University of Delaware
Toolbox

Human Subjects
Protocol Review & Approval Procedures

Deciding what kind of
review your project needs

You are planning a research project that will involve human volunteers, but human subjects procedures are new to you, and you’re not sure where to start. First, think about who the subjects will be and what they will be asked to do:

A. If the subjects will be involved in minimal-risk activities (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 or during the performance of routine physical or psychological examinations or tests), the research may be exempt from board review.

B. If none of the exemptions covers the activities you propose, read the nine categories for expedited review. If one of them appears to cover your project, follow the instructions for expedited review.

C. If none of the expedited or exempt categories covers your proposed research activities, your project will require review by the full Institutional Review Board (IRB).

This three-step decision process is to help you in planning your research; final determination of the type of review that is required will be made by the IRB. Please use the Human Subjects Protocol form for your submissions and submit your protocol using IRBNet (http://www.irbnet.org).  If you have questions, please contact the Research Office at 302-831-2137.


Exemptions

Research in six categories is exempt from review by the IRB, which means that neither expedited nor full board review is required, BUT the exemption must be granted by the IRB. Exempt review is conducted on a rolling basis as protocols are received.

In most instances, the following research categories are exempt from review by the IRB (from Title 45, Code of Federal Regulations, part 46.101(b), 6/18/91).

(1) 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.

(2) 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.

(3) 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.

(4) 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.

(5) 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.

(6) 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.

Notes: These exemptions do not apply to research involving prisoners, fetuses, pregnant women, or human in vitro fertilization.

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.

Department or agency heads refers to federal positions.

Expedited Review

Protocols eligible for expedited review are evaluated on a rolling basis as they are submitted to IRBNet. Research in the following 9 categories may be eligible for expedited review:

(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 8 week period and collection may not occur more frequently than 2 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 8 week period and collection may not occur more frequently than 2 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.

1 An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.

2 Children are defined in the HHS regulations as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.“ 45 CFR 46.402(a).

(Source: 63 FR 60364-60367, November 9, 1998)

Full Board Review

Review of research that will 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), you, the investigator, are required to be present at the IRB meeting when your project is reviewed. The review begins with a short (maximum of five minutes) summary of the research by you, after which board members ask any questions they have. When a student presents a protocol to the IRB, his or her faculty advisor must attend the meeting also.

Protocols must be submitted to IRBNet at least ten working days before an IRB meeting for review at that meeting. 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.

Therefore, 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.

See the Research Office Calendar of Events for dates.

Continuing Review or Reviewal

Protocols are approved initially by the IRB, whether expedited or full board review, for a maximum of one year. In some cases, the IRB requires more frequent review, e.g., four months or six months. If a project that was initially reviewed by the full board will be continuing beyond the initial approval period, a protocol renewal form must be completed and submitted via IRBNet in time for a board meeting before the approval expiration date.

Projects may be renewed up to four times by completing the renewal application. After the fourth renewal, an investigator will receive a special renewal request which requires an expanded renewal submission. In addition to the information required for a new protocol, it is also necessary to include a summary of any findings, adverse events, or variations from the original project. While reminders of upcoming renewal dates will be sent from IRBNet, it should be noted that it is the Investigator’s responsibility to know when his/her protocol will expire and to submit continuation requests in enough time to allow IRB review of the project before it expires.

Regardless of the method of approval, projects will be suspended if a completed renewal form is not received prior to the expiration date noted on the approval document.

Amendments

Researchers may find that it is necessary to make changes to an approved protocol. This may involve changes to the subject population, instruments being used, or other aspects of the methodology.

Prior to implementing any changes, the investigator must obtain approval from the IRB. In many cases, the amendment can be approved in a few days. If a project was originally reviewed by the fully convened board and the amendment is a significant deviation from the original proposal, it will require submission for a full board review.


Unanticipated or Adverse Changes

In those instances in which a research participant suffers an injury or when unanticipated problems occur which may pose a risk to participants, the investigator must submit a report to the IRB as soon as such injury or problem is discovered.


Submission Procedures

All submissions to the University of Delaware IRB must be made using the IRBNet protocol management system (www.irbnet.org). Submissions of new projects should be made using the “Create New Project” feature and should include a protocol form, consent form and all relevant research instruments. Submissions of amendments, continuing review documents, and unanticipated or adverse events should be made in IRBNet using the “Project History” feature from the previously approved protocol (accessible from “My Projects”. The “Project History” selection will take the researcher to a screen that will allow for the creation and submission of a new package of documents tied to the original submission.

Students submitting projects on IRBNet must share those projects with their faculty advisor. Faculty sponsors of student projects as well as the student researcher must electronically sign the project before it is submitted to the IRB. For training on how to use IRBNet click here.

Informed Consent Guidelines

The following elements must be included in an informed consent form, which is a document describing the study in terms the subjects can understand. The consent form is not written for one’s scientific or technical peers, and the use of jargon or scientific terms should be avoided. It is helpful to use the subject headings below in the consent form itself.

1. PURPOSE/DESCRIPTION OF THE RESEARCH
• Clear statement that this is a research study
• Brief, clear discussion of the purpose of the study
• Why subject qualifies to participate in the study (how subject was chosen)
• Length of subject’s participation
• Description of procedures
• Approximate number of subjects in study

2. CONDITIONS OF SUBJECT PARTICIPATION
• A statement of the extent, if any, to which confidentiality of records will be maintained
• Availability of medical treatment if injuries occur: what services are available and who pays
(The following statement may be included when appropriate. Do not offer emergency medical treatment if you have not arranged to provide it: “In the event of physical injury as a direct result of these research procedures, you will receive first aid. If you require additional medical treatment, you will be responsible for the cost.”)
• Why, when subject participation could be terminated by investigator
• Consequences of subject's decision to withdraw from research and procedures
• Assurance of notification of significant findings that may determine subject’s willingness to continue

3. RISKS AND BENEFITS
• Description of risks or discomforts to subject
• Description of possible immediate or future benefits to subject

4. FINANCIAL CONSIDERATIONS
• Compensation to subject, if applicable
• Costs to subject — what aspects of participation will and will not be paid for by research study (i.e., reimbursement for mileage)

5. CONTACTS
• List the investigator’s name, telephone number, and other contact information for subjects’ questions about details of the research, study procedures, follow-up, etc.
• List Chair, Institutional Review Board, University of Delaware, 302-831-2137, as the contact for questions or concerns regarding the rights of individuals who agree to participate in research.

6. SUBJECT’S ASSURANCES
• Assurance that participation will be considered voluntary (refusal to participate or discontinuation results in no loss of benefits to which subject is otherwise entitled)

7. CONSENT SIGNATURES
• Consent required from subject or from parent/guardian if subject is under 18
• Assent required from subjects under 18 who are capable of providing it
• Signed consent forms must be retained by the researcher for three years after completion of the research.

8. DOCUMENT FORMAT
• Title of project should appear at the top of the project consent form.
• Use 12-point or larger type and subject headings (e.g., Purpose of Research, Risks and Benefits, etc.) for subjects’ ease of reading and understanding.
• Number consent form pages to indicate the total length of the document, e.g., 1 of 3, 2 of 3, etc.
• Provide a line on each page for the subject's initials, to acknowledge that he or she has read the page.
• Provide a line for the subject's full signature on the final numbered page.