#22_Justif memo & Attach_22F_REVISED_Consent

Date: March 27, 2012

To: Office of Management and Budget (OMB)

Through: Keith Tucker, Report Clearance Officer, HHS

Seleda Perryman, Project Clearance Officer, NIH

Vivian Horovitch-Kelley, PRA OMB Project Clearance Liaison, NCI

From: Nina Goodman, Project Officer

Office of Market Research and Evaluation

Office of Communications and Education, National Cancer Institute (NCI/NIH)

Silvia Inéz Salazar, Public Health Advisor

Office of Market Research and Evaluation

Office of Communications and Education, National Cancer Institute (NCI/NIH)

Subject: Generic Sub-study, Formative Audience Research for Spanish Template Informed Consent Form under “Formative Research, Pretesting, and Customer Satisfaction of NCI’s Office of Communications and Education,”

(OMB No. 0925-0046-22, Expiry Date 02/28/2013)

Background/Need and Use of Information

Hispanics/Latinos are affected by many economic and cultural disparities in health care, including disproportionate participation in Federally-funded cancer research. In addition, lack of involvement in health research has hindered the development of prevention and treatment efforts for this special population group. This research supports ongoing efforts at NCI to increase participation of Latinos in clinical trials by developing culturally and linguistically appropriate clinical trials information, tools, and processes. Specifically, the current data collection will be used to improve and culturally adapt clinical trials informed consent documents and processes.

The National Cancer Institute (NCI) Division of Cancer Prevention (DCP) previously developed an informed consent template for use in chemoprevention clinical trials. This template was designed to simplify and standardize the informed consent process for chemoprevention clinical trials. The template was originally developed in English. The English-language version is already available on NCI’s Web site (http://prevention.cancer.gov/clinicaltrials/management/consortia/step-1/protocol#consent) for use in clinical settings.

In an effort to better meet the needs of potential Spanish-speaking clinical trials participants, NCI’s Office of Communication and Education (OCE), in collaboration with DCP, have culturally and linguistically adapted and translated the template into Spanish. Prior to making the Spanish version of the template available for use in clinical settings, NCI needs to conduct formative research with a representative Latino population to gain a better understanding of the perceptions of the clinical trial informed consent process for Latinos and to ensure that the Spanish versions of the informed consent template meets the needs of this population.

For this purpose, OCE wishes to conduct in-depth interviews with 30 members of the Spanish-speaking population, to explore their thoughts and opinions regarding the informed consent template for chemoprevention clinical trials and to learn about promising practices related to the consenting process with potential Latino clinical trial participants. The key objectives of this data collection effort are to:

• Receive feedback on the existing Spanish-language informed consent form template and to

• Gain an understanding of the consenting process with Spanish-speaking populations, including potential challenges in the consenting process and linguistic practices.

The information collected will be used to improve the informed consent process and template for Spanish-speaking clinical trial participants.

Participants, Methodology and Research Instrument

NCI will conduct in-depth interviews with 30 Spanish-speaking Latinos who are eligible for participation in a cancer prevention or cancer treatment trial. The attached screener in English and Spanish (Attachment 22A) will be used to recruit participants in order to assure a range of background and experiences. Participants will be recruited in Chicago and Los Angeles by a professional market research firm with experience recruiting Latino participants.

Each in-depth interview will be scheduled in advance and consent to participate in this data collection effort will be obtained from each participant (Attachment 22F). Once the participant arrives at the location where the interview will take place, he/she will be given time to review the consent to participate. In addition, the moderator will verbally review the consent with the participant and confirm his/her preference. Participants will be given time to review the sample consent templates before taking part in the interview (Attachments 22D or 22E). The attached Interview Guides in English (Attachment 22B) and Spanish (Attachment 22C) will be used to direct the interviewer in collecting the data relevant to the purpose. Each interview will last approximately 60 minutes and will be conducted in Spanish by a person fluent in Spanish language and culture.

Participation will be voluntary. A request for Office of Human Subjects Research exemption is also being submitted for this research. The NIH Privacy Act Officer will review the information collection instruments and methodology to confirm that the Privacy Act does not apply to this data collection since NCI is not collecting, maintaining or storing personally identifiable information (PII). Respondents will receive a token remuneration of a $50 gift card for their participation in the interview. An incentive of $50 is necessary because recruiting Hispanics/Latinos representing different acculturation levels, national ancestries, and Spanish language proficiency levels is difficult. In addition, participants will be asked to use their analytical and cognitive skills to provide comments and responses for a twenty page document presenting clinical trials concepts.

Data Analysis

All interview proceedings will be audio taped for the purposes of report writing and analysis only. Names and any other personal identifying information will be kept secure to the extent provided by law, and will not appear on notes, audiotapes, or in the summary report. The market research firm will collect PII but it will not send it to NCI. Once the data collection is complete, research staff will conduct a qualitative analysis by reviewing notes and audio recordings. Research staff will code notes to identify themes and to ensure equal representation of diversity and viewpoints within the data and to synthesize the results. A topline report summarizing key findings and providing study implications and recommendations will be written.

Burden

It is estimated that 80 screeners will need to be completed to recruit 30 participants for the interview. Each interview should take each of the participants approximately one hour to complete. We therefore expect the total respondent burden for this proposed effort to be 50 hours. There have been 19 previous sub-studies approved by OMB under Generic submission OMB No. 0925-0046, totaling 2,706 burden hours requested to date. Estimated cost to the Federal Government is $50,000 (contract submitted by vendor to recruit participants, conduct online survey, submit and analyze dataset).

