I. Classroom Procedures
What must all faculty teaching any research methods course know regarding Classroom Human Subjects (HS) Research Guidelines?
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), contact Sharla Miles at firstname.lastname@example.org.
What classroom projects do the HS research guidelines apply (see Definitions FAQ below)?
The guidelines apply to human subjects research not conducted purely for pedagogical purposes that 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
Examples of class projects that need PHSC review
Any 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. Protecting Your Data When Audio or Video Recording
What procedures do I follow for protecting my data when utilizing audio or video recording procedures during my study?
You will be required to create and implement password-protection or encryption procedures during the data collection phase of your project when using audio or video recording.
What language do I need to include in the IRB Application for addressing audio or video recorded data collection procedures?<
You must inform the IRB that you will be implementing a strict data security plan which allows for password-protecting and encrypting data that is stored on any electronic recording device.
Sample language that could be included in the IRB application follows: No personal information of participants will be recorded. All data files will be stored in a private computer database accessible only to the PI and password protected by a code that will be changed every 4 weeks for security purposes. All audio recordings will be conducted utilizing a laptop and the files will be stored on a personal computer accessible only to the PI and password protected by a password for security purpose
What is the policy for taping and qualitative research?
In order to secure the data and protect the confidentiality of participants, audio and/or video recordings should be password protected and encrypted if they are kept electronically/digitally (i.e., computer, smartphone, other digital recorder, etc.). Researchers are not required to use a computer to tape record. If actual tape is used, then the PI will need to specify (1) that it will be tape rather than digital; (2) how the tapes will be kept secure until they are destroyed, and (3) how and when the tapes will be destroyed.
Who do I contact with questions regarding Compliance (CITI, IRB, IACUC, or Biosafety)?
Sharla Miles, via e-mail at email@example.com or phone 936.294.4875.
How can I tell the status of my IRB application?
Sharla Miles, via e-mail at firstname.lastname@example.org or phone 936.294.4875.
How can a PI view all protocols submitted to the IRB in the last three years?
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.
IV. Informed Consent
Basic Elements of Informed Consent
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;
- Reasonably foreseeable risks or discomforts to the subject.
- Benefits to the subject or to others which may reasonably be expected from the research.
- Disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- Statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
- 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.
- 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.
- 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.
What is the Institutional policy for retaining signed informed consent forms?
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.
For how long should signed informed consent forms be retained by PIs?
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.
What does the DHHS say about extra protections for children as participants in research?
Navigate to the following page for the DHHS FAQ regarding this protected population: Research with Children - FAQs
DHHS extra protection for prisoners as participants in research?
Navigate to the following page for the DHHS FAQ regarding this protected population: Prisoner Research - FAQs
DHHS and the Common Rule, also known as 45 CFR 46
Navigate to the following page for the DHHS FAQ regarding federal requirements for conducting research with human subjects: 45 CFR 46 - FAQs
DHHS and Exempt Research?
Navigate to the following page for the DHHS FAQ regarding federal requirements for how the IRB classifies research involving human subjects to be exempt: Exempt Research Determination - FAQs
DHHS and Informed Consent
Navigate to the following page for the DHHS FAQ regarding the elements of informed consent and the process for obtaining consent: Informed Consent - FAQs
DHHS and the Investigators' responsibilities in the conduct of research involving human subjects
Navigate to the following page for the DHHS FAQ regarding these responsibilities: Investigator Responsibilities - FAQs
Definition of human subjects research that would require PHSC review
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.
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
Please click on the following link for more information: IRB Application Definitions
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."
Exempt IRB Review
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.
Expedited IRB Review
Please review the Categories Eligible for Expedited Review to verify which category applies to your research study.
Full Board IRB Review
If your study involves any of the following, it will automatically be assigned to review at a convened meeting by the IRB:
- Children (age 17 and under; parental consent and child assent in age-appropriate language required).
- 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)/li>
- Prisoners (inmate form required)
- Pregnant women
- Adults with decisional impairment, physical disabilities, or mental disabilities
- Adults who are disadvantaged either economically and/or educationally/li>
- Sensitive subject matter (i.e., deception of research participants, criminal behavior, sexual abuse, drug abuse, etc.)
- 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
Certificates of Confidentiality
Issued by the National Institutes of Health (NIH) and other HHS agencies to protect identifiable research information from forced or compelled disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in civil, criminal, administrative, legislative, or other proceedings, whether federal, state, or local. They may be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects, such as damage to their financial standing, employability, insurability, or reputation. By protecting researchers and institutions from being compelled to disclose information that would identify research subjects, Certificates of Confidentiality help to minimize risks to subjects by adding an additional level of protection for maintaining the confidentiality of private information.
