12.1 Allegheny College’s Responsible Conduct of Research Plan
[Note: This section is written in the second person and is directed towards undergraduates conducting scientific research at Allegheny.]
The following plan was prepared in response to Chapter IV.B. of the National Science Foundation Proposal and Award Guide, a new section of the guide published in October 2009 that provides NSF’s implementation of Section 7009 of the America COMPETES Act regarding responsible conduct of research (RCR). This new addition to the guide took effect on January 4, 2010. Although NSF’s implementation of the plan is specific only to NSF grant submissions on or after January 4, 2010, the College elected to implement the following policy on a pilot basis beginning in January 2010, regardless of source of funding.
Beginning on January 4, 2010, Allegheny College undergraduate students participating in paid research that involves human or animal subjects, supported either by the college with internal funding sources or by external sources such as grants, must participate in training in the responsible conduct of research. At a minimum, students must complete one of the following free courses offered by the Collaborative Institutional Training Initiative (CITI). The basic course options are:
- Biomedical Sciences Responsible Conduct of Research Course, Basic Course
- Social and Behavioral Sciences Responsible Conduct of Research Course, Basic Course
- Humanities Responsible Conduct of Research Course, Basic Course
- RCR for the Sciences
Faculty serving as research mentors may recommend additional modules as appropriate. It is anticipated that the basic course, which consists of between 5 and 10 modules, will take approximately 10 hours to complete. It is not necessary to complete all modules at once. Students are able to save their work and return to it later. Students may complete this portion of their training on their own schedule, either prior to initiating the paid research work or in the early weeks of conducting the paid research work. For paid research conducted in the summer, the RCR modules must be completed by June 15. 109 Prior to initiating their training, students should consult with their faculty research mentor about which basic course to take.
To begin:
- Go to https://www.citiprogram.org/
- Click on Register Here. When asked for your institutional affiliation, use the pull down menu to select Allegheny College. After completing Sections 2, 3, and 4 (optional), click on the Submit button.
- The next page requests information used by Allegheny for record keeping. Please note that only the starred information is required, although you may choose to provide additional optional information. Using the pull down menu, please identify your major role in research. At Allegheny, the major roles are principle investigator, undergraduate student researcher, or IRB member. Please click on Submit once you have completed this page.
- The next page will determine which modules you need to complete for your RCR training. For question 1, click on the appropriate learner group based on your role and the type of any human subjects activities you will conduct. If you are not conducting human subject research, you should leave question 1 blank.
- Next, in response to question 2, click on the RCR Course that you plan to complete: Biomedical RCR, Social and Behavioral RCR, Humanities RCR, or RCR for the Sciences. The Responsible Conduct of Research Courses contain a series of modules identifying ethical dilemmas for a variety of types of research. You do not have to finish the course in one sitting. The program recommends that you spend about an hour and a half on the course at a time.
To receive certification of successfully completing the RCR training modules, you must have an overall score of 85%. You may retake a module as often as you wish. Once you have completed the certification, you will have the option of printing a certificate. CITI will notify the Allegheny administrator when you have been certified and the date of certification. Please note that individual scores and number of attempts will NOT be reported to the Allegheny administrator.
If you have questions, please consult with your faculty research mentor.
(Effective 4 January 2010, Added to handbook 23 July 2011)
12.2 Financial Disclosure Policy
The Financial Disclosure Policy for All Investigators Conducting Research Funded by Federal Grants
The Financial Disclosure Policy is housed in the Employee Handbook. Appendix K
12.3 Intellectual Property Created at Allegheny College
Allegheny College has adopted a policy regarding the ownership of intellectual property created while working at the College. The policy addresses ownership of copyright works created by faculty, ownership of certain patented materials pursued by faculty using College resources, works produced by non-faculty employees, works created by students, and procedures for disclosure of copyrightable works and patent applications.
