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Frequently Asked Questions about the IRB Process
It is important the IRB follows all regulatory guidelines. The government may shut down an IRB if they do not adhere to this practice.
The abbreviation IRB denotes “Institutional Review Board”. Its objective is to scrutinize and sanction research proposals carried out by Noorda College of Osteopathic Medicine (Noorda COM) or its investigators that involve human participants. The foremost aim of the IRB Committee is to safeguard the well-being and interests of the human subjects involved in the study.
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.
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#
The 3 Levels of IRB Board Review
There are three levels of IRB review: Exempt, Expedited, and Full Board Review. Please read about all three before making a determination about your specific project.
If you are still unsure about a specific project, contact the IRB Chair for assistance.
Studies that are determined to meet exempt status are not exempt from human subject protections and ethical principles but are exempt from some regulatory and institutional criteria.
Categories of Research that qualify as Exempt:
1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures [if minors are involved, Full Board review is required], interview procedures [if minors are involved, Full Board review is required], or observation of public behavior UNLESS (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects, and (ii) Any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is NOT already Exempt under #2 if: (i) The human subjects are elected or appointed public officials or candidates for public office, or (ii) Federal statute(s) require(s) without exception that confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. Research involving the collection or study of existing data, documents, records, or pathological or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by or subject to the approval of [Federal] Department or Agency heads and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs, (ii) procedures for obtaining benefits or services under these programs, (iii) possible changes in or alternatives to those programs or procedures, or (iv) payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies, (i) If wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Research that is classified as Expedited only needs to be reviewed by the chair or by a qualified member of the IRB that has been designated by the chair. It is, however, subject to annual review.
A research project is appropriate for Expedited review if it involves only minimal risk, but is not classified as Exempt. Minimal risk is defined as risk that is not greater than what one encounters in ordinary daily life or during the performance of routine physical or psychological examinations or tests.
If your project involves more than minimal risk to participants as defined previously, your project requires a Full Board review.
Protocols involving any of the following will also require Full Board review:
1. Minor subjects (children 17 years of age or younger)
2. Special populations (prisoners, pregnant women, individuals with disabilities)
3. The use of video or audiotape to record subjects
4. Asking questions that may be highly embarrassing or compromising (e.g., sexual behavior, sexual orientation, alcohol consumption, illegal drug use, medical conditions, violations of the law, personal finances, problems in the workplace, etc.)
5. Exposing subjects to graphically violent or pornographic materials
6. Inflicting physical pain upon, attaching electrodes to, or injecting any substance into subjects
7. Creating high levels of stress, fear, discomfort, or tension
8. Threatening subjects in any way
9. Causing subjects to violate laws or official university regulations
10. Providing some subjects with benefits denied to others (this includes payments or rewards for participation, e.g., offering extra credit to participants, etc.)
11. Causing physical or mental exhaustion or engaging subjects in intense exercise
12. Placing individuals in confining physical settings or attaching other devices
13. Exposing subjects to extreme conditions (e.g., bright lights, loud noise, intense pressure, strong odors, complete darkness, extreme heat or cold, sudden movement, etc.)
14. Leaving subjects alone for periods of time longer than 20 minutes
15. Taking hair samples or nail clippings from subjects
16. Taking human tissue samples, drawing blood, or sampling any other bodily fluid
CITI Course Registration
- Biomedical Responsible Conduct of Research
- Research Study design
- Conflicts of Interest
- Revised Common Rule
- Biomedical Research, Basic or Refresher
- Biomedical Responsible Conduct of Research
- Biomedical Data or Specimens only
- Good Clinical Practice
- Health Information Privacy and Security for Clinical Investigators
- Social and Behavioral Best Practices for Clinical Research, if applicable
- Social, Behavioral & Education Research
- Public Health Research