Institutional Review Board - Policies and Procedures

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Contact Information
Overview of the IRB Process
Timeline for Application Review
Application Materials
Required CITI Training
Research Conducted as Part of a Class Assignment
Faculty Sponsors of Research

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Any member of the York College community who wishes to engage in research on human subjects must apply to the College IRB, and wait to receive approval from the Board before commencing with their research. If you have any questions about the IRB, contact the Chair of the IRB.

Contact Information

Questions, applications, and general correspondence relating to York College of Pennsylvania’s IRB should be directed to the Chair of the IRB. They will route materials to the appropriate party. Currently, the Chair is:

Overview of the IRB Process

The IRB’s page(s) in the YCP Knowledge base will provide current forms, directions, guidance, and other documentation necessary for investigators to follow the IRB process. Investigators should familiarize themselves with these documents and check the knowledge base before beginning a new or revised application.

The Principal Investigator (PI) must be a member of the YCP community; the PI will submit all application materials and will communicate with the IRB Chair regarding the application. If the PI is a YCP student, they must have a faculty sponsor of research.

A note on terminology: we use the terms “modification” and “amendment” to refer to changes to applications that have been previously approved by the IRB, and “clarification” to refer to additions to an application made during the consultation process but before approval. Clarifications may be in the form of additional information provided in response to questions from the IRB, or alterations to procedures that were described in the original application. Final clarifications should be collected in one formal document and submitted to the IRB as an appendix to the original application, or in an updated application, but they may result from a process of informal communication between the PI and the IRB.

Below is the process for seeking IRB approval for human subjects research:

1. Principal Investigator (PI) submits an initial application and supporting documentation (see Required Application Materials) to the Chair of the IRB by email (irb@ycp.edu)

2. The Chair of the IRB will acknowledge receipt of the application by email within three business days and initiate an initial review of the application for completeness. The application will then be sent back to the PI if incomplete or the review process will begin.

3. During the review process, protocols will be assessed to determine if they qualify for exempt or expedited review, or if they require full review. This determination will be made using the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) regulations (45 CFR 46) and associated supplementation materials provided by OHRP (ie., https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html)

4. The Chair of the IRB and/or members of the IRB will complete a thorough review of the protocol in accordance with the required type of review (ie., exempt, expedited, or full). Any concerns will be relayed by the Chair to the PI informally (through email and/or by voice). The IRB will work with the PI to find solutions to these concerns, and if necessary bring additional parties into the conversation who may provide useful advice or specialist knowledge.

   1. If necessary, investigators will submit clarifications to the original application.

5. Once the Board is satisfied that the proposed research meets appropriate standards, the Chair will send a memo to the PI indicating that the project has been approved and provide additional or summary information as necessary.

6. If, after a project has been approved, investigators find it necessary to modify their research, they should consult with the Chair about whether a formal modification needs to be submitted to the Board in order to continue with the research.

7. IRB approval lasts only for a calendar year, and research projects lasting more than a year will have to be resubmitted to the Board. The responsibility for completing or ceasing research, or renewing approval, rests with the PI.

The Chair will mediate between the Board and investigators unless they delegate this task to a member of the Board. The Chair may read a large portion of applications and is authorized to approve proposals on behalf of the Board. The Chair may also forward applications to members of the Board and either solicit their feedback or authorize them to oversee the rest of the steps outlined above for that project. When special expertise is needed to properly evaluate a research proposal, an application will be forwarded to a Board member with the relevant expertise, or an outside reviewer may be solicited. The IRB does not currently have funds to pay outside reviewers for their help, so such assistance must be provided pro bono. The entire IRB will only be asked to weigh in on a project when necessary (ie., full review).

Timeline for Application Review

Applications and modifications to applications will be acknowledged within three business days of receipt. Generally, PIs will receive either approval or requests for further clarification within one week of submission if a protocol qualifies for exempt or expedited review. If an application requires additional time for review, including full board review, PIs will be informed of this fact.

The IRB will not give approval to proceed with research until it is convinced all relevant issues have been adequately addressed. Our goal is to facilitate research and not to hold it up, but our chief obligation is to protect research participants and we will not compromise participant well-being, safety, or confidentiality in order to meet investigators’ timelines. That said, if you are under strict time pressure, let us know and we will do what we can to help you meet your deadlines.

Most of the applications we receive are fairly straightforward and easy to process; when delays occur, it is generally because initial applications were incomplete or missing necessary attachments. When we encounter highly complex or technical research projects, or those that entail greater risks to subject safety or privacy, or involve special or vulnerable populations, we may have to seek outside consultations and this can slow our response time. If you anticipate pursuing research along these lines, you are encouraged to make contact with the Chair as soon as possible, even before submission of application materials, so that we can begin planning for your submission.

Investigators are encouraged to check in with the Chair if an application or modification has not been acknowledged within a week, or if, in further stages of the process, they have not heard back from the IRB in what they consider a reasonable time.

Application Materials

For initial applications, please submit a completed application form (currently available for download on this page under "Attachments") along with all additional documentation (informed consent documents, surveys, descriptions of research or debriefing protocols, letters from relevant third parties, CITI training certificates, letter of support from faculty sponsor of research, etc.). Submissions will be deemed incomplete even if they are missing just one necessary attachment, so please double-check that you have included everything that you need to provide. If we realize that a document is missing, you can simply submit that at a later time; you do not need to resubmit the entire package. However, please be aware that careful review of application materials takes time, and we may have to re-review the entire application when a new attachment arrives. Thus piecemeal submission can (and generally does) slow our response time.