It also protects subjects from compelled disclosure of identifying information but do not prevent the voluntary disclosure of identifying characteristics of research subjects. Researchers, therefore, are not prevented from voluntarily disclosing certain information about research subjects, such as evidence of child abuse or a subject's threatened violence to self or others.
PIs and the Certificate of Confidentiality
In most cases, the answer would be NO. In some cases, such as faculty projects coming from the COCJ or maybe the Psychology department, a PI who is making application to one of the federal agencies that can issue a Certificate of Confidentiality may be feel it necessary to apply for this extra protection, but it would depend on the type of data the PI would be collecting.
Review timeline of an IRB application submission
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.
Does the above review timeline include the time it takes for the application to complete the routing process (Department- and College-level reviews)?
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.
Under what circumstances can a review take longer than two to three weeks?
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.
What is the typical review procedure for a Regular Initial or Thesis/Dissertation IRB application?
Approval Chain for IRB Application (Regular Initial) or IRB Application (Thesis/Dissertation)
- Sharla Miles
- Department Chair
- College Dean
- Sharla Miles
If any approver on this list finds that data within the submitted form must be updated prior to approval being granted, it would stop routing through the chain and would be returned to the PI. Reviewers have the option of sending the PI a note that reflects the requested changes. The PI will then need to resubmit the form once they have made those changes.
If a form is resubmitted, this restarts the routing and approval process with the first person in the approval chain. While this may seem unnecessary at first, the system does this in order to protect previous approvers from situations in which the form is changed significantly by the PI. In those cases it may be that someone who previously approved of the details within the application may not approve of the new changes. This process gives them the chance to review the modified form before allowing it to progress through the chain.
If you have any questions related to the new form system or the available IRB applications please contact Sharla Miles. For technical questions or suggestions please utilize the work order system on the web at http://cherwell.shsu.edu/CherwellPortal/Student.
What guidance does the Office of Human Research Protections (OHRP) offer regarding research involving Oral History interviews?
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
- Procedure for IRB application submissions
Does "exempt" research need to be reviewed?
Yes, it does. Only the IRB can decide whether or not research is exempt. All research involving human subjects needs to be proposed. The IRB will then decide whether the research is exempt under law or if it needs further review.
If my study is exempt, does this mean it doesn't need IRB review?
No. Only the IRB can award an exemption for a research proposal. This means that any research you conduct, even if it falls under one of the exempt categories, must undergo IRB review. When an IRB determines that a protocol is exempt from further IRB review, any modification requires that the protocol again be reviewed by the IRB.
Does an "expedited" review mean I'll get approved faster?
Not necessarily. Expedited simply means a different process of review. Expedited means that the proposal does not need to be reviewed by the whole committee during a convened meeting, only by a select member(s). However, a well written and perfectly formed proposal for full/convened review could take the Board less time to review than a poorly organized and poorly written proposal that is expedited.
What is the difference between anonymous and confidential?
Anonymous means not identifiable by name OR some other identifier (e.g., ID number), so the individual cannot be discerned in any way. No one (not even the researcher) can link an individual person to the responses of that person.
br /> Confidential means private, secret, not universally available, or known only to a select few. The researcher can (or could) identify individuals who participated in the study, perhaps through a code. Although the identities will be recorded, the information will only be used for specific purposes related to the project and outlined to the participant in the consent form. The identity of the participants will never be known to the public.
How do I make changes/corrections to my application when it is sent back to me?
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
What is the procedure to follow for informing the IRB of significant changes to my already-approved IRB protocol?
You will need to submit an Amendment to your already approved IRB protocol. Click on the link below to start the Amendment process:
IRB AMENDMENT [FILLABLE PDF FORM]
For all amendment submissions, you only have the option of emailing them directly to Sharla Miles at email@example.com. There is not a current option for uploading these files into the electronic IRB Application System.
What does the IRB consider to be a significant change?
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)
How can I request an extension to my IRB approval?
You will need to submit a Continuing Review form. Click on the link below to start the process:
CONTINUING REVIEW FORM [FILLABLE PDF] - to be completed ONLY AFTER your initial IRB application has been approved, and you are requesting an extension.
For all renewal submissions, you only have the option of emailing them directly to Sharla Miles at firstname.lastname@example.org. There is not a current option for uploading these files into the electronic IRB Application System.
What documentation is required for a continuing IRB review of my research?
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.
When is Continuing Review of my IRB protocol no longer necessary?
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.
How can I close out my IRB protocol once my research and subsequent data analysis are complete?
You will need to submit a Final Report. For all final report submissions, you only have the option of emailing them directly to Sharla Miles at email@example.com. There is not a current option for uploading these files into the electronic IRB Application System. Click below to begin the Final Report process:
FINAL REPORT [Fillable PDF Form]