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UIW has a comprehensive IRB Manual [attached as file] which makes the submission and approval process easy to navigate. 

We submit our IRB Application Form, proposal, study instruments, consent documents,and certificate of ethics training to the

College/ School IRB Representative. The Representative reads proposal and determines the Category Status: Exempt, Expedited, Full Board Review. For Exempt research [which all studies using students in pre/post tests, surveys, interviews, etc are considered], the Representative. recommends changes if needed, If there are no changes, or when changes are done,the Rep. signs the IRB Approval Form. A copy of the signed approval form and proposal are sent to the Office of Graduate Studies

and Research. Graduate Office assigns application number. Subject Consent form is stamped ―IRB Approved‖ and application number is included.
 
We don't have application deadlines.  Our current school IRB Representative is well-informed, helpful, and efficient.  I've applied for and been approved for several exempt research studies. 
 
The Research Protocol Document:

The following sections are required in the Research Protocol.

1.  Specific Aims must be stated briefly and succinctly and should derive logically from the summary of background and significance.

2.  Background and significance should contain a brief review of appropriate animal and human literature and a statement of how the proposed project will relate to or differ from what already has been accomplished. If the proposed research is a pilot study, make this clear and describe why pilot data are needed.

3. Research design and methods must be described in detail, including randomization procedures, timing of procedures, etc. It should be stated whether the procedures will be performed by an investigator or by a member of the research staff, under the supervision of an investigator.  

4. Procedures to be done (a) for research purposes or (b) routinely must be identified. If a proposed study involves patients, rather than normal healthy persons, list all procedures involved in the protocol and specify which will be done for research, and which will be done routinely for their treatment. This information is important to the IRB in assessing risks to subjects.

5.  Subject population must be described with the specific criteria that will be used to include and exclude persons from taking part in the study. If special "sensitive" types of subjects (e.g., children, pregnant women, mentally disabled persons, and prisoners) are to be studied, their inclusion must be justified. On the other hand, exclusion of certain groups must be justified. Minorities and women should be included in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study. For example, women of reproductive potential cannot be excluded from studies on the basis that they might become pregnant, posing a risk to a fetus. Their exclusion must be based on an acceptable scientific rationale. If a study would pose a risk to a fetus, a screening pregnancy test is recommended to rule out pregnancy and the subjects should be properly cautioned about the possible consequences of becoming pregnant during the course of their participation in the study. In addition, they should be informed if participating in a study might effect their future ability to reproduce. Similarly, non-English speaking subjects may not be excluded, without adequate scientific justification. Difficulty in having the consent form translated, for example, would not be adequate to justify their exclusion.

6.  The Research Protocol must contain a section titled, “Consent Methods.”  In this section, the applicant must explain how subjects will be identified, approached, recruited and when, how, and by whom consent will be obtained. The location where signed consent documents will be kept must be specified.

7.  Compensation is commonly offered to offset any inconvenience or expense that the subject may have. State the type and amount of compensation to be offered and when it will be paid. If there will be a delay in the receipt of payment, state the length of time. Whether a particular type of compensation for subject participation in research is appropriate or not will be evaluated on a per-protocol basis. The following guidelines may help investigators in their choice of monetary compensation and payment schedules.

·       The amount of payment provided subjects should not be out of proportion to the level of inconvenience and expected expenses accrued by the subject. If the level of payment is excessively high, this will be considered coercive.

·       Payment for participation should be given to the subject on a prorata basis. This implies that the subject will be paid in direct proportion to his/her actual degree of participation. For example, if a subject completes half of the study, he/she should receive half of what would have been paid for completing the study. Large "balloon" payments at the completion of a study are deemed coercive and will not be approved.

·       Informed consent must, in the case of compensation, contain a detailed account of the terms of payment, including the amount to be paid and a description of the conditions under which a subject would receive partial payment or no payment.

8.  Risks to a subject must be identified, including their frequency (e.g., X in 100) and severity. \

9.  Special precautions that will be taken to minimize the risks should be described, as well as available treatment for irreversible or life threatening adverse effects. Describe also how data will be monitored to insure the safety of subjects.

10. Confidentiality of individual subject records and computer files must be safeguarded. Describe methods to ensure confidentiality and to whom information will be given, what information will be furnished, and the purpose of the disclosure. 

11. Plans for data analyses including justification of the sample size are important to demonstrate the validity of the research plan. The IRB is concerned with sample size estimates to assure that: (a) There are sufficient subjects to ensure a reasonable chance of detecting or ruling out any important clinical or statistical effect, and (b) no more subjects than necessary are placed at risk. Clearly identify the primary variables being analyzed to answer the research questions, including the planned statistical methodology.

