Institutional Compliance Training Resources at Tufts University

Note: This listing may not be complete. If you do not see what you are interested in,
please contact specific offices for additional information.

Title or SubjectBrief Description of Subject or Key Items CoveredRequired or Recommended and for Whom?Method and Medium
Human Subjects Protection - Boston IRB
Collaborative IRB Training Initiative(CITI)

Mandatory training for new PI and research team members conducting human subject research. Continuing education for existing PI/research team members.

For details see: http://tnemcirb.tufts.edu?pid=40


Additional Information

Investigator 101

This two-part program provides basic information on the topics of ethics in research and investigator compliance with federal regulations

Required for all research team members conducting clinical research through the Boston IRB who have not completed either the Rochester or NIH program before March 1, 2004. Recommended for all clinical research investigators.

Online, including a test
Additional Information

Research Compliance: Basic Requirements and Accurate Record Keeping

General Overview of the Regulatory Compliance Environment; OHRP Compliance Areas of Interest and Findings; Role of IRB; Initial and Continuing Review; Recruiting Subjects; Informed Consent Process; 23 Categories of Recordkeeping Essentials

Required for all research team members conducting clinical research through the Boston IRB whose responsibilities involve one or more of these areas, in the judgment of the PI.

Online and post-test/evaluation
Additional Information

Recognizing and Reporting Adverse Events During a Clinical Trial

Defines an adverse event and explains both the IRB's and federal policies and standards for reporting adverse events and impact on studies.

Required for all research team members conducting clinical research through the Boston IRB whose responsibilities involve these areas, in the judgment of the PI.

Online and post-test/evaluation
Additional Information

What Researchers Need to Know about Investigational Drugs and Devices under FDA Regulations (INDs/IDEs)

All of the IRB and Regulatory Requirements for Investigational Drugs and Devices

Required for all research team members conducting clinical research through the Boston IRB whose responsibilities involve FDA regulated research, in the judgment of the PI.

Online and post-test/evaluation
Additional Information

The Impact of HIPAA on Clinical Research

Clinical Trials and HIPAA after August 2002 Privacy Rule

This or the following HIPAA lecture is required for all researchers conducting clinical research in a covered entity (T-NEMC, TUSDM) or using patient information obtained from a covered entity.

Online and post-test/evaluation
Additional Information

A Practical Guide to HIPAA Issues for Research at TNEMC and TUHSC

HIPAA and how it affects research at T-NEMC and TUHSC

This or the prior HIPAA lecture is required for all researchers conducting clinical research in a covered entity (T-NEMC, TUSDM) or using patient information obtained from a covered entity.

Online and post-test/evaluation
Additional Information

IRB Review of Social and Behavioral Science Research

Explanation of the principles and regulations governing social, behavioral and educational research

Recommended for researchers conducting social, behavioral or educational research.

Online
Additional Information

Adverse Events and Human Subjects Research

Explains the regulations and reporting requirements surrounding various types of adverse events and offers practical advice.

Recommended for clinical researchers and IRB members.

Online
Additional Information

Data Safety Monitoring Plans and Boards in Clinical Research-What are They Anyway?

Discusses the need for Data Safety Monitoring Plans and Boards and Integrating Adverse Events in the Protocol, Planning and Reporting Process

Recommended for clinical investigators and IRB members.

Online
Additional Information

Ethical Issues in Research With Children and Pregnant Women

Federal regulations, consent considerations and ethical issues related to these research subjects

Recommended for clinical investigators and IRB members involved with this subject.

Online
Additional Information

Informed Consent to Research

History of Concern with Informed Consent; Study Risks and Benefits; Therapeutic Misconception; Competence and Impaired Capacity; Remedial Interventions; Competence Assessment and Use of Advance Directives

Recommended for clinical researchers and IRB members.

Online
Additional Information

Responsible Conduct of Research: Research Misconduct

Definitions of Research Misconduct; Institutional Policies; Procedures for Reporting and Investigating; Findings and Practices; Resolution of Investigations

Recommended for investigators.

