CONSENT TO BE PART OF A RESEARCH STUDY
1. KEY INFORMATION ABOUT THE RESEARCHERS AND THIS STUDY
Principal Investigator: [Name, credentials,
Faculty Advisor: [Name, credentials, institutional affiliation]
1.1 Key Information
The Human Genomic study’s main purpose is to create precise genome maps. The direct benefit of participating in the study includes the ability to map and sequence genes that have advanced not only to the fundamental understanding of how genes are assembled into genomes, but it has also resulted in highly detailed knowledge of the structure of evolutionary trees, increased our understanding of genetics, and led to the development of new diagnostics and therapeutics for diseases like hypertension and cancer.
2. PURPOSE OF THIS STUDY
These maps will aid in locating genes inside the human genome, as well as assigning genes to their chromosomes. Genetic linkage maps and physical maps are the two types of maps now being developed. Physical maps define the physical position and distance between genes or DNA fragments. Genetic linkage maps determine the relative arrangement and approximate distances between genes and markers on the chromosomes.
3. WHO CAN PARTICIPATE IN THE STUDY
3.1 Who can take part in this study?
The study of the genome needs a lot of seriousness and not everyone can take part in the study. Those whose health conditions are good are the ones who are required to conduct the study as this reduces some of the risks that could be brought about by the poor health conditions of the participants during genetic testing. The study is encouraged to be conducted by a scientist who understands what to do during the study.
4.1 What will happen to me in this study?
In this study, the research that is being done is to create precise genome maps These maps will aid in locating genes inside the human genome, as well as assigning genes to their chromosomes. Genetic linkage maps and physical maps are the two types of maps now being developed. Physical maps define the physical position and distance between genes or DNA fragments. Genetic linkage maps determine the relative arrangement and approximate distances between genes and markers on the chromosomes. After the mapping is complete, the DNA must be sequenced to establish the order of all the nucleotide bases on the chromosomes, as well as the genes contained within the DNA sequence. The development of instrumentation to boost the speed of data collecting and analysis has been a primary priority throughout the project. The study would be conducted on the various field associated with genomic research including the biological laboratory and this study will take three months. However, there are a lot of risks and concerns at the same time. Routine genome sequencing has been acknowledged as having the potential to overwhelm clinicians and patients with confusing and often worrisome information, resulting in anxiety and stress, as well as costly and even harmful follow-up testing. In the study is also one of the risks which will be associated as a result of genetic testing is that testing can make you feel more stressed and anxious. In rare circumstances, the results may be equivocal or ambiguous. Family and personal relationships are negatively affected. If you don’t meet whole-genome testing conditions, you might not be eligible.
4.2 How much of my time will be needed to take part in this study?
To take one survey each month for three months. Each survey is expected to take about six-hour.
5. INFORMATION ABOUT STUDY RISKS AND BENEFITS
5.1 What risks will I face by taking part in the study? What will the researchers do to protect me against these risks?
Some of the expected risks of the study include the physical risks which include pain, illness, pain, disease, or physical discomfort brought about by the methods and procedures of the research. A physical risk may result from the involvement of physical stimuli such as heat, cold, or noise. Engaging a study in a social situation that could involve violence may also create a physical risk. The other risk that is expected during the study is the psychological risk which includes the production of negative affective states such as guilt, depression, anxiety, loss of self-esteem and shock, and altered behavior. Example of psychological risk includes mental stresses, sleep deprivation, and sensory deprivation. Embarrassment, loss of respect from others, naming a subject in a way that will have negative effects, or in any way limiting those chances and powers a person has by relationships with others are all examples of social/economic hazards. Payment by subjects for procedures not otherwise necessary, wage or other income loss, and any other financial costs incurred as a result of participation in the research, such as impairment to a subject’s employability, are all examples of economic risks. Legal risks exist when research methods expose the subject or others to the risk of breaking the law, either by revealing that the subject or others have engaged in or will engage in conduct for which they or others may be criminally or civilly liable, or by requiring activities for which the subject or others may be criminally or civilly liable.
the primary risks of this research is a loss of confidentiality. Unless the investigator has the express agreement of the subject, confidentiality of identifiable information is presumed in all studies involving human subjects and must be preserved. Subjects have the right to be safeguarded from harm and illegal breaches of their privacy, as well as to have their dignity preserved. The more sensitive the study material, the more caution must be taken when collecting, processing, and storing data. Investigators should only acquire personal information that is strictly necessary to the study activity to reduce the danger of losing confidentiality. If personal information must be obtained, it should be coded as soon as possible and securely maintained so that only the investigator and authorized personnel have to access it. Therefore, the physical risks of most genetic information are negligible, especially for those that simply require a blood sample (a method that samples cells from the inside surface of the cheek). Many of the risks linked with genetic testing are related to the test results’ emotional, social, or financial ramifications. People may be enraged, depressed, nervous, or guilty as a result of their outcomes. Genetic testing can generate family strife in some situations since the results can expose information about other family members than the person who gets tested. Genetic discrimination in work or insurance is also a source of worry.
