Form 2 Informed Consent

Study to Estimate Radiation Doses and Cancer Risk From Radioactive Fallout From The Trinity Nuclear Test (NCI)

ATTACHMENT 15A - Informed Consent_Edited_2_23_16-English

Consent Form

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Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of study participants are protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or withdrawing from the study at any time. Refusal to participate will not affect your benefits in any way. The information collected in this study will be kept private to the extent provided by law. Names and other identifiers will not appear in any report of the study. Information provided will be combined for all study participants and reported as summaries. You are being contacted by face-to-face interview to complete this instrument so that we can better understand the diets and way of life of Native Americans, Hispanos, and non-Hispanic whites in New Mexico around the time of the Trinity nuclear test.

Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-XXXX). Do not return the completed form to this address.

TTACHMENT 15A
- Informed Consent


















Identification of the Project

Project to study the diets and way of life of Native Americans, Hispanics and non-Hispanic Whites in New Mexico during the time of the Trinity nuclear test.


Statement of Age of Subject

I am at least 18 years of age and I am in good physical health. I want to participate in the project being done by the National Cancer Institute, Bethesda, MD 20850.


Purpose

The purpose of this project is to learn about people’s diets, activities, and living conditions around the time of the Trinity nuclear test in July of 1945. This will help our team from the National Cancer Institute in their studies of radiation exposure and long-term health effects.


Procedures


I am being asked to participate in a group discussion (focus group) or individual interview about activities and eating habits around the time of the Trinity nuclear test in July 1945. The discussion/interview will take up to two hours. There will not be any right or wrong answers to the questions. I will just be sharing my experiences and memories. There is an option to participate in either the focus group or individual interview.


Confidentiality

I understand that the information I will share will be put together with the answers that each group or person will provide. I understand that my name will not be used, nor will the name of my town or community be used. The group discussion will be audiotaped if all participants give their permission. The interview will be audiotaped if I give my permission. A recording of my voice will not be played to others besides the people in charge of this project. This document and any audio recordings will be kept in a locked cabinet. Both will be destroyed by December 31, 2020. The National Cancer Institute will follow all applicable privacy and confidentiality laws and regulations, and will do all that they can to keep private the information I share private.


Risks

I understand that participating in this project may cause some small risks. I may get upset when I talk about the time of the Trinity test. I can skip any questions, leave the discussion or stop the interview at any time.

Benefits, Freedom to Withdraw, & Ability to Ask Questions

I understand that the purpose of this project is not to help me personally. The National Cancer Institute hopes to learn about - activities and eating habits around the time of the Trinity nuclear test in July 1945. I am free to ask questions or stop participating at any time and without penalty. I understand that there will be no impact or adverse effect on existing healthcare benefits should I refuse to participate or withdraw from the study. I understand that the results of the project do not include the ability to determine my individual future health risks. I understand that the National Cancer Institute will provide me with the name of local healer or other resource if I want it. I understand that the National Cancer Institute will not pay for this healer or other resource.


Contact Information of Investigators

Steve Simon

National Cancer Institute

Telephone: (240) 276-7371

Email: [email protected]



Printed Name of Research Participant Signature of Research Participant Date

_____________________________ ___________________________ __________



Printed Name of Witness Signature of Witness Date

_____________________________ ___________________________ __________






Tape recording

Do you give permission to make an audio tape recording?

Yes No







File Typeapplication/msword
AuthorNational Cancer Institute
Last Modified ByAbdelmouti, Tawanda (NIH/OD) [E]
File Modified2016-08-19
File Created2016-03-02

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