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IRB Process

Effective January 2003

Overview

The Institutional Review Board (IRB) was created to ensure that research involving human

participants complies with ethical standards set by the federal Office for Protection from

Research Risks (OPRR), which operates within the Department of Health and Human Services

(DHHS). Proposals for behavioral, biomedical or other human participants research to be

conducted at or supported by Spring Hill College are subject to review by the IRB and such

research may not be conducted without IRB approval. In the event that this policies and

procedures document does not cover a specific aspect of the review process, the IRB will follow

the guidelines found in

 

OPRR Reports: The Belmont Report (1979) or OPRR Reports: (rev. 2001) or any later revisions to these publications.

The IRB has the authority to approve, require modification in (to secure approval), or

disapprove all research activities covered by this policy including:

1. Research funded externally by way of grant, contract, or similar agreement between the

sponsor (public or private) and the College.

2. Research funded internally by the College by way of grant, contract, or similar agreement.

3. Research conducted upon assignment by the College.

4. Research actively assisted by the use of College facilities, resources, supplies, equipment,

or personnel.

Except when an expedited review procedure is used (see Review Categories and Appendix 1),

the IRB shall review proposed research at convened meetings at which a majority of the members

of the IRB are present, including at least one member whose primary concerns are in

nonscientific areas. In order for the research to be approved, it shall receive the approval of a

majority of those members present at the meeting (OPRR 46.108)

Review Procedure

All principal investigators (P.I.) must submit a completed review application to the IRB chair

and request either Exempt, Expedited, or Full Review. The IRB will act on an Exempt or

Expedited application within fourteen (14) days of the submission/resubmission date. The IRB

will act on a Full application within twenty one (21) days. The P.I. will be informed, in writing,

of the IRB's decision within seven (7) days of the date that the decision is made. (OPRR 46.108,

46.109). All discussion of IRB decisions should be considered confidential. Any questions

regarding IRB decisions should be directed to the Chair of the IRB. It is preferable that questions

regarding decisions related to student research be discussed between the student’s research

advisor and the Chair of the IRB and communicated to the student by the student’s advisor.

REVIEW PROCEDURE

New Research

1. The Principal Investigator (P.I.) must complete the "Application to the Institutional

Review Board" available on the N: drive in the folder “IRB Forms” or from the Institutional

Research web page, http://badgerweb.shc.edu/ICS/IR/IRB.jnz. Applications may be sent via

email (with an electronic signature) or via campus mail to the IRB Chair. The P.I. may seek

review under one of the following categories, which are fully defined in Appendix 1:

a. Exempt Review: research that involves no risk to the participants. Submit three (3)

copies of the application form.

b. Expedited Review: research that involves no more than minimal risk to participants,

or that involves minimal changes to previously approved research during the period of

one year or less from the approval date. Submit six (6) copies of the application form.

c. Full Review: research that involves more than minimal risk to participants, including

research that uses deception of participants. Submit six (6) copies of the application

form.

Exceptions: The only exceptions to the review procedure are "minor" research studies

conducted by students or faculty as part of class work. (See Appendix 2 for the criteria

for this type of research). Student projects that fulfill a thesis or senior seminar

requirement are not considered "minor" research studies; these research projects must go

through the review process.

2. Applications are distributed to the IRB members for individual review. Applications are

considered to be confidential documents and are not to be openly discussed by IRB members

with others outside the IRB, with the exception of the AVPAA.

3. The IRB completes its review within fourteen (14) days [Exempt or Expedited Review] or

twenty one (21) days [Full Review] of the date the application was submitted. The chair of

the IRB communicates this decision to the P.I. within seven (7) days.

a. For Exempt or Expedited review, IRB members submit their written and signed

comments to the chair who then determines IRB action. The chair may consult IRB

members for clarification of their comments or further discussion.

b. For Full review, the IRB will convene to discuss the application. Any action must be

passed by a majority vote of the members present. Research proposals may be

disapproved only after a Full Review.

4. The P.I. may request clarification of the IRB's decision or submit the modifications

requested by the IRB at any time following the initial IRB decision. The IRB will act upon

modified proposals and the decision communicated to the P.I. within fourteen (14) days of

receipt.

Please note: The IRB will make every attempt to deliver timely reviews. However, the

fourteen, twenty-one, and seven-day time limits are only applicable when the College is

in regular session for fall and spring semesters and excludes official College holidays,

spring and fall breaks, intersession, and summer sessions.

ITUTIONAL REVIEW BOARD

Appendix 1: Definitions of Review Categories

Exempt Review

Research involving no or minimal risk and in which the only involvement of human

participants will be in one or more of the following categories:

1. Research conducted in established educational settings, such as that measuring the

effectiveness of teaching techniques or involving educational tests (cognitive, aptitude,

diagnostic, achievement) if the information cannot be linked to the participant.

2. Research using survey or questionnaire procedures providing the responses are not linked

to the participant, and responses do not place the participant at risk of criminal or civil

liability or constitute damage to the participant's reputation or employability.

3. Research involving observation of public behavior, provided that the participant's

behavior is not linked to their identity, and that these observations do not place the participant

at risk of criminal or civil liability or constitute damage to the participant's reputation or

employability.

4. Research involving the collection or study of existing data, documents, records,

pathological specimens, or diagnostic specimens, provided these sources are publicly

available and the data is recorded in such a manner that the participants cannot be identified.

 

Protection of Human Participants, Title 45, Code of Federal Regulations, Part 46

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APPLICATION TO THE INSTITUTIONAL REVIEW BOARD

 

 

Primary Investigator (P.I.)

 

Faculty Advisor (if student P.I.)

