Quick Links Within Human Subjects in Research FAQ
Q: What is the difference between exempt, expedited, and full board review?
A. Investigators may not make category determinations for themselves; however, the following is an explanation of the different review categories.
Exempt research poses little, if any, risk to the subject and only a limited number of procedures for data collection are permitted under exempt review. Exempt research undergoes continuing review every 3 years rather than annually. It should be noted that even when research is exempt from regulatory requirements under the Common Rule (45 CFR 46), institutions and investigators still have a responsibility to adhere to the underlying ethical principles for research involving human subjects.
Expedited research, by definition, must pose no more than minimal risk to the subject and must fit in one of nine defined categories of data collection. Expedited review is completed by one IRB member.
Full Board Review is conducted by the convened IRB for any research presenting more than minimal risk to subject or any research using data collection techniques not explicitly authorized under exempt or expedited review. Please allow additional processing time for board review.
Q: What is considered human subjects research?
A. In order for an activity to be considered research with human subjects, it must meet the definition of research, as well as the criteria for research with human subjects.
U.S. Department of Health and Human Services states that “research means a systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge.” [45 CFR 46.102(2)]
U.S. Department of Health and Human Services states that “human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information.” [45 CFR 102(2)]
Q: What about classroom research?
A. Classroom projects used primarily for teaching purposes do not normally need to be reviewed by the IRB as they typically do not meet the federal definition of human subject research. It is, however, expected that faculty and students will uphold the same standards for the ethical treatment of research participants as other research projects. It is recommended that student researchers complete the CITI course, as required of other researchers, prior to interacting with “subjects.”
Class-based or lab projects for which the primary goal is the generation of generalizable or universal knowledge should be submitted to the IRB for review and approval. For example, a pilot project that will be the basis of a publication, a grant proposal, or a senior project should be reviewed even if it is originally carried out in a class setting and did not qualify for IRB review.
If you will be conducting or supervising a classroom project, please review the classroom research project checklist here to help you determine whether or not you must submit an application to the IRB. Faculty and students may also contact the IRB office at 979.458.4067 or firstname.lastname@example.org to discuss the assignment and obtain assistance in determining if review is needed.
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 of normal persons or during the performance of routine physical or psychological examinations or tests in normal persons. (45 CFR 46)
Q: What is the difference between privacy and confidentiality?
A. Privacy can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. Example: To ensure privacy, interviews should be conducted in a closed office not in a busy restaurant or settings where other individuals can overhear the discussion.
Confidentiality refers to agreement between the researcher and the participant about how private information will be handled, managed, and disseminated. Example: To ensure confidentiality, collected data should be kept in a locked file cabinet that is only accessible by the researcher.
Q: What is the difference between anonymous and confidential?
A. When research is anonymous, the participant gives no personally identifying information about him/herself, and the identity of the participant is not connected in any way to the information gathered or to participation in the study. Example: When a research subject signs an informed consent document then the study is not considered anonymous.
When research is confidential, the participants may provide identifying information; however, the information gathered and identities will be protected. The researchers themselves can link responses back to the subject but do not do so unless needed.
Q: What constitutes pre-existing data or specimens?
A. Pre-existing data or specimens have been previously collected by another researcher or organization, in a non-research environment, or from data that a researcher collected from a previous study that you are now requesting to use for your current research purposes. Use of these items is addressed in the IRB application under the section titled “Retrospective Details.” If any data or specimens have yet to be collected at the time of the IRB application, then they do not qualify as pre-existing.
Q: Can I use data from human subjects that was previously collected without IRB approval?
A. Data that was collected for research purposes without IRB approval may not used. Use of data previously collected for non-research purposes may be approved on a case-by-case basis. An IRB application is required in these instances.
Q: My co-investigator at another institution has an IRB approval from his institution. Do I need one?
A. If you are engaged in research and are a Texas A&M investigator or affiliate member, you are required to obtain IRB approval from Texas A&M University IRB.
Q: Where should I store my research data and consent forms?
A. Original copies of the research data and consent forms should be stored on Texas A&M property.
Q: Is a password protected computer sufficient security for the storage of electronic data?
A. It is a University policy that all work being done for University business on computers must be encrypted. Please contact your department regarding steps that need to be taken.
Q: Is a dietary supplement considered a drug?
A: FDA regulates dietary supplements as a food product, and not typically as a drug. The FDA definition of a dietary supplement is that the supplement is composed of essential nutrients, such as vitamins, minerals, and proteins, herbs or similar nutritional substances (such substances as ginseng, garlic, fish oils, psyllium, enzymes, glandulars, and mixtures of these).
