In compliance with Federal Regulations and Partners Institutional Policies, all trainees, postdoctoral fellows, students and career-development recipients under award mechanisms (e.g., T32, F32, all K awards - K08, K23, K24) must complete training in the Responsible Conduct of Research.
Who is required to have training in the responsible conduct of research?Responsible Conduct of Research (RCR) applies to all trainees, postdoctoral fellows, students and career-development recipients under award mechanisms (e.g., T32, F32, all K awards - K08, K23, K24). NIH notice dated November 24, 2009 NSF-supported students and postdoctoral fellows as identified in the Federal Register notice dated August 20, 2009. Examples: Dissertation: D43, D71 Fellowship: F05, F30, F31, F32, F33, F34, F37, F38 Career Development: K01, K02, K05, K07, K08, K12, K18, K22, K23, K24, K25, K26, K30, K99/R00, KL1, KL2 Research Education: R25, R36 Training: T15, T32, T34, T35, T36, T37, T90/R90, TL1, TU2, U2RRequirements apply to all NIH projects submitted (and subsequently awarded) after January 25, 2010, including competitive renewals. This requirement will be expanded to all continuation (Type 5) applications with deadlines on or after January 1, 2011. PI of a K24: You may fulfill your RCR requirement by completing the full Partners program or lead an annual hospital-based lecture/discussion course on a RCR topic during the period of the K-24 award. PI of NIH institutional training grants (T-32): PIs of NIH institutional training grants are responsible for ensuring that T-32 supported trainees receive research ethics training. This includes notifying trainees of the RCR requirement, requiring completion of the Partners RCR requirements as a condition of the training grant appointment, reporting on RCR activity in the Progress Report, and developing and offering program or department-based activities that supplement the Partners RCR program.
What are the requirements for RCR training? Summary:Each RCR course must adhere to the following requirements: 1. Format: Substantial face-to-face (interactive) discussions among the participating trainees/fellows/scholars/participants; a combination of didactic and small-group discussions (e.g. case studies) with time allotted for questions and answers; and participation of research training faculty members in instruction in responsible conduct of research are highly encouraged. While on-line courses can be a valuable supplement to instruction in responsible conduct of research, online instruction is not considered adequate as the sole means of instruction. 2. Subject Matter: While there are no specific curricular requirements for instruction in responsible conduct of research, the following topics have been incorporated into most acceptable plans for such instruction: (1) conflict of interest – personal, professional, and financial; (2) policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices; (3) mentor/mentee responsibilities and relationships; (4) collaborative research including collaborations with industry: (5) peer review; (6) data acquisition and laboratory tools; management, sharing and ownership; (7) research misconduct and policies for handling misconduct; (8) responsible authorship and publication; (9) the scientist as a responsible member of society; (10) contemporary ethical issues in biomedical research; and (11) the environmental and societal impacts of scientific research. While courses related to professional ethics, ethical issues in clinical research, or research involving vertebrate animals may form a part of instruction in responsible conduct of research, they generally are not sufficient to cover all of the above topics. The goal of the requirements is to provide an overview of many ethically-related concepts in research (i.e. an 8 hour course in conflict of interest or research misconduct would not meet the NIH requirements for RCR training). 3. Faculty Participation: Training faculty and sponsors/mentors are highly encouraged to contribute both to formal and informal instruction in responsible conduct of research. Informal instruction occurs in the course of laboratory interactions and in other informal situations throughout the year. Training faculty may contribute to formal instruction in responsible conduct of research as discussion leaders, speakers, lecturers, and/or course directors. 4. Duration of Instruction: Instruction should involve substantive contact hours between the trainees/fellows/scholars/participants and the participating faculty. Acceptable RCR programs generally involve at least eight contact hours. A semester-long series of seminars/programs may be more effective than a single seminar or one-day workshop because it is expected that topics will then be considered in sufficient depth, learning will be better consolidated, and the subject matter will be synthesized within a broader conceptual framework. 5. Frequency of Instruction: Reflection on responsible conduct of research should recur throughout a scientist’s career: at the undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels.Substantial face-to-face (interactive) time Combination of didactic & small group discussion (time allotted for questions and answers) Research training faculty participation (i.e. as course instructors) May incorporate online instruction but cannot be sole means of instruction At least eight contact hours Training at least once during each career stage, and at a frequency of no less than once every four years.
