APPLICATION INSTRUCTIONS 

This document contains all forms required for submission of a project involving human subjects to the Institutional Review Board (IRB). 

Page 1: The completed page including appropriate signatures, should be submitted with the hard copy version of an application (see below) 

Pages 2-7: These pages comprise the bulk of the application. Each page has major headings (A-D) and several subheadings (numbered). Each subheading is followed by a short description of what might or must be included in the application. The principal investigator should fill out these pages by removing the short descriptions of what might be included and filling in the information as it pertains to their particular project. If you have prior IRB approval from another institution, you do not need to fill out pages 2-7 ---complete page 1 and submit the full application, supporting information and approval notification from the sponsoring institution. (hard copy submission will be sufficient [see below]). 

Supplemental Information: 

All applicants should submit a copy of the Information letter or signed consent form that will be distributed to each person in the study 

All applicants should submit signed waivers or consent forms from groups or institutions who are sponsoring the project (example: a school board, hospital etc.), if appropriate. 

If an applicant is submitting a survey-based project, including a copy of the survey instrument may be required by the IRB. It is in your best interest to submit a copy of the survey instrument with the application 

Submission: 

Applications along with all appropriate forms should be sent to, Dr. Linda Gowans, Chair of the IRB Education Subcommittee, 1304 University Circle, Weber State University, Ogden, Utah 84408-1304. The IRB is requesting that the applicants submit their application in two different formats; an electronic file on disk and a regular paper version. The electronic version is used to expedite approval of applications requiring a full IRB review and the hard copy, including signed forms, is maintained on file as an archive. 

Electronic version: PC Users: Either attach an application document to an e-mail and send it to lgowans@weber.edu or include a diskette containing the document with the complete hard copy. If you are using Corel WordPerfect, save your file as a “rich text format” (.rtf) formatted file. Use the Save As function and choose the rich text format before you save your file. That will convert your file from one format to another. The file can be read by Corel WordPerfect or MS Word software. 

Macintosh Users: Please submit your application using a MAC formatted disk and document format; preferably a MS Word document format or as a “rich text format” (.rtf) formatted file. Use the Save As function and choose the rich text format before you save your file. That will convert your file from one format to another. 

APPLICATION FORM (Attach to each copy of the proposal.) 

INVESTIGATOR'S STATEMENT OF ASSURANCE 

The attached investigation involves the use of human subjects. I understand the University policy concerning the use of human subjects and I agree:

1. To obtain informed consent of subjects who are to participate in this project;

2. To report to the Human Subjects in Research Committee any unanticipated effects on subjects which become apparent during the course, or as a result, of experimentation and the actions taken as the result;

3. To cooperate with members of a committee charged with the continuing review of the project; 

4. To obtain prior approval from the Committee before altering or amending the scope of the projector implementing changes in the approved consent form; and

5. To maintain documentation of consent forms and progress reports as required by institutional policy. 

PRINCIPAL INVESTIGATOR'S SIGNATURE 
Fill in all blanks. Does the subject group include healthy volunteers? ___yes ___no
Does the subject group include ill persons? ___yes ___no 
Are subject groups excluded for medical reasons? ___yes ___no 
Are there vulnerable subject groups? ___yes ___no
      If yes, is the exclusion criteria for the study specified? ___yes ___no 
Are any subjects under the age of 18? ___yes ___no 
Are any subjects under the age of 12? ___yes ___no 
Are any subjects over the age of 70? ___yes ___no 

____________________________________________________________________________
PRINCIPAL INVESTIGATOR'S NAME (typed) 			DEPARTMENT 

____________________________________________________________________________
MAILING ADDRESS/MAIL CODE 					CITY, STATE, ZIP 

____________________________________________________________________________
PRINCIPAL INVESTIGATOR'S SIGNATURE (signed) 		   TELEPHONE 

____________________________________________________________________________
DEPARTMENT CHAIR'S SIGNATURE (signed)        		 TELEPHONE

OR
_____________________________________________________________________
 MASTERS COMMITTEE CHAIR                 				DATE
A. APPLICATION FORM 

The application form must be filled out completely so that committee members may have a clear understanding of the nature and human subject implications of the research proposal. A summary paragraph for each section is sufficient. A statement referring to attached materials is not sufficient and will not be accepted. Applications submitted with incomplete forms will be returned without consideration of the proposal. 

1. TITLE 
Give the complete title as it appears on the grant proposal

2. DESCRIPTION OF THE STUDY 
Include the nature of the study and how human subjects will be used and indicate any special procedures. 

3. DURATION OF THE STUDY 
Estimate the length of time it will take to complete the entire project. If the study extends over one year from date of approval, the researcher must submit an extension request. 

4. MULTICENTER STUDY 
Indicate whether this is a multicenter study and give the number of institutions outside the University which will be participating. 

5. NUMBER OF SUBJECTS 
Identify the total number of subjects to be used in every center. 

6. HEALTH STATUS OF THE SUBJECTS 
Include the information regarding the health of the subjects. 

7. SUBJECT GROUPS EXCLUDED 
Describe any subject groups excluded for medical reasons or vulnerable subject groups.  List the specific exclusion criteria for the study. If more explanation is needed, the committee has further information. 

8. AGES OF SUBJECTS 
Include the information regarding the age of the subjects. 

9. DESIGN OF THE STUDY 
Include a brief statement about the design that will be used. 

10. RISKS TO SUBJECTS 
Describe all the risks to which the study may expose the subjects, including those which are considered to be of low probability. If the risks to the subject are substantial, explain how the risks are justified by the expected benefits. Discuss how possible reactions or side effects will be managed.
ANY MODERATE OR HIGH RISK STUDY MUST GO THROUGH A SEPARATE REVIEW PROCEDURE WHICH INCLUDES THE APPROPRIATE ADMINISTRATIVE OFFICER AND THE UNIVERSITY ATTORNEY. 