The Intellectual Property Created at Allegheny College policy is housed in the Employee Handbook. Appendix H
12.4 Policy for Dealing with Possible Misconduct in Scientific Research Under External Grant or Contract Funding
The integrity of scholarly activity depends upon adherence to high ethical and moral standards. Allegheny College expects such adherence from all engaged in research at Allegheny. In the event that some dishonesty or misconduct occurs that involves a faculty member, the procedures described in the Faculty Handbook, under Section 5.2, Faculty Appointments, Paragraph 55 will be followed. This paragraph details the procedures for inquiry and investigation into allegations of dishonesty in research. In cases involving external funding, if the policy guidelines of external funding agencies conflict with these policies, all requirements of the external agencies supersede the policies of the Faculty Handbook. The policy outlined here describes some such additional requirements, with particular reference to the National Science Foundation (NSF) and department of Health and Human Services (including Public Health Service (PHSS), and National Institutes of Health (NIH). For fuller details, see PHS document 6315, “Initial assurance regarding procedures for dealing with and reporting possible misconduct in science;” Code of Federal Regulations 42 C.F. R. Part 50, Subpart A; 45 C.F.R. 689; and NSF-OIG document 911, “Dear colleague letter on misconduct.”
1. Misconduct may include the following:
The NSF defines misconduct in scientific research as:
- fabrication, falsification, plagiarism, or other serious deviation from accepted practices in proposing, carrying out, or reporting results from activities funded by NSF; or
- retaliation of any kind against a person who reported or provided information about suspected or alleged misconduct and who has not acted in bad faith.
The PHS uses the following definition:
Fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. Misconduct does not include honest error or honest differences in interpretation or judgement of data.
2. When allegations of misconduct are reported, the Provost shall ascertain whether the alleged misconduct affects or involves externally funded personnel or projects.
3. If externally funded activities are involved, and if the Provost and the tenured members of Faculty Council have determined that a prima facie case exists, then the Provost will initiate and maintain contact with the appropriate funding agency as required in federal or state regulations. The Provost will keep the agency informed during any investigations and provide a final report. In the event that there is a reasonable indication of possible criminal violations, the Provost shall notify the agency within 24 hours.
4. The Provost shall take appropriate interim actions to protect Federal funds and ensure that the purpose of the Federal financial assistance is being carried out.
5. The College shall seek to protect, to the maximum extent consonant with policy outlined in the Faculty Handbook, the privacy, positions and reputations of those persons who, in good faith, make allegations of scientific misconduct. The College will also protect and make efforts to restore the reputations and positions of those who have been the object of allegations found to be false.
6. The Provost’s Office shall maintain detailed documentation of all inquiries and investigations for at least three years. These documents are to be made available to authorized individuals from the funding agencies.
12.5 Projects to be Reviewed by the Animal Research Committee
Projects to be reviewed by the ARC include those:
- Involving animals to be conducted in the classrooms or laboratories of the College;
- To be submitted for funding for outside agencies, if required by that agency;
- For which any member of the college community requests a review.
12.6 Procedures for Submitting Animal Research Committee Proposals for Review
- Approval must be secured in writing before the purchase or acquisition of subjects may begin, or, in the case of those projects employing animals bred on-site, before the experimenter may begin any procedures. The information about a proposed study should be submitted to the ARC at least one month prior to the anticipated beginning of the project so as to insure time for review.
- Research proposals should be submitted using the ARC Review Forms. These Forms are available from the Chair and members of the ARC.
- Changes in the research topic, subject or procedure must be approved in advance by the ARC.
- When the ARC has examined a proposal, copies of the evaluation will be sent to key participants (i.e., student, faculty adviser, research supervisor, etc.) This procedure will be followed in cases where permission is given to proceed (perhaps with recommendations for improving the procedure) as well as in those cases where additional information is required. No project may begin until written notice from the ARC is received.
- Projects will normally be reviewed during the regularly scheduled meetings of the ARC. Special meetings may be called by the Chairperson on an “as-needed” basis. All actions of the ARC will be by majority vote by those present.
- The ARC will provide additional reports as required by state and federal regulations.
