LLU Institutional Review Board

NEOMED Institutional Review Board

Guidelines for Protection of Human Subjects in Research

Office of Research and Sponsored Programs

NEOMED’s Institutional Review Board (IRB) is an administrative body established to protect the

rights and welfare of human research subjects. The IRB will review all human studies conducted under the

auspices of NEOMED. NEOMED gives assurance that these institutions will comply with U.S. Department of Health and Human Services regulations for the protection of human research subjects in all applicable studies, regardless of sponsorship. Copies of NEOMED’s Assurance of Compliance are available at the Office of Research and Sponsored Programs.

IS IT HUMAN SUBJECT RESEARCH?

Research is defined as "a systematic investigation, including testing and evaluation, designed to develop or

contribute to generalized knowledge."

Human subject is defined as "a living individual about whom an investigator (whether professional or student)

conducting research obtains

(1)data through intervention or interaction with the individual private

(2)Identifiable private information.

(3)Human specimens of any kind.

Risk is a factor to be considered in evaluating human subject research. Risk is defined as the possibility of harm

(physical, psychological, sociological or other) that may occur as a consequence of any activity that goes

beyond the application of the established and accepted methods necessary, to meet the patient’s needs.

HOW IS IRB REVIEW OBTAINED?

Complete the enclosed application as indicated, using the NEOMED Consent Form Guidelines provided for specific wording suggestions and requirements. The criteria for expedited review are outlined on the following page of these Guidelines. If you are applying for “Expedited Review” or “Exemption,” submit three copies (including the original), if you are submitting to the full board please submit three (3) copies including the original to Research and Sponsored Programs, which serves as the office of the IRB. Each application should contain the following:

(1)typed application form (application is available on the Research and Sponsored Programs web-site)

(2)Certificate of training for Human Subjects Studies, located at (The certificates of individuals not already on file in the ORSP must be attached.)

(3)Consent Form or Informational Sheet (including NEOMED requirements. Remember your consent form MUST meet these requirements in order to receive IRB approval, even if the study is conducted at another facility)

(4)protocol,

(5)questionnaires, advertisements, letters of agreement to participate and any other supplemental information

(6)IRB approval from any other participating settings (including hospitals or universities)

Deadlines: IRB meets on the fourth Tuesday of every other month. Applications must be received in the office of the Research and Sponsored Programs by 4 p.m.14 days prior to the meeting date in order to allow IRB members sufficient time to receive and review the agenda.

Protocol Format: Information about the research study is generally organized in the following outline --

1. Background or rationale for this study.
2. Objectives.
3. Procedures involved. Clearly, identify which portion of the project is experimental. Provide statistical justification for number of subjects. Describe how human subjects will be involved, including recruitment, who will consent the subject, the environment in which subject will be consented, etc.

D.Alternative procedures, if any, that is not included in the study but might be advantageous to the subject.

E.If any deception is required for validity of this study, explain why this is necessary and how subject(s) will be debriefed.

F.Concise review of literature that supports the rationale, objectives, and methodology of the proposed study.

1. If an Investigational New Drug (IND) is involved, provide the following information:

(1)name of drug,

(2)source of drug,

(3)dosage and schedule of administration,

(4)status with Food and Drug Administration and IND#,

(5)review of animal studies and previous human studies,

(6)reported side effects.

1. For an approved drug used in an experiment, provide similar information:

(1)name,

(2)source,

(3)dosage,

(4)how administered,

(5)side effects.

1. If an Investigational Device (ID) is involved, provide the following information:

(1)name of device,

(2)manufacturer,

(3)status with Food and Drug Administration and ID#,

(4)review of animal studies and previous human studies,

(5)reported adverse effects.

IRB Results: Investigators will be notified in writing of the results of IRB review. Approval will include a

determination of the level of risk to subjects, length of approval period, and a certified copy of the approved

consent form or informational sheet. The process from submission to receipt of approval takes approximately four weeks, depending on investigator’s availability to respond to IRB recommendations and concerns. Recommendations and concerns will be sent to the investigator within 2 weeks after receiving the application.

Annual Progress Report: The Office of the Research and Sponsored Programs (ORSP)will send investigators a reminder e-mail to provide a progress report(A Continuation Form or a Closure Form) near the close of the study’s approval period. It is the PI’s responsibility to return a progress report to the ORSP prior to the study’s expiration date. If a progress report is not received prior to the study’s expiration date, the study will be administratively closed by the IRB and all enrollment, study procedures and data analysis must stop immediately until approval is re-established (unless ceasing study procedures would in any way increase the risks to current study participants). The IRB, at its discretion, may also limit the PI from opening any additional studies or continuing any ongoing studies until the required progress report is received for the study in question.

GUIDELINES FOR WRITTEN CONSENT

All individuals being considered for participation as human subjects in research must give prior informed consent. Federal guidelines 45 CFR 46.116 & 117 state that research investigators are responsible for obtaining and documenting informed consent by the use of a written consent form approved by the NEOMED IRB and signed by the subject (or the subject’s legally authorized representative) unless this requirement is specifically waived or altered by the IRB. A consent form must incorporate the NEOMED guidelines.