When does RCR training need to be completed: The PHS seminar and CITI requirements must be completed within 12-months of the NIH or NSF appointment date or, if a direct award, e.g., an F or K award, as of the award effective date. The lecture component must be completed within 12 months of attendance at the PHS seminar. The Partners RCR Program is required of all. Failure to complete the Partners program in accordance with the information contained on this web site may result in termination of support by the Partners hospital that has received the award.
What opportunities are available for researchers to fulfill these requirements? The Partners RCR Program requires the following: 1. Attend the PHS Seminar:2. CITI Training (online) CITI (Collaborative Institutional Training Initiative) RCR Modules can be accessed by any computer with an Internet connection. CITI instructions are available on the CITI RCR Modules page. Required supplemental training not eligible for credit. 3. Participation in no less than four lecture/discussion offerings identified as eligible for RCR credit (1 hour in duration or greater). These courses must be attended within 12-months of attending the PHS-specific RCR introductory session. RCR Courses are offered by both MGH and BWH. Updates will be posted on the RCR site on the 15th of each month.Offered multiple times per year (February, May/June, October) alternating between the BWH and MGH campus. Duration of 4 hours (4 credits). Current BWH Courses Current MGH Courses Language for RCR section of Grant and Progress Report
Completion of the Partners HealthCare (PHS) Responsible Conduct of Research (RCR) Training Program is required of all NIH-supported fellows and career development awardees working at the Brigham and Women’s Hospital (BWH), Massachusetts General Hospital (MGH), McLean Hospital, or Spaulding Rehabilitation Hospital (SRH.) The PHS program consists of three parts: (1) on-line training; (2) a four-hour Partners-specific seminar taught by Partners/Harvard Medical School faculty members and senior administrators; and (3) participation in no less than four lectures/discussions selected by the trainee from a list of hospital-based offerings identified as eligible for RCR credit. For the on-line portion of the program, PHS uses the CITI (Collaborative Institutional Training Initiative) program, Responsible Conduct of Research (RCR) for Biomedical Investigators. Trainees are required to complete the CITI Introduction to RCR Module, in addition to modules devoted toThe Partners seminar focuses on some Partners-specific information, e.g., research compliance/post-award grants management, conflict of interest, and an overview of Partners human subject, stem cell, institutional bio-safety, and animal research policies. The majority of time is devoted to faculty presentations and panels focused on topics such as data integrity and documentation, authorship and publication, mentorship and research misconduct. The Partners seminar is offered three times a year. As a means of getting broad representation from across the diverse scientific disciplines that constitute the Partners community, each seminar is taught by a rotating group of faculty. Recent instructors and the topics they covered includeResearch Misconduct Data Acquisition and Management Responsible Authorship Peer Review Mentoring Collaborative Research Trainees are also required to attend four lectures/discussions taught by hospital faculty. These lectures expand on topics covered in the CITI program, are separate from courses required to work with human subjects or vertebrate animals (which are ineligible for RCR credit) and include, for example, mentor/mentee responsibilities, interactions with industry, data acquisition issues, introduction to clinical research, and ethics and clinical research protocols. Drs. Barbara Bierer, Elizabeth Hohmann and Melissa Frumin, among others, have served as instructors for the hospital-based courses. New trainees are required to complete the full PHS program within 12 months of their appointment to the training grant. Trainees in their fourth year will be required to attend two RCR-approved lecture/discussions to reinforce and supplement RCR training received during their first year. The PHS program will be supplemented on a formal and/or informal basis by faculty associated with this institutional award. Department should insert a description of departmental RCR activities.Dr. P. Pearl O’Rourke: IRB, IACUC, IBS, Privacy Board and research misconduct Dr. Dennis Brown: Data integrity, publication, peer review Dr. Tayyaba Hasan: Research misconduct Dr. Joseph Bonaventre: Faculty panelist commenting on all topics/speakers Dr. Barbara Bierer: Research misconduct Dr. Caren Solomon: Authorship Dr. Henry Kronenberg: Documentation and data integrity Dr. Jianren Mao: Authorship Dr. Charles Serhan: Data integrity Dr. David Altshuler: Mentorship Dr. F. Richard Bringhurst: Conflict of interest
