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 the chairperson of the IRB by sending an email to the irb.chair@gallaudet.edu. Proposals should be submitted two to four weeks prior to the date at which the researcher expects to begin recruiting subjects.

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• The IRB's Role

Explanations of IRB Application Items

IRB APPLICATION FOR RESEARCH REVIEW (MS Word file)

The IRB's Role

The Gallaudet IRB is the campus agency responsible for safeguarding the interests of persons who participate as subjects in research projects here at the University. In brief, the IRB's responsibility is to ensure that all research subjects (1) participate free of coercion, (2) receive enough information to make an informed decision about whether to participate, and (3) avoid excessive risks to their physical and mental well being, their reputation, their finances, or their employability.

The Gallaudet IRB includes members of the University's faculty and staff as well as representation from the community outside of Gallaudet. The leaflet accompanying this application form lists the current IRB members, their phone numbers, and their e-mail addresses. Feel free to contact any of them for advice.Although empowered and obligated by federal statutes to terminate any instance of unethical research, this group sees itself largely as a team of facilitators; guiding investigators when necessary toward research practices that are ethical. The review and approval process may include a certain amount of negotiation between IRB representatives and investigators.The IRB mostly helps to alert investigators about potential risks to subjects that may have been overlooked.There has never been a case where disapproval was the IRB's final judgment.

Whenever a proposed study involves University faculty, staff, students or students' parents as research subjects, federal regulations require investigators to submit their plans to the Gallaudet IRB for review.This is also true any timeGallaudetUniversityfaculty, staff, or students conduct research, even when subjects are not associated withGallaudetUniversity.Normally investigators submit this IRB application form and a copy of the research proposal. The IRB and its staff uses these materials to make two judgments about each project: (1) whether the project is Exempt from IRB oversight as defined on the following page, and (2) whether the project in its entirety complies with federal statutes that define ethical research.Researchers can normally expect a decision from the IRB within ten working days of submitting their materials for review. However, the review process may take longer depending on the complexity of a project, the involvement of subjects from certain protected groups, and the likelihood of risks to participating subjects.Proposals should be submitted to the IRB four to six weeks prior to the date when the researcher expects to begin recruiting subjects.

The official Gallaudet IRB application form appears on the pages that follow, proceeded by explanations of each item.Feel free to contact Chairperson of the IRB, at (202) 651-5943 (V/TTY) or email IRB@Gallaudet.edu for additional help.Submit materials to HMB S-416.

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Explanations of IRB Application Items

The following list refers to specific items on the IRB application form:

I. Identifying Information.

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

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

C. Indicate the PI's mailing address.

D. If the researcher is a student or an off-campus researcher, then a faculty member 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.

E. Indicate whether this project will be supported by personal funds or funds from some other source. Indicate whether a funding decision is still pending or funding has already been granted.

II. Possible Exemption from IRB Oversight.

Certain kinds of research are completely exempted from IRB oversight, however all research with human subjects must be approved by the IRB. Following the initial application and review process, the IRB judges "Exempt" projects to be in compliance with federal regulations for treatment of subjects and requires no further official contact with them. Projects are usually judged as "Exempt" if all phases, components, or aspects of the research can be classified as fitting one or more of the following categories:

Research in Educational Settings: This is research conducted in commonly accepted educational settings involving normal educational practices. For example, a professor might conduct a research project to compare the relative effectiveness of two different instructional methods for accomplishing the customary objectives of the course. Student research projects DO NOT usually fit this reason for an exemption.

Anonymous Test, Survey or Interview: The research uses an educational test (cognitive, diagnostic, aptitude, achievement), a survey instrument, or an interview, and the investigator does not collect or record any information that would identify subjects, ensuring that there will be no connection between the names of subjects and their responses. The interview may not be a face-to-face interview. To qualify for this exemption, subjects may NOT be members of a protected group as defined on the following page. When data collection focuses on issues that may cause emotional distress, the IRB may advise investigators to include notice of this to potential respondents.

Observation of Public Behavior: The research records the public behavior of individuals as its source of data, but ensures that the people who are the focus of the observations will not be identified. An example would be recording the play behavior of children in a park. This exemption does not apply to projects recording the observations with video cameras. Clandestine audio recording is illegal in certain states.

Use of publicly available data, records, or documents: The research uses data available in existing sources such as real estate listings, birth records, TTY directories, yearbooks, or census records provided that individuals are not identifiable beyond the limits of the research project.

Use of existing non-public data, records, or documents: The research uses data available in existing archives such as school files of grade reports, test results, demographic data, or financial records. Research using these types of data are normally classified as "Exempt" provided that the researcher obtains permission from the appropriate individual or agency and provided that individuals are not identifiable beyond the research project.

Note: Projects with multiple components will not be classified as "Exempt" unless each of the components fits one of the foregoing categories.

