- Subjects with Disabilities
Researchers may not eliminate a research subject who meets the articulated criteria for inclusion in the research project because of a disability which may be accommodated. For example, if a subject with a hearing impairment meets the study criteria an interpreter may be provided as an accommodation.
HIPAA (Privacy Rule) regulates the use and transmission of personal health information (PHI).
HIPAA aims to maintain greater privacy of medical records. PHI is health information transmitted or maintained in any form or medium that:
- identifies or could be used to identify an individual; and
- is created or received by a healthcare provider, health plan, employer or healthcare clearinghouse; and
- relates to the past, present or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present or future payment for the provision of healthcare to an individual.
Since UT Austin does not have a medical school (thus, usually not generating PHI) the majority of UT Austin research intersecting with HIPAA involves the transmission of protected medical data. Medical data obtained directly from the research subject does not fall under HIPAA's purview.
- Vulnerable Populations
Special procedures apply to vulnerable populations. The procedures provide additional safeguards in research activities involving:
- pregnant women
- human fetuses
- incapacitated subjects
Investigators must complete and submit a Form for inclusion of pregnant women, fetuses, or neonates in research activities. Prisoners may be unduly influenced by their incarceration to participate in research, and, in order to ensure that their decision to participate is not coerced, the will adhere to Subpart C of 45 CFR 46. Investigators must complete and submit a Form E to request the inclusion of prisoners as research subjects. Children are another vulnerable population requiring special protection (see 45 CFR Part 46, Subpart D or 21 CFR Part 50, Subpart D). Investigators must complete and submit an Form #2D to request the inclusion of children as research subjects. Finally, research activities involving potential research subjects who, for a wide variety of reasons, are incapacitated to the extent that their decision-making capabilities are diminished or absent require additional protective measures. Impaired capacity is not limited to individuals with neurologic, psychiatric, or substance abuse problems. Conversely, researchers should not presume these individuals are cognitively impaired. Investigators must complete and submit an Form B to request the inclusion of subjects with impaired decision-making capacity.
For additional information:
- Financial Conflict of Interest Disclosures
Submission of Financial Interest Disclosures to assure compliance with federal regulations and UT policy was begun in early August. The Objectivity in Research policy became effective on August 23, 2012 and was added to the UT Handbook of Operating Procedures.
The revised policy contains significant revisions to the previous policy and incorporates changes that meet updated federal requirements governing disclosure and reporting of Financial Conflicts of Interest. The new policy will affect all individuals who are responsible for the design, conduct or reporting of research.
The revised policy requires completion of Conflict of Interest training at least every four years by all individuals who are responsible for the design, conduct, or reporting of research. A web-based training course has been implemented and training may be completed at any time.
Upon completion of Conflict of Interest training, all affected researchers will be required to complete a web-based Financial Interest Disclosure (FID) form. There is a delay of 24-48 hours from completion of the training course until the training database is updated. Currently, RSC is emailing a link to the FID form for completion and submission to all individuals who have completed the the training course. Additionally, the revised policy requires completion of the Financial Interest Disclosure form annually or within 30 days of when changes occur.
For information on the new PHS policy, see the Frequently Asked Questions at the National Institutes of Health website. Other updates and changes will be posted by the the Office of Research Support and Compliance (RSC) on this page or one of the pages accessed through the "Conflict of Interest" tab on the left of this page.
- Unanticipated Problems
An “unanticipated problem involving the risks to participants or others” is an event that meets the following three criteria. The event was:
- Related to the research, and
- Caused harm or increased the risk of harm to the participants or others
The Institutional Review Board (IRB) requires PIs to report an unanticipated problem within five days of becoming aware of the problem.
Examples of unanticipated problems include:
- An actual unforeseen harmful or unfavorable occurrence to participants or others that relates to the research protocol (injuries, side effects, etc.);
- An unforeseen development that potentially increases the likelihood of harm to participants or others in the future;
- A problem involving data collection, data storage, privacy, or confidentiality;
- A participant complaint about approved research procedures;
- New information about a research study that indicates a possible change in the research risks to participants (sources may include a publication in the literature, interim findings, safety information released by the sponsor or regulatory agency, or the safety monitoring report);
- Changes in approved research initiated without review and approval to eliminate apparent immediate hazards to the participants.