The definition of the term drug in section 201(g)(1) of the FD&C Act includes, among other things, “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease . . .” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Biological products subject to licensure under section 351 of the Public Health Service Act (42 U.S.C. 262) may also be considered drugs within the meaning of the FD&C Act. It is important to note that the drug definition is not limited to compounds intended for a therapeutic purpose.3 The definition also includes compounds intended to affect the structure or function of the body, without regard to whether the compound is intended to influence a disease process. For example, the definition includes compounds administered to healthy subjects to blunt or provoke a physiologic response or to study the mechanism of action or metabolism of a drug. Note, however, that a dietary supplement (as defined in section VI.C) intended only to affect the structure or function of the body and not intended for a therapeutic purpose is not a drug.
Q: What information should I provide to the IRB when conducting a dietary supplement study?
A: The investigator must submit current, scholarly review of relevant literature that supports the purpose of the research study and valid reports in the existing, established and mainstream literature of risks encountered with the formulation and suggested dose of the supplement, the population proposed for the research, and the actual research procedures. For supplements and/or a subject population and/or a procedure deemed to be higher risk, the review will be more stringent and the committee may require consultation with or oversight or co-investigation by a health care professional. A signed, adequate health history/screening questionnaire should be submitted to reduce the risk to volunteers by screening out potential high risk volunteers. Package interest and toxicity information should also be included. Please note that depending on your study more information can be requested from the IRB.
Q: How do I submit an IRB application or requested revisions?
A: You must submit your application and any revisions requested using our online study management system, iRIS. You can access iRIS at https://imedris.tamu.edu.
Q: Can I submit an application via email?
A. No, you must submit your application using our online study management system, iRIS. You can access iRIS at https://imedris.tamu.edu. Please note that original or duplicate submissions by email, campus or U.S. mail will not be accepted.
Q: Why must we conduct a literature review?
A: Including a literature review in your application serves two primary purposes. First, the review strengthens your application by giving the IRB evidence to support your choice of methodology, population, and other factors. Second, especially in the case of more than minimal risk studies, it can provide support for your application by presenting evidence of the need for your project to be conducted. This will assist the reviewers in evaluating the potential benefits and risks to participants.
Q: My research will be conducted outside the United States. What additional requirements do I need to fulfill?
A. With your IRB submission, you must also submit a cultural evaluation letter, translations of all documents to be viewed by participants (if they do not speak and read English), and authorizations from within the host country. This may include an authorization letter and proof of ethics review from a local institution, and/or an authorization letter from the governing authorities. The full SOP on research conducted internationally may be accessed here: http://vpr.tamu.edu/compliance/rcc/irb/sops/134.
Q: What is PHI authorization?
A: If you are requesting to use Protected Health Information (PHI) from Participants, it is Texas State law that you obtain approval from the participant to collect that information for research purposes and potentially share it with others. This information is subject to HIPAA privacy rules. Please contact the HSPP office if you have questions regarding the use of PHI.
Q: Who signs for the Department Head if he/she is an investigator or staff member on the project?
A. If the Department Head is listed on the protocol, his or her direct supervisor should be assigned in the designated department approval section of your application. This can be the College Dean or the Associate Dean of Research.
Q: Who needs to fill out the Conflict of Interest section of the signoff?
A. The Principal Investigator, Co-Investigators, and all key study personnel must fill out the Conflict of Interest section of the signoff in iRIS. In the case of a student application, the Protocol Director and Faculty Sponsor must also complete this section. If the signoffs are not done correctly, the HSPP analyst will re-assign them for you as they cannot be modified by an investigator after study submission.
Q: Can I make changes to my study after it is approved?
A. Yes, changes must be submitted on an IRB Amendment form in iRIS.
Q: When should I submit my continuing review?
A. You should submit your continuing review form 30-45 days prior to the expiration date. If it is submitted less than 30 days in advance, the project may not be re-approved prior to the expiration date.
Q: What happens if I submit my continuing review after the expiration date?
A. Your project will be terminated the day after the expiration date. At this point, any study activities, including data analysis, should be placed on hold until approval is regained. Any work on the project after the expiration date will be considered non-compliance by the IRB. Federal regulations do not allow a grace period. However, within 3 months of your project expiration you may submit a continuing review for IRB consideration in order to re-active your project. In these instances, you do not need to submit a new application.
Q: What do I need to do when I get a notification that continuing review is due or that my study is about to expire?
A. You need to submit a continuing review application, including uploading the consent document in use. The Continuing Review Application should be submitted at least 30 days prior to the expiration of your approval to ensure adequate time for processing.
Q: Why do I have to report the number of subjects withdrawn from the research?
A: Subjects may discontinue their participation in research at any point for various reasons (e.g., serious adverse events, conflicts with the investigators, transportation problems, etc.).
The IRB’s continuing review procedures in general should provide for review of:
- The number of subjects who discontinued their participation; and
- A summary of the reasons for the withdrawals, if known.
