FAQ
Quick Links Within Human Subjects in Research FAQ
Application
Q: Who can sign for the department head?
A. The department head signs on this unless they have another appointed individual that is designated to sign in their absence. We do not keep a list of the signatories for each department. You will have to go to your department and see who is listed.
Q: Do I need all the signatures?
A. If you are a student, all signatures are required. If you are not a student, the only signature that is not required is the advisor’s signature.
Q: My faculty advisor or department head is unavailable to sign my application. Who can sign in his/her place?
A. The signatory is whoever is next in the chain of command or a specific individual appointed by the department head in these instances. Check with your department to see who is qualified to sign.
Q: My Co-Principal Investigator is unavailable to sign the signature assurance page of the IRB application. Can someone else sign as his/her proxy?
A. No, only the project principal investigator (PI) and co-principal investigator (Co-PI) can attest to the items on the assurances page.
Q: Can I submit an application via email?
A. No.
Q: I submitted an application via the iRIS program. Should I submit a duplicate copy by email, campus, or U.S. mail to make sure you receive it?
A. No, duplicate submissions could cause a delay in the review process.
Q: Why is the UIN on the application?
A. So that when researchers have projects that cross over to multiple compliance units, the application statuses and training information can all up updated and kept in TrainTraq.
Q: Who needs to fill out the conflict of interest form?
A. Any significant study personnel such as the PI and any Co-PIs.
Q: When should I submit my continuing review?
A. 30-45 days prior to the expiration date. If it comes in less than 30 days in advance, we cannot guarantee that the project will be re-approved prior to the expiration date.
Q: What happens if I submit my continuing review after the expiration date?
A. If a continuing review comes in after the date of your project expiration, the project will be administratively closed and you will have to submit a new application as a re-submission. Please refer to the Human Subjects Protection Program (HSPP) office for specific information to be included in your application for re-submission.
Q: Can I make changes to my study after it is approved?
A. Yes, changes can be submitted via iRIS at http://imedris.tamu.edu.
Q: My research will be conducted outside the United States. Is there anything different I need to do for my IRB application process?
A. You still must submit the initial application form. In addition to this a cultural evaluation letter, translations of all documents to be viewed by participants (if they do not speak and read English), letter of verification of translations, and permissions as necessary by the culture and the local authorities will be needed.
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: Why must we conduct a literature review?
A: When conducting continuing review, the IRB should start with the working presumption that the research, as previously approved, does satisfy all of the above criteria. The IRB should focus on whether there is any new information provided by the investigator, or otherwise available to the IRB, that would alter the IRB’s prior determinations, particularly with respect to the IRB’s prior evaluation of the potential benefits or risks to the subjects. The IRB also should assess whether there is any new information that would necessitate revision of the protocol and/or the informed consent document. IRBs have the authority to disapprove or require modifications in (to secure re-approval of) a research activity that does not meet the criteria for re-approval (45 CFR 46.111). If research does not satisfy all of the criteria, the IRB must require changes that would result in research satisfying these criteria, defer taking action, or disapprove the research.
When conducting continuing review and evaluating whether research continues to satisfy the criteria for IRB approval of research, IRBs should pay particular attention to the following four aspects of the research:
- Risk assessment and monitoring;
- Adequacy of the process for obtaining informed consent;
- Investigator and institutional issues; and
- Research progress.
This can only be accomplished if the PI conducts a literature review.
General
Q: What is the difference between exempt, expedited, and full board review?
A. Exempt research is research that is "exempt" from the federal regulations and from continuing review. To qualify for this designation, you must apply via the exempt application process and your study will be reviewed by the HSPP staff to ensure the study qualifies for an exemption.
Investigators may not make this determination for themselves, and the study must meet institutional requirements.
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.
Expedited research, by definition, must pose no more than minimal risk to the subject, and there are a few more data collection procedures permitted. Expedited review is completed by an IRB member, and all federal criteria for approval must be met.
Full Board Review is conducted by the convened IRB for any research presenting more than minimal risk to subjects, or any research using data collection techniques not expressly authorized under exempt or expedited review. Please allow additional processing time for board review.
Q: What is considered human subject 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 don't need to be reviewed 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 whose primary goal is the generation of generalizable or universal knowledge should be reviewed by the IRB. 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.
