The Research Compliance Office at Albany College of Pharmacy and Health Sciences provides access to a variety of resources and training programs to ensure all individuals engaged in research at the College adhere to the highest standards for responsible and ethical conduct.
Below is an overview of these policies and guidelines.
RESEARCH COMPLIANCE, INTEGRITY, AND REPORTING OF CONCERNS
The Research Compliance Officer (RCO) acts to oversee and ensure research compliance with regulations applicable to the use of human and animal subjects, biosafety, and pre-award grants administration.
In this capacity, the RCO ensures that all research conducted at the College adheres to the applicable federal and state regulations. This goal is accomplished by working with the ACPHS Office of Research Administration and with the compliance committees governing animal use, biosafety, human research protections, and radiation use. Additionally, the RCO serves as the College's Research Integrity Officer (RIO).
Comments, concerns, requests, and reports regarding suspected compliance issues, including research misconduct, may be made by contacting the Research Compliance Office at (518) 694-7585. This phone number is answered only by Research Compliance personnel.
When personnel are not available, calls are forwarded to a confidential voice mailbox maintained by the RCO. Anyone reporting concerns via the phone or e-mail has the right to remain anonymous. To the extent possible within the limitations of law and regulation, all information will be treated and maintained as confidential. Any individual may make a complaint in good faith without the fear of reprisal.
The RCO is responsible for fielding questions, comments, and suggestions from the College research community regarding CITI training.
Responsible Conduct of Research Seminar Series (INTD-6010-01, CRN 28507)
Each year, the Research Compliance Office shall coordinate a seminar series led by faculty members covering Responsible Conduct of Research (RCR) topics. Training seminar topics shall include:
- Conflict of interest - personal, professional, and financial
- Policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices
- Mentor/mentee responsibilities and relationships
- Collaborative research including collaborations with industry
- Peer review
- Data acquisition and laboratory tools; management, sharing and ownership
- Research misconduct and policies for handling misconduct
- Responsible authorship and publication
- The scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research
Additionally, the RCO shall be available to coordinate further RCR seminars as requested by the research community and to answer questions regarding research processes at ACPHS. Please contact the office at (518) 694-7585 to request seminars or submit questions.
RESPONSIBLE CONDUCT OF RESEARCH
The National Science Foundation requires that, at the time of proposal submission to NSF, a proposing institution's Authorized Organizational Representative certify that the institution has a plan to provide appropriate training and oversight in RCR (Responsible Conduct of Research) to undergraduate students, graduate students, and postdoctoral researchers whose research will be supported by NSF. Training plans are not required to be included in proposals submitted to NSF but must be made available to NSF upon request.
In order to comply with the NSF's RCR Training Requirements, all undergraduate students, graduate students, and postdoctoral researchers applying for research support from NSF must complete CITI training in RCR or attend an RCR seminar on a yearly basis.
Click the following link to view the National Institutes of Health (NIH) RCR Training Requirements.
Online RCR Training
The Office of Research Integrity (ORI) of the United States Department of Health and Human Services has worked with the research community to develop an engaging, innovative, and effective training video, "The Lab: Avoiding Research Misconduct." The video presents decision points related to work-life-balance, mentoring, data management, responsible authorship, and questionable research practices from the perspective of researchers and administrators. It allows viewers to make ethical and life decisions as one of four characters. The outcome of the video is determined by the decisions - good or bad - made by the learner.
The Institutional Review Board (IRB) of Albany College of Pharmacy and Health Sciences is charged with the protection of the safety, welfare, rights, and privacy of all participants in human subject research conducted under the auspices of the College.
The role of the IRB is to ensure that all human subject research performed by the administration, faculty, staff, or students of the College conforms to federal and state requirements. The Belmont Report, issued in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, defines the ethical principles upon which these requirements are based. The IRB is guided by and adheres to these principles.
At Albany College of Pharmacy and Health Sciences, all human subject research (regardless of whether funded) must be reviewed and approved by the IRB before initiation.
Investigator Training Requirements
The IRB requires that all those involved with the administration of a study, and who interact with study participants and/or their identifiable specimens or data, complete training on the protection of human subjects. This may include students, collaborators, other clinicians, etc.
Research may not commence without proper documentation of completion of this training.
Upon successful completion of the training, a Completion Certificate(s) must be sent to the IRB. The IRB will maintain the certificates for a 36-month (three-year) period from the date the course was completed. Copies of certificates are kept with the protocol.