DEVELOPING THE CONSENT DOCUMENT

Use the NEOMED boilerplate for Informed Consent and/or Informational Sheets. Edit as necessary to make the document appropriate for your research project.

OTHER CONSENT PROCEDURES

The IRB may approve a consent procedure that does not include or which alters some or all of the elements in the NEOMED Guidelines for Written Consent or may waive the requirement to obtain consent provided the Board finds and documents that:

1.The research involves no more than minimal risk to the subjects.

2.The waiver or alteration will not adversely affect the rights and welfare of the subjects.

3.The research could not practicably be carried out without the waiver or alteration.

4.Whenever appropriate, the subjects will be provided with additional pertinent information after

participation.

If the Board approves a waiver of the consent procedures, investigators may be required to distribute an Informational Sheet that is similar to an Informed Consent with the exception of a subject signature. Please see the sample Guidelines for Informational Sheet following instructions for the Informed Consent.

USE OF RADIATION/RADIOACTIVE MATERIALS

Human studies involving non-routine use of radioactive materials and ionizing radiation require that applications be submitted concurrently to both the IRB and NEOMED’s Radiation Safety Committee or the chair of the committee. Application forms are available at the Office of Research and Sponsored Programs. Guidelines as to what kinds of studies require such review appear in the IRB Application, Item VI-E. Final IRB approval will be withheld pending completion of Radiation Safety Committee review.

QUALIFYING FOR EXPEDITED REVIEW

Research activities involving no more than minimal risk and in which the only involvement of human subjects will be in one or more of the following categories may qualify for expedited review as authorized in 45 CFR Part 46.110. This involves an administrative action by the IRB chair and any other IRB member(s) at the discretion of the IRB chair. The primary difference between expedited and full IRB review is that expedited application can be processed at any time, rather than wait for an IRB full board meeting.

GROUNDS FOR EXPEDITED REVIEW

1. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.

1. Collection of blood samples by finger, ear or heel stick or venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.

1. Recording of data from subjects 18 years of age or older using non-invasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject’s privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).

1. Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.

1. Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.

1. Research on individual or group behavior or characteristics of individuals (i.e. surveys with no identifiers)

1. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects’ behavior and the research will not involve stress to subjects (i.e. surveys with identifiers)

1. Continuing review of research previously approved by the convened IRB and the following are true: enrollment is closed, no additional risks have been identified or remaining research activity is data analysis.

1. The study of existing data, documents, records, pathological specimens, or diagnostic specimens such as chart reviews and ANY type of human specimens.

1. Voice recordings made for research purposes such as investigations of speech defects

1. Moderate exercise by healthy volunteers.

QUALIFYING FOR EXEMPT STATUS

The Office of Research and Sponsored Program will review proposed human studies in accordance with 45 CFR 46.101 to make the determination your application qualifies as exempt research. Research involving human subjects may be classified as exempt from Federal policy for protection of human subjects. Acknowledgment of exempt status will be promptly conveyed in writing to the principal investigator. Research classified as exempt or expedited will abide by the same standards for scientific and ethical conduct as full IRB-reviewed research. The difference between exempt and expedited is that exempt research will not be monitored by the IRB and thus has no reporting or record-keeping requirements with the IRB.

GROUNDS FOR IRB EXEMPTION

1. Research on special education instructional strategies, comparison of techniques, or classroom management methods.

1. Research involving educational testing, survey or interview procedures or observation of public behavior.

1. Research involving existing data, documents or pathological specimens IF the sources are publicly available or subjects cannot be identified through any type of identifiers.

1. Research or demonstration projects that are designed to evaluate or otherwise study procedures of public benefit or service programs

1. *Taste and food quality food evaluations and consumer acceptance studies.

*FDA Approved Exemption. FDA does not recognize any other exemption from IRB review.

SUBMITTING FOR EXPEDITED REVIEW OR EXEMPT STATUS

The process for obtaining expedited review or exempt status is similar to regular IRB review except that

applications may be submitted at any time and only three copies of the application materials are needed. The Office of Research and Sponsored Programs, with the assistance of the IRB chair, will determine if the application qualifies for expedited review or exempt status. If it qualifies for exempt status, the investigator will receive a letter from the IRB documenting this determination. The time required for exempt or expedited review depends on the availability of the investigator to make any necessary corrections and the availability of the IRB chair. Do not expect to receive an exemption or an expedited approval in less than two weeks.

FOR ASSISTANCE WITH IRB APPLICATIONS

The Office of Research and Sponsored Programsserves the administrative needs of the IRB and assists investigators with the submission process. The staff is available to answer questions and preview consent

documents. Investigators involved in human subject research for the first time are particularly encouraged to avail themselves of this service. For additional copies of the IRB application, information about submission deadlines, and other assistance, call Trish Wilson, Research Coordinator, Office of Research and Sponsored Programs, at extension 6364, Beth Cline, MS, MLS, Human Protections Administrator, extension 6498, or Julie Aultman, Ph.D., IRB Chair, extension 6113.