IRB Policies and Procedures
Policies & Procedures
- An Overview
- Application Process and Deadlines
- Board Authority and Composition
- Board Determinations
- Closure or Withdrawal
- Continuing Review
- Deception or Incomplete Disclosure
- Dietary Supplements
- Exempt Review
- Expedited Review
- Full Review
- General Data Protection Regulation
- Incentives in Research
- Informed Consent and Assent
- International Research
- Mandatory Reporting
- Mandatory Training
- Non-English Speaking Participants
- Oral History and Journalism
- 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 research.
CITI is the Collaborative Institutional Training Initiative (www.citiprogram.org). Established in 2000 by the University of Miami and currently operated by the Biomedical Research Alliance of New York (BRANY), 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.
A clinical trial 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 biomedical or behavioral health-related outcomes.
Engaged in research activities with humans means that an individual during research:
- obtains the informed consent of human subjects (including explanation of research and answering questions);
- 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 Human Subject (Participant) is a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
International Research is research which is proposed to take place outside of the United States. It may involve activities which take place on foreign soil, which access foreign human subjects remotely (e.g., Internet), or which access data about human subjects from the foreign location.
Once registered at the CITI Program's site at www.citiprogram.org, CITI users may add a training course or learner group to their account at any time. Marywood University's available courses will be shown under a series of five questions, as shown in this table. Investigators should take note of where to submit their completion reports, also indicated in the table.
|Available Courses||Learner Groups within Courses||Complete If||Where to Submit Report||Must Be Renewed|
|Question 1 at CITI
Clinical Trial (Good Clinical Practice)
Staff & Members
|Working with human subjects or identifiable human subject data in research||ERC or IRB via IRBNet||N/A|
|Question 2 at CITI
Responsible Conduct of Research
|N/A||Involved in a Federally funded research project||ERC or IRB via IRBNet||Every 3-4 years (refer to funding source)|
|Question 3 at CITI
Information Privacy Security
|N/A||A student in the School of Social Work||SSW Staff||N/A|
|Question 4 at CITI
Vertebrate Animal- Student
|Working with animals in research or during class activities||IACUC via IRBNet
|Question 5 in CITI
|N/A||A student in the Physician Assistant Program||PA Professor||Unknown|
Educational training in the protection of human subjects is required of all investigators who are engaged in such research. This includes all members of the research team, such as co-investigators and research assistants, but may extend to others who work directly with subjects, such as live interpreters. Research advisors (sponsors) and IRB staff and members must complete this training as well.
Educational training is conducted online through the CITI Program at www.citiprogram.org. Consisting of several modules followed by brief quizzes, each basic CITI course takes approximately two to four hours to complete. Completion of the human training courses is a one-time requirement with no current expiration. Besides human research, CITI makes available several other courses, some solicited by other campus departments, as listed in the above chart or described in more detail, below. Investigators must submit evidence of human research training to the Exempt Review Committee or Institutional Review Board online in the form of completion reports, which show all transcripts (modules and grades). Certificates or "refresher" courses will not be accepted.
- Responsible Conduct of Research Course (RCR) – For Federally Funded Projects
Presenting topics such as authorship, collaborative research, conflict of interest, peer review, research misconduct and responsible mentoring, this course is required only if certain Federal funding will be awarded (e.g., NSF, NIH, USDA, etc.). Learners must earn a minimum passing score of eighty (80) percent for this course. Completion reports are to be submitted to the IRB or ERC, if the course applies. The course must be renewed at intervals set by Federal funding agencies (e.g. four years for NIH clinical trials; three years for other awards). Due to the variable timetables, the CITI site does not establish expiration dates. It is an investigator's responsibility to ensure that training is kept up to date.
- Information Privacy and Security Course - For School of Social Work Students
Presenting the basics of health privacy and information security, this four-module course is required by the School of Social Work (SSW), which uses the CITI site to meet its own requirements for field placements. Completion reports are to be submitted directly to the department, not to the ERC or IRB. Learners must earn a minimum passing score of eighty (80) percent for this course. Optional modules are available as part of the course.
- Animal Research Course(s) - For Vertebrate or Invertebrate Research or Class Demonstration Projects
Presenting such topics as animal care and use, lab procedures, or classroom activities, this course and the learner groups within it are required and managed by the Institutional Animal Care and Use Committee (IACUC). Learners must earn a minimum passing score of eighty (80) percent for this course. Completion reports are to be submitted directly to IACUC via IRBNet. When funding is involved, the Office of Research and Sponsored Programs should also be sent a copy.
- Bloodborne Pathogen Course - For PA Program Students
Presenting such topics as Hepatitis B vaccination, engineering controls, universal precautions and work practices, and emergency response, this five-module course is required by the Physician Assistant (PA) Program, which uses the CITI site to meet its own requirements. Completion reports are to be submitted directly to the requesting professor, not to the ERC or IRB. Learners must earn a minimum passing score of eighty (80) percent for this course.
Available within the human research course, the International module is listed as optional for the majority of learners. However, it must be taken by investigators who will be involved with International research.
