Section 3: General Research Procedures
3.0 Extramural Research
3.1. Public and / or Published Data Sets Not Subject to Human Participants Review
3.2 Guidelines for Research Protocols Requiring Collection and Storage of Genetic Materials
3.3. Scientific Merit
3.4 Confidentiality
3.5 Privacy
3.6 Protecting Participants' Health Information
3.7 Conflict of Interest
3.8 Records Retention Requirements
3.9 Guidelines for Payment of "Finder's Fees" for Research Participant Recruitment
3.10 Guidelines on Compensation for Research Participants
3.10.1 Guidelines for Research Advertisement Content
3.11 Equitable Recruitment
3.12 Funded / Sponsored Research
3.0 Extramural Research
A prerequisite for approval, the IRB requires all off campus research to have documented approval on file from the respective IRB of record for that site. For example, extramural sites may include school districts, day care centers, nursing homes, private clinics, shelters, treatment facilities, churches, or businesses. In the event the extramural site does not have an IRB, the PI should request approval from the institutional entity or official with the necessary authority to approve research. Researchers should determine and follow all host site’s policy and procedures for human subjects research. Researchers should submit approval letters from these institutions or agencies on their letterhead. The letter should grant you permission to use the agency’s facilities or resources; it should indicate knowledge of the study and that it will be conducted at the site. If these letters are not available at the time of IRB review, approval will be contingent upon their receipt. A site letter template is located in Appendix G and on the website, http://www.utexas.edu/research/rsc/humansubjects/forms.html.
3.1. Public and / or Published Data Sets Not Subject to Human Participants Review
- Any changes made to the original Public and/or published datasets, accessible without restriction (e.g., password not needed*), and containing no readily identifiable, individual information. Examples include:
- Inter-University Consortium for Political and Social Research (ICPSR)
- U.S. Bureau of the Census
- National Center for Health Statistics
- National Center for Education Statistics
- National Election Studies
- Public and/or published datasets, accessible without restriction (e.g., password not needed*), and containing readily identifiable information and where individuals can reasonably expect this information to be available to the public (examples include letters to the editor, blogs).
- Public and/or published datasets, with restrictions to access, that contain data that is presented in aggregate form only (e.g., zip code); thus individuals cannot be identified.
* Or in those cases where you must register with a site or organization to gain access, the registration for login and password must be without qualification – anyone could register with this site.
3.2 Guidelines for Research Protocols Requiring Collection and Storage of Genetic Materials
IRB approval must be obtained in most cases in which research activities include the use of data from records or stored specimens (blood, urine, tissue, and other human products). For purposes of this discussion, health care information records (including financial records, pharmacy records, x-rays, CT scans, MRI and other images and recordings), diagnostic specimens, pathological specimens and residual specimens are treated as health care information.
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 donor with the specimen. Some basic information such as age, gender, and diagnosis may be retained with the specimen. The specimen may be shared with researchers from other institutions and or sent elsewhere for analysis. The specimen may be stored indefinitely.
The consent form must clearly state that the specimen was donated for medical research purposes. Donors are not entitled to compensation from any commercial use of the products or derived products from the specimen. The consent form should indicate if the specimen may be used for purposes and research that has not yet been determined. These 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 which are genetically based. The consent form should include a section for the participant to choose whether or not to allow the specimen to be used in genetic research (see 5.2).
3.3. Scientific Merit
It is not the charge of the IRB to comment upon the scientific merit of proposals submitted for review, where scientific merit refers to the value of the research proposal relative to other research proposals. The IRB is responsible to evaluate the scientific or scholarly validity of the research (using its own expertise or the expertise of the Departmental Review Committee) so that the IRB can determine whether the research uses procedures consistent with sound research design, whether the research design is sound enough to reasonably expect the research to answer its proposed question, and what the importance is of the knowledge expected to result from this research.