Projects that are NOT classified as "Exempt" are also thoroughly reviewed for compliance with federal regulations. Investigators are required to obtain signatures on a Letter of Informed Consent (described in this application) by subjects or their representatives. Non-exempt projects also are followed up each year to determine whether they have been completed or whether the investigators have made substantive changes in their original procedures.

III. Human Subjects

2. Subjects' Relationship to the Researcher. Federal guidelines require that all prospective subjects have the absolute freedom to decline to participate in the research or to withdraw even after their participation has begun. Where Protected Groups are involved, those in parental, supervisory, or care taking roles should be afforded the freedom to decline participation or to withdraw. In no case should subjects or their parents/caretakers suffer any penalty for declining to participate or for later withdrawing from the research. This requires that the subject recruitment process be totally devoid of coercion stemming from a relationship with the researcher that is either professional, financial, familial, or social. When the researcher is an instructor proposing to award a grade or credit for participation by his/her students, then the researcher must offer an alternative activity for achieving a grade or credit, and this alternative must be unrelated to the research project.

3. Confidentiality. Closely related to the issue of minimal risk is confidentiality. Confidentiality should not be confused with anonymity. Subject participation is considered anonymous only when names remain completely secret, including to the investigator. In studies involving videotaping, when subject faces are visible on videotape, anonymity is absent, even when names are withheld.

Federal regulations require under most circumstances that subject involvement must be kept confidential to all persons outside the research project, and this includes other subjects. This is particularly true when disclosure of responses or even of participation would constitute risk beyond the minimal level. The privacy of a subject's participation and responses must be maintained at five stages of the research project: recruitment, data collection, data management/ storage, reporting of results, and disposal of data after completion of the project. The degree of effort to maintain confidentiality should be commensurate with the magnitude of the risk to subjects. If the researcher wishes to disclose the identity of subjects beyond the research setting, then this needs to be clearly explicated in the letter of informed consent. Studies that videotape subjects must include a video release form (1) requesting subject permission to videotape, (2) telling subjects who will view the videotape, and (3) informing subjects how the videotape will be disposed of at the completion of the project.

4. Subject Compensation. Freedom to decline or withdraw from participation is also related to the issue of the amount of the remuneration compensating subjects for their participation. According to federal guidelines, subjects should be compensated in money or in kind in an amount that is approximately equivalent to their time and effort. On the Gallaudet campus for example, undergraduate students are paid in the neighborhood of $10.00 per hour, and entry-level graduate students receive $12.00 per hour. When children participate as subjects in a study, their compensation should be age-appropriate. Relatively young children might be appropriately compensated with a prize such as a T-shirt or a set of pencils. Please justify or further explain the rationale for compensation rates if alternative compensation rates are proposed in your study. Subject remuneration should not be so large that it limits subjects' freedom to decline participation; it should not be, in effect, an offer they can't refuse. For certain kinds of studies, like anonymous surveys, it may be either inappropriate or impractical to compensate subjects at all.

IV. Anticipated Risks/Benefits to Subjects

1. Risk to Subjects. Federal guidelines require an assessment by the IRB of whether the risks to subjects posed by participation in a research project are beyond a level that is considered minimal. A minimal risk is defined as no greater than that encountered in daily life or during performance of routine physical or psychological tests. A risk considered more than minimal would be one in which disclosure of subjects' participation or responses outside of the research setting could reasonably place them in danger of criminal or civil liability or be damaging to financial standing, employability, or reputation. Research involving investigation of sexual practices/attitudes or sensitive health issues routinely entails more than minimal risk. In addition, research that collects IQ test scores, academic performance data, or opinions on sensitive cultural issues also poses risk that can be considered beyond the minimal level. Obviously participation in the research should not pose any danger to the physical health of a subject. Note that risk can occur as a result of experiencing the procedures of the research, such as when experiments cause extreme fatigue, anxiety, distress, etc. Beyond the risk that can result from disclosure of a subject's actual responses, a certain amount of risk may stem simply from the disclosure that a subject has participated. This kind of risk can occur in studies of sexual preference, illegal drug use, or the effects of AIDS. When risks exceed the minimal level, the researcher may be advised to take steps to reduce that risk, to demonstrate that risks are balanced by substantial benefits stemming from the completed research, or to more thoroughly clarify or inform subjects of the possible consequences of participating. The researcher may also be advised to prepare procedures that will serve to remedy any adverse effects, for example, minimizing emotional distress by providing personal counseling following participation in the research project.

