IRB Policies and Procedures
Policies & Procedures
- An Overview
- Application Process and Deadlines
- Approval of Research
- Closure or Withdrawal
- Continuing Review
- Deception or Incomplete Disclosure
- Departmental Review Boards
- Dietary Supplements
- European Union’s General Data Protection
- Exempt Review
- Expedited Review
- Full Review
- Incentives in Research
- Informed Consent, Parental Permission and Child Assent
- International Research
- IRB Administration
- IRB Review Process
- Mandatory Reporting
- Mandatory Training
- Non-English Speaking Participants
- Oral History
- Prisoner Research
- Records Retention
- Recruitment of Participants
- Reproductive Risk in Clinical Research
- Research Advisors
- Responsibilities of Investigators and Sponsors
- Revisions to Approved Research
- Separation of Principal Investigators
- Student Research
- Suspension or Termination
- Whistleblower Policy
The purpose is to outline the policies and procedures for mandatory educational training in human and animal research.
CITI is the Collaborative Institutional Training Initiative (www.citiprogram.org). Established in 2000 by the University of Miami and developed with the aid of other research institutions, it is the provider of high quality, peer-reviewed, and web-based educational courses in research ethics, regulatory oversight, research administration, and other topics pertinent to the interests of member organizations and individual learners.
Engaged in research activities with humans means that an individual during research:
- obtains the informed consent of human subjects;
- performs an intervention or interaction with human subjects for the purposes of the research; or
- works with identifiable, private information about the subjects of the research.
A Clinical Trial (for National Institute of Health purposes) is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Educational training in the protection of human subjects or animals is required for all investigators and sponsors/advisors involved in research with humans or vertebrate or non-vertebrate animals. Investigators include members of the research team, such as co-investigators and research assistants, but also may extend to others who work directly with subjects, such as live interpreters (human research).
All persons engaged in research activities involving human subjects must complete one, basic online course through the CITI site (www.citiprogram.org) and submit a completion report containing transcripts of modules taken to the Institutional Review Board or Exempt Review Committee. If a study will involve internal or external funding, but will not require committee approval, then evidence of training must be submitted to Research and Sponsored Programs before the project may begin.
- Human Research Course (HRC) - One basic course must be completed according to primary discipline or role in either:
- Social/Behavioral learner group
- Biomedical learner group
ADDITIONAL COURSES OR INDIVIDUAL MODULES ARE REQUIRED, as follows:
- Federal Funding (e.g., NSF, NIH, USDA etc.): Responsible Conduct of Research (RCR) course
- Clinical Trials Funded by NIH: Clinical Trial Researcher (includes Good Clinical Practice) course; NIH requires renewal every three years.
- FDA Oversight (e.g., drugs, some supplements, devices or biologics): Clinical Trial Researcher (includes Good Clinical Practice) course
- International Research (on foreign soil, including remotely): International module
- School of Social Work Students - Field Placements: Information Privacy Security course; submit to School of Social Work, not the IRB or ERC, since the SSW shares the CITI site for its own purposes.
Interpreters working directly with participants need to complete the Human Research course.
Transcriptionists, document translators, translators of de-identified audio recordings, or other hired professionals performing a specific skill (e.g., X-ray technician) are usually not considered to be engaged in research activities so long as they are not interpreting or analyzing results, and therefore may not be required to complete online training. Decisions about training for these individuals will be made on a case-by-case basis.
Consisting of several modules followed by brief quizzes, each CITI course takes approximately two to four hours to complete. No CITI refresher courses will be accepted.
Completion of the training courses is a one-time requirement and currently does not expire, except for those involved in an NIH-funded clinical trial.
Training evidence provided by investigators who are not affiliated with Marywood University will be evaluated on a case-by-case basis. Evidence of outside training must clearly indicate all topics covered in the course.The Human Research Curriculum (HRC) course covers topics such as:
The Responsible Conduct of Research (RCR) course covers topics such as:
Chart of Available Courses Required by IRB, ERC, IACUC or School of Social Work
Note: Members & Staff tracks are only for members of these boards or office employees. Do not complete Members & Staff tracks unless requested to do so.
|Courses||Tracks Within Courses|
|Human Research Curriculum (HRC)||Social & Behavioral OR Biomedical||Clinical Trial Researcher / Good Clinical Practice (Additional Track)
Only for investigators involving FDA-covered drugs, biologics or devices, or those conducting clinical trials funded by NIH. Such researchers must complete this in addition to the Biomedical basic course.
|Information Privacy Security (Additional Track)
The School of Social Work requires this track for field placements. Send reports directly to the SSW. Do not submit to the IRB/ERC.
|Responsible Conduct of Research (RCR)||Basic Track only required for those involved with federally funded projects which require this training (NSF, NIH, USDA, etc.)|
|Institutional Animal Care & Use Committee (IACUC)||Vertebrate Animal||Vertebrate Animal (Student)||Non-Vertebrate Animal|
- Visit the Collaborative Institutional Training Initiative (CITI) at www.citiprogram.org.