The IRB uses the Collaborative Institutional Training Initiative (CITI) program to complete the training requirement; however, certificates of completion from other trainings which satisfy the requirement may be submitted.
ANIMAL CARE AND USE
The NIH Office of Laboratory Animal Welfare strictly regulates care and use of animals for research and teaching. All animal research in the USA should follow the guidelines for animal care and use as described in the “Guide for the Care and Use of Laboratory Animals"(8th edition).
The federal mandate reads: "Each institution which falls under authority of the federal Animal Welfare Act (AWA; protects all mammals beyond, but not including, rodents) and/or receives Public Health Service (PHS) support for research and teaching involving laboratory animals must operate a program with clear lines of authority and responsibility, a properly functioning Institutional Animal Care and Use Committee (IACUC), procedures for self-monitoring, adequate veterinary care, a program of occupational health, sound animal husbandry practices, and appropriate maintenance of facilities for housing animals."
The IACUC of Albany College of Pharmacy and Health Sciences is charged with ensuring the performance of appropriate animal husbandry and research procedures by all faculty, staff, and students. The IACUC ensures that all animal research performed at ACPHS conforms to federal and state requirements.
At Albany College of Pharmacy and Health Sciences, all animal research (regardless of the funding source) must be reviewed and approved by the IACUC before initiation.
Investigator Training Requirements
The IACUC requires that all those involved with vertebrate animal research complete training on the NIH OLAW guidelines prior to engaging in any research activities. Research may not commence without proper documentation of completion of this training. Upon successful completion of the training, a Completion Certificate(s) must be sent to the IACUC. The IACUC will maintain the certificates for a 36-month (three-year) period from the date the course the course was completed. Copies of certificates are kept with the protocol.
Currently, the IACUC uses the Collaborative Institutional Training Initiative (CITI) program to complete the training requirement.
ACPHS, through its subscription with the Collaborative Institutional Training Initiative (CITI training), offers web-based training in following areas:
- Responsible Conduct in Research (RCR)
- Responsible Conduct in Use of Human Subjects in Research
- Laboratory Animal Welfare
- Good Clinical Practices (GCP)
- Financial Conflict of Interest (FCOI)
CITI training is available to all members of the ACPHS community (students, faculty, and staff).
Certification of training via CITI training is valid for a period of three years. An individual must take CITI’s refresher course prior to the expiration of the three years in order to maintain his or her training certification.
CONFLICTS OF INTEREST
PHS Financial Conflict of Interest Policy
The U.S. Department of Health and Human Services (HHS) has issued a final rule in the Federal Register that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94). An Institution applying for or receiving funding from a PHS-funded agency must be in compliance with all of the revised regulatory requirements.
PHS Required Financial Conflict of Interest Disclosure Form
An “Investigator” is defined as any individual responsible for the design, conduct, or reporting of the results of work performed or to be performed under the sponsored project. “Investigator" includes, but is not limited to the Principal Investigator, Co-Investigators, and any other individuals (including personnel from other institutions) who are involved in accomplishing project objectives, including individuals listed on subcontracts. It may include students, graduate and undergraduate, and other personnel who may be listed as authors on project results, even if they are not paid from the project.
Any person defined as an "Investigator" (including sub-award Investigators) on a proposal being submitted to a PHS-funded agency needs to:
- Complete and submit a Financial Conflict of Interest (FCOI) Disclosure Form prior to submitting the application, even if no relevant financial interest exists.
- Update the FCOI Disclosure Form annually or within 30 days of a change in financial status (acquisition of new financial interest), whichever occurs first.
No application for funding from a PHS-funded agency may be submitted to the agency until all Investigators have completed the required FCOI Disclosure Forms. FCOI Disclosure Forms must be completed even if no relevant financial interest exists.
PHS Required Financial Conflict of Interest Training
Any person defined as an "Investigator" (including sub-award Investigators) on a proposal being submitted to a PHS-funded agency needs to complete Financial Conflicts of Interest (FCOI) Training:
- Prior to engaging in research related to any PHS-funded grant or contract;
- At least every three years; and
- Immediately under the following circumstances:
- Institutional FCOI policies change in a manner that affects Investigator requirements;
- An Investigator is new to ACPHS; or
- ACPHS finds an Investigator noncompliant with ACPHS’s FCOI policy or management plan.