Beginning a new research project

Human Subjects Protection Training:

All individuals listed on protocols submitted to the IRB must complete an appopropriate Human Subjects Protection Training course (NIH training or CITI). This includes students, staff, faculty, and non-Messiah personnel. Recently, the NIH has discontinued their free training course, however the slides and quizzes are availble for free at the links below. A PDF of the training material and a link to the previous NIH training questions are below. Successful completion is defined as receiving an 80% on the quiz. A screenshot of the last page of the quiz (or completion page of other training) must be uploaded into the "PI Documentation" section of each individual's Axiom account before a protocol can be submitted for review. 

NIH Protection of Human Research Participants Course Material

NIH Protection of Human Research Partcipants Quiz Questions

Principal Investigator Responsibilities: 

It is the policy of the Messiah University IRB that the Principal Investigator (PI) on IRB submissions must be an employee of the University throughout the duration of the proposed project. If the PI of an approved project leaves the University before the end date of the project, a new PI must be named using an amendment form before research on the project can continue. 

Adjunct Faculty: Adjunct faculty may serve as PI if one of the following is true:

  1. the start and end dates of the project will fall within their contracted term with no break in the contract occurring during the project
  2. they are serving as the faculty advisor on a student project for a student enrolled at Messiah
  3. they have received approval from the Office of the Provost in which case a  letter from the Provost’s Office should accompany the IRB submission.

PI Responsibilities:

The PI of the study is responsible for:

  1. Ensuring that the IRB submission is complete and accurate
  2. Ensuring that all investigators (including students) have completed the Messiah University human subjects training program (or equivalent)
  3. Ensuring that recruitment is taking place using only the approved methods as outlined in the IRB submission
  4. Obtaining informed consent from human participants using the exact consent form that has been approved by the IRB, providing a copy of the consent to participants, maintaining records of consent documents, and supplying those records to the IRB upon request
  5. Assigning a new PI to the project in the event of discontinuation of employment at the University or extended leaves of absence (i.e., sabbatical, vacation, illness)
  6. Notifying the IRB of an adverse events using the Adverse Event reporting form in Axiom
  7. Notifying the IRB of any proposed changes to the protocol using the amendment form on Axiom and waiting to implement those changes until approval has been granted
  8. Ensuring that the project is conducted in a manner that protects the rights and welfare of human subjects, strictly adheres to the protocol as described in the IRB submission and complies with all HHS and University regulations
  9. Submitting continuing review prior to the expiration date of IRB approval. If the PI does not apply for continuing review, all study activity involving human subjects must stop until approval is granted.

How to Submit a Project for IRB Review:

All proposals must be submitted through Axiom Mentor. Instructions and PDF versions of the forms can be found on the Axiom Mentor site. If you have any questions, please contact the Office of the Provost.

All IRB proposals must be submitted a minimum of 30 days before expected start of the research. Research involving vulnerable populations (children, elderly, pregnant women, persons with mental impairment, prisoners, LGBT+, etc) will require a full IRB review and may take longer than 30 days. IRB proposals submitted after April 15th will be reviewed the following academic year at the end of August.