Forms, Policies & Procedures

Administrative Review

Please review the material carefully and if there are any questions, please refer to the Regulatory Affairs page.

In addition to the types of review listed above, the Institutional Review Board (IRB) may provide administrative reviews when appropriate. Administrative reviews are used in cases in which the University of Delaware needs record of research with human subjects in which UD is engaged, but for which review and approval are not issued by the UD IRB. This is the case, for example, when UD investigators are part of a research team performing research at another institution. Depending on the nature of the research and the collaboration arrangement, UD IRB may rely on the review and approval from the other institution’s IRB. UD keeps record of that reliance via an administrative review.

All UD investigators involved in collaborative research with human subjects must consult with UD IRB and submit that proposed effort to the UD IRB regardless of other IRB reviews sought after.

Case Study vs. Research UD Guidance

Does a Case Report or Case Series Require an IRB Submission?

Review of medical records can constitute human subjects research (HSR) requiring Institutional Review Board (IRB) review and approval. The following is guidance offered in determining when a project involving study of records may be considered HSR by the University of Delaware IRB.

The complete policy and more can be found on the UD Research Office’s web site.

Documentation Consent Process Form and Log

Informed consent is a process and involves providing a potential subject with adequate information about the research to allow for an informed decision about the subject’s voluntary participation in a research study. Informed consent is a process. Documenting informed consent occurs after explaining the research, addressing any questions, and assessing participant comprehension.

• Documentation of informed consent requires the signature of informed consent by the research participant (or their legally authorized representative or parent(s), as applicable) unless a waiver of that signature has been approved by the IRB.
• The forms here are two different suggested templates that can be used so that the person obtaining consent notates the following: current and IRB-approved informed consent forms were used, that he/she explained the research to the participant, ensured that the participant understood the research and that the participant freely agreed to enroll.
• These forms should be utilized at the beginning of the study and throughout the study, when updates and revisions to the consent form(s) require re-consent.
• The templates herein provide a framework for documenting the consent discussion and process with each potential study participant and should be customized to different studies as applicable.
• Modify the form as needed/desired to add or remove any additional consent information, such as:
  • If a legally authorized representative is present

  Information related to signatures as applicable

Exempt Determination Tool

A tool to help determine if research is eligible for exempt status under the Common Rule.

Exemptions

There are five defined categories of research exempt from the regulatory requirements imposed by the “Common Rule.” Exempt review determinations MUST be made by the IRB office and require the submission of a research protocol to the IRB.

Research conducted in established or commonly accepted educational settings involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods.

1. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects, AND (b) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability or reputation.
   Exemption 2 does not apply to children except for research involving observations of public behavior when the investigator does not participate in the activities being observed.
2. Research involving the use of educational tests, survey procedures, interview procedures or observation of public behavior that is not exempt under category 2, if (a) the human subjects are elected or appointed public officials or candidates for public office, or (b) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
3. Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
4. Research and demonstration projects that are conducted by or subject to the approval of department or agency heads and that are designed to study, evaluate or otherwise examine (a) public benefit or service programs, (b) procedures for obtaining benefits or services under those programs, (c) possible changes in or alternatives to those programs or procedures, or (d) possible changes in methods or levels of payment for benefits or services under those programs.
5. Taste and food quality evaluation and consumer acceptance studies, (a) if wholesome foods without additives are consumed or (b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Exempt reviews are conducted as projects are submitted. Review times may vary depending on the overall volume of projects to be reviewed by the IRB at any given time. In most cases, exempt reviews are completed within two weeks from the submission date. A project determined exempt does not require annual continuing reviews. Informed consent forms of projects determined to be exempt will not be stamped by the IRB. The IRB office should be consulted about proposed changes that could affect the exempt classification.