Section 9 of the IRB Policies and Procedures Manual provides further information regarding the review of unanticipated problems.
- International Research
Research conducted by University investigators in foreign countries remains under University purview and guidelines.
While we cannot impose our standards for written documentation on other cultures, we do not relax our standards for ethical conduct of research or for a meaningful consent process. Special attention should be given to local customs and to local cultural and religious norms in drafting written consent documents or proposing alternative consent formats. In some instances it may be appropriate for the to waive some or all requirements for written consent. Research proposals for which this may be reasonable should include explanations of cultural norms or conditions requiring such a waiver (i.e. societies where no written language is used, societies where signatures represent the surrender of spirit or soul to the researcher.) Research projects must have been approved by the local equivalent of an before they are presented to the University . Where there is no equivalent board or group, investigators must rely on local experts or community leaders to provide approval. The requires documentation of this "local approval" before it gives approval.
- Audio/Video Recording
Audio or video recording usually increases the risk to research subjects.
Therefore, we strongly encourage researchers to use audio and video recording only as necessary to conduct research. The consent forms for research involving the recording of audio or video must include the necessary confidentiality provisions:
- that the interviews or sessions will be audio or videotaped;
- that the cassettes will be coded so that no personally identifying information is visible on them;
- that they will be kept in a secure place (e.g., a locked file cabinet in the investigator's office);
- that they will be heard or viewed only for research purposes by the investigator and his or her associates; and
- that they will be erased after they are transcribed or coded. If you wish to keep the recordings because of the requirements of your professional organization with respect to data or because you may wish to review them for additional analyses at a later time, the statement about erasing them should be omitted and you should state that they will be retained for possible future analysis. If you wish to present the recordings at a convention or to use them for other educational purposes, you should get special permission to do so by adding, after the signature lines on the consent form, the following statement, "We may wish to present some of the tapes from this study at scientific conventions or as demonstrations in classrooms. Sign below if you are willing to allow us to do so with the tape of your performance." And add another signature line prefaced by, "I hereby give permission for the video (audio) tape made for this research study to be also used for educational purposes." This procedure makes it possible for a participant to agree to being taped for research purposes and to maintain the confidentiality of the information on that tape.
- Internet Research
IRBs are increasingly presented with research conducted over the internet. The internet opens immense possibilities for data collection, analysis, and transmission. However, it also poses unique and possibly unknown risks. Contrary to popular belief, research conducted over the internet is not anonymous. Internet research often increases the complexity of obtaining a signed informed consent. However, the very nature of the internet and its blurred distinction between the public and private domains, questions the very interpretation and applicability of current policies and regulations for human subject research. Submit all human subjects research utilizing the internet for review.
For more information about internet research, see the following links:
- Report: Ethical and Legal Aspects of Human Subjects Research on the Internet (PDF)
- Article: Human Subject Research and the Internet: Ethical Dilemmas (PDF)
- Research Conducted Off-Campus
Research conducted upon private premises other than The University of Texas at Austin requires approval from that site. The site letter must grant permission for the researcher to conduct research at that site. The letter should be formal (use letter head) and contain contact information for the person signing. The letter should be signed by a party responsible for research and/or the conduct of similar activity at the site. For example, school district letters are typically signed by the superintendent for schools in that district. Letters from private institutions should be signed by a director, executive, owner, or other appropriate official.
Visit the IRB Forms page for site letter templates.
- Storage of Genetic Material
Some studies require the collection and storage of biological specimens. All specimens will be processed for storage, catalogued and placed in a secured facility at The University of Texas at Austin, or another site. All identifying information, including name and any identifying numbers, will be removed from the specimen and will not be retained. As a result, it will be impossible to connect the subject with the specimen. Some basic information such as age, gender, and diagnosis may be retained with the specimen. There is no cost to the subject or subject's insurance company for the storage and use of the specimen.
