CONSENT FORM TEMPLATE - Research Office | Oregon State ...
Guidance and Sample Language for Consent and Assent DocumentsVersion date: July 1, 2019Below are the regulatory elements of informed consent, with corresponding guidance and sample language. These samples are not intended to be comprehensive and should be modified to enhance comprehension as appropriate for the target population of research participants.CONTENTS TOC \o "1-4" \h \z \u General Guidance for Writing Consent Documents PAGEREF _Toc520982035 \h 2Basic Elements of Informed Consent §__.116(b) PAGEREF _Toc520982036 \h 3Consent Element: Research purpose, duration, and procedures PAGEREF _Toc520982037 \h 3Purpose PAGEREF _Toc520982038 \h 3Duration PAGEREF _Toc520982039 \h 3Procedures or Activities PAGEREF _Toc520982040 \h 3Recordings and photographs PAGEREF _Toc520982041 \h 4Future contact PAGEREF _Toc520982042 \h 4Placebo PAGEREF _Toc520982043 \h 4Randomization PAGEREF _Toc520982044 \h 4Blood draws PAGEREF _Toc520982045 \h 4Studies involving radiation exposure PAGEREF _Toc520982046 \h 4Consent Element: Risks PAGEREF _Toc520982047 \h 4Blood draws PAGEREF _Toc520982048 \h 5Pregnancy PAGEREF _Toc520982049 \h 5Pregnancy and studies involving radiation exposure PAGEREF _Toc520982050 \h 5VO2max Testing PAGEREF _Toc520982051 \h 6Conflict of Interest PAGEREF _Toc520982052 \h 6Consent Element: Benefits PAGEREF _Toc520982053 \h 6Consent Element: Alternative Procedures PAGEREF _Toc520982054 \h 7Consent Element: Confidentiality PAGEREF _Toc520982055 \h 7Sharing data/samples PAGEREF _Toc520982056 \h 8Breach of Confidentiality PAGEREF _Toc520982057 \h 8Internet and/or email PAGEREF _Toc520982058 \h 8Focus Groups PAGEREF _Toc520982059 \h 8Certificate of Confidentiality PAGEREF _Toc520982060 \h 8Studies that may reveal violence, abuse, neglect, or self-inflicted injury PAGEREF _Toc520982061 \h 9Genetic Research PAGEREF _Toc520982062 \h 9Recruiting from the Center for Healthy Aging Research (CHAR) LIFE Registry PAGEREF _Toc520982063 \h PAGEREF _Toc520982064 \h 10Consent Element: Research-related injury PAGEREF _Toc520982065 \h 10Risks related to physical injury or mental/emotional harm PAGEREF _Toc520982066 \h 10Consent Element: Contact information PAGEREF _Toc520982067 \h 11Contact information PAGEREF _Toc520982068 \h 11Consent Element: Voluntariness PAGEREF _Toc520982069 \h 11Required vs Optional questions PAGEREF _Toc520982070 \h 11Research during class time PAGEREF _Toc520982071 \h 11Students as participantss PAGEREF _Toc520982072 \h 12Employees as participants PAGEREF _Toc520982073 \h 12When the researchers have a pre-existing relationship with potential participants PAGEREF _Toc520982074 \h 12Prisoners PAGEREF _Toc520982075 \h 12Consent Element: Identifiable information or biospecimens PAGEREF _Toc520982076 \h 12Collection, storage, and or future use of identifiable data or biospecimens PAGEREF _Toc520982077 \h 13Additional Elements of Informed Consent, as applicable §__.116(c) PAGEREF _Toc520982078 \h 14Consent Element: Unforeseeable risks PAGEREF _Toc520982079 \h 14Consent Element: Termination of participation by PI PAGEREF _Toc520982080 \h 14Consent Element: Costs PAGEREF _Toc520982081 \h 14Consent Element: Procedures for withdrawing PAGEREF _Toc520982082 \h 14Consent Element: Significant new findings PAGEREF _Toc520982083 \h 14Consent Element: Number of subjects PAGEREF _Toc520982084 \h 15Consent Element: Commercial profit PAGEREF _Toc520982085 \h 15Consent Element: Research results PAGEREF _Toc520982086 \h 15Consent Element: Whole genome sequencing PAGEREF _Toc520982087 \h 15Additional Miscellaneous Information, as applicable PAGEREF _Toc520982088 \h 15Assent PAGEREF _Toc520982089 \h 15Payment PAGEREF _Toc520982090 \h 16Raffles and lotteries PAGEREF _Toc520982091 \h 16Signatures PAGEREF _Toc520982092 \h 17European Union General Data Protection Regulation (GDPR) PAGEREF _Toc520982093 \h 17General Guidance for Writing Consent DocumentsInformed consent is a process, not just a document. Information must be presented that will enable potential participants to voluntarily decide whether to enroll in the study. Informed consent is a fundamental mechanism to ensure respect for persons through provision of thoughtful consent for a voluntary act. The procedures used in obtaining informed consent should be designed to educate potential study participants in terms that they can understand. Therefore, consent documents must be written in plain language with as few technical terms as possible.Shorter documents result in greater comprehension of the content. Therefore, consent documents should be limited to required elements and presented in a way that highlights key information. Non-essential information should be omitted or captured in a supplemental document. The consent document should be written at a level comprehensible to the population eligible to enroll in the study. According to the US Department of Education and the National Institute of Literacy, 50% of adults in US cannot read a book at the 8th grade level (Organization for Economic Cooperation and Development, 2016). If your study targets the “average” adult in the US, the ideal consent form would be written below an 8th grade reading level, with a readability score of more than 50 (the higher the score, the easier your document is to read). Use Flesch-Kincaid to test the readability level of your document. See Microsoft Office Support for more information. According to Microsoft, this paragraph is written a 14th grade