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Procedure Details:

OWNER: UD Research Regulatory Affairs

RESPONSIBLE OFFICE: Research Office

Procedure Source Email https://research.udel.edu/forms-policies-procedures/?entry=51461

Expedited Review

Expedited review procedures may be used for certain research activities described in the federal regulations. Expedited reviews are done by one or more experienced reviewers designated by the chairperson from among members of the IRB. Projects approved by the expedited review process are subject to the same regulatory requirements as those approved on a full board review and must be periodically reviewed by continuing review before the expiration date set on approval (no longer than one year since approval). Informed consent forms associated with projects reviewed by expedited review will be stamped by the IRB with the approval and expiration dates. IRB-stamped documents are posted in IRBNet after approval and must be used when obtaining the informed consent of research participants. Protocols eligible for expedited review are evaluated on a rolling basis as they are submitted to IRBNet. Review times for expedited reviews vary depending on the total IRB submissions load at any given time and may take, on average, about two weeks from the time of complete submission.

1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
2. Collection of blood samples by finger stick, heel stick, ear stick or venipuncture as follows: (a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an eight week period and collection may not occur more frequently than two times per week; or (b) from other adults and children, considering the age, weight and health of the subjects, the collection procedure, the amount of blood to be collected and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an eight week period and collection may not occur more frequently than two times per week.
3. Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth, if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab or mouth washings; (j) sputum collected after saline mist nebulization.
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment and flexibility testing where appropriate given the age, weight and health of the individual.
5. Research involving materials (data, documents, records or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
6. Collection of data from voice, video, digital or image recordings made for research purposes.
7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
8. Continuing review of research previously approved by the convened IRB as follows:
   (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.
9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
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Procedure Details:

OWNER: UD Research Regulatory Affairs

RESPONSIBLE OFFICE: Research Office

Procedure Source Email https://research.udel.edu/forms-policies-procedures/?entry=51462

Full Board Review

Review of non-exempt research that does not qualify for expedited review, or that may present more than minimal risk to the subjects, must be reviewed at a convened meeting of the University’s IRB. At the University of Delaware (UD) the IRB meets once every month and investigators proposing new protocols are usually invited to attend the IRB meeting to present their research and address any questions the Board members may have. Students having protocols reviewed at a convened meeting and presenting to the IRB must be accompanied by their faculty advisor.

The meeting dates for the IRB, as well as the submission deadline for protocols to be considered for full board review at each month’s meeting, are set well in advance and can be found in the Research Office Calendar of Events. The number of protocols to be reviewed at each meeting may be limited due the constraints of time and the complexity of other items on the agenda. Protocols will be accepted for review in the order received. If the board is not able to review a protocol in a particular month, it will be given priority for review in the following month.

Investigators submitting new projects are normally invited to attend the IRB meeting to present their project to the Board and answer any questions or concerns IRB Members may have. The results from the meeting are later communicated to the PI and any conditions the IRB may have set before approval can be effective will be addressed then. If a new student-led project is to be reviewed by the full board, the academic advisor responsible for the student and project must accompany the student to the meeting.

Projects approved at a convened full board meeting must be periodically reviewed by continuing review before the expiration date set on approval and no less than once a year. Informed consent forms associated with projects reviewed at a full board will be stamped by the IRB with the approval and expiration dates. IRB-stamped documents are posted in IRBNet after approval and must be used when obtaining the informed consent of research participants.

Guide to Intellectual Property

The Ratner Prestia Document gives an overview of the different aspects of patents, trademarks, copyrights, and trade secrets such as how protection is gained, the duration of that protection, who is entitled to the rights, and more.

The complete policy and more can be found on the UD Research Office’s web site.

HIPAA Hybrid Statement

1. Introduction
   As with some other research-intensive institutions¹ , the University of Delaware (“UD”) recognizes that the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) is a consumer protection law intended to protect individually identifiable information relating to the physical or mental health of an individual, the provision of health care to the individual, or the payment for the provision of health care to the individual. HIPAA applies to “Covered Entities,” which include health care providers, health plans and health care clearinghouses that conduct specified transactions electronically (“Covered Entities” or each a “Covered Entity”)² . UD is engaged in both Covered Entity and non-Covered Entity activities. HIPAA allows entities that are engaged in both Covered Entity functions and other activities that are not Covered Entity functions to designate themselves as “Hybrid Entities,” with the result that the HIPAA regulations do not apply to the non-covered functions.