2. Benefits of the Research. Federal regulations encourage research that may produce potential benefits to the participating subjects, to the discipline or profession, or to the community. Benefits are particularly important, especially those accruing to the subject, if the research is accompanied by risks that are beyond the minimal level. "Benefits," in the sense the word is used here, does not pertain to subject compensation for time and effort, which is addressed in an earlier item of the application. A benefit to the subject might be improved self-knowledge resulting from diagnostic testing used in the research. A benefit to the field might be a specific contribution to the theoretical knowledge base or to educational practice. A benefit to the community might be video equipment left for local use following completion of the project.

V. Communication.

All communication with subjects should be understandable to them, whether it is written or direct face to face communication. In particular, the IRB asks for reasonable evidence of researchers' sign communication skills when sign skills are needed to conduct the research. In some cases, the research project may need to include appropriate interpreter support or careful wording of written materials so that they are understandable to young or less skilled readers.

VI. Instrumentation.

Certain kinds of research call for the use of specialized instruments or tests that must be administered according to a standardized procedure. For example, Wechsler Intelligence Scale for Children and the Minnesota Multiphasic Personality Inventory are examples of such standardized instruments. In order to administer such instruments properly, the investigator must have received the requisite training, because erroneous information resulting from a wrongfully administered test procedure could constitute greater than minimal risk to subjects. For example, testing could wrongfully indicate that a research subject is suffering from an emotional or cognitive disorder, and this misinformation could adversely affect self-perception or prompt an unnecessary intervention. Another example concerns the competent use of audiological or physiological measuring equipment. A major concern regarding both instruments and tests is the potential physical or emotional harm that may occur during the process of use by an untrained test or equipment use. Another concern is the potential physical or emotional harm that may occur during the process of an instrument's administration by an untrained person. A final concern is that the erroneous results generated by an untrained test administration may lead to invalid research conclusions. In combination, these concerns require the IRB to inquire whether researchers are qualified to use any specialized instruments/equipment included in their study.

VII. Disclosure of Research.

Researchers sometimes choose to share individual results with their subjects, possibly as an additional benefit of participation. Results could include test responses or scores, interview transcripts, or videotape footage. Alternatively, the researcher may decide NOT to disclose individual data to subjects for a number of reasons including the following: (1) to preserve the integrity of the research design, (2) because explaining the results would demand excessive resources, or (3) because the researcher determines that disclosure of the results might be harmful to the subject. The researcher may also choose to make a decision about disclosing results after completion of the research. Whether the researcher will or will not disclose individual results to subjects or postpone this decision until after the research, this must be stated in the letter of informed consent. When the researcher will disclose the results and they are potentially harmful to a subject, perhaps because the results could give rise to strong negative emotions, the researcher is obliged to provide the subject with appropriate support, and this support should also be guaranteed in the letter of informed consent.

VIII. Informed Consent.

Federal guidelines normally require that research subjec or their appropriate representatives be informed of all aspects of the research project relevant to use of their time, the conditions under which they will participate, and the risks that they will encounter. A sample of such a letter of informed consent is included in this information packet. Specifically, the letter of informed consent should at minimum address the following critical areas: (Letters identify annotated segments in the sample informed consent form)

1. Activities and Conditions: Describe activities in enough detail that the subjects can visualize what they will be engaged in while participating. What will the subject be doing during participation and under what conditions will activities occur?

2. Subject Time Commitment: Indicate how much total time is required of each subject and specify the predicted schedule of activities.

3. Compensation: Specify the rate of compensation. Indicate when and how subjects will be paid. If the compensation is non-monetary, this should be specified.

4. Accessibility of Communication: Make assurances that throughout the project you will use communication that is understandable to subjects.

5. Potential Risks: Identify the possible adverse effects of participating in the research or of being identified as a person who participated. If there are no risks beyond the minimal level, state this. If an interview may touch on potentially sensitive areas such as sexual practices, sexual orientation, or illegal drug use, this should be explained in the Letter of Informed Consent.

6. Confidentiality: Make a guarantee of confidentiality at all phases of the project including disposition of data on completion of the project. If subject identity is to be disclosed outside of the immediate research setting, the audiences should be described in enough detail that the subject can make an informed decision about whether loss of confidentiality is acceptable. This is very important in studies where videotape is used to record research data.

7. Freedom to Withdraw: Assure subjects that they have the freedom to withdraw from the study at any time without penalty.

8. Disclosure of Results to Subjects. Indicate whether you will disclose individual data to subjects. If you will disclose individual results that are potentially harmful, specify supports you will provide in order to minimize risk to the subjects.

Permission to Videotape or Audiotape: If the study will use videotaping to record subject responses, then the investigator must obtain separate written permission to videotape from subjects or their representatives. The videotape permission form should include (1) a statement that the subject gives permission to the researcher to videotape, (2) specification of who will view the completed videotape, and (3) a statement of how the videotape will be handled, stored and used after the project is completed. Copies of sample Permission to Videotape/Audiotape forms are available in the IRB office.