At the start of the competitive segment, Partners HealthCare (PHS) required new NIH-supported trainees to complete one, multi-hour session on Responsible Conduct of Research during their first training year. This training was offered twice a year and available to trainees from the Brigham and Women’s Hospital (BWH), Massachusetts General Hospital (MGH), McLean Hospital, and Spaulding Rehabilitation Hospital (SRH). The session included instruction inIn 2010, PHS senior academic leadership decided that the NIH-mandated RCR program should become a multi-session and multi-media program with online instruction, lectures, and discussion, in addition to drawing more heavily on the hospitals’ scientific faculty. Thus, a new program was developed that combines on-line training; a Partners-specific, large-group session (3-4 hours); and participation in no less than four lectures/discussions selected by the trainee from a list of hospital-based offerings identified as eligible for RCR credit. PHS uses the CITI (Collaborative Institutional Training Initiative) program, Responsible Conduct of Research for Biomedical Investigators, for the online portion of the program. Trainees are required to complete the CITI Introduction to Responsible Conduct of Research Module, in addition to modules devoted toResearch Integrity and Misconduct – Harvard and Partners policies Conflict of Interest Reporting Research, Ownership/Sharing of Research and Technology Transfer Human Subjects in Research Animal Subjects in Research Introduction to Grants Management The Partners seminar focuses on some Partners-specific information, e.g., research compliance/post-award grants management, conflict of interest, and an overview of Partners human subject, stem cell, institutional bio-safety, and animal research policies. The majority of time is devoted to faculty presentations and panels focused on topics such as data integrity and documentation, authorship and publication, mentorship and research misconduct. The Partners seminar is offered three times a year. As a means of getting broad representation from across the diverse scientific disciplines that constitute the Partners community, each seminar is taught by a rotating group of faculty. Recent instructors and the topics they covered includeResearch Misconduct Data Acquisition and Management Responsible Authorship Peer Review Mentoring Collaborative Research Trainees are also required to attend four lectures/discussions taught by hospital faculty. These lectures expand on topics covered in the CITI program, are separate from courses required to work with human subjects or vertebrate animals (which are ineligible for RCR credit) and include, for example, mentor/mentee responsibilities, interactions with industry, data acquisition issues, introduction to clinical research, and ethics and clinical research protocols. Drs. Barbara Bierer, Elizabeth Hohmann and Melissa Frumin, among others, have served as instructors for the hospital-based courses. New trainees are required to complete the full PHS program within 12 months of their appointment to the training grant. Trainees in their fourth year will be required to attend two RCR-approved lecture/discussions to reinforce and supplement RCR training received during their first year. New trainees are required to complete the full PHS program within 12 months of their appointment to the training grant. The PHS program is supplemented on a formal and/or informal basis by faculty associated with this institutional award. Department should insert a description of formal or informal departmental RCR activities offered during the current segment and improvements/changes to offerings in the next segment.Dr. P. Pearl O’Rourke: IRB, IACUC, IBS, Privacy Board and research misconduct Dr. Dennis Brown: Data integrity, publication, peer review Dr. Tayyaba Hasan: Research misconduct Dr. Joseph Bonaventre: Faculty panelist commenting on all topics/speakers Dr. Barbara Bierer: Research misconduct Dr. Caren Solomon: Authorship Dr. Henry Kronenberg: Documentation and data integrity Dr. Jianren Mao: Authorship Dr. Charles Serhan: Data integrity Dr. David Altshuler: Mentorship Dr. F. Richard Bringhurst: Conflict of interest
