NOTE: Effective July 9, 2009, all Human Subjects Protocols must be submitted using IRBNet
Questions? E-mail: hsrb-research@udel.edu

Human Subjects Review Board
Protocol Review & Approval Procedures

IRBNet for protocol submissions

All human subjects research protocol submissions to the University of Delaware IRB must be submitted using IRBNet. Short instructional videos on the use of this system as well as supporting reference documents are available at http://www.irbnetresources.org. Please use the following to log onto the training resources page:

Login: delaware
Password: irb1

In order to submit a human subjects research protocol, researchers must first register as users on IRBNet (http://www.irbnet.org). Once you have registered, you will be able to access the University of Delaware new protocol, protocol amendment, and protocol renewal forms directly. Please remember to upload all relevant study documents including consent forms and study instruments when submitting studies for review.

General information to assist with your protocol preparation is below. Specific questions about protocol submission and using IRBnet may be addressed to hsrb-research@udel.edu or by calling the Research Office at 302-831-2137.

Deciding what kind of review your project needs:

You are planning a research project that will involve human research participants, but human subjects procedures are new to you, and you’re not sure where to start. The first thing you need to do is complete training on the protections of human subjects in research.  Check the calendar for upcoming campus training dates or complete the online training available through citiprogram.org.   
  
Think about who your research subjects will be and what the research activities involve:

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. The exemptions permissible under the Common Rule are listed below.

Exemptions

Research in six categories is exempt from review by the IRB, which means that neither expedited nor full board review is required.  It is important to note that the decision to grant Exempt status to a protocol rests with the IRB, and not with the individual researcher.  Therefore, even if you believe your project is eligible for an Exemption, you MUST submit the protocol to the IRB for review. 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.

Expedited Review

Certain minimal risk research qualifies for expedited review — that is, it does not need to be reviewed by the full IRB at a convened meeting.  Instead the protocol is approved by a subset of the IRB membership with appropriate expertise to evaluate the project.  Often amendments to full IRB approved protocols may also be reviewed under the expedited review process.

Categories of research that qualify for expedited review:

Applicability:

(A) Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

(B) The categories in this list apply regardless of the age of subjects, except as noted.

(C) The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

(D) The expedited review procedure may not be used for classified research involving human subjects.

(E) IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review — expedited or convened — utilized by the IRB.

(F) Categories one (1) through seven (7) pertain to both initial and continuing IRB review.

Research Categories

(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, so if your project does not appear to qualify for an exemption or for expedited review, you should submit a protocol for review by the full board. At UD, you, the investigator, are required to be present at the 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 HSRB, his or her adviser must attend the meeting also.

What to submit for review

Investigators should submit the proposal comprising (1) the Human Subjects Protocol Form (2) the consent form, and (3) copies of all research instruments (e.g. surveys, standardized assessments, etc.)
The protocol is the formal plan of a research activity, including a description of the research methodology, the eligibility requirements for prospective subjects, a detailed description of what subjects will be required to do, potential risks and benefits, and the proposed method of analysis of the data.
Informed consent is the educational process through which prospective subjects are helped to understand the nature of the research and fully informed about what they will be required to do and about the risks and benefits of participation. Only through this process can subjects make a knowledgeable and fully voluntary decision about whether or not to participate. Federal regulations require that several elements be included in the consent process, and in most cases the process must be documented with a consent form, with copies for both the researcher and the subject. The researcher must keep signed consent forms for three years after the research is completed. See the informed consent guidelines for help in writing a consent form.

When to submit

Protocols eligible for Exempt status or Expedited review are considered as they are received; generally turn –around time is just a few days.  Protocol submissions for full board review must be submitted  at least ten working days before an HSRB 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.

Approval

When your protocol has met the requirements for research on human subjects and the IRB has approved it, you will receive official notification, indicating the approval. Protocols are approved for a maximum of one year. In some cases, the HSRB requires more frequent review, e.g., four months or six months. You may not initiate human subjects research before you receive written approval. Any changes to the approved protocol must receive written approval prior to their implementation.

Continuing Review or Renewal

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.

 It is your responsibility to submit renewal documents in time to be appropriately reviewed before the protocol expires.  In general you will receive notification that it is time to submit the renewal indicating whether the project has been completed or will be continuing. If the research will continue beyond the expiration date, a renewal form should be submitted in time to ensure there will be no lapse in approval.

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.

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.

Appeals

Should an investigator disagree with any determination made by the IRB or its committees, he/she may appeal the decision by writing a letter to the board, stating the case for reconsideration and an alternative decision. The board may seek outside opinion as necessary in considering the appeal.

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. All amendment requests should be submitted using the Human Subjects Protocol Amendment Form using IRBNet.  All revised instruments and consent forms, as applicable need to be submitted with the IRBNet amendment form.

Unanticipated or Adverse Events

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 through IRBNet as soon as such injury or problem is discovered. The report should describe the incident and what was done to address the problem. In consultation with the Chair, the need for further action and/or reporting will be determined.

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, Human Subjects 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.

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.