3.4 Confidentiality
Whenever researchers promise participants that their responses and data will be maintained in confidence, all research project members (investigators, directors, transcribers, students, and staff) are required to prevent accidental and intentional breaches of confidentiality. In most cases, confidentiality can be assured by following fairly simple practices (e.g., substituting codes for identifiers, removing survey cover sheets that contain names and addresses, limiting access to identified data, and/or storing research records in locked cabinets). However, all measures used to assure confidentiality of data need to be understood by all research staff before research is initiated, and followed once research is initiated. Confidentiality procedures must be described in research applications that come before the UT-IRB. Researchers should recognize that the assurance of confidentiality includes keeping the identity of participants confidential. Researchers proposing projects that will address sensitive, stigmatizing, or illegal subjects must explicitly outline the steps they will take to assure any information linking participants to the study is maintained in confidence. The requirement of signed consent forms is often waived in sensitive studies, if the consent document is the only written record linking participants to the project and a breach of confidentiality presents the principal risk of harm anticipated in that research. If there is any chance that data or participants' identities might be sought by law enforcement agencies or subpoenaed by a court, a grant of confidentiality should be obtained. Under federal law (Public Health Act § 301(d)), researchers, prior to the initiation of the research project, may request grants of confidentiality to protect against forced data and participant identity disclosures. These grants provide protection for specific research projects where protection is judged necessary to achieve the research objectives. If you believe your research project may require a grant of confidentiality, please contact your Departmental Review Committee Chair or the ORS 471-8871. For more information on Certificates of Confidentiality and their limitations, see: http://grants.nih.gov/grants/policy/coc/index.htm. For Certficate of Confidentiality contacts at the NIH, see: http://grants.nih.gov/grants/policy/coc/contacts.htm. For OHRP guidance on Certificates of Confidentiality, see: http://www.hhs.gov/ohrp/humansubjects/guidance/certconf.htm.
3.5 Privacy
When participants voluntarily permit investigators access to themselves, they exercise their right to privacy. Privacy is the right to authorize or decline access. It should not depend upon the participant’s ability to exert control over another’s access. Thus, an incapacitated adult or infant is unable to control access to their privacy, but regardless, still has a right to privacy. The informed consent process should disclose any risks to privacy and how investigators specifically plan to protect privacy. Investigators are required to follow the privacy protections outlined in the University of Texas at Austin HRPP training. The IRB reviews studies to ensure adequate privacy protections and prevent unnecessary invasions of privacy. Privacy is best protected by making sure the research is designed so that participants will be comfortable with the way investigators interact or intervene with them. Investigators must maintain the confidentiality of all private and identifiable information unless disclosure is mandated according to federal, state, or local law.
3.6 Protecting Participants' Health Information
Even in those circumstances where an exemption to the signed consent requirement applies, a signed authorization from the research participant, permitting the use and disclosure of his or her Protected Health Information (PHI), will still be required, UNLESS specifically waived by the IRB (see 5.4 below). In the event that serious harm may result from granting access to the subject, or his or her authorized representative, or the PHI, the information may not be divulged. Confidentiality is best maintained by anonymous data collection. In the event that the Privacy rule is more restrictive than the procedures described in the consent requirements, the more restrictive rule must be followed.
3.7 Conflict of Interest
All investigators, consultants, and/or IRB members are required to disclose any conflicts of interest according to University of Texas at Austin conflict of interest policy found in the Handbook of Operating Procedures and Policy Memoranda (http://www.utexas.
edu/policies/hoppm/h0511.html). Conflicts of interests that might affect the protection of participants are prohibited unless a management plan is in place that prevents the conflict of interests from affecting the protection of participants. Management plans that are considered include: partial or complete divestment, limiting involvement of the conflicted individual, additional oversight or disclosure. Disclosure alone cannot be used to manage conflicts of interests that might affect the protection of participants. Consultants found to have a conflict of interest will not serve as consultants for the study under review.
In cases in which the Committee on Objectivity in Research (OIR) identifies a situation involving possible institutional conflict of interest, such cases will be sent to the Institutional Compliance Officer for review and disposition.
Institutional Conflicts of Interest are handled according to University of Texas at Austin Institutional Conflict of Interest in Human Subjects Research policy found in the Handbook of Operating Procedures and Policy Memoranda (http://www.utexas.edu/policies/
hoppm/11.B.02.html).
3.8 Records Retention Requirements
The IRB collects, prepares and maintains adequate documentation of the following types of IRB activities. All records will be accessible for inspection and copying by authorized representatives of OHRP, DHHS, FDA, Sponsors, university officials, and internal auditors at reasonable times and in a reasonable manner (45 CFR 46.115(b).
- Research Protocol Files:
Per Section 2.4 of this Manual, the following pertinent information on all submitted research protocol files (45 CFR 46.115(a)(1) is kept. The IRB Office will keep such protocol files in the office for three years after study closure. At that time, they will be destroyed. Electronic protocol files that are withdrawn or not approved will also be destroyed three years after the date of withdrawal or determination that the study was not approved.
Per Section 2.2 of the Manual, Minutes of each IRB meetings (45 CFR 46.115(a)(2) are recorded in writing and contain the following information. See Section 2.2 for details of information recorded in minutes. Minutes are kept for an indefinite period in the ORS; however, minutes that entirely reflect protocol files that have been destroyed (see above)-- per this policy and procedure section, may also be destroyed.