Online
Additional Information

Conflict of Interest

Discussion of various situations and relationships that can give rise to conflicts of interest involving research

Recommended for researchers interested in this subject.

Online
Additional Information

Ethics of the Use of Living Research Subjects

Perspectives on the history and ethical use of animals in research; description of the regulatory environment that applies to the care and use of animals in research

Recommended for researchers interested in this subject.

Online
Additional Information

The Ethics of Human Subjects Research from Compliance to Conscience

Discusses ethics in human subject research from Nuremberg to the present; the development of federal oversight and current emerging trends

Recommended for researchers interested in this subject.

Online
Additional Information

The Privacy Rule - Have the Nuts and Bolts Changed?

Some practical HIPAA issues for research identified and explained after the implementation of the HIPAA Privacy Rule

Recommended for clinical researchers who may handle PHI (protected health information).

Online
Additional Information

Social, Behavioral and Educational (SBER) IRB
Collaborative Institutional Training Initiative Program (CITI)

Basic Modules on Human Subject Protections for Social, Behavioral and Educational Research

Required for all SBER IRB Members & investigators (faculty, research staff, students, faculty research advisers and research assistants). Exception - Fletcher School of Law and Diplomacy (IRB exemptions only).

Online
Additional Information

Collaborative Institutional Training Initiative Program (CITI)

Refresher Modules on Human Subject Protection for Social, Behavioral and Educational Research

Individuals requiring continuing or self-identified additional training, or corrective education.

Online
Additional Information

Fletcher Reading

IRB educational reading

Required for all Fletcher investigators (faculty, research staff students, student research advisers and research assistants) applying for IRB exemption.

Online
Additional Information

Medford Research Administration
(Grant) Budget Preparation Tips

Topics include general information about regulatory compliance, grant budget preparation tools, budget detail, justification and document preparation.

Recommended for faculty members and researchers submitting grant proposals, department administrators.

Work shop with Power Point
Additional Information

Research Animal Care and Use - Boston Campus
Initial Mandatory Animal Care and Use Seminar

Topics include: History of laboratory animal regulations; Federal and state regulations; Institutional policies; IACUC and its responsibility; Protocols and amendments; Monitoring compliance and reporting non-compliance; Federal reports and site inspections; Minimizing pain and distress in laboratory animals; Searching for alternatives to painful/distressful procedures; Justification of animal numbers; Post-procedural care and monitoring; Facility access and husbandry; Occupational health and safety; Use of anesthetics and analgesics; Importations, exportations, transportation and ordering; Endpoints and DLAM health checks; Proper euthanasia.

Required within the first 3 months for anyone on the Boston campus who has contact with live animals and all IACUC members.

PowerPoint presentation with lecture and small group discussion
Additional Information

Renewal Mandatory Animal Care and Use

Renewal training topics are similar to initial training topics.

Required every three years for anyone on the Boston campus who has contact with live animals and all IACUC members.

Online and post-test/evaluation
Additional Information

Research Animal Care and Use - Medford Campus
Initial Mandatory Animal Care and Use Seminar

Medford Campus topics are the same as those for the Boston campus.

Required within the first 3 months for anyone on the Medford campus who has contact with live animals and all IACUC members.

Either PowerPoint presentation with lecture or small group discussion following the User's Guide (dependent on size of group)
Additional Information

Research Animal Care and Use - Grafton Campus
IACUC Animal Welfare Training Video

Regulations and TCSVM policies regarding Animal Welfare of Research Animals

Required for all Grafton personnel listed on an IACUC Protocol, incoming veterinary students and all IACUC members.

Live lecture and video tape
Additional Information

Other Research Training - Grafton Campus
GLP Annual Training

Good Laboratory Practices Regulations as mandated by the FDA for GLP Studies

Required for those who work under GLP studies

Lecture and PowerPoint presentation
Additional Information

Environmental Health & Safety
Right To Know (Hazard Communication) Live Training

The OSHA Hazard Communication Standard is required for all new employees. Information about chemicals, steps to reduce exposures, substituting less hazardous materials, and establishing proper work practices.

Required for all new employees.