level.Use of illustrations, diagrams, color, and supplemental materials are encouraged when their use may enhance comprehension.Write directly to the reader, as though you are explaining the facts in person. Consent language should be written in the second person (“you” or “your child”), not in the first person (“I”).Minimize passive voice to the extent possible. Example of passive voice: “A summary of results will be sent to all study participants.” Example of active voice: “We will send you a summary of the results.”Additional guidance is available from the Office of Human Research Protection.Basic Elements of Informed Consent §__.116(b)Consent Element: Research purpose, duration, and proceduresFrom the regulations: A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental.PurposeGuidance: Clearly and briefly state the purpose of the research.Sample language: This study is about {briefly describe the purpose of the study}.Sample language for studies involving deception: For scientific reasons, this consent form does not include all of the information about the research question being tested. The researchers will give you more information when your participation in the study is over.DurationGuidance: Insert the expected length of time it will take for study visits or scheduled procedures, as well as the total expected length of participation (for example, the interview will take about one hour; you will be asked to visit the lab three times and each visit will take about two hours). Avoid references to specific dates in case your study does not begin or end on schedule.Sample language: Your participation in this study will last about {insert the expected length of time it will take a participant to complete the study}. Procedures or ActivitiesGuidance: Make clear that the activity involves research and describe the overall experience that will be encountered. If the study activities are complex, lengthy, or repetitious, it may increase comprehension to provide simple charts or calendars and supplemental documents that include the detailed descriptions.Sample language: You should not be in this study if {include primary exclusion criteria in simple terms}. We are asking you if you want to be in this study because {insert brief description of study population}.If you take part in this study, we will ask you to {include overview of study activities in simple terms}.Recordings and photographsGuidance: Indicate whether audio or video recordings will be made or whether photographs will be taken. Clearly state whether recording is required or optional. If required, explain that they should not enroll if they do not wish to be recorded. Future contactSample Language: We may contact you in the future for another similar study. You may ask us to stop contacting you at any time.PlaceboSample Language: We may give you a placebo.? A placebo has no active ingredients.?RandomizationSample Language: This study involves a process called randomization.? Randomization means that you are put into one of the groups by chance.? It is like flipping a coin {modify if more than two groups (like drawing names from a hat)}.?? The group that you will be in will not be chosen by you or the researchers. You will have a {insert chance – equal, one in three, etc.} chance of being placed in any group.?Blood drawsSample Language: We will draw about {insert teaspoons/tablespoons or other lay measurement} of blood by putting a needle into a vein in your arm. This is the standard method used to obtain blood for tests.? {If more than one draw will occur, insert the following sentence} We will take a total of {insert teaspoons/tablespoons or other lay measurement} of blood over the course of this study.Studies involving radiation exposureGuidance: Describe the equipment that will be used, how much radiation participants will receive for each set of scans performed and for the cumulative dose from the study using mrems and a lay comparison.Consent Element: RisksFrom the regulations: A description of any reasonably foreseeable risks or discomforts to the subject.Guidance: All reasonably foreseeable risks, discomforts, inconveniences, and harms that are associated with the research activity should be described. Investigators should be forthcoming about risks and not understate reasonably foreseeable risks. Do not include evaluative statements about the risks, such as, “Risks are minimal.” If the actual probability of risk is known, this information can be included if it could further enable a participant to assess their personal risk. For example, “In previous studies, about 10% of the participants felt dizzy after the [intervention].”If collecting individually identifiable information (such as names or birthdates), a potential for breach of confidentiality exists. Depending on the type of study, some risks may be better described as things that could make the participant “uncomfortable” – such as fatigue or embarrassment. Sample language: Some things that could happen to you if you are in this study are {include reasonably foreseeable risks in simple terms}.Blood drawsSample Language: The risks of having blood drawn from your arm include some pain when the needle goes in and a small risk of bruising and/or infection at that site.? Some people get lightheaded, nauseous, or faint.? You are less likely to have these problems if you drink at least two glasses of water and have a snack before the blood draw {modify for fasting draws}.? The American Red Cross recommends