- Membership Files and IRB Roster: 45 CFR 46.115(a)(5) IRB member files and the IRB roster 45 CFR 46.103(b)(3):
- Name
- IRB training documentation
- Earned degrees
- Representative capacity
- Indications of experience such as board certifications, licenses, etc. sufficient to describe each members chief anticipated contributions to IRB deliberations
- Relationship of the member to the organization
- Affiliation status
- Position on IRB (Chair/Vice-Chair; Primary member/alternate member; voting; non-voting; ex-officio). If the member is an alternate member, the primary member for whom s/he represents will be so designated.
- Changes in Committee membership will be reported to OHRP as required.
- Curriculum Vitae / Resume
- Records Required of and related to the PI of the study protocol. The principal investigator or project director shall maintain, in a designated location, all records relating to research which is conducted for at least 3 years after completion of the research. All records must be accessible for inspection and copying by authorized representatives at reasonable times and in a reasonable manner. Consent forms are to be available for inspection by authorized officials of University of Texas at Austin administration, the Institutional Review Board, DHHS, the FDA (as appropriate), regulatory agencies and/or sponsors as applicable to the research protocol in question. Should a principal investigator or project director depart from The University of Texas at Austin prior to the completion of the research protocol, the investigator is responsible for initiating mutually satisfactory arrangements with their department and The University of Texas at Austin administration as to the disposition of executed subject consents. It is noted that if the PI makes a verbal inquiry of the IRB or ORS, such offices may respond verbally, with no written documentation. If however, the PI submits a written request, the IRB will respond to the PI with a written response outlining the determination. This written response may take the form of either a formal letter or an email. When written requests are submitted all documentation will be maintained as part of University of Texas at Austin IRB records. Other than minutes, IRB records not related to a specific research activity (i.e., records that are not relevant to a specific protocol file) will be kept for three years and then destroyed.
3.9 Guidelines for Payment of "Finder's Fees" for Research Participant Recruitment
University of Texas at Austin Institutional Review Board does not permit the payment of finder's fees and / or bonus payments (monetary or in kind) in any form, due to the potential that such a practice could be perceived as coercive and bordering on unethical research subject recruitment. In addition, several professional associations and groups have stated that this practice is unethical (e.g., AMA, APA).
3.10 Guidelines on Compensation for Research Participants
The guidelines outlined below are meant to assist investigators in determining a reasonable amount of compensation that can be given to research participants and also place some boundaries on what is and is not “reasonable.” The “reasonableness” of a particular sum of money or other form of payment should be based upon the time involved, the inconvenience to the subject, reimbursement for expenses incurred while participating, and should not be so large as to constitute a form of undue influence or coercion.
During the initial review of a research protocol, the IRB is required to review both the amount of compensation proposed and the method and timing of disbursement to assure that neither are coercive or present undue influence. The following are some additional guidelines:
- Any compensation should not be contingent upon the subject completing the study, but should accrue as the study progresses.
- Unless it creates undue inconvenience or a coercive practice, compensation to subjects who withdraw from the study should be made at the time they would have completed the study, had they not withdrawn.
- Compensation given as a “bonus” or incentive for completing the study is acceptable to the IRB, providing that the amount is not coercive. The IRB is responsible for determining if the incentive amount is not so large as to be coercive or represent undue influence.
- The amount of compensation should be clearly set forth in the informed consent document.
3.10.1 Guidelines for Research Advertisement Content
The IRB must review and approve all advertisements that will be used to recruit subjects to a specific research study. Generally, advertisements used to recruit research subjects should be limited to information that a potential subject would need to determine if they are eligible and interested in participating. More specifically, the ads should include information such as:
- Name and address of the research facility;
- The condition or disease that will be the focus of the research;
- Purpose of the research with reference to the fact that the study is investigational;
- Summary of criteria for eligibility to participate;
- Time and other commitments that will be required of the subject;
- Location of the study and the office to contact for further information.
The ads should not:
- Contain explicit or implicit claims of safety and efficacy or equivalency or superiority to approved procedures or treatments;
- Emphasize the amount of reimbursement that subjects will receive. The ads may state that reimbursement for time, travel, etc. will be given;
- Promise a favorable outcome or benefits;
- Include exculpatory language;
- Promise “free treatment” when the intent was only to say participants would not be charged for taking part in the investigation;
- For FDA-regulated research, advertisements should not:
- Make claims, either explicitly or implicitly, about the drug, biologic or device under investigation that were inconsistent with FDA labeling;
- Use terms, such as “new treatment,” “new medication” or “new drug” without explaining that the test article was investigational;
- Allow compensation for participation in a trial offered by a sponsor to include a coupon for a discount on the purchase price of the product once it had been approved for marketing.
