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Office of Research Compliance

RCR Focus Areas

There are nine content areas that are outlined by the Office of Research Integrity (ORI):

  1. Data Acquisition and Management, Sharing and Ownership
  2. Conflict of Interest and Commitment
  3. Human Subjects
  4. Animal Welfare
  5. Research Misconduct
  6. Publication Practices and Responsible Authorship
  7. Mentor/Trainee Responsibilities
  8. Peer Review
  9. Collaborative Science

 

1. Data Acquisition and Management, Sharing and Ownership
This area includes the acceptable ethical practices for acquiring, managing, sharing and maintaining ownership of research data. The area applies to both the physical and social and behavioral sciences. Information encompasses other areas such as: data retention and how data is stored; analysis of data; data as intellectual property; privacy and confidentiality of data; the collection and ownership of data when conducting research funded by a grant or contract; and the maintenance of data in electronic format.  Data should be maintained and secured in such a way as allow it to confirm research findings, establish priority, and be reanalyzed by other researchers.  Data should be stored in such a way as to protect confidentiality, be secure from physical and electronic damage and destruction and be maintained for the appropriate time frame dictated by sponsor and Institute policies.  Conditions imposed by sponsors, the Institute, and other sources may affect data acquisition, management, sharing and ownership.

Additional Resources: 
Data Management - MMC Guidance Document

 

2. Conflict of Interest and Commitment
Conflicts of interest may relate to competing financial obligations, relationships and obligations with colleagues or patients, and conflicts related to publication. Conflicts of commitment may arise when working on multiple research projects and challenges with time constraints in trying to do effective research, scholarship and service/community obligations.

Additional Resources:
Conflict of Interest Guidance - MMC SOP GA 104C
Conflict of Interest Disclosure Form - MMC SOP GA 104B

 

3. Human Subjects
Maine Medical Center has an Institutional Review Board (IRB) that reviews, approves and monitors all research projects that involve human subjects to ensure that all researchers comply with federal and institutional guidelines regarding the ethical treatment of individuals in research studies. All researchers who plan to conduct studies involving human subjects must receive IRB approval prior to initiating their study.  Investigators who participate in human subject research must complete training in human subject research, and otherwise must comply with IRB policies and procedures.  For more information on MMC's IRB go to www.mmcri.org/irb.  For information on protection of human subjects go to www.mmc.org/hrpp.

Additional Resources:
MMC Human Research Protection Program

MMC Good Clinical Practices SOP's

MMC IRB SOP's

 

4. Animal Welfare
Maine Medical Center has an Institutional Animal Care and Use Committee (IACUC) that reviews, approves and monitors all research projects that involve animals as subjects to ensure that all researchers comply with federal and institutional guidelines regarding the ethical care and treatment of animals in research studies. All researchers who plan to conduct studies involving the use of animals as subjects must receive IACUC approval prior to initiating their study. Animal care research issues include: ensuring the humane treatment of animals; the care and use of animals in research facilities; avoiding and minimizing pain and distress when conducting research with animals; ensuring that all persons working with animals are qualified and trained; and designing research studies ensuring that the benefits of the study outweigh the risks to animal welfare. The MMC Research Institute Animal Research Program maintains Full Accreditation from the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC).  More information regarding AAALAC may be found at AAALAC Facts.

Additional Resources:
IACUC- MMC's Institutional Animal Care and Use Committee

IACUC Links - A list of links that give information about care and use of laboratory animals

 

5. Research Misconduct

This applies to all areas involving practices of research misconduct. A new federal policy was recently implemented to further enforce the importance of regulation in this area (www.ori.gov). This area addresses the importance of establishing procedures for reporting misconduct in research and protections for whistleblowers. Additional issues in this core area include: the importance of understanding the difference between error vs. intentional misconduct, fabrication and falsification of data, and plagiarism.

Additional Resources:  
MMC's Office of Research Compliance

US Office of Research Integrity

Research Misconduct- APA's guidelines

 

6. Publication Practices and Responsible Authorship
Issues in this core area include: the importance of citations in research, decisions around authorship credit, and publication of research procedures.