IRB review of this information may shed light on problems related to the conduct of the research. For example, a high rate of subject withdrawal secondary to serious adverse events may provide the investigator and IRB insight related to the risks of the research possibly are greater than expected according to the perceptions of enrolled subjects. This insight may lead the investigator and/or IRB to conclude that modifications are necessary prior to proceeding with the study (45 CFR 46.111(a)(1) and (2)).
Q: Does every application go to full board?
A: No, most research activities can be processed as exempt or expedited and do not go before the convened IRB.
Q: My study has been assigned to the review committee agenda. What happens now?
If you receive a notice stating that your project has been assigned to the review committee agenda, your project will be reviewed at an Institutional Review Board meeting. The meeting dates are listed on our website under the IRB Schedule.
One week before the meeting, the HSPP staff will send you more information on the meeting and request an RSVP if you wish to attend. While your attendance is not necessary to complete the review, you may wish to be available to address any potential concerns presented by the Committee. Please note that this is a closed meeting, so you will only be invited in if the Committee has questions regarding your project. The Committee may or may not have questions in relation to your project.
If you choose to RSVP, you will receive a final e-mail from the HSPP staff including the date, time, and location of the meeting as well as where to park and the location of the waiting area.
Should the committee have any questions and you are unable or choose not to attend, you will be asked to provide a contact phone number to reach you.
You will receive notice of your project’s approval or any requested revisions typically within a week following the convened meeting.
Q: Who needs to complete CITI training?
A: All study personnel working with participants or who have access to research data must have CITI training in human subject protections. You must complete the CITI course with a minimum overall score of 90%. Training must be updated by all study personnel every three years. CITI is a web-based ethics training course for those conducting research with human subjects available at www.citiprogram.org. Please affiliate yourself with Texas A&M University and register for the learners group that pertains to your research, either Group 1: Biomedical Research Investigators and Key Personnel or Group 2: Social and Behavioral Research for Investigators and Key Study Personnel. Before submitting any type of application to the IRB, please make sure all study personnel training is up to date.
Q: How long is the training good for?
A: Training is good for three years. A refresher course must be completed every three years. The refresher course is automatically added to your training list 60 days prior to your training expiration. You should receive an email when your refresher course is due at 30, 60, and 90 days prior to expiration.
Q: If I am a registered user, how do I add a new course?
A: Log in to www.citiprogram.org. On your menu page, there will be a link that reads “Add a course or update your learner group.” On that page, there will be a set of check boxes and you designate the ones that apply to you. This page also has check boxes to add animal research training if that applies to you. Do not check it if it doesn’t apply. The last section is the Responsible Conduct of Research training. This is required for NIH or NSF funded investigators. If you are not funded by one of the two you may mark “Not at this time.” If you are, check the one that applies to you.
Q: How do I check the expiration date of my CITI training?
A: Go to www.citiprogram.org and log in. Once you have logged in, you will see a list of the training modules you have completed or need to complete. Under “Status” the system will say “Passed” with the date that you passed the course. Your training expires three years from that date.
Q: How do I write my consent form?
A: Templates for consenting instruments are available on our website under Consent Information. Using the templates is preferred as it helps to ensure that required language is being used and items are being addressed appropriately. If you choose to write your own consent form, you must include all federally required elements of consent, available here. The HSPP staff may also ask you to revise your consent form to meet institutional guidelines.
Q: What is exculpatory language?
A: Exculpatory language is when subjects are made to waive or appear to waive any of their legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents for liability for negligence (45 CFR 46.116).
No language in the consent process may include any exculpatory language. Do not include any language that appears to “put words in the participant’s mouth.”
Examples of exculpatory language: I agree… I understand… I acknowledge… You agree… You understand…
Q: How does the consent process change when working with minors?
A. When working with minors (children under the age of 18), the parents or legal guardians of the children must grant permission for their child to participate in the research project. In addition, assent must be obtained from the children. Minors cannot provide legal consent, so a minor expresses willingness to participate in a research project through the assent process. Depending on their age, children can give verbal assent rather than signed assent. Parental consent and minor assent can be waived under certain circumstances. To learn more about assent and research, contact the HSPP office. Information on parental permission, minor assent, and waivers can be accessed on our website under Consent Information.
Q: Do I have to obtain consent?
A: Under very specific circumstances, consent can be waived. If you would like to request a waiver of consent, please mark “Waiver of Consent” in your application in section 18. You must be able to justify each criteria listed in the waiver of consent form that opens up in your iRIS application.
Q: Do I have to obtain signed consent?
A: Under very specific circumstances, signed consent can be waived. If you would like to request a waiver of documentation of consent, please mark “Waiver of Documentation of Consent” in your application in section 18. You must be able to justify at least one of the criteria listed in the waiver of documentation of consent form that opens up in your iRIS application.