- Overall risk of cardiac events is about 6 events per 10,000 tests
Conflict of Interest
Sample 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.
- 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: Benefits
A description of any benefits to the subject or to others that may reasonably be expected from the research.
Guidance: Any benefits to subjects 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 subject. If there is no reasonable expectation of benefit, the subject should be told this. Payment to subjects should not be listed or described as a benefit of participating 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 . 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
A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
Guidance: If subjects can have the same experience or receive the same resources without being in the study, this should be clearly stated.
Consent Element: Confidentiality
As applicable, see additional section on collecting identifiable private information or identifiable biospecimens.
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
Guidance: Subjects 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 subject population is part of a small or well-defined group.
While it is necessary to include a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained, it is not necessary to describe the mechanisms employed to protect that confidentiality. In other words, describe who might have access, not how access to identifiers will be prevented.
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 (i.e. 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.
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
- 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.
- If the results of this project are published, your identity will not be made public.
Sharing data/samples
Guidance : If data or samples will be shared with individuals or organizations external to OSU (e.g., 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 Confidentiality
Sample Language: There is a chance that we could accidentally disclose information that identifies you.
Internet and/or email
Sample Language: The security and confidentiality of information collected from you online cannot be guaranteed.
Focus Groups
Sample 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 Confidentiality
Guidance: When a researcher obtains a Certificate of Confidentiality, the subjects must be told about protections afforded by the Certificate and any exceptions to those protections - i.e., the circumstances in which the investigators plan to disclose, voluntarily, identifying information about research participants (e.g., 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 template 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 injury
Sample Language: Under Oregon law, researchers are required to report to the appropriate authorities any information concerning child abuse or neglect. The researchers may also report threats of harm to self or to others.
Genetic Research
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.
Guidance: 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 subjects, whether or not genetic counseling would be available and who would pay for such counseling.
Recruiting from the Center for Healthy Aging Research (CHAR) LIFE Registry
Guidance: 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.
ClinicalTrials.gov
Guidance: If the study is a clinical trial and will be posted to ClinicalTrials.gov, the sentence below must be included verbatim.
Required language: A description of this clinical trial will be available on http://www.ClinicalTrials.gov, 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 injury
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 harm
Guidance: If research-related injury (i.e., 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 subject. The compensation and treatment should be described, or the subject should be told where further information might be obtained. The regulations prohibit requiring subjects to waive or appear to waive any of their legal rights.
Sample language for unfunded and federal funded studies: If you have been injured because you are in this study, . 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, . Costs related to the treatment of research-related injuries .
Consent Element: Contact information
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 information
Guidance: Suggested language is provided but may be altered if there is no reasonable expectation that participants would be able to contact or communicate with the PI or IRB (e.g., 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: . 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 [email protected] .
Consent Element: Voluntariness
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.
Sample language: Your participation in this study is voluntary. If you decide to participate, you are free to withdraw 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 subject’s request if that data is essential for assessing or tracking risks to the subject or others as it relates to adverse events.
Required vs Optional questions
Guidance: If the study involves interviews, surveys, or questionnaires, with optional questions, include a statement that the participant is free to skip any questions that he/she 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 time
Guidance: If study activities take place during class time, explain what participants will do during that time if they choose not to participate.
Students as subjects
Sample 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 subjects
Sample 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 subjects
Sample Language: Your decision to take part or not take part in this study will not affect your relationship with the researcher.
Prisoners
Sample 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 biospecimens
One of the following statements about 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; OR
- A 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 : The language in option 1 is incompatible with the European Union’s GDPR and cannot be used if data will be collected from people in the EU.
Collection, storage, and or future use of identifiable data or biospecimens
Guidance: If you plan to store data or samples, explain how long they will be retained (i.e., indefinitely, five years, destroyed when the study is completed), how they will be stored (i.e., with or without identifiers), what they will be used for, whether they will be shared, and whether subject permission will be sought for future studies.
Note: 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 European Union’s GDPR and cannot not be used if data will be collected from people in the EU.
language for biological samples: We may store your sample indefinitely. Because it is not possible for us to know what studies may be a part of our future work, we ask that you give permission now for us (or other researchers) to use your sample without being contacted about each future study[1]. Future use of your sample will be limited to studies about . We will remove information that identifies you before it is shared or used in a new study, but there is still a chance that someone could figure out that the information is about you.[2]
Sample language for data: Because it is not possible for us to know what studies may be a part of our future work, we ask that you give permission now for us (or other researchers) to use your personal information without being contacted about each future study. Future use of your information will be limited to studies about . We will remove information that identifies you before it is shared or used in a new study, but 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 risks
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: There may be risks related to the study procedures that are not yet known to the researchers.
Consent Element: Termination of participation by PI
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: If there are any circumstances under which a subject's participation may be terminated by the investigator without regard to the subject's consent, please describe them here (e.g., subject does not come in for critical visits or does not follow instructions for study activities, etc.
Consent Element: Costs
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 (e.g. lab tests, treatment at an outside facility, parking, lost, damaged, or unreturned study equipment, etc.).
Consent Element: Procedures for withdrawing
The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.
Consent Element: Significant new findings
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: If applicable, insert 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.
Consent Element: Number of subjects
The approximate number of subjects involved in the study.
Consent Element: Commercial profit
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 results
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 subjects and whether shared results will be individual or aggregate level.
Consent Element: Whole genome sequencing
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 applicable
Assent
Guidance: A verbal assent process is generally more appropriate for children up to age seven. Written assent documents can be used for ages eight and above. This template can provide 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.
Assent is a process, not just a form. Information must be presented in a way that enables people to choose whether to participate as a research subject.
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 send you a summary of the results.
Sample language for parental consent forms: This research study has been explained to my child in my presence in language my child can understand. He/she has been encouraged to ask questions about the study now and at any time in the future.
Payment
Guidance: 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 (e.g., extra credit, gift certificate), separately from monetary compensation and include the approximate value when appropriate.
Compensation 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 subjects 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 subjects should anticipate. Contact the HRPP office for more information.
Sample language: You > be paid for being in this research study.
Raffles and lotteries
Guidance: These incentives are permitted in some circumstances. Please see the policy on the HRPP website for additional information.
Sample Language: We will give/pay everyone who enrolls in this study _____. We will also enter your ____(name, code, ticket number, etc.) into a drawing for ____ (prize, dollar amount). The chance of winning is about ___ in ___ (i.e. 1 in 100). We cannot guarantee that you will win a prize. 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 activities.
Signatures
Guidance: The IRB strongly discourages use of the "first person" statement in consent documents (using, "I have been fully informed about. "). Such statements ask subjects to make statements that the subject is not in a position to verify (e.g., the subject has no way to verify that the investigator has provided full and complete information).
European Union General Data Protection Regulation (GDPR)
The General Data Protection Regulation will be in effect May 25, 2018. The aim of the GDPR is to protect people in the EU 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 the EU.
Guidance and sample language will be provided soon. In the meantime, contact the OSU Office of Information Security if you plan to collect data from research participants who reside or will be in the EU at the time of data collection.
Throughout this guidance, we have noted where the language is thought to be incompatible with the GDPR.
[1] This language addresses the requirement at 45CFR46.116(b)(9) related to the collection of identifiable private information or specimens.
[2] The latter half of this sentence addresses the 21 st Century Cures Act definition of identifiable, sensitive information as any information through which an individual is identified; or for which there is at least a very small risk… that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.
