Study Registration Procedure

Clinical Trial Registration in North America

Those who are carrying out clinical trials can register them in publically accessible registries. When you search on clinicaltrials.gov, you can search all registered clinical trials by condition or disease, other terms (such as name of principal investigator), or by country.

The purpose of registering clinical trials is to ensure healthcare providers, potential participants of new clinical trials, and the general public have as much up-to-date information about current clinical trials as possible. This also is a process that helps reduce publication bias

clinicaltrials.gov  (large scale, 398,101 studies currently registered, run out of USA by the U.S. National Library of Medicine, but includes studies conducted all around the world). There are also other registries, such as ISRCTN which is an international registry with 21,451 registered studies. A study can be registered in more than one registry. You can search for studies by medical condition/disease, treatment, country, researcher name, or study registration number. You can also see if the study is complete or recruiting participants.

Review committees

Definition/How it is conducted: Review committees, such as Independent Data and Safety Monitoring Boards (DSMBs) are designed to periodically review a clinical trial with the goal of ensuring participant safety and validity of the data being collected. 

Purpose/Benefits: They have the power to suggest “stopping rules”, which determine when the trial should be suspended or terminated. They regularly monitor all sites in which a clinical trial is taking place, and report to the research ethics board that this clinical trial was approved by. 

Example: These committees are made up of scientists, academics, and members of the community, and should be a third party with no conflicts of interest.
Benefits/Limitations: Not all studies are required to have a DSMB, and this is determined by the research ethics board at the beginning of the trial, depending on the risk and complexity of the proposed research study.

Clinical Trial Ethics

The ethical principles that guides today’s research can be traced to the inhumane experiments in Nazi concentration camps during World War II. After the war, a series of trials, in what became known as the Nuremberg Trials, was conducted to prosecute representative leaders of Nazi military, politics, and economy. In light of the unethical experimentations, a set of ethical principles for human experimentation was created: The Nuremberg Code.

The Nuremberg Code

• The results of the research must be useful and unobtainable by other means
• The research must be rationally based on knowledge of the disease or condition to be studied
• It must avoid unnecessary suffering
• The study cannot include death or disabling injury as a foreseeable consequence
• Its benefits outweigh its risks
• The research must use proper facilities to protect participants 
• The study must be conducted by qualified individuals
• Participants may withdraw from the study if they wish
• Investigators must be prepared to stop the study should participants die or become disabled as a result of participation
• Participation must be voluntary 

Along with the Nuremberg Code, the Belmont Report of 1979 became the prototype for future codes and principles for ethically conducted research. This code sought to identify the basic ethical principles that should underlie the conduct of human biomedical and behavioral research. 

The Belmont Report 1979

1. Principle of Respect: participants must give consent and those who cannot must be protected
2. Principle of Beneficence: researcher must not harm the participants, must minimize risks, and maximize possible benefits
3. Principle of Justice: researcher is not bias and institutionalized individuals must be protected

From these historically paramount codes, other ethical guidelines evolved including but not limited to the Tri-Council Policy Statement (1998/2014). 

Tri-Council Policy Statement (TCPS)

1. Respect for Persons
   • Recognize the intrinsic value of human beings and the respect and consideration that they are due
   • Respect autonomy and protect those with diminished autonomy 
   • Ensure the person can deliberate and choose without interference
   • Requirement to seek free, informed, ongoing consent
2. Concern for Welfare
   • Quality of a person’s experience of life
   • Control of information about the person
   • Aim to protect welfare of participants
3. Justice
   • Obligation to treat people fairly and equally 
   • Distributing burdens/benefits of research participation so that no segment of population is unduly burdened by harms/denied benefits

What do ethical considerations in research look like today?

5. Potential for Harm

• All risks including physical, social, legal, and psychological must be kept at a minimum at all times

6. Results Communication

• Results are accurately reported and free of research misconduct

Voluntary Participation:
Research participants are free to participate or opt out of the study at any point during the research.

Informed Consent:
Research participants must be informed of the purpose, benefits, risks, and funding behind the research before the decide to participate or not.

Anonymity:
Personally identifiable data is not collected. While it may be impossible to truly anonymize data collection, researchers must employ their best efforts to ensure anonymity.

Confidentiality:
Researchers know who their participants are, however such information must be hidden from everyone else, You must anonymize personally identifiable information to ensure that it cannot be linked to other data by anyone else.

Potential for Harm

Purpose/Benefits: They have the power to suggest “stopping rules”, which determine when the trial should be suspended or terminated. They regularly monitor all sites in which a clinical trial is taking place, and report to the research ethics board that this clinical trial was approved by. 

Example: These committees are made up of scientists, academics, and members of the community, and should be a third party with no conflicts of interest.
Benefits/Limitations: Not all studies are required to have a DSMB, and this is determined by the research ethics board at the beginning of the trial, depending on the risk and complexity of the proposed research study.