I. CLASSROOM PROCEDURES FAQ
Q: What must all faculty teaching any research methods course know regarding Classroom Human Subjects (HS) Research Guidelines?
A: Please click on the following link for assistance with determining when classroom research is purely for instructional purposes and when it is Human Subjects research requiring the review of SHSU's Institutional Review Board (IRB), also called the Protection of Human Subjects Committee (PHSC): Classroom HS Research Guidelines.
Q: To what classroom projects do the HS research guidelines apply (see Definitions FAQ below)?
A: The guidelines apply to human subjects research conducted purely for pedagogical purposes that does not meet the definition of human subjects research that would require PHSC approval. The guidelines are intended to apply to those courses where students are being taught research methodology and are required to develop and conduct a research study involving human subjects. The assignment must be clearly stated in the course syllabus, and the research project is to be performed by students enrolled in an undergraduate or a graduate course at SHSU as a requirement for completion of the course.
Q: What are some examples of class projects that need PHSC review?
A: Many graduate level research (see Note below) and a few undergraduate courses require students to conduct research that meets the definition of human subjects research. These class projects require IRB review and approval. Investigations designed to develop or to contribute to generalizable knowledge are those that seek to draw general conclusions, inform policy or generalize findings beyond a single individual or an internal program.
Note: Thesis or dissertation projects involving human subjects conducted to meet the requirement of a graduate degree are considered generalizable, and require IRB review and approval.
II. CONTACTS FAQ
Q: Who do I contact with questions regarding Compliance (CITI, IRB, IACUC, or Biosafety)?
A: Sharla Miles, or phone (936) 294-4875
Q: How can I tell the status of my IRB application?
A: To inquire about application status, contact Sharla Miles, or phone (936) 294-4875
Q: How can a PI view all protocols submitted to the IRB in the last three years?
A: PIs must email Sharla Miles to request any past IRB applications submitted within the last three years. The turnaround time for expediting these requests is 24-48 hours.
III. INFORMED CONSENT FAQ
Q: What are the basic elements of informed consent?
A: The basic required elements of informed consent can be found in the HHS regulations at 45 CFR 46.116(a). The regulations require that the following information must be conveyed to each subject:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
- A description of any reasonably foreseeable risks or discomforts to the subject;
- A description of any benefits to the subject or to others which may reasonably be expected from the research;
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
- an explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; and
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Q: What is the Institutional policy for retaining signed informed consent forms?
A: PIs should maintain all signed consent forms in their office in a locked file cabinet to facilitate anonymity. If the PI is a student, the IRB strongly recommends that these forms be retained in their faculty sponsor’s office in a locked file cabinet to maintain a research participant’s anonymity.
Q: For how long should signed informed consent forms be retained by PIs?
A: PIs should retain these forms in a locked file cabinet in their office for up to 3 years after the research has ended. If the PI is a student, the IRB strongly recommends that these forms be retained in their faculty sponsor’s office in a locked file cabinet to maintain a research participant’s anonymity.
IV. POLICY FAQ
Q: What is the definition of human subjects research that would require PHSC review?
A: Per the federal regulations 45 CFR 46, under which the University operates, research is defined as a systematic investigation, including research development, testing, and evaluation designed to contribute to generalizable knowledge. A human subject is defined as a living individual about whom an investigator conducting research obtains data through intervention with the individual or identifiable private information. Any research meeting this definition is subject to PHSC review.
Q: Can you provide more information on the following terminology regarding the IRB application: Identifiable data or records; Protected Health Information (PHI);Direct identifiers; Indirect identifiers; De-identified records; Minimal Risk?
A: Please click on the following link for more information: IRB Application Definitions
Q: What does minimal risk mean?
A: "Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."
2. Exempt IRB Review
Q: What constitutes an Exempt IRB Review?
A: If your study involves any of the Categories Eligible for Exempt Certification, then the IRB process will be less difficult. Regardless if you even think that your study falls under the Exempt category, it is a strict Institutional policy that the SHSU IRB MUST make that determination for the PI.
3. Expedited IRB Review
Q: What constitutes an Expedited IRB Review?
A: Please review the Categories Eligible for Expedited Review to verify which category applies to your research study.
4. Full Board IRB Review
Q: What constitutes a Full Board IRB Review?
A: If your study involves any of the following, it will automatically be assigned to review at a convened meeting by the IRB:
- research involving children (age 17 and under; parental consent and child assent in age-appropriate language required)
- research with college students who are legal minors (i.e., some colleges/universities allow high school students to take college courses; parental permission and student assent required)
- research involving prisoners (inmate form required)
- research involving pregnant women
- research involving adults with decisional impairment, physical disabilities, or mental disabilities
- research involving adults who are disadvantaged either economically and/or educationally
- The Belmont Report adds three populations to the above list: research involving racial minorities, the very sick (i.e., patients with cancer, HIV, etc.), and the institutionalized
- Research involving sensitive subject matter (i.e., deception of research participants, criminal behavior, sexual abuse, drug abuse, etc.)
5. Other IRB Review FAQ
Q: What is the review timeline of an IRB application submission?
A: Applications are reviewed in the order they are received. The time required for review and approval of an average IRB application, carefully prepared in accordance with the recommended guidelines, submitted by an applicant who has completed the required training in the protection of human subjects, is approximately two to three weeks.
Q: Does the above review timeline include the time it takes for the application to complete the routing process (Department- and College-level reviews)?