Lecture & handouts
Additional Information

Right To Know (Hazard Communication) Online Training

This is the Online version of the OSHA Hazard Communication Standard which is required for all new employees and available to those who do not attend a live session.

Required for all new employees.

Online training
Additional Information

RCRA Live Training

Hazardous waste satellite accumulation area rules

Required for all lab and facilities personnel once per year or see the Online version below as an alternative.

Lecture and Power Point
Additional Information

RCRA Online training

This is the Online version of RCRA which is an alternative available to those not attending a live presentation.

Required for all lab and facilities personnel once per year or see the live version above as an alternative.

Online training
Additional Information

Chemical Hygiene Online Training Module

This Online training module for Hazardous Chemicals includes proper waste handling and chemical storage.

Required for all new lab personnel in Grafton and recommended for all new lab personnel in Boston and Medford.

Online training
Additional Information

Bloodborne Pathogens

Discussion of hazards of HBV, HCV, HIV, needle stick injuries, disposal of contaminated items, etc. Post-exposure actions to avoid infection.

Required annually for all at risk groups, medical and dental students, veterinary students, dental staff, medical staff, research scientists working with human source materials.

Lecture & handouts
Additional Information

DOT Hazardous Materials Shipping Initial Training

Proper shipping and signage for hazardous waste and discussion of current regulations.

Required for all new EH&S or Facilities personnel signing hazardous waste manifests

Lecture and Handouts
Additional Information

DOT Hazardous Materials Shipping Refresher Training

Proper shipping and signage for hazardous waste. Review of current regulations.

Required for all current EH&S or Facilities personnel signing hazardous waste manifests

Lecture and Handouts
Additional Information

Radiation Safety- Initial and Refresher Training

Basic radiation physics principles; safe work practices; lab rules; regulations and conditions of license

Required for all individuals working with or in the vicinity of radioisotopes.

Lecture, PowerPoint, Handouts
Additional Information

Laser Safety Training

This training includes laser system classifications; fundamentals of laser operations; bio-effects of laser radiation on eyes and skin; good safety practices; supervisor and employee responsibilities

Required once for all new users of Class IIIb or IV lasers.

Lecture & handouts
Additional Information

Spill Prevention Control and Countermeasures (SPCC) training

Discussion of Tufts' written SPCC Plan; oil storarage locations and loading procedures; review spill pathways, spill prevention and emergency response procedures

Required for all new facilities personnel who handle or store oil products and when there are significant changes to the plan or regulations

Lecture and Handouts
Additional Information

Laboratory Hazards for Tufts Police

In-Service Laboratory Hazards Training for all Tufts Police Officers. First Responder Training

Required for all officers and senior staff.

Lecture & handouts
Additional Information

Combined RCRA, Haz Comm, Confined Space, Lockout Tagout, Ladder Safety Training

RCRA, Haz Comm, Confined Space, Lockout Tagout and Ladder Safety regulations and procedures

Required for all Facilities supervisors and staff.

Lecture & handouts
Additional Information

Chemistry Graduate Student Laboratory Safety Training

General Lab Safety Practices for Chemistry Grad student

Recommended for all chemistry graduate students.

Lecture and Handouts
Additional Information

Boston School of Occupational Therapy Training

General Safety training for BSOT students

Required for all BSOT students.

Lecture and Handouts
Additional Information

Safe Lifting-Preventing back injuries

Mailroom Staff and Supervisors

Safe Lifting Techniques to minimize the risk of back injuries.

Lecture & handouts
Additional Information

Finance Division
Grant Management: Planning, Spending and Managing for Department Administrators

Topics covered include program income, the internal notice of grant award, proper acccounting, A21, A110, expense transfers, overexpenditures on grants, effort reporting and grant closeout.

Strongly recommended for all department administrators (dept managers, staff assistants, admin assistants, etc.) who support research faculty with grants.

Conducted in class, using PowerPoint presentation.
Additional Information

Grant Management Compliance for the PI

Topics covered include program income, the internal notice of grant award, proper acccounting, A21, A110, expense transfers, overexpenditures on grants, effort reporting and grant closeout. The content in this course is more summarized than the prior grant management course.

