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: SAN JOSE STATE UNIVERSITY
HUMAN SUBJECTS-INSTITUTIONAL REVIEW BOARD
PROTOCOL NARRATIVE
Prior approval by the Human Subjects-Institutional Review Board is required for all research involving human subjects to be conducted by 91 students, staff, or faculty. Procedures may not begin until approval is received.
The following information is provided to assist you in preparing your protocol narrative for review by the Human Subjects-Institutional Review Board. Your responses should be written in a manner which can be understood by a non-specialist. Please complete all sections of this template. If any section is not applicable, list the heading and simply indicate N/A.
Instructions are bracketed and in italics. Please remove instructions prior to submission.
I. application
[Attach a complete IRB Application - Request to Use Human Subjects in Research to the front of the protocol narrative. The application, as well as all other IRB related forms and templates are available on the Office of Graduate Studies and Research website: HYPERLINK "http://www.sjsu.edu/gradstudies/irb/" http://www.sjsu.edu/gradstudies/irb/
NOTE: 91 students must have a responsible faculty member who has read the protocol, signed the application, and completed the required IRB training]
ii. project title
iii. investigators and staffing
[List all personnel, including the primary investigators, who will assist in conducting the research in the table below (add additional rows as needed)]:
NAME OF INDIVIDUAL
QUALIFICATIONS
RESPONSIBILITIES
[YOUR NAME]
MSW STUDENT
PRIMARY INVESTIGATOR
Primary Investigator(s) Signature:
_________________________________________________________________________________________
iv. involvement of other institutions
[a. If research will be conducted through other institutions that either serve as a source of subjects, a source of records and information, or on whose facilities your project will be conducted, list the name of each institution involved. Attach copies of permissions from participating institutions, organizations, or agencies. Permission from such institutions or agencies should be on their letterhead and should include: the title of the study, the inclusive dates for which the permission is granted, and the title and type written name of the individual with the authority to grant such permission, in addition to their signature. Email permissions with the appropriate contact information for the institution will also be accepted.
b. Disclose any affiliation that you have with the participating institution, including whether you are an employee, an intern, or have a personal financial interest within the institution.
c. Address any potential conflict of interest, real or perceived, that may arise as a result of your affiliation with a participating institution (e.g., whether you have a direct role in the treatment, assessment, or training of potential participants; whether you have a supervisory role over potential participants; whether you are providing services to potential participants unrelated to your research activities).
Please also keep in mind that access to certain kinds of records such as student records, employee records, and medical records are subject to privacy rules. In most cases, such records, when they contain individually identifying information, cannot be accessed for research purposes without the permission of the subject.]
v. abstract
[Briefly state the problem, background, importance of the research, the hypotheses or questions to be addressed, and the goals of the proposed project.]
vi. human subjects involvement
[Please complete all sections below. If a section is not applicable, indicate N/A.]
A. subject population
[Describe the subject population in terms of age, gender, race, ethnicity, etc., including the estimated number of participants. State any inclusion/exclusion criteria used to select subjects. Explain the rationale for employing the type of subjects selected for the study.]
b. recruitment plan
[Describe the procedures for selecting subjects. Explain how subjects will be recruited. Stipulate who and where the potential subjects are, how they will be contacted, and what will be said to recruit them and by whom. Attach any recruitment materials, such as sign up sheets, flyers, or text for media postings.]
c. research methods and design / procedures
[Include a description of the project design and procedures. Describe what the subjects will do, step by step, and the duration of the study. State where, when, and by whom the research will be conducted. If treatment is to be done, state the qualifications of the practitioner.]
d. materials and devices
[a. List the kinds of data instruments that will be used and attach copies to the protocol (e.g., surveys, questionnaires, interview questions, data intake sheets). If translation into another language is necessary, submit both the English version and the translated version of the data instruments, AND include the Verification of Translation Accuracy Form completed by someone other than the investigator(s) who is adept in the language.
b. Describe any cognitive or psychological tests that will be employed and provide representative examples of any computer stimulus or other test materials.
c. Describe how the investigator will record information and any devices that will be employed, including information on whether audio/video recording devices will be used. If participants will be recorded or photographed, describe how these materials will be used, including whether or not they will be presented in publication or dissemination.]
e. confidentiality
[a. Indicate whether or not any identifying information will be collected and/or reported. Describe reporting methods. If identifying information will be collected but not reported, describe mechanisms for maintaining confidentiality (e.g., pseudonyms, coding system). If subjects are to be identified with the data, indicate the extent to which the subjects name or other identifiers will be used.