Providing detailed information in the protocol about the experimental design and scientific rationale for the planned study, as well as the outcomes of past animal and human studies. Assemble a research team with the knowledge and experience to carry out the study. Make sure the sample size you’re planning on using is big enough to get useful results. To reduce unnecessary risk, collect data from standard-of-care procedures, especially for invasive or dangerous treatments (e.g., spinal taps, cardiac catheterization). Include suitable precautions in the research design, such as a data safety monitoring plan, the presence of skilled employees who can respond to crises, and data confidentiality protocols (encryption, codes, and passwords). The psychological risk could also be mitigated by providing counseling resources to participants
5.1.1 What happens if I get hurt, become sick, or have other problems because of this research?
The University may be able to assist me with obtaining emergency treatment, if appropriate, but my insurance company will be responsible for the cost. By signing this form, I do not give up as I have the right to seek payment if am harmed because of being in this study.
5.2 How could I benefit if I take part in this study? How could others benefit?
I and other participants might benefit from being in the study by getting the certificate of complication.
5.2.1 Will the researchers provide information to me about what they learn from analyzing my [type of biospecimen]?
They might learn things regarding my wellbeing as a component of the exploration. On the off chance that this occurs, this data will be given to me. [Insert a depiction of the sorts of exploration results that might be returned, under what conditions members will be given examination results, and how members will be notified.] I might have to meet with experts with the skill to assist me with diving more deeply into the examination results. The review group/study won’t take care of the expenses of any subsequent conferences or activities.
5.3 Will the researchers tell me if they learn of new information that could change my willingness to stay in this study?
Yes, the researchers will tell me if they learn of important new information that may change my willingness to stay in this study.
6. ENDING THE STUDY
6.1 If I want to stop participating in the study, what should I do?
I’m are allowed to leave the review whenever. Assuming I leave the review before it is done, there will be no punishment to me. I won’t lose any advantages to which you may somehow be entitled. Explaining to the scientists why you are leaving the review, your reasons might be kept as a feature of the review record. The scientists will keep the data [and kind of biospecimen] gathered with regards to me for the examination except if you request that we eliminate the data from our records and annihilate the [type of biospecimen]. On the off chance that the specialists have effectively involved my data in research investigation, it won’t be imaginable to eliminate your data.
7. FINANCIAL INFORMATION
7.1 Will I be paid or given anything for taking part in this study?
I will get a testament for fruition of the review and $800 of remuneration for my investment in the review. Assuming the members pull out from the exploration before the finish of the review, the member would be made up for the time taken in the examination and the leftover cash to be conveyed to others similarly and he won’t be granted a declaration of consummation. Since this study pays more than $600 in installments in a schedule year, this data will be shipped off the Internal Revenue Service (IRS) for charge announcing purposes and an additional a tax document (Form 1099) will be shipped off your home.
8. PROTECTING AND SHARING RESEARCH INFORMATION [AND BIOSPECIMENS]
8.1 How will the researchers protect my information?
The IRB is in charge of examining planned studies to ensure that suitable safeguards are in place to preserve participants’ privacy and data confidentiality. Human participants in research must have proper safeguards in place to protect study data confidentially. Maintaining confidentiality entails securing information that has been shared in a trusting relationship with the assumption that it will not be shared with others without consent, unless in ways that are consistent with the original disclosure. When applicable (i.e., through participants’ informed consent), confidentiality in human research also refers to the investigator’s agreement with participants about how their identifiable private information would be handled, managed, and distributed. Individuals may only agree to contribute information for research purposes. It’s best to keep study data without any identifiers if at all possible, so that individual participation is anonymous and the data obtained can’t be traced to the person. PPII obtained: before research (e.g., PPII received from private records to assess eligibility or contact prospective participants); during data collection, analysis, and dispensation; and after study closure are all subject to confidentiality requirements (if PPII is retained). Researchers are responsible for adhering to the IRB-approved researcher-participant agreement for the collection and safeguarding of research data, as well as protecting participants from harm caused by confidentiality breaches.
