Abstract
The GRSSM website is offered as a free service to the public. GRS offers a Code of Reasonable Expectations ("GRS Code"), information, self-help tools, and referral to other resources for use by prospective human research subjects (prospects). The GRS Code and self-help tools serve as benchmarks against which prospects can compare an offer to participate in research (an offering). An offering is often called a protocol, study, or trial. The principal means of access to these GRS resources is through getresearchsmart.org. Decades of experience have been drawn upon by GRS authorship, including extensive knowledge of federal regulations (both strengths and weaknesses), and review of thousands of protocols and related consent documents.
GRS Goal
Even the playing field between those who are identified or select themselves for study and those who conduct such research studies, such that (1) a code of reasonable expectations for subject protections and related investigator commitments is relied upon as a common benchmark, (2) all parties optimally benefit, (3) administrative burdens upon the research enterprise are minimal, and (4) the benefits of prudent research are accelerated for the benefit of mankind.
Objectives
GRS strives to further its program goal and objectives, as follows: (1) establish a Code of Reasonable Expectations and related investigator commitments (i.e., standards) to which both prospects and investigators can confidently refer in their respective actions, (2) develop self-help information and tools for prospects that also serve as a roadmap for investigators, (3) place the developed GRS Code, information, and tools online to educate prospects, investigators and others, (4) attract interested parties for possible collaboration in GRS efforts, (5) seek from visitors to the GRS website how the initiative can be improved and grow, (6) create an atmosphere that encourages elective adoption by prospects, subjects, investigators, institutions, and/or editorial bodies, and, by force of precedent, (7) create a dynamic for universal voluntary adoption and/or incorporation into national and/or international codes.
Evaluation
Direct measures of success can be expected to include growth in visitors to this website, personal testimonials, endorsements, investigator and/or editorial acceptance, and development of independent products and services that are inspired by and/or linked to the GRS website. Growth in citation of the GRS website and reliance on content by others will serve to indirectly measure the website's influence. Improved rates at which prospects sign up for and/or remain in high risk trials might also be a positive sign. National and international adoption and/or related legislative initiative would be the ultimate measure of the website's unequivocal influence on public policy.
Summary
GRS is an online, self-help and free service for those considering participation in human subject research. GRS products, services, and resultant opportunities include: (1) a benchmark Code of Reasonable Expectations to which subjects may refer and to which investigators can elect to hold themselves, (2) self-help tools and services with which subjects can prepare prior to consideration of consent, (3) an elective means by which prospective subjects can seek a personal written declaration from investigators to expectations held in common by both, (4) an opportunity for voluntary, proactive, and universal adoption of the GRS Code and Declaration by investigators, (5) adoption and/or promotion of the GRS Code and Declaration by editorial entities, (6) promotion by local print or other media relying, in part, on prepared and posted materials, and (7) eventual validation through acceptance, use, and adoption by all involved.
(08-03-06)
|