Because they interact with participating subjects and are often engaged in the informed consent process, live interpreters must complete the Human Research course. Transcriptionists, document translators, interpreters 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.
How to Register and Select Courses at CITI:
- 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.
- CITI's Steps 2, 3 and 4: Supply your name, email address, username, password and country of residence. If you have a secondary email account, add it. If not, leave it blank.
- CITI's Step 5: Click yes or no to indicate if you will purchase continuing education credits. This involves a fee and is optional.
- CITI's Step 6: Indicate language preference and other institution-specific questions.
- CITI's Step 7: Enroll in required courses by checking the appropriate boxes under the below sections. You can also return later to add them by selecting your institution and then scrolling to the bottom of the page to click "Add a course."
- Question 1 - Human Research Course: Those working with human subjects will typically select one learner group. The Social/Behavioral course is most common. Those working on an FDA-monitored clinical trial (e.g. drugs, biologics, devices) must take both the Biomedical and Clinical Trial (Good Clinical Practice) courses. Only those serving on the IRB or working in the IRB office may select the IRB Members and Staff course. It contains both Social/Behavioral and Biomedical course modules, including one module specific to members.
- Question 2 - Responsible Conduct of Research Course: Those working on a Federally funded project requiring this basic, RCR course will choose this selection in addition to the human research course or courses. It is most common for NIH, NSF and USDA. Refer to the funding agency.
- Question 3 - Information Privacy and Security Course: Those in the School of Social Work (SSW) involved in field placements may be asked by the SSW to select this course. IT IS NOT REQUIRED BY THE IRB/ERC. Do not submit this report to the IRB or ERC. The SSW uses CITI for its own purposes. Submit your report directly to the SSW only.
- Question 4 - Animal Research Course: Those working with animals will select the appropriate course. Do not submit this report to the IRB or ERC unless it asks. Submit your report directly to the IACUC via IRBNet and/or the Office of Research & Sponsored Programs.
- Question 5 - Bloodborne Pathogen Course: Those in the Physician Assistant (PA) Program may be asked by a professor to select this course. IT IS NOT REQUIRED BY THE IRB/ERC. Do not submit this report to the IRB or ERC. The PA Program uses CITI for its own purposes. Submit your report directly to your requesting professor only.
- 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 at the bottom of the page when viewing the courses for you institution.
- After each course is completed, the CITI system will make its completion report available for downloading. See How to Access Your Completion Report below to retrieve it.
How to Add a Course after Registration:
- Visit the Collaborative Institutional Training Initiative (CITI) at www.citiprogram.org and log in.
- Next to Marywood University or your home institution, click the blue View Courses button.
- Scroll to the bottom of the page, and click Add a Course.
- Choose the appropriate course(s). If you add the wrong course, choose Remove a Course, which is also listed on the screen described in step 3.
- Complete the course(s) at your leisure. After completion, the CITI system will make its completion report available for downloading. See the below steps to retrieve it.
How to Affiliate with Marywood if Unaffiliated:
If you are not affiliated with Marywood University and the ERC or IRB determines that your institution is missing some required modules, it may ask you to affiliate with Marywood to select those modules. If you affiliate with Marywood and select a course that you have already taken, any previously taken modules will automatically carry over, so long as the course numbers are exactly the same. This should leave you with only outstanding modules to complete.
- Visit the Collaborative Institutional Training Initiative (CITI) at www.citiprogram.org and log in.
- On the main screen under Institutional Courses, select the Add Affiliation button.
- Type in Marywood. Once located, click on its name.
- Read the information provided, check the boxes, and then click Continue.
- Supply requested information and finalize your affiliation. When it asks you to select courses, select the appropriate ones based on the above chart and policies.
How to Access Your Completion Report at CITI:
- Visit the Collaborative Institutional Training Initiative (CITI) at www.citiprogram.org and log in on the homepage.
- Next to Marywood University or your home institution, click the blue View Courses button
- Under Completed Courses, locate the course you wish to access. Note that if you have taken the human course's social/behavioral learner group, it will be labeled as "Social Behavioral Research Researcher, Student or Sponsor." The SSW's Information Privacy Security course is labeled here as either "Researcher" or "Clinicians."
- Click the gold View-Print-Share Record button for the appropriate course.
- On the left under Completion Report, click the blue View/Print button. This will access the full transcript (modules and grades). DO NOT click the button under Completion Certificate on the right.
- Save the .pdf document to a computer or flash drive.
- If submitting to the ERC or IRB, continue with step 8, below. If you have taken an IPS, IACUC, or Bloodborne Pathogen course, submit to the appropriate department as outlined in the above chart.
- 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 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 (as long as there's no expiration date) 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 have been uploaded into your IRBNet user profile.
Questions about online training requirements or the CITI website should be directed to email@example.com or 570-348-6211, x. 2418.
Related Institutional Policies
- Educational Training in Human Participants Protection for Investigators
- 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
07/05/2019 - Updated as a result of the Revised Common Rule
08/25/2020 - Updated the CITI instructions for learner group selection
10/19/2020 - Clarified the RCR training renewal requirement
04/21/2021 - Updated definitions, course information, chart, and procedures