Recommended for all investigators at Tufts.

Conducted in class, using power point presentation.
Additional Information

PeopleSoft Reports

This course reviews the four basic PeopleSoft financial reports generated weekly: financial summary, transaction detail, open commitment, labor. Specific fields and drill down capability will be covered.

Recommended for all individuals who are designated as "manager" of each deptid and/or grant. Also recommended for those administrators who support such managers and provide assistance with budget and expenditure review.

Conducted in class, using PowerPoint presentation and logging into PeopleSoft
Additional Information

Department Salary Reporting and Projections

This course is a two-part course (demonstration and computer lab) and is for all employees who, per their School's Budget and Fiscal Officer, is given access and responsibility for managing the salary of all associated employees for their department. Specifics of the class include downloading data for projections, analyzing actual salaries in different formats and review of salary expenditures from a budget management view.

Recommended for those who have access to this report.

Conducted in class, using power point presentation, followed by hands-on exercises in a computer lab (in class #2).
Additional Information

Finance Forms, Policies and Procedures

Content includes all of the accounting forms used for internal and external procurement and the associated policies and procedures set by Tufts. Some federal regulations pertaining to the forms are covered. Areas of discussion will include interdepartmental requisitions, travel and business expense, hiring and paying consultants, requisitions and purchase orders and foreign tax/alien payment issues.

Recommended for all staff with financial administrative responsibilities, typically those persons that support managers, faculty or directors with the processing of finance forms.

Conducted in class, using PowerPoint presentation
Additional Information

Grant Compliance
Effort Reporting at Tufts
Expense Transfers on Grants
Obtaining a P-Card
P-Card Guidelines
Travel MasterCard
The Tufts Marketplace

These courses are available as e-learning courses and each online course is no longer than 15 minutes in length

Strongly recommended for all department administrators(dept managers, staff assistants, admin assistants, etc.) who support research faculty with grants.

Go to http://learncenter.uit.tufts.edu to register to become a user. Use your utln as a user name. Allow 48 hours for security set-up. Online courses can be launched by clicking on Finance, then on Web Based Training. A tip sheet can be obtained by visiting http://finance.tufts.edu/training/downloads/learning_center_tips.pdf, then clicking on Learning Center Tip Sheet.

Privacy and Security
HIPAA Privacy and Security Rules

Training of individuals in "HIPAA covered entities" whose positions involve access to HIPAA protected medical information

Required for all individuals whose positions involve access to HIPAA protected information

Online training courses
Additional Information

Gramm-Leach-Bliley

Video discusses the privacy and security obligations under the Gramm-Leach-Bliley Act. Applies to cerain operations that have access to nonpublic personal financial information.

Required of individuals in GLB covered offices, with access to nonpublic personal financial information, namely student financial services, bursar and treasury.

Online training courses
Additional Information

Office for Institutional Diversity
Americans With Disabilities Act On-Line Training program

Legal requirements and general overview of ADA law. Some sensitivity to managing employees or /teaching students with disabilities is included. Includes a brief overview of Tufts ADA policy.

Required for all new and exisitng Tufts managers and faculty members.

Online web access
Additional Information

Sexual Harassment On-Line Training Program

Legal overview of sexual harassment law; how to recognize sexual harassment in additionto the responsibilite's of managers.

Required for all new and exisitng Tufts managers and faculty chairs.

Online web access
Additional Information

Remedial training

Training that OID requires a department/unit to host as a result of one or more grievances filed under the non-discrimination policy. Grievance(s) can either be substantiated or not.

Usually required or strongly recommended.

Lecture/small group participation-style
Additional Information

Annual Sexual Harassment Training

Annual Sexual Harassment training that covers recent case law that may affect the internal processing of sexual harassment complaints.

OID staff, HR reps, sexual harassment resurce persons, legal counsel, and other upper-level managers required to attend.

Lecture/small group participation-style
Additional Information

Annual Affirmative Action Training

Training for all affirmative action officers on the aa officers council on new and progressive changes to affirmative action law.

Required of all affirmative action officers.

Group/lecture OR individual training one on one by OEO staff
Additional Information