- If new to the website, click Register in the upper right corner of the page. If already registered, click Login.
- CITI's Step 1:
- Under Select Your Organization Affiliation, type Marywood University into the search box.
- Click the checkbox agreeing to the Terms of Service.
- Click Continue to Step 2.
- CITI's Steps 2, 3 and 4: Supply your name, email address, username, password and country of residence.
- CITI's Step 5: Click yes or no to indicate if you will purchase continuing education credits (optional; not required by Marywood University).
- CITI's Step 6: Indicate language preference and other institutional specific questions.
- CITI's Step 7: Enroll in required courses by checking the appropriate boxes under each section.
- Question 1 (Human Research Course): Those working with human subjects will check a box for one learner group within this course (e.g., social/behavioral, biomedical, etc.). The IRB Members and Staff group is only for those serving on the IRB or working in the IRB office.
- Question 2 (Responsible Conduct of Research Course): If you will be working on a federally-funded project requiring RCR, check the box next to this basic course.
- Any additional requirements are described above in the policies.
- Click Finalize Registration. You will now be able to access the Main Menu of your account. Learners may complete course content on their own schedule and sign in any time to view their progress.
- To begin a course, click on the course name.
- If you need to change your course registration, click on Add a Course or Update Learner Group.
- After each course is completed, the CITI system will make available a completion report for downloading.
Accessing Completion Reports and Submitting via IRBNet:
- Visit the Collaborative Institutional Training Initiative (CITI) at www.citiprogram.org and log in on the homepage .
- Under Completed Courses, locate the course you wish to access. Then, click the yellow View-Print-Share Record button.
- On the left and under Completion Report, click the View / Print button. The board requires the full report (transcript) version, which will show all completed modules and course grades. Do not click Completion Certificate.
- Save the .pdf document to a computer or flash drive.
- Log in to IRBNet at www.irbnet.ort, and upload and submit the training reports in one of the following ways (see also IRBNet Instructions for Researchers document). Do not use IRBNet's "External Account" transfer feature. Marywood University does not subscribe to it, so it will not function.
- Upload the report to the project package with other application materials. Submitting the reports in this manner will require the action to be repeated with each new project if you have more than one.
- Upload the report directly to your IRBNet user profile (must be your own profile, not another's). Submitting the reports in this manner will take place one time (exception: NIH clinical trial requirement) and carry across multiple IRBNet projects. You do not need to link training reports to a particular study, as staff will see them so long as they've been uploaded into your IRBNet user profile.
Questions about online training requirements or the CITI website should be directed to Ms. Courene M. Loftus, MPA, CIP, at (570) 961-4782 or firstname.lastname@example.org.
- Educational Training in Human Participants Protection for Investigators (Research Team)
- Educational Training in Human Participants Protection for IRB Members and IRB Administrative Personnel
- Educational Training in Responsible Conduct of Research
- Educational Training in Animal Research
08/30/2013 - Updated
07/07/2014 - Updated with the word biologics; chart adjusted
04/10/2015 - Updated with additional information on Information Privacy and Security
07/31/2015 - Updated procedures and contact information for questions
12/14/2016 - Updated to include new contact information and Animal policy link (related policies)
02/28/2017 - Updated instructions about full completion report with modules instead of general certificate
06/09/2017 - Updated CITI definition and added link
09/14/2017 - Updated procedures to match revised CITI site
03/15/2018 - Updated NIH-related definition and training requirements; updated procedures section
05/14/2018 - Updated RCR content, per a change approved by Marywood University's Policy Committee
05/23/2018 - Added that IPS course report should be submitted to the SSW
09/06/2018 - Updated how to submit reports
09/20/2018 - Updated additional courses for clarity
12/12/2018 - Updated procedures to reflect updates to CITI's website.