   ¹For Example, Vanderbilt University (https://ww2.mc.vanderbilt.edu/osp/51235).

   ²https://www.hhs.gov/hipaa/for-professionals/covered-entities/index.html.

2. Hybrid Entity Status Assessment
   Based upon an assessment of UD units and a review of HIPAA standards, UD designates itself as a Hybrid Entity under HIPAA. Identification of individuals and entities that are part of the UD Covered Entity (“UDCE”) is complicated by the fact that UD is engaged in multiple covered functions and non-covered functions with a mission that includes education, health care, and research. Workforce members often have multiple roles, both covered and non-covered. Therefore, determination of those entities and individuals who are included in the UDCE is a dynamic and ongoing process that is based upon the data used and/or being disclosed, not based upon any particular overall department mission or activity.

   The UDCE includes health-related research centers, interdisciplinary programs, and University-wide programs. Whether a UD function or individual’s activity on behalf of UD is included in the UDCE is hereafter determined based not upon any particular department or unit, but instead upon the data being used and/or disclosed.

3. Categories of Data
   The following defined categories of data are critical to the determination of covered functions and activities:

   A. Individually identifiable health information (IIHI) is information collected from an individual that is created or received by a health care provider, employer, plan or 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 health care to an individual and identifies the individual, or can reasonably be used to identify the individual.

   B. Protected Health information (PHI) is IIHI that is transmitted or maintained in any form or medium by a covered function within the UDCE. This specifically excludes education records, which are protected by other privacy regulations, and employment records held by UD in its role as an employer. This also excludes research health information (see definition below), which is protected by other regulatory requirements.

   C. Research Health Information (RHI) is IIHI that is used for research purposes but that is not PHI, and thus is NOT subject to the requirements of HIPAA. RHI is IIHI that is created in connection with research activity and is not created in connection with patient care activity. When a researcher is not also functioning as a health care provider, and creates IIHI in connection with pure research activities (no patient care involved) the IIHI is not PHI and is not subject to the privacy and security rules of HIPAA. If a researcher is also a health care provider and IIHI is created in connection with the researcher’s health care provider activities, then the IIHI is PHI subject to HIPAA. IIHI that is created as PHI and is needed for research purposes may be disclosed to a researcher (the same individual healthcare provider who is also a researcher may disclose PHI to herself in her research role) pursuant to the IRB approval process, which includes proper patient authorization or IRB waiver of authorization. After the PHI is properly disclosed to the research setting, the IIHI transferred to the research setting becomes RHI, which is no longer subject to the requirements of HIPAA. In certain cases such as interventional clinical trials it is expected there will be two copies of some IIHI: a copy kept in the patient’s medical record which is PHI and subject to HIPAA, and a copy of the same data kept in the research record which is RHI and not subject to HIPAA.

   D. Key Determinants: The key determinants as to whether or not information is IIHI and not protected by the Privacy Rule or PHI and protected are: 1) the function being performed by the provider or health plan; and 2) the purpose for which an entity or workforce member has received, created or maintained the medical information (e.g., treatment, payment, operations). Record keeping practices are not the determinant. For example, an assessment of fitness for duty generates PHI when the UDCE administers or oversees a test of a UD employee. When the employee authorizes UD, the health care provider, to turn over the information to UD, the employer, it is a part of the employee’s employment record and no longer PHI. It is important to note that in most circumstances (exceptions include workplace injury, illness or medical surveillance) the employee must provide a signed authorization to the UD health care provider to release the information to UD, the employer.