that you do not donate more than 1 pint (32 tablespoons) of blood within a 2-month period.? Tell the study team if you have recently had your blood drawn for any reason.PregnancyGuidance: Insert explanation of any study activities that may involve risks to the participant or to an embryo or fetus if the participant is or may become pregnant.Sample language: This study involves activities that are not safe for pregnant women. So, if you can become pregnant, we will do a pregnancy test before {describe the testing or intervention method}. – AND/OR – There may be a risk of harm to an unborn child.? You must use an effective form of pregnancy prevention while you are enrolled in this study.? We will discuss the risk with you in more detail.? Notify the study team immediately if you think or know that you have become pregnant during the course of this study.Pregnancy and studies involving radiation exposureSample Language: You may not participate in {the aspect of the study causing the radiation exposure/bone scan} if you are pregnant or suspect you may be pregnant.?? If you can become pregnant, {the aspect of the study causing the radiation exposure/bone scan} must be performed within the first few days of the beginning of your last period to reduce the risk of performing the scan on a developing embryo.? Notify the study team immediately if you think or know that you have become pregnant.VO2max TestingSample Language: The risks of being in this study include:Acute exercise may present a risk of sudden deathCardiac event (for example, heart attack or arrhythmia)Overall risk of cardiac events is about 6 events per 10,000 testsSerious injuryFallingPhysical discomfort from the test and equipmentFatigueMuscle aches, cramps, joint painMuscle strain and/or joint injuryDelayed muscle sorenessAbnormal blood pressure/heart rateShortness of breathLightheadedness, faintingDizzinessNauseaConflict of InterestSample language: A conflict of interest occurs when a researcher or the University has a financial or other interest that could affect the research. In some situations, the results of a study might lead to a financial gain or other benefit for the researcher(s) and/or the University.{Insert one of the statements below, followed by a brief description of the potential conflict}One or more of the researchers working on this study has a conflict of interest. Oregon State University has a conflict of interest.One or more of the researchers working on this study and Oregon State University have conflicts of interest. If you have questions or concerns about this, please contact the Human Research Protection Program office at (541) 737-8008. Consent Element: BenefitsFrom the regulations: A description of any benefits to the subject or to others that may reasonably be expected from the research.Guidance: Any benefits to participants or others that may reasonably be expected from the research should be described. Investigators should be frank about benefits and not overestimate or magnify the possibility of benefit to the participants. If there is no reasonable expectation of benefit, the participant should be told this. Payment to participants should not be listed or described as a benefit of being in the research.Sample language when direct benefit to participants is anticipated: Some good things that might happen to you if you are in this study are {include any direct benefits}. We are not sure that these things will happen.Sample language when no direct benefit to participants is anticipated: This study is not designed to benefit you directly. Consent Element: Alternative Procedures From the regulations: A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.Guidance: If participants can have the same experience or receive the same resources without being in the study, this should be clearly stated.Sample language: You could {insert information about the alternative} instead of being in this study.Consent Element: ConfidentialityFrom the regulations: A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.Guidance: Participants may be indirectly identifiable if, for example, direct quotes are used, the organization the person is affiliated with is named, there are sufficient data points to re-identify the individual, or the people who are invited to participate are part of a small or well-defined group. Describe who (researcher team, employer, funder, people outside of OSU) might have access to identifiers, not how access to identifiers will be prevented (encryption, locked cabinets, etc.).If audio or video recordings will be made, explain who will have access, if they will be used for educational purposes, and when they will be destroyed.If FDA-regulated, the FDA should specifically be listed as a regulatory agency that may access or inspect records (for example, “The FDA, other regulatory agencies and Oregon State University employees…”).If the study is funded, include sponsor as an entity that may see the information.As applicable, see additional section on collecting identifiable private information or identifiable biospecimens.Sample language options: Your participation in this study is anonymous. We plan to make the results of this study public but we will not include your name or other information that identifies you.Other people may learn that you participated in this study but the information you provide will be kept confidential to the extent permitted by law. Research records will be stored securely. Regulatory agencies and Oregon