Guidelines for Alternative RCR Programs

These Guidelines are issued by the Boston University Office for Research Compliance (ORC) and Responsible Conduct of Research Advisory Committee to codify the policies and procedures for review of proposals for Alternative RCR Programs in accordance with the Boston University RCR Plan. The RCR Advisory Committee advises the Office of Research Compliance, headed by the Associate Vice President for Research Compliance (AVPRC), who makes final decisions on recommendations of the RCR Advisory Committee.

The BU RCR Plan states, inter alia:

It is understood that RCR can be taught and learned in many ways, and that principles can vary from discipline to discipline. For this reason, it is the intent of the BU Plan for RCR instruction to provide flexibility in its content and delivery methods in such a way that it addresses the specific needs, issues, and concerns of various target audiences among numerous disciplines. (Page 3)

The Office of Research Compliance, in consultation with the RCR Advisory Committee, will establish and communicate minimum instruction standards for each target audience (undergraduates, graduate students, post-doctoral fellows, and faculty). These standards will incorporate minimum requirements of funding agencies, such as the NIH requirement of participating in at least eight contact hours. (Page 7)

Each year, the Office of Research Compliance offers a core program for instruction in the Responsible Conduct of Research, in coordination with participating schools and departments. This program will be reviewed by the RCR Advisory Committee and will be open to target audiences (undergraduates, graduate students, post doctoral fellows), regardless of their funding sources.

It is anticipated that the Core program will include at least the following two instruction programs:

• An introductory web-based instruction program for undergraduates;
• An advanced instruction program, utilizing a selection of web-based resources, together with four, two-hour live sessions with group-based discussions lead by faculty “facilitators” from various departments

Departments, schools, and programs may propose alternative RCR Instruction Programs for their degree candidates, their postdoctoral fellows, or open to a wider audience. These RCR instruction programs may be, for example, part of a full course in research methods, or may be stand-alone RCR instruction programs. Proposals for these alternative programs will be reviewed and approved by the Office of Research Compliance, in conjunction with the RCR Advisory Comitteee, to ensure that minimum standards are met. Office of Research Compliance will provide assistance and resources to any departments wishing to develop their own alternative RCR Instruction Programs. (Pages 7-8)

For BU RCR Instruction above the introductory level, the RCR Advisory Committee and Office of Research Compliance have approved Minimum Standards.

The Office for Research Compliance will assist, upon request of departments and graduate programs, in the development of proposals for Alternative RCR. Office of Research Compliance will, as desired, send representatives to departments, graduate programs and schools to provide information about Alternative RCR Proposals and Resources.

The Office of Research Compliance will accept and review, together with the RCR Advisory Committee, proposals for Alternative RCR, Programs. Proposals will be submitted jointly by department chairs and graduate program directors using a standard Proposal Form, The Proposal Form includes the following key elements:

• Components of the Alternative RCR Program
• Faculty Instructors
• Coverage of RCR Topics
• Time commitment to RCRResponsible Conduct of Research
• Special qualifications or interest of instructors to teach RCR.

It is expected that Proposals will cover these components thoroughly and will meet the Minimum Standards.

Proposals for Alternative RCR will be initially reviewed as follows:

1. BU Research Compliance will preliminarily review each new proposal; if the Pproposal is not complete or does not clearly meet Minimum Standards, Research Compliance may request that the proposal be revised and re-submitted prior to review by the RCR Advisory Committee.
2. When a proposal is ready for review, Research Compliance will submit the proposal to the members of RCR Advisory Committee.
3. The RCR Advisory Committee may:
   1. Recommend approval of the proposal;
   2. Defer decision and seek additional information; or
   3. Recommend disapproval of the proposal.

Term: Approval of a Proposal for an Alternative RCR Program shall have a term of three (3) years.

Amendments: During the three-year term, the submitters are responsible for notifying the Office of Research Compliance in advance and seeking approval to make any significant change in the approved Alternative RCR Program, such as change of faculty, course components, or time commitment to RCR instruction.

Continuing review: Annually after the initial approval, a continuing review process will be conducted by the RCR Advisory Committee, as follows for each approved Alternative RCR Program:

1. Office of Research Compliance will annually request the submitters of the approved Alternative RCR Program to submit a Continuing Review Report Form
2. The Report will be reviewed by Office of Research Compliance staff and the Primary Reviewer; findings from the review will be reported to the RCR Advisory Committee.
3. The RCR Advisory Committee may then:
   1. Recommend acceptance of the Continuing Review Report;
   2. Withhold approval of the Continuing Review Report and seek to resolve any concerns by further consultation with the submitters.