All of the above comments also apply to revisions of previously approved applications. Additiona

lly, please make clear in your revised application what has changed to facilitate a timely review of your protocol.

Required CITI Training (New for 1/1/24)

As of January 1, 2024, when submitting new protocols or amending or renewing existing protocols, all researchers (faculty or student) and faculty sponsors of research listed on a protocol will be required to complete the 9 required modules in the Social and Behavioral Research - Basic Course administered by CITI Program every three years. Certificates expire after 3 years and will need to be renewed by again completing the training.

Note that it takes roughly 2.5 hours to complete this course; please plan accordingly.

Instructions for completing CITI training

Follow these instructions for registering with CITI and accessing the required course content:

1. On https://about.citiprogram.org/, click register.

2. Click “Select your organization affiliation” and type in York College of PA; select “York College of PA”. Check the “I AGREE…” box and then the “I affirm” box.

3. Use your YCP email address and correct personal information to make your account. Create a username and strong password; save this information for later use. Answer additional questions before finalizing registration.

4. For “Your CE Credit Status” select “NO”

5. Enter your YCP email address again for “Institutional email address”

6. For role, faculty should select “Principal investigator” and students should select “student researcher” 

7. Read this next part carefully and select the appropriate responses for the questions.

   1. Question 1: select “Social and Behavioral Research Investigators:

   2. Question 2: Faculty should select “Faculty Researchers” and students should select “Student Researchers”

   3. Question 3: Do not check anything

   4. Question 4: Do not check anything

   5. Question 5: Select “Not at this time.”

   6. Question 6: Select “Not at this time.”

8. PLEASE NOTE: CITI may assign additional modules; You are only required to complete the “Social & Behavioral Research - Basic Course” to submit a research protocol to the IRB.

Depending on the nature of a submitted research protocol, additional CITI training modules may be assigned by the IRB chair on an ad hoc basis.

Researchers should submit their active (unexpired) CITI training certificate and the certificates of any collaborators or faculty sponsors as an attachment with their protocol documents. To access your certificate:

1. Once you have completed the Social and Behavioral Research - Basic Course, it should be listed under “Completed Courses”. 

2. Click “View - Print - Share Record” and then “View/Print” your Completion Report (quiz scores must be shown). 

3. Save the PDF and submit it with your application.

Research Conducted as Part of a Class Assignment

A class assignment is conducted by students enrolled in an official York College of Pennsylvania for-credit class. It typically only lasts while the student is enrolled in a class or specific sequences of classes. This designation is important because it establishes a supervising instructor, who is responsible for ensuring the ethical conduct of research and the protection of any human research subjects. We recommend that students complete CITI training as a course requirement before conducting any research project.

If the class assignment is designed to teach research methods or analyses to students through collecting, analyzing, and reporting results only to the instructor, the class assignment does not require IRB approval if all of the following conditions are met:

• The project is not intended to create new knowledge or lead to publication.

• Is typically initiated in a single term and ends with the semester of enrollment.

• Is conducted on campus or with persons known to the students.

• Does not involve any sensitive questions (such as sexual activity, victimization, use of any alcohol or illegal drugs, or illegal activities, disabilities or other health information—to name a few – If you are unsure use the IRB process).

• Does not involve vulnerable populations (such as those under the age of 18, prisoners, or cognitively impaired—to name a few – If you are unsure use the IRB process).

  • Classroom assignments involving research in a K-12 educational setting that would be "exempt" under 45r CFR § 46.104(d) should contact the IRB chair (irb@ycp.edu) for guidance

• Does not involve any possibility of physical, social, or psychological harm to participants.

• Does not involve a public presentation.

Additional Instructor Responsibilities and Requirements

The instructor is responsible for monitoring any unforeseen impacts of the data collection and making modifications as needed.

Printed instructions or a verbal instruction script that describes the course assignment and the name and contact information for the instructor must be provided to every participant. Emphasis should be placed in the instructions that participation is completely voluntary and can be ended at any point at the subject’s discretion.

Where possible, require anonymous data collection that is not linked to individuals.

 If identifying information is collected, it must be stored separately from information collected about the individuals.

Monitor student plans for classroom or group project data collection, analysis, and reporting and ensure design protections for everyone’s safety and confidentiality.

The destruction of the data at the completion of the course, or very soon after (no longer than two months after the conclusion of the semester).

Specific student instruction about the privacy and security vulnerability associated with networked computers as well as general privacy and vulnerability concerns.

If your assignment does not meet the criteria you should submit an IRB application for review; please be mindful of the IRB review processes and timeline.

Faculty Sponsors of Research (New for 1/1/24)

Faculty sponsors of research include instructors of courses in which students are completing IRB-approved research projects or faculty members who are mentoring student researchers. Students submitting research protocols to the IRB are required to have a faculty sponsor listed on their protocol as either a collaborator or an instructor. Students should obtain a brief letter from the faculty sponsor indicating their support for the project; this letter should be submitted with the research protocol.

All faculty sponsors of research (including instructors of courses in which students are completing research) are also required to complete CITI training. Their CITI training certificate should be submitted as part of the student’s research protocol (see Required CITI Training)