State University employees may access or inspect records pertaining to this research as part of routine oversight or university business. Some of these records could contain information that personally identifies you. Sharing data/samplesGuidance: If data or samples will be shared with individuals or organizations external to OSU (for example, collaborators, site of research, etc.), provide general information about what will be shared, with whom, and whether it will be individually identifiable. Note that names of individual recipients of shared data or samples are not necessary.Sample language: We will share your responses with researchers at other universities, but we will not include your name. Breach of ConfidentialitySample Language: There is a chance that we could accidentally disclose information that identifies you.Internet and/or emailSample Language: The security and confidentiality of information collected from you online cannot be guaranteed.Focus GroupsSample Language: We will ask members of the focus group to maintain the confidentiality of comments made during the discussion.? However, there is still a risk that comments you make during the discussion may be shared outside of the group.Certificate of ConfidentialityGuidance: When a researcher obtains a Certificate of Confidentiality, the participants must be told about protections afforded by the Certificate and any exceptions to those protections. For example, the circumstances in which the investigators plan to disclose, voluntarily, identifying information about research participants (for example, child abuse, harm to self or others, etc.). This information should be included in the consent form.? The researchers should eliminate provisions in the consent form that may be inconsistent with the Certificate protections (such as references to disclosures required by law, since the Certificate enables researchers to resist disclosures that would otherwise be compelled by law).? Researchers may not represent the Certificate as an endorsement of the research project by the DHHS. If the study is NIH-funded or you have or plan to obtain a Certificate of Confidentiality from the NIH, include the relevant language below in the consent document:Sample language: Most people outside of the study team will not see research information that includes your name. This includes people who try to get your information using a court order. We could give out this information if you gave us permission. We will give out this information if we need to report child abuse or neglect, or if we think you are planning to hurt yourself or others.Studies that may reveal violence, abuse, neglect, or self-inflicted injurySample Language: Under Oregon law, we are required to report to the appropriate authorities any information concerning child abuse or neglect. We may also report threats of harm to self or to others.?Genetic ResearchGuidance: Additional information that may be provided includes whether or not participants have the option of knowing the results of their genetic analysis, whether incidental findings will be shared with participants, whether or not genetic counseling would be available and who would pay for such counseling. Note: GINA requires IRB review of genetic research on biological specimens even if the project is limited to research on samples without individual identifiers (anonymous or coded specimens). See the Fact Sheet for Researchers and Institutional Review Boards for more information.Sample language: A Federal law, called the Genetic Information Nondiscrimination Act (GINA), makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law will protect you in the following ways:Health insurance companies and group health plans may not request your genetic information that we get from this research or when making decisions regarding your eligibility or premiums.Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.This law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.Recruiting from the Center for Healthy Aging Research (CHAR) LIFE RegistryGuidance: CHAR requires that researchers who recruit from the LIFE Registry provide them with a list of participants who were recruited from the Registry. If participants will be recruited from the Registry, please insert the following paragraph:Sample Language: If we contacted you through the Center for Healthy Aging Research (CHAR) LIFE Registry, we will be providing CHAR with any updates to your contact information. We will also tell them whether you chose to participate in this research study.Guidance: If the study is a clinical trial and will be posted to , the sentence below must be included verbatim.Required language: A description of this clinical trial will be available on , as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.Consent Element: Research-related injuryFrom the regulations: 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.Risks related to physical injury or mental/emotional harmGuidance: If research-related injury (such as, physical, psychological, social, financial, or otherwise) is possible in research that is more than minimal risk, an explanation must be given as to whether any compensation and treatment will be provided to an injured participant. The compensation and treatment should be described, or the participant should be told where further information might be obtained. The regulations prohibit requiring participants to waive or appear to waive their legal rights. Sample language for