11. BENEFITS TO SUBJECTS AND OTHERS 
Include all remuneration to the subjects including the amount given or prorated for those who do not complete the study. Subjects may not be offered compensation in order to induce them to participate in the study. 

12. COSTS TO BE BORNE BY SUBJECTS 
Specify the charges relating to the study for which the participant will be financially responsible.

13. IS CONFIDENTIALITY ASSURED 
State how research subjects will be recruited or selected and how their participation will be solicited in the study. State specifically the procedures used to obtain informed consent from each one. Researchers must obtain and document informed consent from each participant or their representative before they participate in the study. See the section on informed consent. 

Describe explicitly how the security and confidentiality of all information received and the privacy of all subjects will be maintained. 

14. CONTRACT OR GRANT NUMBER 
Include the contract or grant number, sponsoring agency, and/or granting agency. 

15. NAME OF PRINCIPAL INVESTIGATOR AND DEPARTMENT 
Include the names of all of the investigators, the principal investigator's name and signature, mailing address, telephone number, University Department, and Department Chair's signature. 

B. DESCRIPTION OF THE STUDY 
This should be brief (no longer than two pages) and should include:
	1. Background information. 
2. Experimental methods (including description of the study, population, research design, and interpretation of significant results).
	3. Description of recruitment procedures (include all advertising methods).
4. If the proposal is deemed moderate or high risk, submit ten copies of the complete proposal as well as any other information that is appropriate to the review of the study. 

C. INFORMED CONSENT The human subjects’ in Research Committee, in conformance with federal guidelines, requires documentation of informed consent. The committee may, for some or all subjects, waive the requirement that the subject or the subjects legally authorized representative sign a written consent form if it finds that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context. In cases where the documentation requirement is waived, the committee may require the investigator to provide subjects with a written statement regarding the research. 

No informed consent, whether oral or written, may include any exculpatory language through which the subject or representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability from negligence. 

The entire consent form must be written in the second person and in language totally intelligible to an average person who has no background in science or scientific technology. 

BASIC ELEMENTS OF INFORMED CONSENT 
In seeking informed consent, the following information shall be provided to each subject:

1. A statement that the study involves research, an explanation of the purposes of there search, and the expected duration of the studies expected participation, a description of the procedures to be followed, and identification of any procedures which are experimental.

2. A description of any foreseeable risks or discomforts to the subject. 

3. A description of any benefits to the subject or to others which may reasonably be expected from the research. 

4. A disclosure of any alternative procedures or courses of treatment, if any, that might be advantages to the subject.

5. A statement describing the extent, if any to which confidentiality of records is maintained and that notes the possibility that the food and drug administration may inspect the records, if applicable.

6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and if so, what they consist of, or where further information may be obtained.

7. An explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, and whom to contact in the event of a research -related injury to the subject.

8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. 

ADDITIONAL ELEMENTS OF INFORMED CONSENT 

When appropriate one or more of the following elements of information shall be provided to each subject:

1. A statement that the particular procedure may involve risks to the subject (or the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.

2. Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subjects consent.

3. Any additional costs to the subject that may result from participation in the research. 

4. The consequences of the subject’s decision to withdraw from the research and procedure for orderly termination of participation by the subject.

5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.

6. The approximate number of the subjects involved. 

Except as previously stated, informed consent shall be documented by the use of a written consent form approved by the committee and signed by the subject or the subjects legally authorized representative. A copy shall be given to the person signing the form. 

Except as previously stated, the consent form must be either of the following:
1. A written consent form that embodies the elements of informed consent. This form maybe read to the subject or legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed. 

2. A short form written consent stating that the elements of consent have been presented orally to the subject or subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the committee shall approve a written summary of what is to be said to the subject or representative. Only the short form itself is to be signed by the subject or legal representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining the consent shall sign a copy of the summary.  A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form. 

If the study requires only that subjects complete a questionnaire, ordinarily a consent form does not need to be completed. Instead, the questionnaire may begin with description of the study and its purpose. A statement that the person is not required to complete the questionnaire, (i.e. that participation is voluntary) and that by completing the questionnaire, and turning it in, a subject has expressed his willingness to participate. A copy of the questionnaire, including this explanatory statement, must be submitted to the committee. 

The committee may waive the requirement that an investigator document consent for some or all subjects if it finds and documents that the only record linking the subject to the research would be the consent document, or the only significant risk to the subject is potential harm resulting from breach of confidentiality. Each subject is asked whether he or she wants there to be a record linking the subject with the research. The subject's wishes on this will govern. 

D. EXPERIMENTAL SUBJECT'S BILL OF RIGHTS

The rights below are the rights of every person who is asked to be in a research study. 
As an experimental subject, I have the following rights:
1. To be told what the study is trying to find out

2. To be told what will happen to me and whether any of the procedures, drugs, or devices are different from what would be used in standard practice.

3. To be told about the frequent and / or important risks, side effects or discomforts of the things that will happen to me for research purposes.

4. To be told if I can expect any benefit from participating and, if so, what that benefit might be.

5. To be told what other choices I might have and how they may be better or worse than being in the study.

6. To be allowed to ask any questions concerning the study both before agreeing to be involved and during the course of the study.

7. To be told what sort of medical treatment is available if any complications arise.

8. To refuse to participate at all or to change my mind about participating after the study is started. 

9. To receive a copy of the signed and dated consent form. 

10. To be free of any pressure when considering whether I wish to agree to be in the study.