Sticky question

[Kingbandit]

Our institution is having a major issue with the excepted practice to only enroll a patient into a single research project at a time.

Does your institution have a policy? Do you practice this as a norm?

I have scoured the Belmont, CFR, ICH and our policy and procedures. I can not find mention of a 30 day moratorium on enrolling/re-enrolling into a new study.

Please help my doctors are fighting over keeping their patients for their studies if this is the rule.

[anc33]

30 days is usually standard practice but participation in other studies should be addressed in your protocols. If you are doing drug studies you definitely need to make sure that there is a washout period which could be much longer than 30 days depending on the half-life of the drug. It is hard to judge the situation without more details, especially without knowing what type of studies your facility does. Personally, as a coordinator, I would be wary of enrolling a patient on another study so soon.

[lauraburke]

You have got to be kidding me! We do not have such a broad sweeping policy since our organization has many researchers doing studies involving the same patients. We may have a patient who is on a drug trial who is also involved in a social science study or a nursing research study. The inclusion/exclusion criteria should be specific enough to clarify sound scientific rationale for exclusion, not an outdated policy that reflects "because that's the way we've always done it!" Let's start thinking and putting these careful thoughts into writing! It's VERY appropriate to let patients be involved in more than one study at a time, depending on what is being studied. I've had patients who, at the same time, had an investigational cardiac device implanted, were taking an investigational antidysrhythmic drug, participated in a qualitative nursing research study where they explained how they coped with living with chronic heart failure, and were in the experimental group of an NIH funded study to evaluate using Customized Computer Home Care - a website to learn to better manage their chronic cardiac disease by tracking their symptoms, meds, diet, and activity and communicating with their nurses, therapists, physicians, and other patients to cope with their illness. I've very glad that our organization is forward-thinking enough to see that research can take many forms.

[anc33]

I don't think that enrolling a patient into a QOL study (for example) and a drug study simultaneously is an issue unless is it expressly forbidden in one of the protocols. Even if participation was OK per protocol, the questions asked or interventions from one study could affect the other and the validity of the data could be in question. Also, if you were doing two studies that required blood draws, you could inadvertently go over the maximum allowable amount (for us this is defined by our IRB). As I said, we would need more information from the OP as to what kinds of studies they do to see if it is an issue.

[featherzRN, MSN]

So far, we do only drug studies and inclusion/exclusion always states in our studies that they have to wait at least 30 days after exiting a drug or device study. I am guessing a study that involves something non drug/device related would be fine.