Completion of the Partners HealthCare (PHS) Responsible Conduct of Research (RCR) Training Program is required of all NIH-supported fellows and career development awardees working at the Brigham and Women’s Hospital (BWH), Massachusetts General Hospital (MGH), McLean Hospital, or Spaulding Rehabilitation Hospital (SRH.) The PHS program consists of three parts: (1) on-line training; (2) a four-hour Partners-specific seminar taught by Partners/Harvard Medical School faculty members and senior administrators; and (3) participation in no less than four lectures/discussions selected by the trainee from a list of hospital-based offerings identified as eligible for RCR credit. For the on-line portion of the program, PHS uses the CITI (Collaborative Institutional Training Initiative) program, Responsible Conduct of Research (RCR) for Biomedical Investigators. Trainees are required to complete the CITI Introduction to RCR Module, in addition to modules devoted toThe Partners seminar focuses on some Partners-specific information, e.g., research compliance/post-award grants management, conflict of interest, and an overview of Partners human subject, stem cell, institutional bio-safety, and animal research policies. The majority of time is devoted to faculty presentations and panels focused on topics such as data integrity and documentation, authorship and publication, mentorship and research misconduct. The Partners seminar is offered three times a year. As a means of getting broad representation from across the diverse scientific disciplines that constitute the Partners community, each seminar is taught by a rotating group of faculty. Recent instructors and the topics they covered includeResearch Misconduct Data Acquisition and Management Responsible Authorship Peer Review Mentoring Collaborative Research Trainees are also required to attend four lectures/discussions taught by hospital faculty. These lectures expand on topics covered in the CITI program, are separate from courses required to work with human subjects or vertebrate animals (which are ineligible for RCR credit) and include, for example, mentor/mentee responsibilities, interactions with industry, data acquisition issues, introduction to clinical research, and ethics and clinical research protocols. Drs. Barbara Bierer, Elizabeth Hohmann and Melissa Frumin, among others, have served as instructors for the hospital-based courses. The PHS program will be supplemented by….. Include a description of the mentor’s role in RCR training.Dr. P. Pearl O’Rourke: IRB, IACUC, IBS, Privacy Board and research misconduct Dr. Dennis Brown: Data integrity, publication, peer review Dr. Tayyaba Hasan: Research misconduct Dr. Joseph Bonaventre: Faculty panelist commenting on all topics/speakers Dr. Barbara Bierer: Research misconduct Dr. Caren Solomon: Authorship Dr. Henry Kronenberg: Documentation and data integrity Dr. Jianren Mao: Authorship Dr. Charles Serhan: Data integrity Dr. David Altshuler: Mentorship Dr. F. Richard Bringhurst: Conflict of interest
At the start of the competitive segment, Partners HealthCare (PHS) required new NIH-supported trainees to complete one, multi-hour session on Responsible Conduct of Research during their first training year. This training was offered twice a year and available to trainees from the Brigham and Women’s Hospital (BWH), Massachusetts General Hospital (MGH), McLean Hospital, and Spaulding Rehabilitation Hospital (SRH). The session included instruction inIn 2010, PHS senior academic leadership decided that the NIH-mandated RCR program should become a multi-session and multi-media program with online instruction, lectures, and discussion, in addition to drawing more heavily on the hospitals’ scientific faculty. Thus, a new program was developed that combines on-line training; a Partners-specific, large-group session (3-4 hours); and participation in no less than four lectures/discussions selected by the trainee from a list of hospital-based offerings identified as eligible for RCR credit. PHS uses the CITI (Collaborative Institutional Training Initiative) program, Responsible Conduct of Research for Biomedical Investigators, for the online portion of the program. Trainees are required to complete the CITI Introduction to