12.7 Projects to be Reviewed by the Institutional Review Board
Projects to be reviewed by the Institutional Review Board include research activities:
- Conducted by a member of the College community or research conducted at the College by persons who are not members of the College community;
- To be submitted for funding to outside agencies, if required by that agency
- For which any member of the college community requests a review;
- Involving human participants while a faculty member is at another institution or collaborating with colleagues from another institution, unless that faculty member has obtained the approval of an IRB at the other institution (Note: approval from another institution must be sent to the College IRB);
- Involving the sharing of data or tissue from a previously approved project.
- Used for institutional research that collects new data or goes beyond the normal internal management uses of information analysis, or when questions arise in institutional research concerning compliance with protection of human participant guidelines.
12.8 Procedures for Obtaining Institutional Review Board Approval of Projects
- Approval must be secured in writing before any recruitment of participants may begin. The specific procedures for the submission of proposals, including deadlines, answers to frequently asked questions, and required forms are available on the IRB web site.
- Researchers may request an exemption from review, an expedited review, or a full board review from the IRB. Decisions of the IRB are sent to key participants (i.e., student, faculty advisor, administrator, etc.) in writing. No project may begin until written permission is received.
- Full board review requires that a quorum of the members of the IRB are present, including at least one nonscientist, and that accurate records of decisions and votes are maintained. Email and proxy votes are not permitted for full board reviews.
- Projects will normally be reviewed during the regularly scheduled meetings of the IRB. Special meetings may be called by the Chairperson as needed. All actions of the IRB require a majority vote of the membership of the IRB. Members of authorized sub-boards will not be considered as part of the membership of the IRB when conducting full IRB reviews.
- The IRB makes every effort to work with researchers to ensure that all research is in compliance with relevant governmental and disciplinary ethical standards. In the event that permission to conduct a project is denied, that decision is final. The College administration may, at its discretion, refuse to allow an approved project to proceed, but it cannot give permission to permit a project which has been denied by the IRB.
12.9 Statement of Principles Regarding Research with Animals
The Statement of Principles pertains to Allegheny’s institutional commitment to the rules and regulations regarding research with animals as specified in the Guide for the Care and Use of Laboratory Animals published by the Office of Animal Laboratory Welfare of the National Institutes of Health. Sections One and Two of Allegheny’s Institutional Assurance of Compliance read as follows:
I. Applicability of Assurance This Assurance is applicable to all research, research training, experimentation, biological testing, and related activities, involving live, vertebrate animals supported by the Public Health Service (PHS) and conducted at this institution, or at another institution as a consequence of the subgranting or subcontracting of a PHS‐conducted or supported activity by this institution. “Institution” includes the following branches and major components of Allegheny College: Academic Departments and Programs and faculty included in the Natural Science, Humanities, and Social Science Divisions. All branches are located on the main campus in Meadville, Pennsylvania.
II. Institutional Commitment
- This institution will comply with all applicable provisions of the Animal Welfare Act and other Federal statutes and regulations relating to animals.
- This institution is guided by the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training.”
- This institution acknowledges and accepts responsibility for the care and use of animals involved in activities covered by this Assurance. As partial fulfillment of this responsibility, this institution will make a reasonable effort to ensure that all individuals involved in the care and use of laboratory animals understand their individual and collective responsibilities for compliance with this Assurance as well as all other applicable laws and regulations pertaining to animal care and use.
- This institution has established and will maintain a program for activities involving animals in accordance with the Guide for the Care and Use of Laboratory Animals.
- This institution agrees to ensure that all performance sites engaged in activities involving live vertebrate animals under consortium (subaward) or subcontract agreements have an Animal Welfare Assurance and that the activities have Institutional Animal Care and Use Committee (IACUC) approval.
(Revised Spring 2007)
12.10 Statement of Principles Regarding Research on Human Participants
All research at Allegheny that involves human participants must be approved in advance by the Institutional Review Board (see Section 3.10 above) and be conducted in accord with the principles outlined in the “The Belmont Report,” which is available on the US Department of Health and Human Services (DHHS) website. Additional information is available on the Allegheny College IRB website.
(Revised Spring 2012)
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