Researchers share the results of their works with colleagues and the public in a variety of ways. Early results are usually shared during laboratory meetings, in seminars, and at professional meetings. Final results usually are communicated to others through scholarly articles and books. Whether structured or informal, responsible publication in research should ideally meet some minimum standards. All forms of publication should present: a full and fair description of the work undertaken; an accurate report of the results; and an honest and open assessment of the findings. In assessing the completeness of any publications, researchers should ask whether they have described: what they did (methods); what they discovered (results); and what they make of their discovery (discussion).  

The names that appear at the beginning of a paper serve one important purpose. They let others know who conducted the research and should get credit for it. It is important to know who conducted the research in case there are questions about methods, data, and the interpretation of results. Likewise, the credit derived from publications is used to determine a researcher's worth. Researchers are valued and promoted in accordance with the quality and quantity of their research publications. Consequently, the authors listed on papers should fairly and accurately represent the person or persons responsible for the work.

Additional Resources:
Authorship Responsibility- From the Office of Research Integrity

Public Access Policy- NIH's public access policy

Responsible Authorship- APA's guidelines for responsible authorship

 

7. Mentor/Trainee Responsibilities
This area focuses on the roles of undergraduate and graduate students and post-doctoral fellows as mentees/trainees and their relationships with mentors. Additional issues in this core area include: handling conflicts between mentors and mentees/trainees; the role of mentors and trainees in a research relationship; and selecting a mentor.

While conducting investigations, researchers often assume the added role of mentor. The mentor-trainee relationship is complex and brings into play potential conflicts. The essential elements of a productive mentor-trainee relationship are difficult to codify into rules or guidelines, leaving most of the decisions about responsible mentoring to the individuals involved. Common sense suggests that good mentoring should begin with: a clear understanding of mutual responsibilities; a commitment to maintain a productive and supportive research environment; proper supervision and review; and an understanding that the main purpose of the relationship is to prepare trainees to become successful researchers.  Knowing the importance of personal commitments, researchers should carefully consider what responsibilities they have to trainees before they take on the essential task of training new researchers. Trainees, in turn, should be we aware of their responsibilities to mentors before accepting a position in a laboratory or program.

Additional Resources:
Mentor/Mentee Training Resources- From the Office of Research Integrity

Responsible Mentoring- APA's guidelines for responsible mentoring

 

8. Peer Review
This area involves the timely review and evaluation of scientific work by one's professional colleagues. In conducting peer review, issues such as offering constructive, thorough, non-personal bias, attention and respect for confidentiality and timeliness are stressed. Additional issues in this core area include: ethical obligations for reviewers of manuscripts; the importance of meeting deadlines when conducting peer review; assessing the quality and appropriateness of research methods; examining how quality research may be compromised; how to judge or evaluate the importance of research; and how to conduct confidential peer reviews in the case of grant proposals, manuscripts for scientific publication and personnel matters.

Additional Resources: 
Peer Review Resources - From the Office of Research Integrity

Peer Review Guidelines- APA's guidelines for responsible peer reviews

 

9. Collaborative Science
Researchers often collaborate with colleagues who have the expertise and/or resources needed to carry out a particular project. Collaborations vary from being as simple as one researcher sharing specific techniques with a colleague or as complex as multi-centered clinical trials that involve academic research centers, private hospitals, and for-profit companies studying thousands of patients in different geographic regions. Any project involving more than one person requires some collaboration. Additional issues in this area include: developing management plans to address financial issues and research compliance; establishing roles and relationships for each member in the collaboration, establishing criteria to determine authorship, responsibilities for submitting reports, and how intellectual property rights and ownership issues will be resolved.

Additional Resources:
Collaboration Resources-  From the Office of Research Integrity

Collaborative Guidelines- APA's guidelines for responsible peer reviews

 

 

Maine Medical Center Research Institute 81 Research Dr Scarborough, ME 04074 (207)396-8100

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