Frequently Asked Questions (FAQ)
IRB Review of Research
Types of Review
Letters of Agreement
IRB REVIEW OF RESEARCH
Any activity that meets the definition of "human subjects" and "research" by the federal regulation needs IRB review.
"Research" is defined as a systematic investigation designed to develop or contribute to generalizable knowledge (e.g., dissemination of findings through publications and/or presentations at regional/national/international conferences with the intention to apply the results to a larger population beyond the site of data collection or the population studied).
"Human subjects" is defined as a living individual about whom an investigator conducting research: 1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or 2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
If you are working with existing data that contains private information with direct identifiers (e.g., name, social security number) or indirect identifiers (e.g., study code), it meets the definition of "human subjects" and therefore IRB review is needed.
If the primary goal is to evaluate the program for internal purposes (not for generalizable knowledge), it does not meet the definition of "research" and therefore does not need IRB review.
For collaborative research involving multiple institutions that are considered "engaged" in research (please see the guidance document that explains when an institution is considered engaged), an Institutional Authorization Agreement (also known as the Reliance Agreement) can be established for a single IRB review. The IRB of Record (reviewing IRB) will be responsible for reviewing and approving the collaborative research and other institutions will rely on the IRB of Record to eliminate the need for a separate, independent review.
If the primary goal is to fulfill a course/major requirement (not for generalizable knowledge), it does not meet the definition of "research" and therefore does not need IRB review.
Faculty advisors must review all the IRB documents prior to submission and write a Faculty Statement. Please visit our IRB Submission and PACS page to download the Faculty Statement template.
All submissions are facilitated through PACS. Please visit our IRB Submission and PACS page for more information and to access PACS.
All submissions are reviewed as soon as they are received. We highly recommend that you submit your IRB application as soon as possible to provide sufficient time for review and approval. Please note that studies that require full board review are reviewed at our monthly convened meeting during the fall and spring semesters. Although initial feedback can be provided any time during the year for research requiring full board review, a decision to approve/approve with contingencies/reject will not be made until the scheduled convened meeting. The deadlines for research requiring full board review are available on our HSRRC website.
You can access the IRB forms/templates as well as detailed instructions on how to submit an IRB application on our IRB Submission and PACS page. Please be sure to use the most recently updated forms/templates.
All investigators, faculty supervisors (when applicable), and research personnel are required to complete a human subjects research training available through CITI. Depending on the nature of your research, you may take Group 1: Biomedical Research Training or Group 2: Social and Behavioral Researchers Training. Please visit our Training and Education Requirement page for more information.
All investigators, faculty supervisors (when applicable), and research personnel (e.g., research assistants) listed on the protocol must complete the required human subjects research training.
CITI certification is valid for 4 years.
If you have a valid CITI certification for conducting human subjects research from another institution, you do not need to complete the training again. Please be sure to upload your CITI certification along with your IRB application in PACS.
TYPES OF REVIEW
Research that involves minimal risks and falls into one of the eight federally defined exempt categories can receive exempt determination. However, exempt research still requires IRB review although they are exempt from some of the federal regulations. These studies are reviewed by the IRB Coordinator. Exempt review process is less rigorous than expedited and full board research but is held to the same ethical standards to protect the human subjects involved in research.
Research that involves minimal risks and falls into the federally defined expedited categories can receive expedited review. Expedited reviews are conducted by the IRB member(s) and must adhere to the federal regulations.
Studies involving vulnerable population and/or more than minimal risks are reviewed at a convened meeting by the full board. Please contact our office to discuss whether your research will likely require full board review.
Exempt research: You will receive a response within 2-3 business days after the submission of your initial IRB application and 1-2 business days from receipt of any subsequent requests for revisions and/or documents. Time from initial receipt to final approval is dependent on the response time of the investigator to submit the requested revisions and documents. Once all the requested revisions and documents are received and accepted, the approval letter will be sent within 2 business days.