4. Determining Covered Functions Criteria
   The following criteria are used to determine whether a function or individual workforce member is included in the UDCE:

   A. Health care or health plan use or disclosure: When the use or disclosure of IIHI is carried out in connection with a health care provider or health plan function by UD workforce members, the individual’s health information is defined as PHI, and HIPAA privacy and security regulations apply to those functions and to the workforce members who carry out those functions;

   B. Functions that support health care or health plan: When the use or disclosure of IIHI is carried out by business, financial, legal or administrative functions on behalf of UD’s health care provider and health plan activities, the individual’s information is PHI and the HIPAA privacy and security regulations apply to those functions and to the workforce members who carry out those functions;

   C. Employer and education functions: When the use and disclosure of IIHI is carried out by UD in its capacity as an employer or an educational institution, the information is not PHI and those UD functions are not subject to the privacy or security regulations of HIPAA, but the confidentiality of the individual’s health information is protected by other state and federal law, as well as by UD policy; and

   D. IRB functions: PHI may only be disclosed to a researcher for use in connection with an IRB-approved or exempt protocol and pursuant to a waiver or authorization. When a researcher requests access to PHI that has been created, received or maintained by the UDCE, the Privacy Rule requires that the UDCE receive specific assurances that the PHI will be protected once disclosed to the researcher for use as RHI, and UD must account for certain disclosures as required by the HIPAA regulations. UD’s IRB will function as the Privacy Board as defined by HIPAA.

   E. Examples of UD workforce members who may provide services to covered functions: Workforce members of the following components of UD may provide administrative functions on behalf of the UDCE (use of PHI subject to the requirements of HIPAA) and on behalf of non-covered components of UD (IIHI not subject to the requirements of HIPAA):

   • Alumni Relations (https://www.udconnection.com/)
   • Development (https://www1.udel.edu/giving/)
   • Economic Innovation & Partnerships (http://www.oeip.udel.edu/)
   • Environmental Health & Safety (https://www1.udel.edu/ehs/)
   • Finance and Administration (https://sites.udel.edu/vpfinance/)
   • General Counsel (https://sites.udel.edu/generalcounsel/)
   • Institutional Research & Effectiveness (https://ire.udel.edu/)
   • Institutional Review Board (https://www1.udel.edu/research/preparing/humansub.html)
   • Internal Audit (https://www1.udel.edu/Treasurer/internalaudit.html)
   • Public Safety (https://www1.udel.edu/police/)
   • Research & Research Compliance (https://www1.udel.edu/research/about/index.html)
   • Risk Management (https://sites.udel.edu/vpfinance/departments/risk-management/)
   • Other UD entities that perform covered functions within the UDCE, such as:
     1. Applicable Academic Programs
        • College of Agriculture and Natural Resources (https://canr.udel.edu/)
        • College of Arts and Sciences (https://www.cas.udel.edu/Pages/default.aspx)
        • Alfred Lerner College of Business and Economics (https://lerner.udel.edu//)
        • College of Earth, Ocean, and Environment (https://www.ceoe.udel.edu/)
        • College of Engineering (https://www.engr.udel.edu/)
        • College of Health Sciences (https://chs.udel.edu/)
        • College of Education and Human Development (https://www.cehd.udel.edu/)
        • Biomechanics & Movement Science  (https://sites.udel.edu/bioms/)
        • Cognitive Science (https://www.lingcogsci.udel.edu/)
     2. Research Centers/Institutes
        • Applied Science & Engineering Laboratories (http://www.asel.udel.edu/)
        • Center for Bioinformatics & Computational Biology (http://bioinformatics.udel.edu/)
        • Center for Biomedical Engineering Research (http://www.cber.udel.edu/)
        • Center for Environmental Genomics (http://www.ceoe.udel.edu/ceg/index.shtml)
        • Center for Science, Ethics & Public Policy (http://www.sepp.udel.edu/)
        • Center for Spintronics and Biodetection (https://wiki.physics.udel.edu/csb/Main_Page)
        • Center for Translational Cancer Research (https://www1.udel.edu/ctcr/)
        • Delaware Biotechnology Institute (http://www.dbi.udel.edu/)
        • Delaware Design Institute (http://ddi.udel.edu/)
        • Delaware Physical Therapy Clinic (http://sites.udel.edu/ptclinic/)
        • Delaware Rehabilitation Institute (http://www1.udel.edu/dri/)
        • Institute for Global Studies (http://www1.udel.edu/global/)
        • Institute for Transforming Undergraduate Education (http://www1.udel.edu/inst/)
        • Small Business & Technology Development Center (http://delawaresbdc.org/)
     3. University-wide Units
        • Academic Enrichment Center (https://www1.udel.edu/AEC-workshop/resource.html)
        • Counseling & Student Development (http://sites.udel.edu/counseling/)
        • Student Health Service (http://www1.udel.edu/studenthealth/)
        • Student Services for Athletes (http://www.bluehens.com/SportSelect.dbml?DB_OEM_ID=29100&SPID=176008&SPSID=1036210)
5. Protected Health Information transfer between covered and non-covered componentsA. Patient authorization required: When workforce members who provide services to the UDCE perform services on behalf of non-covered components of UD, these non-covered functions are not part of the UDCE. Workforce members must not disclose PHI to non-covered UD components without the individual or patient’s authorization, or waiver of authorization by the IRB in the case of disclosures for research purposes, as required by the Privacy Rule.

