Rutgers University
?ADDENDUM: CONSENT TO STORE IDENTIFIABLE [CHOOSE: BIOSPECIMENS AND/OR INFORMATION] IN A RESEARCH REPOSITORY FOR FUTURE RESEARCHThis Addendum Consent template should be used when asking subjects to allow the research team to store and use biospecimens or information collected during the primary research—including requests for additional samples—for future research when their participation in the Repository activities is OPTIONAL to taking part in the main study.If participation in the Repository activities is REQUIRED, do not use this Addendum Consent template. Instead, add your request to collect/store specimens or information for future research to the Main Consent to take part in research. INSTRUCTIONS:[BLUE] highlighted text provide instructions to guide you in constructing the consent document. [GREEN] highlighted text provide different scenarios/options. Delete all instructional text and scenarios that are not applicable to your study.The consent document should be written at a 6th to 8th grade reading level.TITLE OF STUDY: [Add the Title of the study here.]PRINCIPAL INVESTIGATOR: [Add the PI’s name and credentials here (i.e. M.D., Ph.D., etc.).]We ask your permission to store some [specify-type/amount of Biospecimen or type of information] collected [Choose: ‘from or about you during’ OR [‘in addition to what was collected during the main study’] for future research. You may still participate in the main study even if you say no to this request to store [choose: biospecimens or information about you] for future research. How and where will my [Choose: Biospecimens Or Information] be stored and by whom? [Identify the name & address of the IRB- approved Research Repository where the biospecimens or information will be stored for future use, who owns the Repository and any sponsors. Describe the purpose of the Repository and specific research topics it addresses, if any. Consistent with the Standard Operating Procedures of the Repository, explain which investigators may request specimens or information for research. Sample text appears below.]Here is some information about the Research Repository:The XYZ Research Repository is owned and operated by Dr. Smith, MD. The repository is at: 123 Main Street, Any City, NJ, 12345. The sponsor, who helps pay the costs of operating the Repository is Company A. The purpose of the repository is to store [choose: biospecimens or information] to be used for future research by investigators at this University and other universities in the United States. The goals of research are to better understand [specify, e.g., Disease X] and to develop better means to [specify, e.g., prevent, diagnose and treat Disease X]. There is no set limit to the number of individuals that may provide [biospecimens or information] to the repository. The more [choose: biospecimens or information] available, the more useful the repository will be for scientific research.How and what [Biospecimens Or Information] will be collected from or about me?[Explain what and how biospecimens or information will be collected. List specimens to be collected in order of most invasive to least invasive procedure. NOTE: If the specimens or information were collected during the main study—and discussed in the main consent, simply state that here in a brief sentence and delete the rest of this section.]We will collect [specify, e.g., bone marrow, a lung biopsy, cancerous tissue] from you by [explain]; [and/or]We will collect a blood sample from you by drawing about [specify] of blood from a vein in your arm; [and/or]We will collect a urine sample from you.We will collect information about you [specify exactly what information you will collect. Be clear about what identifiers, if any, will be linked to the information] by [specify…e.g. looking at your medical record or asking you to complete a questionnaire, etc.] What are the risks of harm or discomfort I might experience if I take part? [List the risks of harm and discomfort associated with each type of procedure to obtain specimens. If the specimens were collected for the main study and risks of physical harm were described in the main consent, no need to repeat it here. Sample text appears below.]Physical Risks of Harm: If [specify, e.g., bone marrow, a lung biopsy, cancerous tissue] is collected from you, the possible effects are [explain].If a blood sample is taken from you, there are few risks of harm. Possible effects from drawing a blood sample include mild pain, bruising and infection at the site of needle insertion. Fainting or light-headedness can sometimes occur, but usually last only a few minutes. Infection is rare.If a urine sample is collected from you, there are no known physical risks of harm.List also in this section, harms that may result from a breach of confidentiality if information collected were accidentally disclosed. Sample text appears below.]Psychological or Social Risks Associated with Loss of Privacy:While the databases developed for this Repository will be coded to protect your personal information, people may develop ways in the future that would allow someone to link your information back to you. It is also possible that there could be violations to the security of the computer systems.There also may be other privacy risks that we have not foreseen.GINA language? [If you anticipate research will or may include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of collected biospecimens), contact the IRB for further guidance.]What Are The Benefits Of Participation? [Itemize the benefits to people that participate in the Repository. Sample text appears below.]You will not benefit personally from providing [choose: biospecimens or information] for this Repository because research usually takes a long time to produce meaningful results. However, your participation may help investigators [specify: understand, prevent, or treat the diseases and conditions studied in the future].How Will Information About Me Be Kept Private And Confidential? [Describe how specimens or information will be coded and stored. Highlight the ways in which subjects’ privacy and confidentiality will be protected.][Choose: Biospecimens or Information] stored in the Repository will be kept confidential so that neither the investigator nor the Sponsor can link