unfunded and federal funded studies: If you have been injured because you are in this study, {insert description of plan or process that may be followed}. Oregon State University has no program to pay for the treatment of research-related injuries. Sample language for industry funded studies: If you have been injured because you are in this study, {insert description of plan or process that may be followed}. Costs related to the treatment of research-related injuries {insert the sponsor’s language for coverage of these injuries}.Consent Element: Contact informationFrom the regulations: 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.Contact informationGuidance: Sample language is provided but should be altered if there is no reasonable expectation that participants would be able to contact or communicate with the PI or IRB (for example, no access to telephone or internet; language barrier). When that is the case, local contact information for an individual or organization that can answer pertinent questions about the research and the participant’s rights should be provided.Sample language: If you have any questions about this research project, please contact: {insert name(s) and contact information for the Principal Investigator}. If you have questions about your rights or welfare as a participant, please contact the OSU Human Research Protection Program office, at (541) 737-8008 or by email at IRB@oregonstate.edu.Consent Element: VoluntarinessFrom the regulations: 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.Guidance: The reference to benefits that participants may be concerned with are those that are connected to the study topic. See sample language for multiple scenarios below.Sample language: Being in this study is voluntary. If you decide to be in the study, you are free to stop at any time without penalty. We may keep and use information that we collected about you while you were in the study unless you ask for that information to be destroyed.Note: The language in the consent form or process should not promise that data will be destroyed at a participant’s request if that data is essential for assessing or tracking risks to the participant or others.Required vs optional questionsGuidance: If the study involves interviews, surveys, or questionnaires, with optional questions, include a statement that the participant is free to skip any questions that they would prefer not to answer.? If answering all questions is required, clearly state that while study participation is voluntary, all questions must be answered in order for their individual responses to be included in the study results.Research during class timeGuidance: If study activities take place during class time, explain what participants will do during that time if they choose not to participate.Students as participantsSample Language: Your decision to take part or not take part in this study will not affect your grades, your relationship with your professors, or your standing in the University.Employees as participantsSample Language: Your decision to take part or not take part in this study will not affect your job.When the researchers have a pre-existing relationship with potential participantsSample Language: Your decision to take part or not take part in this study will not affect your relationship with the researcher.PrisonersSample Language: Choosing to take part or choosing not to take part in this study will not impact the length of your sentence, your parole, or any other aspect of your incarceration.Consent Element: Identifiable information or biospecimensFrom the regulations: One of the following statements must be included for any research that involves the collection of identifiable private information or identifiable biospecimens:A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; ORA statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.Note 1: The language in option 1 is incompatible with the General Data Protection Regulation (GDPR) and cannot be used if data will be collected from people in the European Union or the broader European Economic Area (EEA). Note 2: The language in option 1 should be included if data sharing is a requirement of the sponsor or of the journals to which you intend to submit a manuscript. Example: From NSF Proposal & Award Policies & Procedures Guide (PAPPG) Chapter XI.D.4.: Investigators are expected to share with other researchers, at no more than incremental cost and within a reasonable time, the primary data, samples, physical collections and other supporting materials created or gathered in the course of work under NSF grants. Grantees are expected to encourage and facilitate such sharing. From PLOS: PLOS journals require authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception.Note 3: The Office of the Registrar will not approve a consent process that asks OSU students to consent to future unspecified research. This language is also incompatible with the General Data Protection Regulation (GDPR) and cannot be used if data will be collected from people in the European Union or the broader European Economic Area (EEA).Guidance: If you plan to store data or samples, explain how long they will be retained (for example, indefinitely, five years, destroyed when the study is completed), how they will be stored (that is, with or without identifiers), what they will be used for, whether they will be shared, and whether participant permission will be sought for future studies.Sample language for