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Assume nothing - stay alert     Speak up - be a player       Know - then decide - be critical

If you recently have either been approached by or sought out an investigator to pursue participation in research, this site is for you. It can also be of value to investigators who wish to best serve the interests of prospective subjects (prospects) and optimize consenting by and retention of research subjects. The better prospective subjects are in evaluating offerings, the better for all involved; so, above all, remember to assume nothing, speak up, and know - then decide.

Proper attention to subject protections and investigator responsibilities can be expected to result in an optimal outcome for all involved. Many prospects may retreat from opportunities to participate in research for lack of insight into related issues and understanding how best to proceed. On the other hand, others may be too willing to participate for the wrong reasons. A confident and informed prospect may be more likely to consent when appropriate and not consent when inappropriate. Investigators ultimately benefit from greater human subject awareness if it leads to fewer withdrawals after research has begun due to second thoughts. Doing what’s right for the subject is good for all.

The outcome of research has been and will continue to help mankind. However, the consequences of its conduct are not always innocuous. Risks can range from inconvenience to death. Any endeavor that includes death as a possible outcome deserves to be approached with care. Voluntary participation in research deserves an active and vigilant state of mind. Ultimately, both prospective and consenting research subjects need to focus on their best interests. Here’s why.

Current regulatory standards aimed at protecting subjects don’t always apply (e.g., privately funded research that is not subject to existing federal or other requirements). Where these standards do apply, they are not necessarily (1) adequate (e.g., compensation), (2) sufficiently comprehensive (e.g., conflicts of interest), or (3) entirely satisfactory (e.g., confidentiality).

Of course, a lot of research is relatively innocuous. Some, so much so, that little or no mandatory protections (such as independent ethical review and informed consent) are required, even when U.S. federal minimum requirements for protection would otherwise apply. Also, some research is performed without knowledge of the affected subjects (such as record reviews). This kind of research may be acceptable as long as certain conditions exist and suitable precautions are in place. However, more risky research (e.g., involving invasive procedures) ordinarily requires conscious decisions by or on behalf of those to be studied. For that, ASK^SM before you decide about participation!