 

Program

 

Phone Number

 

Email Address

 

 

Title of Project

 

Project start date

 

Expected end date

 

 

Submission date

 

The project is

 oNew                  oContinuing 

[To maintain continuous approval for projects that last more than one year, submit a continuing application at least one month prior to the yearly expiration date.] 

 

Review requested (select one)

o Exempt             o Expedited         o Full 

[See Appendix 1 of the IRB Policy and Procedures for full definitions of the review categories.] 

 

Project type

o Non-funded (or student) research

o Externally funded research

Supporting agency (if any) 

 

 

 

The P.I. will receive written notification of the IRB's decision within three (3) weeks of receipt of this application 

If you have questions regarding this application, please contact the chair of the IRB

 

 

____________________________________________        _____________________

Signature of Primary Investigator                                               Date

 

____________________________________________         _____________________ 

Signature of Faculty Advisor(if applicable)                              Date 

 

o Please check this box if you would like further comments or questions for consideration.
INDICATE THE REVIEW CATEGORY FOR WHICH YOU ARE APPLYING.

 

o  Application for exempt review based on the following category(ies).  Check all categories that apply. See Appendix 1 for complete definition of this review category.  Submit one (1) signed copy of all application materials to the Chair of the Institutional Review Board via email (electronic signature) or campus mail.

o    Research conducted in established or commonly accepted educational settings and involving normal educational practices. 

o    Research involving the use of educational tests, if information from these sources cannot be linked to the participant. 

o    Research involving survey or questionnaire procedures where responses are not linked to the participant. 

o    Research involving observation of public behavior where the participant's behavior is not linked to their identity. 

o    Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, where these sources are publicly available and data cannot be linked to the participant. 

 

o   Application for expedited review based on the following category(ies). Check all categories that apply.  See Appendix 1 for complete definition of this review category. .  Submit one (1) signed copy of all application materials to the Chair of the Institutional Review Board via email (electronic signature) or campus mail.

                o   Collection of voice video, digital, or image recordings made for research purposes. 

o    Research on group or individual behavior or characteristics or behavior (including, but not limited to research on perception, cognition, motivation, communication, cultural beliefs, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. 

o    Collection of hair and nail clippings in a non-disfiguring manner.  

o    Collection of deciduous teeth at the time of exfoliation, or of deciduous or permanent teeth if routine patient care indicates a need for extraction. 

o    Collection of excreta and external secretions (including sweat), saliva, skin cells, sputum, placenta removed at delivery, and amniotic fluid at time of rupture of the membrane prior to or during labor. 

o    Recording of data from adult participants (18+ years of age) using noninvasive procedures (not involving general anesthesia or sedation) routinely used in clinical practice, excluding procedures involving x-rays or microwaves.  Examples: physical sensors that are applied either to the surface of the body or at a distance; weighing or testing sensory acuity; moderate exercise, muscular strength testing. 

o    Collection of blood samples by finger stick, heel stick, ear stick or venipuncture from adult participants (19+ years of age) who are in good health, not pregnant, and who weigh at least 110 pounds. 

o    Collection of supra- and sub gingival dental plaque and calculus in a routine manner. 

o    Study of existing data, documents, records, pathological specimens, or diagnostic specimens that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis). 

o    Continuing review of research previously approved by the convened IRB where no new participants will be recruited. 

o    Research on drugs or medical devices that are not new investigations. 

 

o    Application for full review. See Appendix 1 for complete definition of this review category.   Submit one (1) signed copy of all application materials to the Chair of the Institutional Review Board via email (electronic signature) or campus mail.

oINSTRUCTIONS: Please type your responses.  If needed, continue each response on additional pages.  After completion submit the required number of copies to the chair of the Institutional Review Board.

 

1.   Purpose and objectives of the research: Give enough background information to support the importance of the project, its expected contribution, and the hypothesis under study.

 

2.   Participants: Include a discussion of the characteristics, number and any payment of participants. Explain the participant selection process and how you will initially contact potential participants.  If you will be working with participants from another institution or organization, attach documentation of that agency’s permission for you to do so and any pertinent regulations from those agencies.  If minor children are to take part in the research, attach a parent information letter. 

 

3.   Method or Procedure: Describe the way in which data will be collected, including where the study will take place, who will collect data, length of participation, what data will be recorded and how.  List and describe any apparatus that will be used.  Attach copies of any survey or interview questions to be used.  If deception is used, provide a rationale. 

 

4.   Assessment of risk: Determine if participants are at more than minimal risk for physical, psychological, social, financial, legal, or political harm.  (This includes research involving DECEPTION of participants). Describe procedures (such as informed consent) that will be used to minimize potential risks to participants.  If participants are at greater than minimal risk, responses to Attachment 1 must be included in this application. 

 

5.   Risk-benefit ratio: Research involving human participants can be approved only if expected benefits outweigh potential risks.  Describe possible benefits to the participants, a class of participants, society in general, or the advancement of science.  State your reasons for believing that the benefits of the proposed study outweigh potential risks.

 

 

6.   Methods of obtaining informed consent from participants:  Who will obtain informed consent? If signed consent is needed, where will consent forms be stored?  Attach a copy of the script for oral informed consent (Exempt Review) or the full written informed consent form (Expedited or Full Review). Please see the guidelines for informed consent to be sure you include all elements of consent (i.e., assurances of anonymity and confidentiality, voluntary nature of participation, etc.).

 

7.   Confidentiality: Describe procedures to be used to maintain confidentiality including who will have access to identifying information, where data will be stored, when data will be destroyed, and in the event that findings are published or made public, how participants' identities will be masked.

 

 

Function of the IRB

SPRING HILL COLLEGE

INSTITUTIONAL REVIEW BOARD

POLICIES AND PROCEDURES

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