Institutional Review Board

As per the regulations laid down by the Department of Health and Human Services (DHHS), the term “human subject” pertains to a person who is alive and is the subject of investigation by a researcher, whether they are a professional or a student. This includes situations where the investigator obtains information or biological samples through interaction or intervention and subsequently utilizes, examines, or analyzes said information or samples. It also covers instances where the investigator acquires, utilizes, studies, examines, analyzes, or produces identifiable private data or biospecimens.

This research endeavor is a methodical examination that encompasses the development, experimentation, and assessment of data, with the aim of contributing to knowledge that can be applied in a broader context.

• Presenting the study’s results and outcomes at a conference or submitting them for publication is considered to be “generalizable knowledge.”

• However, if the findings are employed or executed exclusively for internal purposes, they do not meet the criteria for “generalizable knowledge.” If there are any queries or concerns, they should be communicated in written form to IRB@noordacom.org.

The IRB recommends that the Principal Investigator (PI), who is a faculty member, draft and submit the protocol as the individual who will assume primary responsibility of the proposed research investigation. Noorda COM students may be involved as part of the research team.  All members of the research team are under the supervision of the faculty member, as the PI.

The PI and all involved study team members are required to complete a set CITI training courses (Link: https://noordacom.box.com/s/k52bjm9ury0ev6f9b0ona6mr382wsgvm)

Save your certificates (sample shown below) and attach with IRB submission.

To comply with Noorda College of Osteopathic Medicine’s (NoordaCOM) IRB policies, the Principal Investigator (PI) of a research project must be a member of the NoordaCOM faculty or staff. This is necessary as faculty/staff would serve as the primary point of contact. Student researchers must be identified as “Student Researchers” or “Staff.” Co-PIs or Co-investigators can either be from NoordaCOM or external institutions. Furthermore, PIs are expected to be aware of the institution’s regulations and assume overall responsibility for human subject research.

PIs are required to:

• Submit all human subject applications and communications with NoordaCOM’s IRB

• Maintain and safeguard the IRB documents and study files

• Keep records in accordance with the institutional and federal record retention guidelines

• Develop and comply with data and safety monitoring plans

• Appoint and train study staff and team members

• Address and resolve participant grievances and issues.

The submission is reviewed for completeness and internal consistency. Based on that administrative review, the investigator may receive a ‘Changes Requested’ email asking for corrections, clarifications, or additional documents. The next step is review based on the level of IRB review.

The IRB Committee meets once a month. New IRB submissions are recommended to be submitted 2 weeks prior to the meeting date. Well-prepared submissions result in fewer requests for clarifications, modifications, or additional materials. Rapid response from the PI helps speed the approval process. IRB submission reviews may take 4- 8 weeks. Expedited and Exempt submissions may have a shorter turn-around time. There may be additional time if an ad-hoc reviewer is needed.

Things that may delay approval:

• Incomplete application: Missing information and/or documents
• Failure to cross-check information on the application, consent form, and additional documents
• Failure to proofread the application and relevant documents

Reviewers look at purpose/hypothesis, methodology, handling of informed consent, interactions with high risk or sensitive issues, study risks and benefits, participant and data confidentiality, collection, and storage. Provide as much information as possible so reviewers have a clear understanding of the study design and the PI’s efforts towards the protection of human subjects.

For a copy of the NoordaCOM IRB rubric click here: (https://noordacom.box.com/s/ai7jeji3lcet1j0ef0lvfz8qwzm65ne8)

• Approved: The PI is notified that the application is approved and does not require modification.

The approval period for any research is 1 year.

• Request for revision & resubmission: Additional information, clarification, or revisions are requested by the IRB. The PI must complete the revisions and resubmit the responses to the specific inquires along with revised forms and documents. This is the most common outcome. PIs are recommended to allow adequate time for the IRB review. It should not be assumed that immediate approval is obtained with the initial IRB Committee meeting.
• Tabled: If the proposal generates significant discussion, requires discussion with an ad-hoc reviewer, or needs additional time for review/discussion, the application will be reviewed at a subsequent IRB meeting.
• Disapproved: If applications are judged to be ethically or scientifically unsound. This is a rare, but possible outcome.

Under no circumstances may a research investigation be started before the IRB decision on approval or exception is received.

• Full committee (Non-exempt) review: Any study involving greater that minimal risk, including studies with vulnerable questions or sensitive questions.
• Expedited IRB review: Research involving no more that minimal risk to subjects, including minimal amounts of biospecimens, review of records and data, and survey research. The IRB Chairs or a designated IRB member can review and provide recommendations.
• Exempt IRB review: Research with minimal risks to human subjects. May include educations tests, surveys, interviews, or review of documents/records.

Exempt, Non-exempt, and Limited review forms can be accessed from the IRB Box folder.

Every participant must provide their consent unless the IRB has granted a waiver for the consent or one of its components, or the research has been determined to be exempt by the IRB.

A sample consent is provided here.

There are circumstances where a waiver of documentation of consent may be granted by the IRB. In all cases, the IRB requires a document that will be used for consent purposes. This could be in the form of short text, a cover letter, or a script, ie when consent will be presented orally.

Forms for Deviations, Adverse events, and Amendments can be accessed from the IRB Box folder.

When the study is finished, the PI must submit a Study Closeout Report form, which can be accessed from the IRB Box folder.

• Do nothing if the study is not being continued
• If the study is to be continued, and the IRB approval has lapsed, a new IRB submission is required. The PI would need to state that this is a resubmission of a previously approved study and include the original NCOMIRB#