A: No. The 2-3-week timeline begins after the IRB application comes out of routing—meaning that the faculty sponsor (if applicable), Chair and Dean have submitted their approval. Once an application is sent to the IRB for review, please allow approximately two to three weeks to receive the IRB's review decision.
Q: Under what circumstances can a review take longer than two to three weeks?
A: If an IRB reviewer requests modifications to no-more-than-minimal-risk studies, the review is most likely to take longer than two to three weeks to complete. Furthermore, full committee review may take longer depending on when in the meeting cycle the application is received. Final approval is dependent upon requested modifications, if any, being satisfactorily completed.
Q: What guidance does the Office of Human Research Protections (OHRP) offer regarding research involving Oral History interviews?
A: For faculty, research involving oral history interviews is not under the purview of the IRB. The following is the guidance pertaining to this matter: OHRP Letter to the Oral History Association.
V. PROCEDURAL FAQ
1. New IRB Application Submission
Q: What is the procedure for IRB application submissions?
A: The SHSU in-house application system for Institutional Review Board (IRB) reviews, which can be accessed from any computer, is found on SamWeb. The pathway for accessing the system follows: SamWeb > Miscellaneous > Forms > IRB Application.
The following documentation could potentially be required for IRB review:
- Collaborative Institutional Training Initiative (CITI) certificate
- Support Letters (i.e., other schools aside from SHSU, prison, agency, business)—MUST be on institutional letterhead with original signature from the institution's administrative official
- Phone Interview
- Form for Involving Inmates in Research
- Consent Form
- Assent Form
- Cover Letter
- Parental Consent Letter
Q: How do I make changes/corrections to my application when it is sent back to me?
A: If corrections are needed on your application before the routing process begins, you will receive an email from SamWeb (a.k.a. the SHSU IRB Form system). The subject line will be "Form Returned for Corrections: IRB Application #." Click on the link within the email to navigate to the IRB Form system. From there, you will be able to open your application to make the necessary modifications, which are sent to you in a separate email. Once you have completed the revisions, you must click Submit to return your application to Sharla Miles. You will also be prompted to complete and submit an IRB response letter detailing the modifications that were made and where they were made (i.e., in the application, in the consent form, in the recruiting documentation, etc.); you will be required to email the letter to Sharla Miles.
2. IRB Amendment Application Submission
Q: What is the procedure to follow for informing the IRB of significant changes to my already-approved IRB protocol?
A: You will need to submit an Amendment to your already approved IRB protocol. Click on the link below to start the Amendment process:
Q: What does the IRB consider to be a significant change?
A: The following revisions to an already-approved protocol require the submission of an Amendment and must be reviewed by the IRB:
- Administrative Details (i.e., addition/deletion of research personnel, change of a phone number or email address)
- Inclusion or exclusion criteria
- Testing frequency or methods (i.e., a new questionnaire, more frequent blood draws)
- Treatment parameters
- Stopping or modification rules
- Consent Document
- Recruitment Procedures (i.e., payment schedules, advertisements)
3. IRB Continuing Review Application Submission
Q: How can I request an extension to my IRB approval?
A: You will need to submit a Continuing Review form. Click on the link below to start the process:
NEW CONTINUING REVIEW FORM [FILLABLE PDF] - to be completed ONLY AFTER your initial IRB application has been approved, and you are requesting an extension.
Q: What documentation is required for a continuing IRB review of my research?
A: For the IRB to meet its regulatory obligations (45 CFR §46.109), SHSU’s IRB requires the following documentation for a continuing IRB review of research:
- A brief project summary (this could be included (a) as part of a progress report described in the next bullet, (b) provided as a separate document, or (c) be addressed by referencing other documents made available to the IRB, including the informed consent document(s));
- A progress report [NOTE: the following information is requested in the SHSU IRB Continuing Review form] that includes the following:
- The number of subjects accrued (for multicenter research studies, the number of subjects accrued at the local institution and the number accrued study-wide, if available, should be provided);
- A brief summary of any amendments to the research approved by the IRB since the IRB’s initial review or the last continuing review;
- Any new and relevant information, published or unpublished, since the last IRB review, especially information about risks associated with the research;
- A summary of both any unanticipated problems and available information regarding adverse events (the amount of detail provided in such a summary will vary depending on the type of research being conducted; in many cases, such a summary could be a brief statement that there have been no unanticipated problems and that adverse events have occurred at the expected frequency and level of severity as documented in the research protocol and the informed consent document)
- A summary of any withdrawal of subjects from the research since the last IRB review, and the reasons for withdrawal, if known; and
- A summary of any complaints about the research from subjects or others since the last IRB review;
- The latest version of the IRB-approved protocol and informed consent document(s);
- Any proposed modifications to the informed consent document or protocol;
- Any other significant information related to subject risk.
Q: When is Continuing Review of my IRB protocol no longer necessary?
A: Once all activities described in the IRB-approved protocol are finished (i.e., obtaining research data through interaction or intervention with Human Subjects or obtaining identifiable private information about Human Subjects, which includes using, studying, or analyzing identifiable private information), the research project no longer needs to undergo continuing review. For example, when the only remaining activity of a research project involves the analysis of aggregate data sets without individual subject identifiers, no further continuing review is necessary. At that point the IRB can formally close the IRB file for that project and advise the investigator of that action.
4. IRB Final Report Submission
Q: How can I close out my IRB protocol once my research and subsequent data analysis are complete?
A: You will need to submit a Final Report. Please click below to begin the Final Report process: