HIC#: insert number
COMPOUND AUTHORIZATION AND PARENTAL PERMISSION FOR PARTICIPATION IN A RESEARCH PROJECT
310 FR. 3a (2016-1)
Specify both the Yale University academic research entity, and, if applicable, the non-academic partner, e.g.:
YALE UNIVERSITY SCHOOL OF MEDICINE – YALE-NEW HAVEN HOSPITAL
YALE UNIVERSITY SCHOOL OF MEDICINE – YALE-NEW HAVEN HOSPITAL—SAINT RAPHAEL CAMPUS
YALE UNIVERSITY SCHOOL OF MEDICINE—CONNECTICUT MENTAL HEALTH CENTER
YALE UNIVERSITY SCHOOL OF PUBLIC HEALTH
YALE UNIVERSITY SCHOOL OF NURSING—YALE NEW HAVEN HOSPITAL
YALE UNIVERSITY SCHOOL OF MEDICINE—THE APT FOUNDATION
YALE UNIVERSITY SCHOOL OF NURSING
Be sure to delete any entities that do not apply.
INSTRUCTIONS: This template is designed to provide guidance in the development of a consent form that also incorporates and satisfies the elements required of a HIPAA Research Authorization Form (RAF). (The combination of these 2 forms is known as a Compound Authorization Form). Italicized sections include suggested text and further instruction and guidance. Note that sections shown in square brackets must be edited for each specific protocol. Not all sections will apply to every protocol. Therefore, delete those which do not apply as well as this and other instruction paragraphs prior to submitting the form(s) to the HIC.
Study Title: [Insert title of the study.]
Principal Investigator: [Insert name.]
Funding Source: [Insert name of company or agency.]
[If the study involves different consent forms for different populations, identify the population group as the subtitle of the study. Example Healthy Controls Form vs. the Form for Diabetic Adolescents.]
Invitation to Participate and Description of Project
Suggested Text:
We are inviting your child to participate in a research study designed to look at [state what the study is designed to discover or establish.] Your child has been asked to participate because he/she [explain briefly why the prospective subject is eligible to participate]. [If appropriate, state the approximate number of subjects or research sites involved in the study.]
In order to decide whether or not you wish your child to be a part of this research study you should know enough about its risks and benefits to make an informed decision. This permission form gives you detailed information about the research study, which a member of the research team will discuss with you. This discussion should go over all aspects of this research: its purpose, the procedures that will be performed, any risks of the procedures, possible benefits and possible alternative treatments. [Note: If the protocol is not a treatment protocol, delete “any possible alternative treatments”.] Once you understand the study, you will be asked if you wish your child to participate; if so, you will be asked to sign this form.
Description of Procedures
Suggested Text:
If you agree to your child participating in this study, your child will be asked to [describe the study procedures clearly, in roughly chronological order.]
Guidelines:
Ø Describe the procedures using lay language, short sentences and short paragraphs. The use of subheadings may help to organize this section and improve readability.
Ø Define and explain medical and scientific terms in ordinary language (for example, the amount of blood to be drawn should be given in terms of teaspoons, tablespoons, ounces or milliliters). A medical or scientific term, drug name, etc. may be used throughout the permission form once it has been explained in lay language.
Ø Distinguish clearly between any procedures that are experimental and those that are part of subjects’ standard clinical care. Specify the subject’s assignment to study groups, length of time for participation in each procedure, the total length of time for participation, frequency of procedures, location of the procedures to be done, etc.
Ø For research involving randomization of subjects into different groups, specify (and explain) the randomization procedures.
Ø For research involving the use of placebo, clearly define the term placebo.
Ø For research involving interviews, surveys, questionnaires, etc., clearly describe the content of the instruments. It may also be helpful to provide a representative sample of the types of questions subjects will be asked.
Ø For research involving review of subjects’ medical record, the permission form should explain what types of information will be collected, and why.
Ø Under HIPAA the consent form and HIPAA Research Authorization form (RAF) can be combined for the same study, e.g., a single research purpose. (Example: the collection of blood in a clinical trial to evaluate response to ALS treatment.) HIPAA also allows combining the consent and authorization for a study with authorization for the creation or maintenance of a research database or repository. Combining study authorization with database or repository authorization requires that these distinct uses must be clear and must allow for the research subject to provide separate authorization for the database or repository. Example: the subject is given the option to provide permission for sharing information for purposes related to the ALS trial AND in a separate statement, the subject provides a ‘second” permission to bank the biologic material for use in future research studies. If selecting this option, investigators are reminded to retain the signed combined form for the full duration that the banked data or biologic sample will be retained for future research purposes.
Ø When relevant, any plans to return information to subjects, to medical records, to primary care physicians, or others must be made explicit in the permission form.
If this is a Phase II or III controlled clinical trial with FDA oversight, or a controlled trial with health outcomes of an FDA regulated device, the following language is required by the FDA. This language can also be used for NIH-supported clinical trials registered at clinicaltrials.gov:
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
(For more information on registering clinical trials, contact YCCI.)
If appropriate, add:
You will be told of any significant new findings that are developed during the course of your child’s participation in this study that may affect your willingness to continue to participate.
Ø For research involving optional genetic or related testing, the permission form should describe the scope of the research that will be performed with subjects’ DNA or tissue (e.g., cancer, aging, mental health, etc.) If the genetic testing is not optional, revise the wording as appropriate.
