Instructions for Application
Researchers from Gallaudet

ALL research projects involving human subjects or information previously obtained from human subjects must be submitted to and approved by the IRB before recruitment of subjects begins.

This document gives information to assist in completing the IRB application form. Feel free to contact Dr. David R. Penna, Chairperson of the IRB, at (202) 651-5400 (V/TDD) or send email to Dr. Penna, if you need additional help. Proposals should be submitted two to four weeks prior to the date at which the researcher expects to begin recruiting subjects.

Explanation of Items on the Application Form

I. IDENTIFYING INFORMATION A. List complete title of project. This should match the title of the proposal submitted with this application. Give best estimates of project beginning and completion date.

B. List full name and department affiliation of all investigators. Indicate the principal investigator. Provide phone numbers and email addresses where available.

C. If the research is a student, a faculty or professional staff member at Gallaudet must serve as the Gallaudet sponsor of the project. The sponsor is responsible for having thoroughly reviewed the proposal and having determined that the project is methodologically sound. This person is responsible for on-going monitoring of the conduct of the research and should be willing to represent the student if necessary in discussions with the IRB.

D. Give name of outside agency from which funds have been requested or received. If outside funding has been requested, route all IRB materials through Gallaudet's Office of Sponsored Programs. If special in-house funding is requested (or obtained) give the name of that fund. Other projects should list "internal" as funding source.
 

 II. TREATMENT OF SUBJECTS A. To the extent the research questions and design allow, subjects from all age, gender, ethnic groups should be invited to participate.

B. Subjects may be recruited via bulletin boards and other public advertisements. Subjects may only be recruited during class time under the following conditions:

1. Instructors may allow the researcher or a representative to come to the class and describe the research and characteristics of subjects sought. The instructor should leave the class during this discussion and should not be made aware of which students elect to participate.

2. Students must be made aware that their decision whether to participate will not affect their class grade or their receiving any other regular services from Gallaudet.

3. If the research is to be conducted during class--or if class credit is offered in return for participation--at least one other comparable activity (for the same credit) must be available during the same period. Students may elect either of the activities in which to participate without any penalty for choosing not to participate in the research project.

 C. If subjects are to be paid, the payment must not be so high as to be "coercive." Payment should be based upon the amount of time spent by the subjects, that is, a set amount should be paid for each hour or portion of hour subjects participate. Subjects may be given a "bonus" payment when data collection tasks have been completed.

D. If subjects can be identified because names are taken or because in-depth background information will be obtained which could lead to identification and if the information to be obtained is in any way sensitive or puts the subject at risk, the following procedures must be followed:

1. Identifying information must be kept in a locked file to which only the principal investigator has access.

2. Only group summary data may be reported.

3. Data should be entered for analysis using identification numbers instead of names or official college ID numbers.

 E. In list form, tell us exactly what subjects will be required to do.

F. Give your best estimate of the time required from each subject.

III. ANTICIPATED RISKS/BENEFITS TO SUBJECTS

Potential risks must be minimized to the extent possible and must be balanced by potential benefits from the research. "Risk" is defined by federal regulation as including any procedures which endanger the subjects' physical or psychological health or their reputation. Research involving investigation (via questionnaires, interviews or other methods) of sexual practices/attitudes and/or sensitive mental health issues is always considered to entail some risk. Scores on IQ tests, academic performance levels, opinions on sensitive cultural issues are also considered to put the subjects at some risk. Each proposal will be reviewed to estimate potential for risks to subjects.

The presence of risk does not necessarily prevent approval of the project. However, projects investigating sensitive areas or presenting any other form of risk must be expected to produce important benefits. In addition, sensitive projects in which any information which could identify subjects is collected must utilize informed consent procedures. See the attached discussion and examples of informed consent procedures/documents if this is the case.

IV. ATTACHMENTS

Note the additional information which needs to be submitted with the application form. In some cases, the review can begin with only items A-D submitted. Final approval cannot be given until ALL items have been submitted or the IRB has informed you that you do not need to use informed consent procedures.

V. SIGNATURES

All necessary signatures must be obtained before the review will begin.

SEND A COPY OF THE APPLICATION FORM AND THE REQUIRED COPIES OF SUPPORTING INFORMATION LISTED IN "IV" ABOVE TO: SALLY DUNN,
                   IRB COORDINATOR,
                   GALLAUDET UNIVERSITY,
                   HMB S416,
                   800 FLORIDA AVE. NE,
                   WASHINGTON DC 20002-3695.

MS. DUNN CAN BE REACHED AT X5400 OR SEND HER AN E-MAIL.

 
INSTRUCTIONS FOR USING IRB APPLICATION FORM: 
To use this form from the WWW, please:
1) download the form from the web;
2) print the form; 
3) fill out the form; 
4) mail or fax your completed form to Sally Dunn at Gallaudet University (202) 651-5295.
Last updated: 2001