biological samples: We may keep your blood sample forever.? We do not know what studies we might do in the future. We would like your permission now to use or share your blood sample without having to ask you again in the future.??We will only use your blood sample in other studies about diabetes. ?We will remove your name and any other information that identifies you before we use it in a new study or share it with other researchers. There is still a chance that someone could figure out that the information is about you. Sample language for data (1): We may keep information about you forever. We do not know what studies we might do in the future. We would like your permission now to use or share your personal information without having to ask you again in the future.? We will only use your information in other studies about how people spend money. ?We will remove your name and any other information that identifies you before we use it in a new study or share it with other researchers. There is still a chance that someone could figure out that the information is about you.Sample language for data (2): We may keep information about you forever. We do not know what studies we might do in the future. We would like your permission now to use your personal information without having to ask you again in the future.? We will only use your information in other studies about how people spend money. ?We will remove your name and any other information that identifies you before we use it in a new study. We will not share your responses or other information about you with people outside of the study team. There is still a chance that someone could figure out that the information is about you.Sample language for data (3): The information that you give us will only be used for this study. We will not share information about you with others or use it in future studies without your consent. There is still a chance that someone could figure out that the information is about you.Additional Elements of Informed Consent, as applicable §__.116(c)Consent Element: Unforeseeable risksFrom the regulations: A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable.Sample Language: We may not know about all of the risks of being in this study. Note: If this language is relevant for your study, it may make sense to follow this with information about how you will handle significant new findings (see additional consent element).Consent Element: Termination of participation by PIFrom the regulations: Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject's or the legally authorized representative’s consent.Guidance: Describe any circumstances under which the researcher might end a participant's enrollment in the study (for example, participant does not come in for critical visits or does not follow instructions for study activities, etc.). Consent Element: CostsFrom the regulations: Any additional costs to the subject that may result from participation in the research.Guidance: Insert any costs to the participants for which they will not be compensated or procedures that will be billed to their insurance (for example, lab tests, treatment at an outside facility, parking, lost, damaged, or unreturned study equipment, etc.).Consent Element: Procedures for withdrawingFrom the regulations: The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subjectConsent Element: Significant new findingsFrom the regulations: A statement that significant new findings developed during the course of the research that may relate to the subject’s willingness to continue participation will be provided to the subject.Guidance: A statement that if significant new findings develop during the course of the research, those findings will be provided to the participant if the information might impact their willingness to stay in the study. Consent Element: Number of subjectsFrom the regulations: The approximate number of subjects involved in the study.Note: This is not necessary for minimal risk studies.Consent Element: Commercial profitFrom the regulations: A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit. Consent Element: Research resultsFrom the regulations: A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.Guidance: Explain whether and how study results will be shared with participants and whether shared results will be individual level or aggregated.Consent Element: Whole genome sequencing From the regulations: For research involving biospecimens, whether the research will (if known) or might 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 that specimen). Additional Miscellaneous Information, as applicableAssentFrom the regulations: …the IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved.?Guidance: Assent?is a person's agreement to participate in research. Mere failure to object is not assent. A verbal assent process is generally more appropriate for children up to age seven. Written assent documents can be used for older children when appropriate. The guidance in this section provides a framework for obtaining assent from children, as well as from adults who lack the capacity to provide consent. The investigator should respect the decision of a minor or cognitively impaired participant who chooses not to participate, even when the parent or legally authorized representative is willing to consent on their behalf. Like consent, assent is a process, not just a document. Information must be presented in a way that enables people to choose whether to