12. Literature cited should include relevant references to support the study background, significance, and research procedures to be used.

 

The IRB Application Form:

Application for Institutional Review Board Approval Form

University of the Incarnate Word

 

(PLEASE TYPE INFORMATION)

Title of Study:  Click here to enter text.

 

College/School or Division/Discipline: Click here to enter text.

 

Investigators

Principal Investigator - A UIW PI must be designated for all projects in which UIW is engaged in research.

Name:

Click here to enter text.

 

Phone #:

Click here to enter text.

E-mail:

Click here to enter text.

Address:

Click here to enter text.

 

 

 

 

Co-Investigator(s) – List all co-investigators and provide contact information on each one

Name:

Click here to enter text.

 

Phone #:

Click here to enter text.

E-mail:

 Click here to enter text.

Address:

Click here to enter text.

 

 

 

 

Faculty Supervisor of Project, Thesis, or Dissertation

Name:

Click here to enter text.

 

Phone #:

Click here to enter text.

E-mail:

 Click here to enter text.

Address:

Click here to enter text.

 

 

 

 

 

 

Research Information

 

Research Category: Exempt   Expedited Review   Full Board Review

 

Purpose of Study:

Click here to enter text.

 

 

Number of Subjects:

Click here to enter text.

 

Number of Controls:

Click here to enter text.

Duration of Study:

Click here to enter text.

Does this research involve any of the following:

YES

NO

Inmates of penal institutions

Institutionalized intellectually handicapped   

Institutionalized mentally disabled

Committed patients

Intellectually handicapped outpatient       

Mentally disabled outpatient     

Pregnant women

Fetus in utero                  

Viable fetus

Nonviable fetus        

Dead fetus

In Vitro fertilization         

Minors (under 18)

For each "Yes", state what precautions you will use to obtain informed consent?

Click here to enter text.

 

How is information Obtained? (Include instruments used. Attach copy of instrument to this application.)

Click here to enter text.

 

Confidentiality – Are data recorded anonymously?    Yes     No

 

If answer is “No”, how will the study subjects’ confidentiality be maintained?

Click here to enter text.

 

Benefit of research:  Click here to enter text.

 

 

 

Possible risk to subjects: Click here to enter text.

 

 

Funding Source:

Click here to enter text.

Funded by:  

Click here to enter text.

Grant Proposal Pending: 

Click here to enter text.

Not Funded:

 

               

 

 

CHECKLIST:

               Research protocol

               Informed consent documents

               Instruments used for data collection

               CITI certificate of training on the protection of human subjects

 

If change in research occurs the Board must be notified before research is continued.

 

 

SIGNATURES

Original Signatures are required. This application will not be processed until all signatures are obtained.

Signature of the Principal Investigator

The undersigned accepts responsibility for the study, including adherence to DHHS, FDA, and UIW policies regarding protections of the rights and welfare of human subjects participating in the study. In the case of student protocols, the faculty supervisor and the student share responsibility for adherence to policies.

 

Print Name of Principal Investigator:

 

 

 

Signature of Principal Investigator:

 

Date:

Signature of Faculty Research Supervisor – Required

By signing this form, the faculty research supervisor attests that he/she has read the attached protocol submitted for IRB review, and agrees to provide appropriate education and supervision of the student investigator above.

Print Name of Faculty Supervisor:

 

 

Signature of Faculty Supervisor:

Date:

Signature of Co-investigator(s)

Print Name of Co-Investigator:

 

1.

 

Continue if there are more co-investigators. All must sign.

 

Signature of Co-Investigator:

Date:

 

 

 

         

 

 

APPROVAL SIGNATURE(S)

Signature of the IRB College/School Representative:

Print Name of College/School Rep.:

 

 

Signature of College/School Rep.:

Date:

 

Signature of the IRB Chair (if needed)

Print Name of IRB Chair:

 

 

Signature of IRB Chair:

Date:

 

 

Application Number:

 

The Researcher must use copies of the stamped consent form. Other communications to the study subjects must also be stamped with the IRB approval number. Electronic surveys must have the IRB approval number inserted into the survey before they are used.

 

IRBs are filed by their number and helps the Graduate Office keep track of submissions and communications. Please refer to this number when communicating about the IRB.

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833.38 kB16:51, 24 Jun 2013cmackinnonActions
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Good to hear you have experience in submitting IRB applications.
Posted 13:23, 14 Jul 2013
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