Many research studies in which the specimen may be used have not yet been determined. Some studies may involve genetic research. Genetic research is about finding the specific location of genes on chromosomes, learning how genes work, and developing treatments and cures for diseases that are genetically based. Since it is impossible to connect subject with the specimen, subjects will not be contacted in the future about any planned studies involving the specimen. However, all such studies must be reviewed and approved by the IRB. The specimen may be shared with researchers and will be stored indefinitely.
See Section 17.1 of the Policies and Procedures manual for additional information.
- Certificates of Confidentiality
- IRB Reliance
What is IRB Reliance?
IRB Reliance is when an IRB agrees to rely on another IRB for the review and approval of a research project. IRB Reliance can be established between institutions or between an institution and an independent IRB, such as Western IRB or the NCI Central IRB. A reliance arrangement is particularly useful when multiple study sites are following the same study protocol or procedures. Reliance arrangements can also be useful when some of the study sites or partners do not have their own IRB.
Reliance agreements may be put in place when:
- UT Austin has agreed to be a reviewing IRB for one or more other institutions / organizations
- UT Austin has agreed to rely on the IRB of another institution or an independent IRB
Anytime a researcher affiliated with UT Austin is engaged in the conduct of human subject research and wishes to rely on an IRB other than the UT Austin IRB, the Office of Research Support and Compliance must agree to the arrangement, and UT Austin must sign a reliance agreement with the reviewing IRB. An individual is considered engaged in the conduct of human subjects research when carrying out activities such as consenting subjects, collecting data, or analyzing identifiable data.
How is IRB Reliance Documented?
In order to establish a reliance arrangement, the participating institutions or organizations must enter into a reliance agreement to document the arrangement. This agreement may be called a reliance agreement or an authorization agreement. These agreements are most often study specific; however, some master agreements exist to document the reliance arrangement between institutions for any study. Reliance agreements must be signed by an authorized institutional official since the agreement is between institutions and not between investigators.
Has UT Austin signed any master reliance agreements?
UT Austin has signed the following master agreement(s). We will be adding additional agreements with commercial IRBs for review of industry sponsored research.
- SMART IRB, which is an IRB reliance agreement signed by more than 400 institutions and independent IRBs. Check the SMART IRB website to determine if an entity has signed the SMART IRB agreement.
Until specific agreements are signed with the major independent IRBs, UT is able to utilize the SMART IRB agreement to facilitate reliance with these IRBs.
How do I request a reliance arrangement if I want UT Austin to serve as the reviewing IRB (IRB of Record)?
First, you should contact the Office of Research Support and Compliance at email@example.com to determine that the UT IRB is willing to serve as the IRB of Record (reviewing IRB) for other participating sites. Until further notice, the UT Austin IRB will consider serving as the IRB of Record when the study involves no more than 4 sites. If a study will involve more than 4 sites, please discuss options with the RSC IRB Manager or Assistant Vice President for Research Support and Compliance.
When you are ready to submit your study for review, you should submit your study as usual. You will make the request in Section 4a of the IRB Proposal Template that asks for information about study locations. Each relying site must complete the form “Site Specific Application for Relying on the UT IRB.” This application and any supporting documentation should be submitted to the UT IRB by the UT PI.
UT PI directed study with relying sites: When study procedures will occur at multiple sites and all study procedures are being directed by the UT PI (i.e., no site PIs), requests for reliance from participating sites can be made at the time of the initial submission or via amendments.
Multicenter study: If the study is a multicenter study where all sites have their own PI and will follow a standardized protocol, your initial submission should not identify any relying sites. The UT IRB will approve the protocol and template forms, such as informed consent. After the initial submission is approved, you should submit an amendment to add non-UT Austin sites. The reason for adding sites via amendment after the initial protocol is approved is so that template forms can be approved before relying sites submit these forms with institution specific information for IRB review. Otherwise, if the UT IRB requires changes to any of the template forms, each site would need to make changes to the documents they had submitted for review.
What information needs to be provided by a relying site when the UT Austin IRB is serving as the reviewing IRB?
