Self-help for Subjects of Human Research
A prepared prospect is an investigator's best subject!
A Friendly Website
Know your motivation and compare it with what's offered. Assume nothing, speak up, and know - then decide (ASKSM)!
Life can confront us with the unexpected. When it does, knowing what to do can make it a lot easier and can even be a lifesaver.
If offered participation in research, what would you do? Now there's a website that's dedicated to the unsuspecting amongst us who may receive such an offer. It's a helping hand.
The user-friendly website (getresearchsmart.org) is a free service to the public. The website content draws on years of research protection experience. The result aims to make choices easier for the rest of us who are unfamiliar with the issues of this specialized field.
Basic Expectations
Participation in research is an option not an obligation. Amongst others things, subjects deserve to (1) have explained and understand (a) the research, (b) its risks and benefits, and (c) protections; (2) be chosen without bias; and (3) consent without pressure or withdraw or decline without consequence.
Existing protections for research subjects can be thought of as vertically integrated layers of administrative precautions. Protections are developed on behalf of prospective subjects without their involvement. As a result, each subject remains in the dark until approached to consent, and is then at a disadvantage.
The GRSSM Website
This website aims to provide information that can be helpful to prospective research subjects.
Self-help tools are posted with which prospective subjects can more easily and confidently participate in making their own decisions. These tools can help balance procedures for their protection which are undertaken by others with greater participation by themselves.
Knowledge-Skills-Abilities
Prospective subjects can learn from information posted on the website and links to other sources, print out one page summaries of reasonable expectations for research subject and consult a checklist to help evaluate proposed research.
The GRS website can help sensitize prospective subjects to the need for heightened alertness, such as when the role of your doctor changes from clinician to investigator. Overall, the website can help prospective subjects learn about possible protections, retrieve evaluation tools, and more confidently decide.
Knowledge gained can result in new skills that arise from a different way of thinking about research opportunities. Acting with benefit of this new knowledge and skills can better enable prospective research subjects to be of help to themselves.
History Highlights Need
Isolated organizations first began establishing ethical review bodies for the independent review of human research in the mid 1950s. These bodies (called Institutional Review Boards or IRBs) have evolved to review both the science and the ethics of proposals, set conditions, and ensure consent, unless properly waived. By the 1960s, evidence surfaced that liberties were being taken in the treatment of humans as subjects of research. By the mid 1970s, a crescendo of urgency prompted Congressional action (provoked by the now infamous Tuskegee Syphilis Study). The first versions of current federal regulations were created to spell out the required procedures for protections, but only for research conducted or supported by what is now the Department of Health and Human Services (DHHS).
A national commission produced the Belmont Report (ethical principles of Autonomy, Beneficence, and Justice). The Belmont principles can be thought of as (1) respect for persons, (2) minimal risks in pursuit of maximum benefits, and (3) fairness in selecting who participates, considering who is likely to ultimately benefit.
By the early 1980s, the now DHHS completed the process of perfecting and extending protections to specified vulnerable populations. By the early 1990s, the vast majority of the basic rules were adopted by most federal departments and agencies. The Food and Drug Administration has overlapping and additional rules of its own (for research subject to regulation under the Food, Drug and Cosmetic Act). However, it must be appreciated that all these rules only apply to federally conducted, supported, or regulated research or as may be otherwise voluntarily adopted.
The remainder of the 1990s were punctuated with numerous cases of noncompliance with existing requirements. This resulted in heightened attention by all concerned. Over the past fifty years, while improvements were being made in procedural protections, prospective research subjects did not equally advance in their abilities to more actively participate in their own protection.
Helping Hand Beckons
The GRS website is available when you need it and in a form that's easy for you to use. Think of it as an entry level springboard from which you can access (1) tools, (2) information, (3) links to other resources, in pursuit of the same morally defensible standards that are important to you.
In conclusion, as stated at the outset, know your motivation and compare it with what’s offered. Assume nothing; speak up; know - then decide (ASK)!
(04-07-06)
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