Risks and Discomforts. The only foreseeable risk is a breach of confidentiality; however researchers will protect all personally identifiable information with password protected documents and computers, as well as locked filing cabinets (see Confidentiality section below.) There are no other foreseeable risks or discomforts associated with this study.
Risks and Discomforts. 6.1 Risks associated with the publication of your data 11
6.2 Risks associated with the creation of cell lines from your tissues 12
6.3 Risks associated with your receipt of data from the PGP-UK 13 6.4 Physical risks and discomforts. 14 6.5 Data Safety Monitoring Board 15
Risks and Discomforts. Although your therapist and the Repository Guardian will make every effort to protect your identity, there is an extremely small risk of loss of confidentiality. In the highly unlikely event that the data in the repository should become linked to your identity and distributed to an outsider, sensitive information about you and your therapy could become available to an insurer, employer, relative, or someone else.
Risks and Discomforts. Certain questions and/or having her weight/height measured may cause her to feel mild feelings of discomfort or embarrassment during this study. Additionally, a breach of confidentiality is a potential risk of participation. These risks are minimal.
Risks and Discomforts. Potential risks and discomforts include:
1) Potential loss/compromise of privacy and confidentiality via the participant or member of the study staff accidentally sharing identifiable information with someone inappropriate. It is possible that the families could be identified by the public and be brought to the media's attention. Subjects may choose to publicize their participation in this study via the media. This decision could result in the patients being able to be identified by participating "Challengers," due to the small number of participating family members. Subjects will be made aware of this possibility prior to enrolling.
2) Physical harm from Phlebotomy/Saliva Collection – Blood drawing causes minimal risk of minor discomfort, bruising or rarely, dizziness or fainting. There are no known risks associated with providing a saliva sample by spitting into the collection container. If we use a pipette or swab to collect saliva from an individual who has difficulty spitting, i.e. an infant, the tool may touch the inner part of the mouth, which could lead to an unusual feeling and potentially provoke a response, i.e. crying in an infant. There is a very small risk of scraping the inside of the mouth with a pipette/swab.
3) Psychological, emotional or social harm from participation in genetic studies – There is a possibility of release of “sensitive” genetic information to third parties who might discriminate, as well as psychological impact on patients and relatives of learning of genetic status. Whole genome sequencing is a relatively new genetic technology that allows for the screening of all of an individual's genetic material at one time. The use of whole genome sequencing in a research setting is increasing rapidly, and it is being considered as a potential option for clinical testing in the future. However, the analysis and reporting of whole genome sequencing is still new. Therefore, it is possible that we could identify results that are unexpected or difficult to interpret. Because the results of this study will be submitted for publication and the small number of participants, it may not be possible to completely refrain from sharing these results with participants, potentially resulting in psychological stress on participants. Therefore, any incidental findings that might be recognizable to the participant through publication would first be cleared with the ICOB and/or CCI before being published. The purpose of this study is to improve the ...
Risks and Discomforts. The PGP-UK is a new form of public genomics research and, as a result, it is impossible to accurately predict all of the possible risks and discomforts that you might experience as a result of your participation in this study. In this section you will read about the risks that we have identified as potentially relevant to your participation in the PGP-UK. You are strongly encouraged to think carefully about these risks, as well as any other risks or discomforts that you anticipate might arise as a result of your own unique circumstances. These might include your own health or medical conditions, your family and personal relationships or any other factor that is specific to you. In addition to understanding the risks outlined in this Article VI, you should feel confident that you have sufficient knowle dge (via the educational and testing materials available on the PGP-UK website or through other sources) of genetics, human subjects research and the benefits and risks of participation in this study to make an informed decision about whether participation is right for you. We strongly encourage you to discuss this study and its potential risks with your immediate family members as well as with your doctor and/or other qualified health care providers. We also encourage you to discuss with the Principal Investigator directly any additional concerns that you may have regarding the risks to you of participating in this study. Finally, because the science in this area is evolving, and data will be collected on an ongoing basis by the PGP-UK, the risks involved because of your participation in this study, as well as the likelihood and severity of such risks, will change over time. You will not be asked to review and re-sign this consent form every time new information related to the risk of participation becomes available. However, the PGP-UK will try to update this consent form and the study website as frequently as possible to reflect the latest information about the risks of participation. Participants and prospective participants are strongly encouraged to check the website regularly and to update their contact information with the PGP-UK in order to obtain the most current information regarding the risks and discomforts of participation.
6.1 Risks associated with the publication of your data
(a) Risks associated with public disclosure
(i) The public disclosure of your genetic and trait data could cause you to learn – either directly, from a family member or ...
Risks and Discomforts. The risks of participation are minimal. You will not be asked to report any identifying information about yourself or your school in the interview. Further, no cross-school comparisons of individual schools will be made, so there is no risk of schools or individuals being singled out. The only record linking you to the research will be the consent form. Your signature will appear on the consent form, but the forms will be secured separately from the interview notes and will not be accessed by anyone other than the the three individuals working on the study.
Risks and Discomforts. There are few risks associated with participating in this study. However, one risk is discomfort answering questions regarding sex and condom-use. You may also feel discomfort after sharing information that you may not have shared before.
Risks and Discomforts. There is minimal risk in this study. However, answering questions may cause some frustration or anxiety for some people. If you feel uncomfortable, you can refuse to answer any questions or stop the interview or survey at any time.
Risks and Discomforts. We do not think that being a part of this interview will cause you any physical or psychological harm beyond what you might face in everyday life. We will not be asking personal questions. However, since the materials are about postpartum depression, it could create some discomfort. If you are uncomfortable answering a particular question, you are free not to answer the question. You are also free to stop the interview at any time.