Advertisements conforming to the above guidelines may be approved for any advertising format, e.g., posted flyers, newspapers, internet advertisements, radio/television, slides shown prior to films at movie theaters. However, the IRB must review the final copy of printed advertisements to evaluate the relative size of type used and other visual effects. To avoid multiple requests for IRB review and approval, investigators should specify in their original request all advertising formats that are anticipated.
3.11 Equitable Recruitment
The IRB will only approve studies demonstrating equitable subject recruitment, taking into account the purposes of the research and the setting in which it will be conducted. The IRB evaluates all research applications to verify that investigators have demonstrated equitable selection and recruitment (distributive justice) of all research subjects and have made every effort to ensure diversity of subject selection. In particular, the IRB evaluates any special problems that may occur with proposed research involving vulnerable populations, such as children, prisoners, pregnant women, cognitively-impaired individuals, and economically or educationally disadvantaged persons. The IRB ensures that proposed sampling efforts do not favor some classes of participants solely due to ease of availability, compromised positions, or manipulability. IRB reviewers also require researchers to make every effort to include women and members of minority groups, if appropriate to the research purpose.
3.12 Funded / Sponsored Research
For information on “General Policies, Integration of Teaching and Research, Faculty Initiative, Restrictions on Publication, Benefits of Research, and Social Action and Advocacy,” please refer to http://www.utexas.edu/policies/hoppm/h0508.html or The UT-Austin Handbook of Operating Procedures (HOP).
Any Sponsored or funded human participant research project requires both IRB and OSP review and approval. Investigators should submit documentation online via IRBaccess (IRB) or the Research Manager System (OSP). The IRB and OSP databases interface and each office will confirm approval before the distribution of funds. If the IRB application indicates funding or a sponsor, then the application cannot be processed until it is assigned an OSP number. Correspondingly, if the OSP proposal indicates human participant involvement OSP cannot award funds until receipt of confirmation of IRB approval. OSP is notified of IRB approval through the database or the investigator may submit a copy of the IRB approval letter. OSP reviews contracts and grants to ensure that institutional officials who have established contracts with other agencies are not the final signatories.
All proposals to sponsoring agencies and the grants or contracts resulting from the proposals must be reviewed and approved at certain administrative levels before transmittal to the sponsoring agency. In most cases, a proposal, after preparation and initiation by the individual faculty member, must be reviewed and approved in turn by:
- Office of Sponsored Projects (preliminary review)
- Department Chairman (or Unit Head)
- Dean (or Director)
- IRB (if necessary)
- Office of Sponsored Projects (final review)
- Vice President for Business Affairs (fiscal/legal)
- Executive Vice President and Provost (final institutional approval)
In some cases, depending on the nature of the proposed activity, the cost of the project, or institutional commitments involved, review and approval by the U.T. System administration may be required. Principal investigators (project directors) should contact the Office of Sponsored Projects during proposal preparation to ascertain the required approvals.
All proposals must be accompanied by the form, Application for Review and Approval of Proposal for Grant or Contract. The summary information contained on the completed form will facilitate administrative review and approval, and thus help to expedite processing. Copies can be obtained from the Office of Sponsored Projects: http://www.utexas.edu/research/osp/
Persons Authorized to be Principal Investigators or Project Directors for Sponsored Projects
When The University accepts a grant or contract from an outside sponsoring agency, certain legal and ethical obligations are stated or implied in the document of agreement. The University becomes responsible for the proper performance of the stated work and for fiscal management of the funds received from the sponsor. Sponsors usually require that an individual be named to oversee the project with the reasonable assurance that the agreed responsibilities will be discharged faithfully and prudently in the mutual interest of the sponsor and The University and over the full period of the award.
In order to implement these obligations only individuals in the categories shown below are authorized to be principal investigators or project directors for sponsored projects. Only in rare instances will others be authorized, and then only with the prior written approval of the Associate Vice President for Research/Director of the Office of Sponsored Projects.
- Members of the faculty in the professorial ranks (instructor, assistant professor, associate professor and professor)
- Directors (code 1000)
- Research scientists/engineers (code 1000) and senior research scientists/engineers (code 1000)
- Special research associates at the Applied Research Laboratory.