your individual research results with your identity. Your [Choose: biospecimens or information] will be given a code number, and only information related to your age, sex, race, health condition and other relevant clinical information collected in the main study will be linked with the sample’s code number. Your name, date of birth, address, or other personal identifying information, will not be linked with the sample(s) you give.Is There Other Important Information To Consider?Yes. There is no cost to you to take part in the Research Repository. Nor will you be paid to take part in the Repository. It is possible that future research using your [choose: biospecimens or information] may lead to the development of new tests, techniques, drugs or other commercial products. Should any products or services result from future research, there is no plan to share any of the profits with you. [If there is a plan to share profit from products developed from research, explain that here.]Results from tests done for our research using your [choose: biospecimens or information] will not be returned to you, your family members, your doctor, or outside parties. It is possible, however, that members of regulatory authorities, such as the U.S. Food and Drug Administration, Rutgers Institutional Review Board, or other persons required by law may be allowed to look at this information. [If you anticipate returning research clinically relevant research results, state that here and disclose how and under what conditions such information will be returned.] What Are Your Rights If I Agree To Take Part In The Research Repository?You have the right to ask questions about any part of our storage and future research at any time. You should not sign this form unless you have a chance to ask questions and have been given answers to all of your questions. Your participation in the Research Repository is voluntary. You do not have to participate. If you do, you can change your mind at any time.If I Say Yes Now, Can I Change My Mind And Take Away My Permission Later?Yes. If you take part in the Research Repository now, but change your mind later, you can write or email Dr. Smith at 123 Main Street, Any City, NJ 12345 [Email: sampleemail@rutgers.edu] and tell her to destroy [choose: any remaining biospecimens or information] of yours that are currently in the repository.However, please note that it may not be possible to destroy biospecimens or information and information that may have already been distributed to investigators and used in research prior to your request. Dr. Smith will keep records linking your identity with the [choose: biospecimens or information] for a period of X years from the end of the study. Until those links are destroyed, you may ask that your [choose: biospecimens or information] be destroyed. [If options exist, add which of the following apply. If not, delete this section.]Please tell us if and how you wish your [choose: biospecimens or information] to be used for future research. Please add your Initials to indicate the ways you permit your samples and information to be used: My [choose: Biospecimen or information] may be used for future research as follows:_____ only on Disease [specify]_____ on any research topic important to researchersPlease tell us if we may contact you in the future to tell you about other ways you may participate in this research or other research we are conducting by signing your initials next to your choice. The investigators may contact me in the future to ask me to take part in more research.Yes ____ No _____Who Can I Contact If I Have Questions?If you have questions about taking part in this study, you can contact the study doctor: (Provide investigator’s name, Department and contact number).If you have questions about your rights as a research subject, you can contact the IRB Director at:List ONLY the IRB reviewing your research. Then delete the other 2 IRBs: Newark HealthSci IRB (973)-972-3608; OR New Brunswick/Piscataway HealthSci IRB (732) 235-9806 OR Arts and Sciences IRB (732) 235-2866 or the Rutgers Human Subjects Protection Program at (973) 972-1149 or email us at humansubjects@ored.rutgers.edu.AUTHORIZATION TO USE HEALTH INFORMATION FROM YOUR MEDICAL RECORD FOR FUTURE RESEARCH PURPOSES[If you plan to store information collected from medical records, add the following section. If not, delete this Authorization.]Because information about you and your health is personal and private, it generally cannot be used in this future research studies without your written authorization (permission). If you sign this addendum consent form, it will provide that authorization. The details of what information we will collect from your medical record and how we will use it are discussed in the main consent under the heading, “Authorization To Use Your Health Information For Research Purposes” near the end of the main consent document. If you authorize the use of your health information collected from your medical record for future use, we will collect the following information about you: [List or describe any and all medical information that will be collected and stored for future research. For example: all information in a medical record, certain information indicating or relating to a particular medical condition, etc.] And, if you agree to allow us to use your health information for future research, you are permitting us to share this information with our research collaborators at [specify broadly what organizations may receive this information. What is stated here should be consistent with what you stated on page #1 of this Addendum].AGREEMENT TO PARTICIPATESubject Consent:I have read this entire consent form, or it has been read to me, and I believe that I understand what has been discussed. All of my questions about this form and this study have been answered. I agree to take part in this Research Repository.Subject Name (Print):Subject Signature: Date:Signature of Investigator/Individual Obtaining Consent:To the best of my ability, I have explained and discussed all the important details about the study including all of the information contained in this consent form. Investigator/Person Obtaining Consent Name (Print):Signature: Date: ................
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