CONFIDENTIALITY AND DATA SECURITY

Will personal identifiers be collected (e.g., name, social security number, license number, phone number, email address, photograph)? Yes No

Will identifiers be translated to a code? Yes No

Describe how you will protect participant confidentiality and secure research documents, recordings (audio, video, photos), specimens, and other records.

Participants will be asked to create a unique identification code (e.g., consists of first three letters of their birth month, followed by their birth date) and indicate this at the start of the pre- and posttest measures. There will be no electronic or paper form in the survey that contains the participant’s name.

This study involves the audio recording of participants during the focus group. Neither the participant’s name nor other identifying information will be associated with the audio, audio recording, or the transcript. Only the research team consisting of myself, my dissertation advisor, and members of the dissertation committee will be able to listen to the recordings. The tapes will be transcribed by the researcher onto an electronic password-protected document and erased once the transcriptions are checked for accuracy. Transcripts of the interview may be reproduced in whole or in part for use in presentations or written products that result from this study. Participants’ names or any other identifying information (i.e., participant’s voice) will not be used in written products or presentations resulting from the study. The digital voice-recording device will be stored in a locked filed cabinet. All paper work (e.g., informed consents) will be stored in a locked file cabinet at the FPH-Hilo location, where only the PEAK program manager and I will have key-access. A copy of the consent forms and any other paper materials obtained from participants and/or their parents/legal guardians will be kept in a locked file cabinet in my advisor’s office at University of San Francisco to which only she and I will have access.

4. CONSENT

4a. Informed consent

Do you plan to use a written consent form that the participant reads and signs? Yes No

*If “no,” you must complete Section 4b or 4c below. If “yes,” describe how consent will be obtained and by whom.

If PEAK participants aged 14 to 17, are interested in participating in this study, the program manager will include the study consent form with the PEAK information packet that is already

sent home to parents/legal guardians. The study consent form includes information about the study (i.e., pre-/post- tests, focus group, consent to audio-recording, and

privacy/confidentiality) and requires written consent in the form of a signature from the parent/legal guardian and the youth. To culturally adhere to the methods in which PEAK typically obtains informed consent from youth and parents/legal guardians, the child and parent/legal guardian forms in this study have been combined. Interested youth who are considered legal adults (ages 18-19) will be asked to provide their written consent on site. All participants will return the appropriate forms to the program manager at the start of the first session. See respective combined child and parent/legal guardian assent/consent form and adult consent form attached.

If the participants are minors under the age of 18 years, will assent forms be used? Yes No N/A

If “no,” please explain.

Upload to the online IRB system the consent form(s) that the participants and/or

parent/guardian will be required to sign, and the assent forms for children under the age of 18, if applicable.

Note: All consent forms must contain the following elements (quoted directly from Office for Human Research Protections regulations, available at:

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.116 ). The IRB has consent templates containing all required elements, and we ask that you use these templates.

If you believe it is important to create your own consent form, you are free to do so but please ensure that your consent form has each of the following elements and indicate you have done so by checking this box:

I have chosen to create my own consent form and have ensured that it contains the 8 essential elements listed below:

(1a) A statement that the study involves research, (1b) an explanation of the purposes of the research, (1c) the expected duration of the subject's participation, (1d) a

description of the procedures to be followed, and (1e) identification of any procedures which are experimental;

(2) A description of any reasonably 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 appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

(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 subjects' rights, and whom to contact in the event of a research- related injury to the subject; and

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

4b. Waiver of documentation of written informed consent (Complete only if answered "no" to 4a)

The regulations allow instances in which the IRB may waive the requirement for

documentation of informed consent, that is, the collection of a signed consent form. If you are requesting a waiver of written documentation (signed) of informed consent, please answer the following questions:

Will the only record linking the participant and the research be the consent document and the principal risk to the participant would be from breach of confidentiality? Yes No

Do you consider this a minimal risk study that involves no procedures for which written

consent is normally required outside of research (see 2B above for definition);? Yes No

Explain why you are requesting waiver or modification of documentation of written (signed)

informed consent and how you plan to obtain consent.

4c. Waiver or modification of informed consent (Complete only if answered "no" to 4a)

The regulations also provide an opportunity for the IRB to waive the requirement for informed consent or to modify the informed consent process, provided the protocol meets the following criteria:

(1) The research involves no more than minimal risk to subjects (see 2b above for definition);

(2) The waiver of alteration will not adversely affect the rights and welfare of the subjects; (3) The research could not practicably be carried out without the waiver or alteration; and (4) Whenever appropriate, the subjects will be provided with additional pertinent

information after participation.

If you are requesting a waiver or modification of informed consent (e.g., incomplete disclosure, deception), explain how your project meets the requirements for waiver or modification of informed consent, as outlined above.

Appendix C

Memorandum of Understanding

This Memorandum of Understanding (MOU) is entered into by and between: Jennifer Ho of the University of San Francisco (USF) and Keith Kuboyama of Family Programs Hawaii (FPH)