told me it was true! Nurses (LPN, RN) cannot dispense or administer medication in clinical trials.

How can such an important issue be so unknown and so un-enforced? When I asked the people at the state professional licensing department if they could provide me with a copy of this little-known law stating I could not perform this task, they told me that it is under pharmacy law, not nursing law.

When I asked about the Delegation of Responsibility Signature page, found in every regulatory binder on which the physician investigator (PI) signs off, I was informed that MDs cannot delegate tasks that fall under the provision of their licenses, and that pharmacists, MDs, and nurse practitioners are the only ones licensed to dispense and administer. The official also said, Pharmacists should be the only ones dispensing study drugs and physicians should be the only ones giving them to subjects.

This is absurd. I have been a nurse for 30 years. For 30 years, I have dispensed and administered drugs under a physician license. Now, because Im in research, it changed? In a research setting, PIs do not have time to do it all. If they did, nurse coordinators would not exist. Additionally, consider the non-hospital and non-university private clinical sites that lack private pharmacists to dispense the unit dose research drugs received from the sponsor. Should a PI have to randomize, dispense, and administer every drug, for every subject, at every visit?

Worse yet, when I telephoned my nursing liability insurance carrier to ask if my LPN license covered me to administer medication, I was told, Youre covered. We cover you for everything that is allowed under your license description as stated by your individual state law.

I have been working as a research nurse coordinator for seven years and have never been covered for liability or malpractice. Nobody seems to know about this law! I have checked with IRBs and pharmaceutical sponsors, but everyone appears to be in the dark.In the end, I wonder, why should any of them care? They wont lose their licenses in a lawsuit.

Under this law, coordinators without a medical background are unllikely to be hurt professionally. However, if you are a nurse, trained to be a study coordinator, you stand to lose your livelihood!

At this stage of my informal personal investigation, I contacted the ACRP and asked their help in researching this matter. I hoped the organization would assist in getting to the bottom of this question. But, it seems no one really knows the answer. I feel compelled to delve further into this issue, to spread the word to fellow nurses to inquire with their local governments and find out if they bear any liability.

This law should be reviewed by professionals who understand the nature of research. If this is a gray area, lacking rules and guidance, then both must be clearly written to recognize the future of research growth. I look forward to any suggestions from the clinical trials community.

A Concerned CCRCNew York

Is email safe?
Having returned from the recent Computer Validation Workshop (Vienna, Austria, 2224 April, 2002) organized by the Drug Information Association, I could not refrain from writing you to make a pair of remarks regarding the question of whether email can be considered a safe means of information transfer in clinical trials.

One of the presentations contained the assertion that email cannot be considered a secure electronic document. Though this statement was made in the context of a lecture regarding good automated manufacturing practice (GAMP) forum in the Internet, it still provoked an uneasy feeling: email is widely used (and generally considered to be secure enough) for clinical-trial-related communication, which is quasi-confidential by definition.

According to FDA, the Internet is an open system, an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system (21 Code of Federal Regulations 11, Definitions). This, however, does not preclude the use of email for transfer of important information provided that certain requirements are met. Persons who use open system[s]shall employ proceduresSuch procedures and controls shall include [those] identified in 11.10, as appropriate, and additional measures such as document encryption and use of appropriate digital signature standards to ensure records authenticity, integrity, and confidentiality (21 Code of Federal Regulations 11, Sec. 11.30).

Logical security of email means that users have their own logins and passwords (at least within the mail system they use). Mail traffic should be directed through an encrypted channel, known as secure socket layer (SSL), which is regarded as protected for data transfer in electronic data capture, electronic subject diaries, and remote data entry systems andif we take an example without any relation to clinical trialsin credit cards data transfer within Internet-connected bank systems.

Physical security of email is in fact the same as that of the mail server and communication channels used for data transfer; and while communication security is usually ensured by the Internet service provider, the server (where the mail messages are stored upon their receipt or until dispatch) is, so to speak, under the jurisdiction of the interested party (email client). You can hardly find a company that would say its servers and communications are open and accessible to everybody. In fact, all the information is circulating within the companys intranet, whose physical and logical security are strictly regulated by SOPs of the information technologies department.

Creating an electronic signature [using Pretty Good Privacy (PGP) or SSL] does not pose any problems either.

Thus, in terms of security, a correctly configured and documented email system seems to be quite an acceptable means of information transfer in clinical trials. Are there any other opinions?

Roman BorovikovManager, Information Technologies Dept.
InnoPharm Ltd.
Smolensk, Russia

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