Estimates of Burden Hours
Types of Respondents	Instrument	Number of Respondents	Frequency of Response	Average Time Per Response (Hours)	Total Hour Burden
General Public	Screener (Attachment 22A)	80	1	15/60	20
Latino adults eligible for prevention or treatment clinical trial	In-depth Interview Guide (Attachment 22B and 22C)	30	1	1	30
Total					50

List of Attachments (separate files)

22A: Screener in Spanish and English

22B: Interview Guide in English

22C: Interview Guide in Spanish

22D: Sample Informed Consent template in Spanish

22E: Sample Informed Consent template in English

22F: Consent to Participate in In-Depth Interview (Spanish and English versions attached

below)

Attachment 22F: Consent to Participate in In-Depth Interview

(Spanish Version)

First page is for the participant and second page is for the researcher.

Permiso para participar en la entrevista

Acerca de este Proyecto

Le hemos solicitado que participe en una entrevista sobre sus opiniones y pensamientos acerca de cómo está presentada la información en la plantilla de consentimiento para estudios clínicos/esnayos clínicos. Sus respuestas ayudarán a los profesionales de la salud a entender el punto de vista de cada participante, al igual que a entender cuán bien funcionan los diseños que se han propuesto. La entrevista, incluyendo las instrucciones, durará no más de 60 minutos, y será dirigida por una persona capacitada para dicha entrevista.

Grabaremos esta entrevista en una cinta de audio casete. Asimismo, los miembros del equipo que están encargados de la entrevista escucharán y observarán las grabaciones. Hacemos todo esto para redactar un informe preciso. No permitiremos que ninguna persona ajena a este proyecto escuche ni observe las grabaciones sin su previa autorización. Todo lo que usted diga y haga será seguras conforme lo exige la ley. No pondremos su nombre ni en el informe, ni en las grabaciones.

Los riesgos asociados con su participación en esta entrevista se espera que sean mínimos. Este estudio no está diseñado para ayudarle a usted personalmente, sino para ayudar a los investigadores a entender mejor a las diversas audiencias de la plantilla de consentimiento y hacer mejoras al contenido, la estructura y la presentación de la información. No tendrá que responder ninguna pregunta que no le parezca y puede dejar de participar en la entrevista en cualquier momento y sin ninguna penalidad.

Este proyecto está patrocinado por el Instituto Nacional del Cáncer (“National Cancer Institute” en inglés). Si tiene alguna pregunta acerca de este proyecto, sírvase llamar a Silvia Salazar al: teléfono 301-451-4070. Puede llamar a este número si tiene preguntas sobre sus derechos como participante en este proyecto o si cree que ha sido perjudicado. Deje un mensaje con su nombre y número de teléfono y alguien le devolverá la llamada lo antes posible.

Le agradecemos el tiempo brindado.

Consentimiento del Participante

Mi firma verifica que he leído una hoja titulada “Acerca del Proyecto” y que comprendo mis derechos como participante. Estoy de acuerdo en participar en la entrevista de hoy. Entiendo que durante la entrevista se solicitarán mis opiniones y pensamientos acerca de cómo está presentada la información en la plantilla de consentimiento.

Autorizo ser grabado en cinta de audio casete. Entiendo que únicamente las personas que trabajan en este proyecto podrán oír y observar las grabaciones. Entiendo que ni mi nombre ni ninguna otra característica que me identifique se utilizará en ningún informe ni en los demás productos que puedan resultar de este proyecto.

Firma: ________________________________________________________________

Nombre: ______________________________________

Fecha: ___________________________

Consent to participate will be given to participants in Spanish because the interview will be conducted in Spanish. The English version is for review purposes only.

Attachment 22F: Consent to Participate in In-Depth Interview

(English Version)

Permission to Participate in Interview

About this project

We have asked you to participate in an interview about your opinions and thoughts about how information is presented in the informed consent template for clinical trials. Your responses will help healthcare professionals understand the point of view of each participant and also help understand how the proposed designs work. The interview will be conducted by someone skilled and trained on how to conduct interviews. Including the time to read instructions, the interview will not last more than 60 minutes.

We will record the interview using an audio cassette. Also, members of the team that are in charge of the interview will observe and listen to the recordings. We are doing all of this so that we can write an accurate report. We will not allow anyone outside of this project to listen or observe the recordings without your prior authorization. Everything you say and do will be kept secure to the extent provided by law. We will not include your name in the report or recordings.

The risks associated with your participation in this interview are minimal. This study is not designed to personally help you but to help the researchers better understand the diverse audiences for of the informed consent form and to make improvements in the content, structure and the presentation of information. You do not have to respond to any question that you object to and you may stop participating in the interview at any time and without penalty.

This project is being sponsored by the National Cancer Institute. If you have any questions about this project, feel free to call Silvia Salazar at (301) 451-4070. You may call this number if you have questions about your rights as an interview participant in this project or if you believe that you have been harmed. Leave a message with your name and phone number and someone will return your call as soon as possible.

We thank you for your time.

Participant consent

My signature verifies that I have read the document entitled “About this Project” and that I understand my rights as a participant. I agree to participate in this interview today. I understand that during the interview, I will be asked about my thoughts and opinions about how information is presented in the informed consent template.

I give permission for an audio cassette recording. I understand that only the people that are working on this project will be able to observe and listen to the recordings. I understand that neither my name nor any personally identifiable characteristic will be used in any report or the other products that may result from this project.

Signature: ________________________________________________________________

Name : ______________________________________

Date: ___________________________

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