Responsible Conduct of Research Module, in addition to modules devoted toResearch Integrity and Misconduct – Harvard and Partners policies Conflict of Interest Reporting Research, Ownership/Sharing of Research and Technology Transfer Human Subjects in Research Animal Subjects in Research Introduction to Grants Management The Partners seminar focuses on some Partners-specific information, e.g., research compliance/post-award grants management, conflict of interest, and an overview of Partners human subject, stem cell, institutional bio-safety, and animal research policies. The majority of time is devoted to faculty presentations and panels focused on topics such as data integrity and documentation, authorship and publication, mentorship and research misconduct. The Partners seminar is offered three times a year. As a means of getting broad representation from across the diverse scientific disciplines that constitute the Partners community, each seminar is taught by a rotating group of faculty. Recent instructors and the topics they covered includeResearch Misconduct Data Acquisition and Management Responsible Authorship Peer Review Mentoring Collaborative Research Dr. P. Pearl O’Rourke: IRB, IACUC, IBS, Privacy Board and research misconduct Dr. Dennis Brown: Data integrity, publication, peer review Dr. Tayyaba Hasan: Research misconduct Dr. Joseph Bonaventre: Faculty panelist commenting on all topics/speakers Dr. Barbara Bierer: Research misconduct Dr. Caren Solomon: Authorship Dr. Henry Kronenberg: Documentation and data integrity Dr. Jianren Mao: Authorship Dr. Charles Serhan: Data integrity Dr. David Altshuler: Mentorship Dr. F. Richard Bringhurst: Conflict of interest Trainees are also required to attend four lectures/discussions taught by hospital faculty. These lectures expand on topics covered in the CITI program, are separate from courses required to work with human subjects or vertebrate animals (which are ineligible for RCR credit) and include, for example, mentor/mentee responsibilities, interactions with industry, data acquisition issues, introduction to clinical research, and ethics and clinical research protocols. Drs. Barbara Bierer, Elizabeth Hohmann and Melissa Frumin, among others, have served as instructors for the hospital-based courses.
The PHS program is supplemented on a formal and/or informal basis by faculty associated with this institutional award. Include a description of the role of mentor/sponsor’s role in RCR training.
Institutional Training, Education, and Institute Development Awards:Individual Fellowship:Nature of RCR instruction Extent of trainee & faculty participation Any changes to the 5 components from plan described in awarded application Specific training faculty who contributed to formal instruction since last budget period reporting Individual Career Development Awards:Specific instruction for fellow Subject matter Format Frequency Duration When training did or will take place Discuss formal and/or informal activities Discuss extent sponsors or senior fellow participated Instruction received Participation as course director in both formal and informal – past budget period of applicable If RCR instruction occurred prior to budget period, date of occurrence Any individualized instruction appropriate to career stage reporting
How do I prove attendance at RCR courses? All trainees/fellows/career awardees must provide documentation attesting to completion of the four courses within a 12-month period (in addition to the required PHS Seminar). An RCR Attestation Form is provided to meet this requirement. BWH and MGH trainees/fellows/career awardees should submit this form electronically to the RCR mailbox PHSRCR@partners.org.
Contacts: Partners Research Compliance Office Mary H. Mitchell Director of Research Compliance 617-954-9597 mmitchell14@partners.org Eartha Mitchell Research Compliance Coordinator ELMitchell@Partners.org Please send any questions about whether a course is RCR-eligible to the RCR mailbox at PHSRCR@partners.org. MGH Office of Research Career Development orcd@partners.org Clinical Research Program at MGH Stacey Grabert, Pharm.D., M.S. Assistant Director of Education crpedu@partners.org
Want to teach a course to fulfill your RCR requirement? RCR Tool kit: Tools for developing programs on responsible conduct of research for postdocs.Contact:
Clinical Research Program at MGH Stacey Grabert, Pharm.D., M.S. Assistant Director of Education 617-643-7710 sgrabert@partners.org