TEMPLATE CONSENT FORM PLEASE NOTE: 1) ADAPT this template so that information is as simple, clear, and appropriate for

your subject population as possible. 2) Statements in brackets and italics are instructions or examples; do not include in the actual consent form. 3) Use suggested wording (in regular font, not italics) as is if appropriate, or revise if needed. ADD THE LETTERHEAD OF YOUR INSTITUTION CONSENT TO PARTICIPATE IN RESEARCH Title of Study [insert study title here] Introduction My name is _______________ [if there are co-investigators, note here, e.g., "and my research colleagues are ___________ and ___________"]. I am a(n) [undergraduate/ graduate student/ faculty member] at the Babes-Bolyai University, Cluj, Romania, in the School/Department of _________. I am [We are] planning to conduct a research study, which I invite you to take part in. You are being invited to participate in this study because [specify reason why prospective subject is being recruited for study] Purpose The purpose of this study is to __________. [Give brief explanation of why study is being done, using one or two sentences written in clear language understandable to the target population]. [If appropriate: About [state total goal for number of subjects] people will take part in this study. [Give a short description about cohorts, if any. For multi-site studies, give figures for both the whole study and for local enrollment at .] Procedures If you agree to be in this study, you will be asked to do the following: [Discuss screening procedures first, if any, or refer to a separate screening consent form if used. List and describe procedures/ tests/ activities chronologically and their frequency, using bulleted format. Indicate location where procedures will take place (e.g., lab, home, or other setting, and amount of time needed for each procedure. Also note total amount of time required for study participation, at the beginning or end of this section.] [If there are any screening procedures:] Before you begin the main part of the study... You will need to have the following screening tests/ procedures to find out if you can be in the main part of the study. [List and describe tests/ procedures as appropriate. If more than one screening procedure will be done, use bulleted format.]

[If screening procedures are described above/separately:] During the main part of the study... If the screening procedure shows that you can be in the main part of the study and you choose to continue, this is what will happen next:] [List procedures and activities as appropriate. Use bulleted format. See examples below.] You will be asked to view two 15-minute videotapes; one will be of pleasant content and the other of unpleasant content. After viewing both videotapes, you will take part in a focus group discussion led by _______ or _______. Everyone in this focus group will have viewed the tapes. You and the other group members will be asked to discuss reactions to scenes in both tapes. An audiotape will be made of this discussion, which is expected to last about 30 minutes. You will then be given a questionnaire that asks about your reactions to the videotapes. It should take about 15 minutes for you to complete this questionnaire. You will also be given a standard paper-and-pencil personality test. It should take about one hour for you to complete this test. [Explain any follow-up procedures, including timing of each.] [Note: If the study involves deception or incomplete disclosure which necessitates a debriefing process, a general statement may be added here or in the Benefits discussion that more information will be given to subjects at the conclusion of the study, e.g., "At the end of the study, we will explain in greater detail what we hope to learn from this research." If the investigator believes that such a statement would bias study results, he/she should discuss this in the protocol as part of the justification for use of deception or incomplete disclosure.] Study time: Study participation will take a total of approximately two hours. Study location: All study procedures will take place at ___________. [If different procedures will take place at different locations, specify accordingly]. Benefits [Explain possible benefits appropriate to the study, both direct (individual) and indirect (general benefits to society or scientific knowledge), e.g.:] There is no direct benefit to you anticipated from participating in this study. However, it is hoped that the information gained from the study will help [e.g., health professionals better understand/learn more about ___________.] Risks/Discomforts [List procedures and activities as appropriate. Use bulleted format. See examples below.] Some of the videotapes are likely to produce unpleasant feelings, but you will be able to stop watching at any time if you feel too uncomfortable. Some of the focus group discussion questions may make you uncomfortable or upset, but you are free to decline to answer any questions you do not wish to or to leave the group at any time. [State if compensation will be affected should the individual not complete any portion of the study, e.g., "Please note that if you discontinue study participation you will