b. Specify how data/materials collected will be kept safe and who will have access to the data/materials.]
f. compensation
[State any compensation that will be awarded to subjects for participation in the study (e.g., cash payment, gift card, course credit, free treatment). If students will receive extra credit or course credit, state the alternative method(s) that will be available for earning the credit for those who do not wish to participate.]
g. potential benefits
[List any potential direct benefits such as health-related or psychosocial benefits to an individual research subject. List any indirect benefits such as how the research may contribute to the acquisition of generalizable knowledge.]
h. potential risks
[Describe any potential risks - whether physical, psychological, social, legal, or other - and assess their likelihood and seriousness. Examples of risks include: physical injury, allergies to the materials used in the study, loss of privacy, the release of potentially damaging personal information, psychological trauma, and emotional discomfort (e.g., anxiety, stress, depression).]
I. risk reduction
[Describe the procedures for protecting against or minimizing each potential risk listed above. For example, risk of loss of privacy may be reduced by storing all research material in a locked cabinet, by using codes rather than participant names on surveys, or by conducting an anonymous study. Describe special safety procedures, as needed, to avoid harm to subjects. List any psychological and/or medical help available in the event of harm. For example, if the risk of emotional discomfort is high, the investigator should provide the subjects with a list of referrals for counseling and attach this information to the informed consent document.]
vii. informed consent
[Please complete all sections below. If a section is not applicable, indicate N/A.]
A. consent process
[Describe procedures for obtaining informed consent from subjects, including procedures for obtaining assent from minors. Indicate who will obtain consent/assent, what language will be used, where and when consent/assent will be obtained, and what steps will be taken to minimize the possibility of coercion or undue influence.]
b. special consent provisions
[If some or all subjects will be cognitively impaired, visually impaired, physically impaired, or have language/hearing difficulties describe how capacity for consent will be determined. If you anticipate the need to obtain informed consent from legally authorized representatives, please describe how you will identify an appropriate representative and ensure that their consent is obtained.]
c. waiver of written consent
[If you would like to request a waiver for obtaining written consent from participants, provide a justification for the request and include a description of alternative procedures for obtaining informed consent.
Written consent may be waived under certain circumstances. For example, when participants come from a culture that has an oral rather than written tradition, investigators may submit an informed consent script, outlining the manner in which informed consent will be obtained verbally. Written consent can also be waived when the only record linking adult subjects to the research would be the consent document, such as in anonymous surveys, and the principal risk would be potential harm resulting from a breach of confidentiality. In such cases, the signature line on the standard consent form is replaced with a statement such as Your completion of the survey indicates your willingness to participate. Please keep this information for your records and do not write any information that could identify you on the survey.]
d. debriefing
[If the study involves deception, describe the debriefing procedures that will be enacted and attach any informational materials that will be distributed to participants.]
e. consent forms
[Attach the appropriate consent form, letter, or script that will be used. If a paper copy is to be distributed to participants, it must be on 91 departmental letterhead.
If translation into another language is necessary, submit both the English version and the translated version of the consent document(s), AND include the Verification of Translation Accuracy Form completed by someone other than the investigator(s) who is adept in the language.
Sample consent forms/templates are provided on the 91 IRB website. Follow the format and instructions provided with these templates whenever possible.]
viii. other
[If there are issues which the board should consider which do not fall into any category above, please describe them here.]
PAGE 2
PAGE
Make sure to use this option. Do not leave a section blank without any note.
Be sure to do this.
This is for YOUR signature.
See the template provided.
Do not leave a section in blank.
This has to be very much in details so review can see how you actually recruit potential participants. Try as best as you can.
Keep this in mind. Provide as detailed procedure as possible.
This means you need to come up with the actual instrument to be used for your study.
I guess to most of you this will be N/A
If potential risks are minimal, state that: potential risks involved in the proposed study are expected to be minimal and the probability and magnitude of harm or discomfort may be no greater than what would be encountered in daily life
Or , no risk is anticipated.
Related to what you said in H.
If you are doing a secondary data analysis not involving patient records, student records, and active/open cases of foster youth, you do not need informed consent.
Keep in mind that they want to know process/ procedures
To many of you this will be N/A
This is for anonymous survey. Also see the information regarding consent form provided by the IRB.
Once you finalize your consent form, I will provide 91 letterheads.
Review the templates thoroughly and include ALL the information required.
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