How Do I Begin?

 

I.        Is it research involving human participants?

       

·        Research is defined as:  A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge, or a clinical investigation.

 

·        Human participants are 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, or (2) identifiable private information.

 

 

If yes, your research requires IRB review.

 

II.      Education

 

Complete the on-line IRB required education course found at www.citiprogram.org

 

III.    Level of Review

 

Decide the level of review required

 

a.      Exempt

b.      Expedited

c.      Convened

 

Instructions, guidelines and forms are found at https://irbweb.umc.edu/WebKit/

 

 

Exempt Research

 

Submit 1 copy of the following to the IRB office:

 

·        Claim of Exemption form

·        HIPAA Disclosure Form

·        Research Protocol

·        All questionnaires, survey instruments, interview questions, discussion guides and/or data collection instruments

 

 

 

 

 

Categories of exempt research:

 

1.      Research in normal educational settings, involving normal educational practices.  This MAY include children.

 

2.      (a)  Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) in which participants CANNOT be identified, or release of the information would not be harmful to the participant. This category MAY include children.

 

(b)    Research involving the use of survey procedures, interview

procedures, or observation of public behavior in which participants CANNOT be identified, or release of the information would not be harmful to the participant.  This category MAY NOT include children.

 

3.      Survey, interview, or testing of public officials, elected or appointed, or candidates for public office.

 

4.      Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, and the participants cannot be identified, directly or through identifiers linked to the participant.  This category MAY include children.

 

                Existing data means that the data, documents, records, or    

                specimens are in existence prior to IRB review.  Specimens

                obtained prospectively from future discarded clinical samples

                DO NOT qualify for exemption.

 

5.      Research and demonstration projects that are conducted by or subject to the approval of Federal Department or Agency heads, and which are designed to study or evaluate public benefits or services (such as Medicare, Public Assistance).  This category MAY include children.

 

6.      Taste and food quality evaluation and consumer acceptance studies.  This category MAY include children.

 

 

Please note, to qualify for exemption all study activities must fit within one or more of these categories.

 

 

 

 

 

 

           


Expedited Review

 

Submit one copy of the following to the IRB office:

 

·        Initial Application form

·        HIPAA Disclosure form

·        Complete research proposal/protocol that was submitted for funding

·        Data Collection Sheet

·        All appendices, questionnaires, surveys, interview guides, recruitment letters and/or advertisements

·        If you are not requesting a waiver of written consent, Informed Consent Document(s) written at an 8th grade level

 

Categories of research that qualify for expedited review:

 

1.      Clinical studies of drugs and medical devices that do not require investigational new drug or investigational exemption application.

 

2.      Collection of blood samples by finger stick, heel stick, ear stick or venipuncture (from healthy, nonpregnant adults who weigh at least 110 pounds, the amount drawn may not exceed 550 ml in an 8 week period and may not occur more than 2 times per week; from other adults and children, considering the age, weight, health, collection procedure, amount and frequency, the amount drawn may not exceed the lesser of 50ml or 3ml per kg in an 8 week period and may not occur more than 2 times per week) by finger stick, heel stick, or venipuncture.) 

 

3.      Prospective collection of biological specimens for research purposes by noninvasive means (hair/nail clippings, saliva, sweat)

 

4.      Collection of data through noninvasive procedures (not including general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays, microwaves

 

5.      Research involving materials that have been collected or will be collected solely for non-research purposes (chart reviews)

 

6.      Collection of data from voice, video, digital, or image recordings made for research

 

7.      Research on individual or group characteristics or behavior, surveys, interviews, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

 

Please note, to qualify for expedited review all study activities must fit within one or more of these categories and the study must present no more than minimal risk to participants.   The IRB Chairman may review the submission and refer it to the convened board for further consideration.

Convened Review  

 

Submit 20 collated copies of the following documents to the IRB office:

 

·        Initial Application form

·        HIPAA Disclosure form

·        Informed Consent Document(s) written at an eighth grade level

·        Complete research proposal/protocol that was submitted for funding

·        All appendices, questionnaires, surveys, interview guides, recruitment letters and/or advertisements

 

Where applicable, also submit: One (1) copy of the Investigator’s Brochure

                                                       Two (2) copies of Consent/Assent Document(s)

                                              

                                

 

IV.  Review and Notification

 

Exempt and expedited research will be reviewed by the IRB Chairman.   Submissions requiring convened review will be assigned to one of the Boards and go to the next available meeting.  You will receive email notification of the IRB’s decision and any request for additional information.  Hard copies of all correspondence will also be sent to you via campus mail. 

 

 

VI. Tracking

 

      You may log into the IRB database, RISC to view study information, including all correspondence from the IRB.  You can also grant access to this information to other study personnel by clicking on the “Access” tab.  https://irbweb.umc.edu/WebKit/    

               

 

 

 VII.  Pre-Review

 

The IRB office will pre-review your consent document any time prior to submission, at your request.