8.1.1 Special Protection
The government Genetic Information Nondiscrimination Act (GINA) by and large makes it illicit for medical coverage organizations, bunch wellbeing plans, and most businesses to victimize you in light of your hereditary data. This regulation doesn’t safeguard you against hereditary separation by organizations that sell disaster protection, incapacity protection, or long haul care protection. Under this regulation:
● Health care coverage organizations and gathering wellbeing plans may not demand the hereditary data that we get from this exploration
● Medical coverage organizations and gathering wellbeing plans may not utilize the hereditary data that we get from this exploration while settling on choices in regards to your qualification or charges
● Bosses with at least 15 representatives may not utilize the hereditary data that we get from this exploration while intending to enlist, advance, or fire you or while setting the conditions of your work
GINA doesn’t make a difference to the accompanying gatherings; in any case, these gatherings have approaches set up that give comparative insurances against separation:
● Individuals from the US Military getting care through Tricare
● Veterans getting care through the Veteran’s Administration (VA)
● The Indian Health Service
● Government workers getting care through the Federal Employees Health Benefits Plans.
8.2 Who will have access to my research records?
College, government authorities, concentrate on backers or funders, evaluators, and additionally the Institutional Review Board (IRB) may require the data to ensure that the review is done securely and appropriately. Assuming that you get any installments of $600 or something else for participating in this review, the [institution] bookkeeping division might require your name, address, Social Security number, installment sum, and related data for charge announcing purposes. Additionally, Federal or State regulation might require the review group to give data to government offices. This is to forestall mischief to you or others, or for general wellbeing reasons.
8.3 What will happen to the information [and/or biospecimens] collected in this study?
We will keep the data [and/or biospecimens] we gather about you during the examination, [including data we gain from investigating your [type of biospecimen]], [for future exploration projects/for study recordkeeping or different purposes (describe)]. Your name and other data that can straightforwardly distinguish you will be put away safely and independently from the exploration data we gathered from you.
8.4 Will my information [and/or type of biospecimens] be used for future research or shared with others?
We might utilize or share your examination data [and/or sort of biospecimen] for future exploration studies. Assuming we share your data [and/or sort of biospecimen] with different analysts it will be de-distinguished, and that implies that it won’t contain your name or other data that can straightforwardly recognize you. This exploration might be like this review or totally unique. We won’t request your extra educated assent for these investigations.
8.4.1 Special Requirements
A portrayal of this clinical preliminary will be accessible on the National Institutes of Health (NIH). This Website wo exclude data that can recognize you. Probably, the Website will incorporate a rundown of the outcomes. You can look through this Website whenever.
Since this exploration gets financing from the National Institutes of Health (NIH), we present your genomic data to a public storehouse supported by the NIH. It contains data regarding many individuals. NIH is an exploration office that is essential for the central government.
We will name your data with a code, rather than your name or other data that could be utilized to straightforwardly distinguish you. All things being equal, there is plausible that when your genomic data is joined with other data accessible to analysts, either now or later on, they might have the option to recognize a gathering you have a place with (like an ethnic or racial gathering or individuals having a specific sickness), or more outlandish, you actually. NIH doesn’t permit individuals to attempt to distinguish people whose genomic data is in a NIH-supported store. Different analysts will have controlled admittance to your genomic data. This implies that they should get endorsement from NIH to get genomic data from the storehouse.
We will put the data we gather from you into a storehouse. The archive contains data regarding many individuals. Your data will be [de-distinguished – or-named with a code, rather than your name or other data that could be utilized to straightforwardly recognize you.
9. CONTACT INFORMATION
Who can I contact about this study?
If you need help, contact the specialists recorded beneath to:
● Get more data regarding the review
● Pose an inquiry regarding the review methods
● Report a sickness, injury, or other issue (you may likewise have to tell your standard specialists)
● Leave the review before it is done
● Express worry regarding the review
Principal Investigator: Marjan Assefi
Faculty Advisor (for student projects; delete if does not apply):
If you have questions about your rights as a research participant or wish to obtain information, ask questions or discuss any concerns about this study with someone other than the researcher(s), please contact the following:
[ Institutional Review Board OR ETHICS COMMITTEE OR OTHER REVIEW BODY]
[CITY], [STATE], [ZIP CODE]
Telephone: [XXX-XXX-XXXX] For International Studies, including the appropriate
For international studies, including the US Country Code for the phone number. For projects reviewed by an in-country IRB or ethics committee, include contact information for that organization and place it before the IRB-HSBS contact information.
10. YOUR CONSENT
Consent/Assent to Participate in the Research Study
By signing this document, you are agreeing to be in this study. Make sure you understand what the study is about before you sign. I/We will give you a copy of this document for your records and I/we will keep a copy with the study records. If you have any questions about the study after you sign this document, you can contact the study team using the information in Section 9 provided above.
I understand what the study is about and my questions so far have been answered. I agree to take part in this study.
Print Legal Name: _____________________________________________________
Date of Signature (mm/dd/yy): ___________________________________________