Expedited research: You will receive a response within 2-5 business days after the submission of your initial IRB application and 2-3 business days from receipt of any subsequent requests for revisions and/or documents. Time from receipt to final approval is dependent on the response time of the investigator to submit the requested revisions and documents. Once all the requested revisions and documents are received and accepted, the approval letter will be sent within 2 business days.
Full Board research: Although initial feedback can be provided within 2-5 business days after the submission of your initial IRB application, research requiring full board review are reviewed at a convened meeting which occurs monthly September-December and February-May. A determination letter (to approve/approve with contingencies/reject) will be sent 1-2 business days after the convened meeting.
*International research may take longer to review as consultation from an expert is sought to gain sufficient knowledge of the local research context.
Informed consent template is available on our IRB Submission and PACS page. Please use the updated template on our website and adapt to your study.
The Common Rule (federal regulation for protecting human subjects in research) allows IRBs to waive the requirement for obtaining informed consent or to approve an informed consent that omits some or all of the required elements of informed consent. In order for the IRB to waive or alter consent, the following requirements have to be met:
- The research involves no more than minimal risk to the subjects;
- The research could not practicably be carried out without the requested waiver or alteration;
- If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
- Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
The Common Rule (federal regulation for protecting human subjects in research) allows IRBs to waive documentation of informed consent (i.e., obtaining signature) in the following circumstances:
- The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;
- The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
- If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
Yes. Complete the 'Waiver of Documentation of Consent' section of the protocol narrative and adjust your informed consent accordingly.
No. Electronic informed consent is acceptable as long as it contains all the required elements of informed consent. Please use the informed consent template available on our IRB Submission and PACS page and adjust your informed consent accordingly.
Stamped informed consents are available in PACS. Please click the 'Documents' tab within your approved study and download the PDF version of the informed consent under 'Final.'
You must submit a modification through PACS for any changes you make to your research procedures, research personnel, consent documents, recruitment, study population, compensation, data collection tools, etc.
If your study received expedited approval prior to the implementation of the Revised Common Rule (Jan 21, 2019), you need to submit a continuing review through PACS. Continuing review requirement for expedited research does not apply to expedited studies approved on or after the implementation of the Revised Common Rule. Exempt research (regardless of when it was approved), does not need continuing reviews. Research approved by the full board requires continuing review through PACS.
You may close your study if all the research milestones below are complete:
- Study is permanently closed to enrollment OR was never open for enrollment;
- All subjects have completed all study-related interventions OR not applicable (e.g. study did not include interventions, no subjects were enrolled);
- Collection of private identifiable information is complete OR not applicable (no subjects were enrolled); AND
- Analysis of private identifiable information is complete OR not applicable (no subjects were enrolled);
You can submit your modification/continuing review/closure through PACS by clicking 'Create Modification/CR' within your approved study.
LETTERS OF AGREEMENT
Yes. If you are recruiting students from a classroom, you need a letter of agreement from the instructor. Please use the letter of agreement template available on our IRB Submission and PACS page and adjust the letter accordingly.
If you are simply posting flyers, a letter of agreement may not be needed. Please contact our HSRRC office (email@example.com/ 607-777-3818) to verify whether a letter of agreement is required for your study.
If you are recruiting patients (or employees) from local clinics, you need a letter of agreement from the clinic stating that they give you permission to recruit their patients (or employees). Please use the letter of agreement template available on our IRB Submission and PACS page and adjust the letter accordingly.
If you are simply posting electronic flyers, a letter of agreement may not be needed. Please contact our HSRRC office (firstname.lastname@example.org/ 607-777-3818) to verify whether a letter of agreement is required for your study.
- Breach of confidentiality
- Psychological/emotional discomfort/distress
- Social risks (e.g., embarrassment, alterations in relationships with others, loss of respect from others)
- Economic risks (e.g., loss of employment, financial costs)
- Legal risks (e.g., criminal prosecution)
It is possible that there may be no foreseeable risk associated with participation in research. However, please carefully assess any potential risk (even if it's low in probability and magnitude) and consult the HSRRC office if you have any questions (email@example.com/ 607-777-3818).