The rights or interests during and after the research process are always intriguing to many people, especially the Certificate of Confidentiality.
If you are wondering about the purpose of this type, don’t worry because we will explain everything you need to hear about these special documents. If you desire to understand more details, please refer to the following section!
Table of contents
- What Is The Certificate Of Confidentiality?
- The Primary Purpose Of A Certificate Of Confidentiality
- What Is The Operating Mechanism Of The CoC?
- Which Subjects Meet The Conditions To Be Granted CoC?
- What Studies Will The CoC Automatically Cover?
What Is The Certificate Of Confidentiality?
If you often hear the acronym CoC, it is “Certificate of Confidentiality”, a type of certification that helps protect privacy for subjects participating in sensitive research.
Usually, sensitive research is prone to legal issues like subpoenas and court orders. These requirements are made because of verifying the participant’s identity or information. In this case, the CoC will be the factor that helps you protect against these requirements.
Although the NIH (National Institutes of Health) grants this benefit for all the research they fund, you can still own CoCs in research outside of NIH funding.
The Primary Purpose Of A Certificate Of Confidentiality
The primary purpose of a certificate of confidentiality is to safeguard against legal requirements. The most common examples are court orders and subpoenas related to the characteristics or identity of any of the study participants.
Specifically, institutions that receive this type of assistance have the right to decline to obey with disclosures in legislative, civil, criminal, and administrative proceedings.
In addition, the CoC is also intended to protect any sensitive and identifiable info (individual data of participants). This issue can include mental health, sexual attitudes, illegal threat behavior, and many more.
Moreover, approval from the Institutional Review Board (IRB) is important in determining whether your project is eligible to benefit from this type of certification. Participants in a study with a CoC need to ensure compliance with the terms set forth.
The IRB may collect if the info influencing someone negatively and identifying information is disclosed. Specifically, these categories can be mentioned as health, employability, insurable and financial data.
What Is The Operating Mechanism Of The CoC?
The CoC sets legal responsibilities on parties that have access to/possession of sensitive details records. In addition, other types of personally identifiable info (ex: health data) are also included in this certification.
Covered components include participant records, reporting forms, and a variety of other relevant administrative documents. Specifically, the records described above will be required to be shielded from disclosing participant identities or other identifying information in biomedical/behavioral studies.
Which Subjects Meet The Conditions To Be Granted CoC?
If you want to know who will be eligible to receive the CoC, you can immediately refer to the following list of approved subjects:
- Research participants are legally incompetent subjects or minors.
- Subjects participated in NIH-funded studies.
- Detainees, prisoners, or federal/state correctional facilities.
Note: You (participant) will not be provided with and cannot use shielded health info from the above subjects.
What Studies Will The CoC Automatically Cover?
Starting from the end of 2016, NIH has funded the following subjects:
The research subject is “human”
The federation has made regulations regarding this aspect of research and includes identifiable exempt studies. This issue includes behavioral, clinical, biomedical, and even exempt studies.
In this case, the information must be recorded so that the “human” participant cannot identify the info related to the identity.
Use or collect biological samples
This type will usually be easily identifiable personally. Furthermore, there is a small risk that others have a way to deduce an individual’s identity.
Create data on a personal level
In general, any identifiable data such as the human genome within biological samples.
Other studies related to personal info
Although it is an extremely small risk in the research, scientific methods can investigate the matter’s identity.
In general, the primary purpose of a Certificate of Confidentiality is to protect research against the law. In addition, the relevant details are answered in detail above.
It is worth mentioning that being aware and knowledgeable about these benefits will keep you safe from many risks in the future. If you care about this subject, refer to our related suggestions. Hope this information is helpful!