receive payment/course credit only for the hours of the study you complete. If you remain in the study but choose not to answer any questions you don't wish to, you will still receive the full amount of compensation."] [For all forms:] Breach of confidentiality: As with all research, there is a chance that confidentiality could be compromised; however, we are taking precautions to minimize this risk. (See below for more detail.) Confidentiality [Since there is no legal privilege between investigator and subject, a "guarantee" of complete or "strict confidentiality should not be given or implied in the consent form. This section should explain how the researchers will minimize the risk of breach of confidentiality. Any regulatory or other agencies which may have access to the research records should also be noted, e.g.:] Your study data will be handled as confidentially as possible. If results of this study are published or presented, individual names and other personally identifiable information will not be used [if appropriate, add phrase such as "unless you give explicit permission for this below"]. To minimize the risks to confidentiality, we will... [Explain data security measures to be taken, e.g., storage, coding, encryption, limited access to study records, etc.] [Sensitive/reportable research information: If there is a reasonable expectation (from the topic under study and/or the subject population) that reportable information may be disclosed to the researcher during the study, an appropriate statement should be added, e.g.: We will keep your study data as confidential as possible, with the exception of certain information that we must report for legal or ethical reasons, such as child abuse, elder abuse, or intent to hurt yourself or others.] Retaining research records: When the research is completed, I may save the [samples/ tapes and notes/ study records] for use in future research done by myself or others. I will retain this study information for up to XX months/years after the study is over. The same measures described above will be taken to protect confidentiality of this study data. [Or if different, give accurate information about retention and use of study data in future, e.g., "I will destroy the samples/ tapes and notes/ study records at the end of this study."] [Ownership of specimens if inclusion of such a statement is applicable, this recommended wording should be used:] If you consent to giving blood or tissue specimens (including cheek swab and saliva samples) as part of this study, these specimens will become the property of the Babes-Bolyai University. The specimens and the DNA they contain may be used in this research and in other research, and may be shared with other organizations. The specimens could lead to discoveries or inventions that may be of value to the Babes-Bolyai University or to other

organizations. Under state law, you do not have any right to money or other compensation stemming from products that may be developed from the specimens.] Alternatives [if appropriate] [Additional bullets should include, if appropriate, alternative specific procedures/treatments.] Costs of Study Participation [if appropriate] [Clearly state whether there are any costs associated with study participation (and if so, specify what they are).] Compensation In return for your time/ effort/ travel expenses, you will be paid $XXX for taking part in this study. [If non-monetary compensation, e.g., course credit, will be offered for participation, state here. Describe any pro-rating or bonuses, e.g.: "If you do not complete the study, you will receive $XXX for each week of participation." Also, specify method and timing of payment, e.g.: "A check will be mailed to you about 6 weeks after your participation in the study has ended."] [OR, if there will be no payment:] You will not be paid for taking part in this study. [NOTE: Many social-behavioral studies involve only minimal risk of harm to subjects. However, if the study involves greater than minimal risk, this statement is required:] Treatment and compensation for injury If you are injured as a result of being in this study, treatment will be available. The costs of this treatment may be covered by the Babes-Bolyai University, depending on a number of factors. For further information about this, you may contact the office of Babes-Bolyai University IRB 01 Public Health at: Babes-Bolyai University, Cluj, 71 Traian Mosoiu St., 400132; or irb01@publichealth.ro. Rights Participation in research is completely voluntary. You have the right to decline to participate or to withdraw at any point in this study without penalty or loss of benefits to which you are otherwise entitled. Questions If you have any questions or concerns about this study, you may contact ___________ [lead investigator name(s)] at ___________ [phone number(s)] or [email address]. [If there are additional informational sources related to the study, e.g., patient representatives, local contacts, etc., list here with contact information.] If you have any questions or concerns about your rights and treatment as a research subject, you may contact the office of Babes-Bolyai University IRB 01 Public Health or irb01@publichealth.ro.

CONSENT You have been given a copy of this consent form to keep. If you wish to participate in this study, please sign and date below. _______________ Date _______________ Date

Participant's Name (please print)

Participant's Signature

Person Obtaining Consent

_______________ Date

[If third party consent is requested and has been addressed in the IRB-H application:] AND/OR: _______________ Date _______________ Date

Legally Authorized Representative

Person Obtaining Consent