participate. Write directly to the reader, as though you are explaining the facts in person. Assent language should be written in the second person (“you”), not in the first person (“I”). Minimize passive voice to the extent possible. Example of passive voice: “A summary of results will be sent to all study participants.” Example of active voice: “We will tell you and your parents what we learned from the study when it is over.”Sample language for parental consent forms: The researcher talked to me and my child about the study. They asked us to talk to them about any questions that we have now. We know that we can call them in the future if more questions come up. PaymentGuidance: Clearly describe the monetary compensation (total amount, average total amount, amount per visit, amount per hour, etc.). If compensation is pro-rated when a participant withdraws prior to completing the study, explain how it is pro-rated. If participants must complete the study activities in order to receive compensation, please state. Describe any non-monetary compensation (for example, extra credit, gift certificate), separately from monetary compensation and include the approximate value when pensation offered in the form of checks and compensation greater than or equal to $600 paid within one calendar year requires the collection of identifying information for the purposes of tax reporting. In these cases, the consent document must inform participants that they will be asked to provide their Social Security Number or Individual Tax Identification Number to receive payment. In the event that the target population is known not to possess such identification, a flat tax may be withheld from payments large enough to require reporting to the Internal Revenue Service (IRS). If this is the approach to be taken by the PI, the consent document should include a brief statement indicating that taxes will be withheld from the study payment and an estimate of the net amount participants should anticipate. Contact the HRPP office for more information.Sample language: You will be paid $5 for being in this research study even if you skip questions that you do not want to answer. Raffles and lotteriesGuidance: These incentives are permitted in some circumstances. Please see the HYPERLINK "" policy on the HRPP website for additional information.Sample Language: We will give everyone interested in this study an OSU coffee cup and a raffle ticket. We will enter all of the ticket numbers into a drawing for an iPad. The chance of winning is about 1 in 100. We cannot promise that you will win anything. We can enter you into the drawing even if you choose not to be in the study or if you choose not to finish the study activities. SignaturesGuidance: The IRB strongly discourages use of the "first person" statement in consent documents (using, "I have been fully informed about..."). Such statements ask participants to make statements that the participant is not in a position to verify (for example, the participant has no way to verify that the investigator has provided full and complete information).European Union General Data Protection Regulation (GDPR)Guidance: The effective date for the General Data Protection Regulation was May 25, 2018. The aim of the GDPR is to protect people in the European Union and the broader European Economic Area (EEA) from privacy and data breaches. The scope of the regulation is broad and can include data collected from residents of other countries when they are visiting EU or EEA countries. A Compilation of Guidances on the GDPR can be found on the Office of Human Research Protections website.Contact the OSU Data Protection Officer if you plan to collect data from research participants who reside or will be in EU or EEA countries at the time of data collection.Consent ProcessThe GDPR requires that consent from the participant be freely given, specific, informed, and an unambiguous indication of the participant's wishes. Consent must be made by a statement or by a clear affirmative action signifying agreement to the processing of their personal data [Article 4, GDPR]. Because explicit consent is required from participants before data about them can be collected for research, the IRB will not be permitted to waive the requirement for obtaining informed consent and cannot approve a plan that is limited to notification or “opt-out” if participants are located in the EEA. Consent ElementsThe majority of required consent elements outlined in the GDPR align with the elements required from research participants in the US. Three additional elements must be included in the consent document, as applicable:1. Contact informationParticipants must be provided with contact information for the researcher and a Data Protection Officer. The contact information for the DPO at OSU is: Tom Ordeman, Data Protection Officerdpo@oregonstate.edu(541) 737-9800Oregon State UniversityA008 Kerr Administration BuildingCorvallis, OR 97331-45012. Transfer of data from the EEA to the USWhen data will be transferred from participants or researcher sites in the EEA to the US, researchers must disclose to participants that US data privacy laws have not been deemed adequate by the European Commission. 3. Transfer of data from the US to the EEACollaborators in the EEA will only be able to receive and analyze personal data sent from researchers in the US if the consent process included the GDPR-required elements. ................
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