IRB PROTOCOL REVIEW(Full Board/Expedited) EXAMPLE GUIDE

PURPOSE OR OBJECTIVES: (Limit to one page)(Criteria: States the purpose of the research and gives a fair explanation of the research procedures. Experimental procedures must also be identified.)

Example: The purpose of this research is to determine what makes a good guitar and what musicians look for when they go to buy one. I am doing research for my ISAT 180H class, which is a class that gives me Honor’s credits in GISAT 141 and GISAT 112. The goals of 180H are to allow students to design experiments and to make their own measurements. I plan to measure the sound of a guitar through laser technology and I am using this survey to get feedback from other musicians about their preferences with the guitar itself and the sound that it produces.

PROCEDURES:1. Research design and sampling

(Criteria: Selection of subjects is equitable, explains research design and sampling.)a. Explains task and procedures from the subject’s point of view (what will he or she be expected to

do?).b. Estimate the total amount of time for the person involved in the study.c. Explains the frequency of procedures and includes any additional costs or charges for the

research procedures with estimated amounts.d. States why the individual is eligible to participate or what criteria will be used to determine

eligibility.

2. Method of collecting dataa. Must state how the research data will be collected

Example: Participants will fill out surveys individually in a classroom setting and will be given class credit for participating. Upon completion of the questionnaires the participants will be asked to put their completed questionnaires in a drop box placed at the back of the room.

b. Emphasize possible risk : (Criteria: Risks to the subjects are minimized. Risks to the subjects are reasonable in relation to anticipated benefits.) Describes any foreseeable risks or discomforts the subject will bear. Includes all reasonably common risks as well as potentially serious risks and, if possible,

indicates the likelihood of occurrence. Risks may range from inconvenience to bodily pain. Researcher should not overlook “soft” risks such as confidentiality and embarrassment. Decisions about invasive procedures will always involve a degree of uncertainty regarding the

harmful effects. Calculating the probability that these situations will occur can aid in explaining the risks.

The view of the nature of a risk will vary from participant to participant. The researcher should be sensitive to the difficult task of determining if the participant is more of a risk taker, is ignoring the risk(s), or have not adequately understood the probability of the risk(s).Example: The investigator does not perceive any risks from your involvement in this study.OR: phrase if there are Risks InvolvedExample: The investigator perceives the following are possible risks arising from your involvement in this study: …

c. Protection of subjects: Researcher needs to address the issue of participant consent (usually achieved by providing

consent forms that will be signed by both the subject and the investigator / or a cover letter used with “anonymous” research.)

Alternatives : Researcher may state alternative procedures or courses of treatment, if any, that

might be advantageous and available to the subject. The alternative may simply be nonparticipation.

Participation & Withdrawal Example: “Participation is entirely voluntary. Participants can withdraw at any time without consequences of any kind.” However, once responses have been submitted and anonymously recorded participants will not be able to withdraw from the study.(Anonymous research only.) (Not applicable for surveys, see website for more details.)

3. Time frame of study:(Criteria: Researcher should state when research will begin and end. This time frame should correlate with projects dates stated on “page 1” of the protocol.)Example: “Research will begin upon IRB approval and will end in May 2005.”

DATA ANALYSIS1. Discuss how confidentiality of subject and their responses will be maintained:

a. The researcher should incorporate the means of collating, aggregating and analyzing the research data in this section.

b. The researcher must describe the level of confidentiality of the research data and the measures that the researcher plans to take to ensure that confidentiality is maintained.

c. The researcher should describe the steps that will be taken to protect the participant’s privacy. In addition, under what circumstances records will be made available and to whom.

d. The researcher should include any techniques that may be used for identifying data, such as creation of a numeric code. Subjects should be assured that their identity will not be disclosed.

e. However, in special circumstances, such as for reportable conditions like child abuse, absolute confidentiality may not be possible. If this or a similar possibility exists, then the researcher should explain the circumstances under which information must be disclosed and to whom.

Example: “An anonymous online survey is being given so that names, e-mails and other personal information will not be connected to those individuals who choose to take the survey.  Any e-mail lists used to distribute the survey will not be shared with others, will be kept completely confidential, and will be destroyed after the survey is administered to ensure confidentiality.”

2. Discuss how data will be stored to ensure confidentiality of subjects:Example: “Participants’ signed consent forms will be contained in a secure location separate from the questionnaires. The questionnaires will not have any identifying information on them. All data will be accessible only to the researcher(s) and the research advisor.”

REPORTING PROCEDURES1. Identified audience to be reached in the report of the study

Example: “The target audiences to be reached in the report of this research are fellow dietetics majors, dietetics faculty, and other interested faculty at James Madison University.”

2. Identified the presentation method(s) to be usedExample: “The presentation of this research report will take place at the Senior Dietetics Research Poster Presentation (April 2005). While individual responses will be kept in confidence, aggregate data will be presented representing averages or generalizations about the responses as a whole.  No identifiable responses will be presented in the final form of this study. All data will be stored in a secure location only accessible to the researcher.  Upon completion of the study, all collected data will be destroyed.”

3. Discussed how feedback will be provided to subjects:Example: “Participants in this study will be given the opportunity to see research results by contacting the primary researcher for dates and time of the Presentation, as stated in the cover letter. Participants will also have the option of receiving a summary of results by contacting the primary researcher.”Example: “Final aggregate results will be available to participants upon request.”

EXPERIENCE OF THE RESEARCHER1. Prior relevant experience of the researcher, supervisor, and/or consultants

a. If the researcher(s) have no research experience, they should state so:Example: “This is the researcher’s first research experience. The advisor, Dr. Sample, has 10 years of research experience and will guide me through the study.”

ADDITIONAL ATTACHMENTS (if applicable) Consent Form Letter of Permission Cover Letter Questionnaire Tests Additional attachments relevant to the study

Consent Form Used When: (CONFIDENTIAL RESEARCH) Subject is being interviewed Subject is being recorded (audio/video) Face-to-face interaction between researcher and subject Identifying information being collected from subject (name, ss #, race, etc.)Ex: Research involving focus group discussions / Research involving audio taped interviews

Letter of Permission Used When: Conducting research at a site other than JMU

o “Signed” site letter from the appropriate authority is required before the research can be officially APPROVED

Cover Letter Used When: (ANONYMOUS RESEARCH) Subject’s identity is to remain “anonymous” (“Anonymous” meaning that the researcher can in NO

WAY identify the subject) No identifying information is being requested A survey/questionnaire is being administered and the researcher will not be present while the

surveys/questionnaires are being completed or that the participants will place their completed surveys/questionnaires in an envelope/box provided to ensure anonymity (Must be stated in the protocol and in the cover letter)

Ex: - Research involves passing questionnaires out on campus in the Quad, where participants are asked to place their completed questionnaires in a drop box that is provided to ensure anonymity. The drop box will be collected after the allotted time and the questionnaires will be stored in a secure location accessible only to the researcher.

Research Proposal Checklist: http://www.albright.edu/irb/irbProtocolChecklist.docInformed Consent Checklist: http://www.albright.edu/irb/irbInformedConsentChecklist.doc

http://www.albright.edu/irb/irbProtocolReviewExGuide.doc