If you think that there is a possibility that you may use a classroom project for research, please fill out the initial application form. Faculty and students may contact the IRB office at 979.458.4067 or irb@tamu.edu 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.
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 identity of the participant cannot readily be determined by the investigator (or any study personnel) and the identity of the participant is not connected to information gathered. In order for a research project to be anonymous, the research is not able to link response back to the subject.
When research is confidential, the participants can be identified; 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?
A. Pre-existing data is data that has been previously collected by another researcher or organization in which you are requesting to use for your own research purposes.
Q: Can I use data from human subjects that was previously collected without IRB approval?
A. Review of previously collected data that is from human subjects requires IRB approval.
Q: My co-investigator at another institution has an IRB approval from his institution. Do I need one?
A. If you are actively engaged in research and are a Texas A&M investigator, you are required to obtain IRB approval.
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 in the event of an audit for a minimum of seven years.
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 foods and not as drugs. 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).
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.
Continuing Review
Q: What do I need to do to obtain continuing review?
A. You need to submit a continuing review application, a clean copy of current consent documents, and signed Conflict of Interest statements for PI and Co-PIs. The continuing review application should be submitted 30 days prior to the expiration of your approval to ensure adequate time for processing.
Q: Why must we submit copies of all the consent forms used during the last approval period?
A: OHRP guidance states that at the time of continuing review, the IRB should review a copy of the sample informed consent document submitted by the investigator to verify that the investigator is using the most recently approved version and that the document contains the most accurate, up-to-date information about the research.
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 indicate that the risks of the research are greater than expected and may lead the IRB to conclude that the research should not be approved for continuation because the risks to subjects are not being minimized or are not reasonable in relation to the anticipated benefits to the subjects and the importance of the knowledge that may reasonably be expected to result (45 CFR 46.111(a)(1) and (2)).
Full Board
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 a convened IRB.
Training
Q: Who needs to complete training?
A: The PI is responsible for making sure that all study personnel working with participants and touching research data (including the advisor if the PI is a student) has human subjects training. 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 the institution and register for the learners group that pertains to your research. Before submitting any types of application to the IRB, please make sure all study personnel training is up to date.
Q: How do I print my CITI completion certificate?
A: Go to www.citiprogram.org and log in (if you do not remember your login information there is a link to click and it will email it to you). Once you have logged in, under your institution you will see a list of the training modules you have completed or need to complete. Next to that the status will say passed with the date, and next to that there will be a link to print the completion report. Click the link to print.
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. For example, you can add or remove Biomedical or social and behavioral research. 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 for 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: Is the responsible conduct for research training required?
A: This is required for NIH or NSF funded investigators. If you are not funded by one of the two this training is optional and you may mark “Not at this time.” If you are, check the one that applies to you. If your name is listed on the grant, you are required to take it.
Q: How do I check when my training expires?
A: Go to www.citiprogram.org and log in (if you do not remember your login information there is a link to click and it will email it to you). Once you have logged in, you will see a list of the training modules you have completed or need to complete. Next to that the status will say passed with the date. Three years from that date is when your training expires.
Submitting an Application
Q: Where do I send my application or revisions?
A: The preferred method is via email to irb@tamu.edu. These methods are available as well:
- In person: 750 Agronomy Road, Suite 2701, College Station, Texas (Map)
- Campus Mail: HSPP/IRB, Mail Stop 1186
- US Mail: Office of Research Compliance and Biosafety, 1186 TAMU, College Station, Texas 77843-1186
Consent
Q: Do I have to use the templates?
A: Yes, using the templates is required as it helps to ensure that required language is being used and items are being address appropriately. Certain elements are required to be addressed in the consent process, and they are included for you in the consent templates.
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: What is assent?
A. Assent is given when a minor (child under the age of 18) is willing to participate in a research project. Due to their legal status, they cannot give consent. When working with minors, permission must be given by the legal guardian of the child in addition to obtaining the child’s assent unless otherwise waived by the IRB. Depending on their age, children can give verbal assent rather than signed assent. To learn more about assent and research, contact the HSPP office.
Q: Can consent be waived?
A: Under very specific circumstances, consent can be waived. More frequently, documentation of consent is waived. This happens in situations when a subject does not sign a physical form but gives their consent to participate. For example, documentation of consent if often waived for studies that are completed on-line. If you would like to request a waiver of consent or consent documentation, please download the waiver form and submit with your application.