Medical and clinical research tests the safety and effectiveness of medical devices, treatments, or drugs for humans. It also finds the right dosages and uses. Two key roles exist: the sponsor and the study investigator. The sponsor ensures quality control. The study investigator runs the trial. Both ensure ethical standards. Everyone involved must follow good clinical practice (GCP).

The clinical research community's first self-regulation effort was in 1964. The World Medical Association created the Declaration of Helsinki (DoH).

These ethical codes of practice (DoH) stated:

• The well-being of human subjects takes precedence over the interests of the scientific community

• Requires the written consent of participants 

• Cautions personal relationships with the researcher

• Limits the use of placebos 

• The participants should benefit from their participation and should have access to post-study treatment

• Public disclosure: The study design, all results (good or bad) and the potential conflicts of interest (including funding and sponsors). 

It was a good start, but insufficient. In 1996, the International Council for Harmonization aimed to standardize clinical trials on humans. It also sought to protect these subjects. The council introduced ethic-based standards. These standards detail the IRB's governance, operations, and responsibilities. There are 13 principles of Good Clinical Practice (GCP). Each trial step must consider these principles. Additionally, trials should follow both DoH and GCP guidelines, and all regulations. The principles of GCP are as follows:

Ethical Principles

• A clinical trial should consider both DoH and GCP guidelines as well as all regulatory requirements.
• Non-compliance puts potential study subjects at risk and offers no benefit to subjects.

Risk-Benefit Analysis

• Foreseeable risks should be weighed against the anticipated benefit for individual trial subjects.
• Should only be initiated and continue if the anticipated benefit(s) justify the risks.
• Conduct a risk-benefit analysis on behalf of the subject before you begin.
• After benefits and risks have been defined the study protocol should include measures to reduce risk as much as possible. But this risk-benefit analysis should continue throughout the study and with changes reconsideration should be made.

Rights, Safety and Well-Being

• The rights, safety and well-being of trial subjects are the most important considerations and should prevail over interests of science and biology.
• Every element of a study should be deemed safe for participants and necessary to fulfill the objective of the study.
• Example: Long term collection of blood-samples
• May not be GCP compliant
• Can be painful (repeated)
• Only should be done if absolutely necessary

Adequate Data

• Available non-clinical and clinical information on a study drug or device should be adequate to support the proposed clinical trial.
• Must know based on this information that there is a reasonable ground to believe it could have benefits to humans.

Study Protocol 

• Clinical trials should be scientifically sound and described in a clear, detailed protocol (including safety measures, etc.)

IRB Approval 

• Each trial should be completed in compliance with a study protocol approved by the applicable institutional review board (IRB). This approval is required before the study can proceed. 
• Deviations from this can mean GCP non-compliance.
• IRB = Physicians, nurses, statisticians, community members/advocates and others.  

Medical Care

• All medical care given to and medical decisions made on behalf of subjects should be the responsibility of a physician or a dentist.
• Data collection, drug administration can be done by a nurse practitioner or a phlebotomist.
• Medical decisions can only be made by a certified medical professional.

Qualified Staff

• Each individual involved in conducting a trial should be qualified by education, training and experience to perform study tasks. This should be well documented and regularly kept to date.

Informed Consent

• Freely given informed consent should be obtained from every subject before clinical trial participation.
• No study activities are to be carried out with a subject without signed consent forms.

1. • If filled out incorrectly (like a missing or wrong date) means that the study is no longer GCP compliant.

Information Management 

• All clinical trial information to be recorded, handled and stored in a way that allows it to be accurately reported, interpreted and verified.
• Check out our activity on creating and maintaining a lab book. This explains how to record information so that a study can be repeated and verified!
• Generally, there is a data storage system to archive data once the study is complete.

Confidentiality

• The confidentiality of records that could identify subjects should be protected, respecting applicable privacy and confidentiality rules and regulations. Access to these records should also be limited.

Good Manufacturing Practice (GMP)

• Study drugs and devices should be manufactured, handled and stored in accordance with applicable good manufacturing practice principles and used in accordance with the approved protocol.

Quality

• Procedures should be implemented to ensure that the quality of every aspect of the trail has been considered. 

These principles aren't laws. Each country sets its own rules based on good clinical practice (GCP). However, if a law conflicts with GCP, the law takes priority.