   B. Disclosure between Health Plan and Providers: Workforce members who provide business and finance services to both UDCE providers and UDCE health plans cannot use or disclose PHI between those entities unless it is allowed in the Privacy Rule.

Direct Inquiries to:

Sean Hayes, J.D., Ph.D.
Research Advisor
Institutional Privacy Officer
Email: hayes@udel.edu
Phone: 302-831-7445

OR

Cordell Overby, Sc.D.
Associate Vice President for Research & Regulatory Affairs
Email: overbyc@udel.edu
Phone: 302-831-2383

The complete policy and more can be found on the UD Research Office’s web site.

Human Subjects in Research and Research-Related Activities

1. SCOPE OF POLICY
   This policy addresses the University of Delaware (“UD” or “University”) obligation to ensure the protection of the rights and welfare of individuals used as subjects in research-related activities and applies to all University departments, units, faculty, staff and students.
2. POLICY
   UD bears full responsibility for the performance of all research involving Human Subjects, including complying with federal, state, and local laws as they may relate to such research. In meeting its obligations in this area, the University is guided by the ethical principles set forth in the report of the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the “Belmont Report”), and adheres to the regulations of Title 45, Part 46 of the Code of Federal Regulations, 45 CFR 46, and the University’s FWA with the U.S. Department of Health and Human Services (and all other requirements from governmental entities with legal jurisdiction oversight) for the protection of Human Subjects in research.

   The UD Provost appoints the Deputy Provost for Research & Scholarship as IO for research involving Human Subjects. The Deputy Provost for Research and Scholarship may appoint the Associate Deputy Provost for Research & Regulatory Affairs to act in the capacity of IO. …

The complete policy and more can be found on the General Counsel’s web site.

IRB Review Types

The University of Delaware (UD) requires that ALL research activities involving human subjects, bio specimens and/or tissue samples from humans, and/or private identifiable data be reviewed and approved by the IRB prior to their start. All submissions to the UD IRB must be made using IRBNet. Depending on the research proposed the IRB may issue different types of review as prescribed in the pertinent regulations and policies:

IRBNet New User Registration

The University of Delaware uses the IRBNet system to manage its IRB Protocols with research concerning human subjects. If you are not already registered with IRBNet, it is necessary that you do so in order to produce the documentation that will be reviewed by the University of Delaware’s IRB. After review, the IRB office will communicate with the principal investigator and request any clarifications or edits that need to be completed before approval can be issued.

Once a review has been completed, decision letters are uploaded in IRBNet and are always accessible to the investigator(s). Informed consent documents from projects approved via an expedited or full board review will be stamped with the IRB approval and expiration date and also uploaded in IRBNet. Informed consent must be obtained using the stamped version of the approved documents, (i.e., participants signatures need to be collected in a copy of the stamped informed consent.) No IRB stamp is added to informed consent documents associated to projects deemed exempt.