If appropriate, include:
Optional Specimens for Future Storage/Genetic Testing
You are invited to allow some of your child’s samples (called specimens) and related information to be stored (banked) for future research [for X purpose]. This may help researchers in the future learn more about how to prevent, find and treat [X disease(s)/condition(s)].
Your child’s specimens will be stored for an unlimited time [If specific dates of storage are known, describe], and may be used to make a cell line that will live indefinitely. Future research may look at your child’s genes, which are the units of inheritance that are passed down from generation to generation. Genes are responsible for many things about you such as eye color, hair color, blood type and hundreds of other traits. Future genetic analysis may possibly include finding out the details of how your child’s DNA is put together, such as whole exome or genome sequencing, or genome wide association studies (that is, looking at genes other than those associated with a specific disease). The materials at some point may be injected into animals in some of the research. We expect that there will be widespread sharing of these specimens and associated information. (Exclude what is inapplicable to your type of research: e.g., in pharmacogenetic research, genome sequencing and animal studies are unlikely.)
When your child’s specimens and information are stored, we are careful to try to protect your child’s identity from discovery by others. Your child’s samples and information will receive a unique code. Other researchers will only receive coded samples and information, and will not be able to link the code to your child. Strict security safeguards are in place to reduce the chance of misuse or unplanned release of information.
Using your child’s specimens for research will probably not help him/her. We do hope the research results will help people in the future.
There is a risk that your child’s information could be misused [Give examples]. The chance of this happening is very small. We have protections in place to lower this risk [Describe]. There can also be a risk in uncovering genetic information. New health information about inherited traits that might affect your child or your blood relatives could be found during a research study. Very rarely, health or genetic information could be misused by employers, health insurance companies, and others. There is a federal law called the Genetic Information Nondiscrimination Act (GINA) that, in general, makes it illegal for health insurance companies, group health plans, and most employers (except those with fewer than 15 employees) to discriminate against you or your child based on your genetic information. However, it does not protect you against discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.
Your child’s specimens and information will only be used for research and will not be sold. There is a possibility that this research may lead to development of products that will be commercialized. If this happens, there is no plan to share any financial gain with you or your child.
Research results will not be returned to you or your child’s doctor. If research results are published, your child’s name and other personal information will not be given.
If you know that your study will involve a GWAS analysis and depositing to the NIH GWAS repository, include the following:
Your child’s specimen will also be given to the National Institutes of Health Genome-Wide Association Studies (GWAS) repository. GWAS studies look at the genetic differences that exist along the human genome, which is the complete set of human genes. These studies look for common traits, such as blood pressure or weight, or for the presence or absence of a disease or condition.
The NIH GWAS repository stores genetic information from many studies and shares that information with researchers. We will send the genetic information about your child and other participants in this study to the NIH GWAS repository. It will be coded and de-identified. NIH will not identify or make any attempt to identify information as coming from your child or any other individual. NIH will share the collected information with researchers who submit applications to NIH. Special data sharing committees will review those applications and decide whether or not to share the genetic information. The researchers who receive data must promise to keep the data confidential and to use it only for the purpose approved by NIH.
The goal of GWAS studies is to look for genetic connections which may explain how to identify, prevent, and treat health problems. For example, GWAS data may be used to find out:
· who is more likely to develop a certain illness, such as asthma, cancer, or diabetes, or a condition like high blood pressure or obesity;
· what genes affect the progress of a certain disease or condition; and
· what genes may affect treatments which now may or may not work in certain people.
GWAS research will not directly benefit your child, but could lead to a greater understanding of the interaction between genes and health. This knowledge could help others in the future.
The choice to take part is up to you. You may choose not to let us store and use your child’s samples, and your child’s care will not be affected by this decision. If you decide that your child’s samples can be kept, you may change your mind at any time. Contact the study staff by phone or mail at [XX phone -- add country code if applicable, XX address] to let them know you do not want your child’s samples used any longer. Your child’s samples will either [Researcher should choose one or allow subject to indicate choice] be destroyed, or made anonymous (the code linking them to you will be destroyed).
I agree to allow my child’s samples and information to be stored and used for future research as described above: (initial your choice)
_____YES ______No
Risks and Inconveniences
Guidelines:
Ø Identify all reasonably foreseeable risks, discomforts or inconveniences associated with the study, and describe how they will be managed.
Ø For studies where the primary risk is breach of confidentiality, use this: There are no physical risks associated with this study. However [some questions may make you uncomfortable and] there is the possible risk of loss of confidentiality. Every effort will be made to keep your child’s information confidential; however, this cannot be guaranteed.
Ø Risks should be listed in hierarchical order, from most likely to least likely to occur.
Ø When relevant, risks to pregnant women or to a fetus should be explicitly stated.
Ø For studies taking place at the YNHH-Saint Raphael campus the reproductive risks section ofthe consentdocument should instruct study participants to practice "family planning methods" acceptable to the study investigator.” The terms “contraception” and “birth control” may not be used.
Ø In addition to physiological risks/discomforts, describe any psychological, social, legal or financial risks that might result from participating in the research.
Ø Where such information is available, the permission form should state the likelihood of risks occurring. For example, “most subjects in a similar study had headaches and felt nauseous,” or “10 out of 100 people who took drug X felt dizzy.”
Ø If appropriate (e.g., if the research involves an experimental intervention or therapy), please include the following statement: “Participation in this study may involve risks that are currently not known.”
Ø Include only those risks that are associated with the research. Risks associated with standard clinical procedures that would be done whether or not the patient is in the study should not be listed.