Relying sites must provide:
- Site specific application for relying on the UT IRB
- Any study documents that have been customized for the site (i.e., informed consent form)
How do I request a reliance arrangement if I want UT to rely on another IRB?
First, contact firstname.lastname@example.org before you proceed with any submission to ensure that UT is amenable to relying on the other IRB. Taking this step can save you time in the long run.
Once you have determined that UT is willing to rely on the external IRB, you must submit an abbreviated submission in IRBaccess to formally request the reliance. Instead of submitting the standard Protocol Template, you should submit the following documents:
- Request to Rely on an External IRB form
- PI’s curriculum vitae
- Study protocol or IRB application approved by the reviewing IRB, if applicable
- Informed consent(s) and HIPAA authorizations that will be used at UT Austin
- Approval letter for the study from the external IRB, if already approved
- Any local context form(s) required by the external IRB
- Verification of all applicable institutional approvals, such as IBC approval
The submission will be reviewed for compliance with institutional requirements and other typical requirements of an external IRB including:
- Determining the PI is qualified and has appropriate credentials and privileges to conduct the research
- Verifying that all research personnel have completed CITI human subjects training and GCP training, if applicable
- Verifying that a COI review has been completed, and sharing any COI management plan with the external IRB
- Conducting HIPAA approvals for waiver of authorization, if applicable
- Confirming that IBC approval is in place, as needed
UT will correspond with the PI and/or the external IRB to finalize the reliance arrangement and document the agreement.
How do I know if UT needs to enter into a reliance agreement with the reviewing IRB?
Whenever the research personnel, including PI and all study staff, will be representing themselves as UT affiliated individuals during the conduct of the study, UT needs to enter into a reliance agreement with the reviewing IRB.
After my study is approved by an external IRB, what are my responsibilities?
- Responsibilities with the Reviewing (External IRB)
When your study is approved by an external IRB, you are responsible for following all of the policies of the reviewing IRB. The study PI and all research personnel should be familiar with the policies of the Reviewing IRB. These responsibilities may be outlined in the reliance agreement or the approval letter, but typically will include:
- Adhering to the study procedures approved by the reviewing IRB
- Submitting any changes for approval prior to implementation (amendments) including changes in study personnel
- Reporting all unanticipated problems and noncompliance within deadlines established by the reviewing IRB
- Reporting any changes in financial relationships that may be perceived as a COI
- Cooperating with any post approval monitoring requests
- Responsibilities with the UT IRB
Even though your study is approved by an external IRB, you still have some responsibilities with the UT IRB. These include:
- Submit the following as amendments to your UT submission:
- PI and personnel changes to UT for approval prior to submitting to the reviewing IRB [required because most reliance agreements require UT to verify personnel qualifications and training]
- Addition of drugs or devices
- Change in research funding
- Submit a report on your UT submission when:
- An Unanticipated Problem occurs at the UT site (see the UT IRB Policies and Procedures Manual Section 9: Reporting Unanticipated Problems)
- The reviewing IRB determined that an Unanticipated Problem occurred at the UT site
- The reviewing IRB determined that Noncompliance occurred at the UT site
- Close the study with the UT IRB when the reviewing IRB closes the UT Austin site
- Submit the following as amendments to your UT submission:
What should I do if my grant proposal requires a plan for Single IRB Review, or I am asked to collaborate on a grant that will propose Single IRB Review?
It is important to verify with the RSC any plans for use of a single IRB before a grant proposal is submitted. If you are preparing a grant proposing that the UT IRB serve as the reviewing IRB, it is particularly important to contact email@example.com at least 2 weeks before your proposal is due to ensure the UT IRB is willing to serve. Similarly, if the grant will require that UT rely on an external IRB, it is important to contact firstname.lastname@example.org in plenty of time to receive a response prior to the grant deadline.
IRBs may charge for the review of external site submissions, even on federally funded projects. Thus, it is important to consider potential IRB charges in grant budgets. At the present time, the UT IRB is not charging a fee for the review of external sites. When another IRB will serve as the reviewing IRB, it will also be important to determine whether that IRB will change a fee for initial and ongoing reviews for the UT site, and account for these charges in your budget.