Any research into human subject need to be approved by whatever committees are required by:

1. Your country’s legal requirements
2. Your institutional requirements
3. Your funder’s requirements
4. Your collaborator requirements

Typically this is review by an Institutional Review Board (IRB) or a scientific review committee followed by review by a local or national Independent Ethics Committee (IEC), which is an independent body responsible for ensuring the protection of the rights, safety and well-being of human subjects involved in a trial.
Usually the institutional review will ensure the science is valid, that the study is safe and also consider administrative, operational and financial issues such as whether the study will impact on others programmes, if there is the appropriate staff capacity and whether or not the finances are in order.

Regulatory approvals submission
Prior to initiating a clinical trial, researchers must obtain approval from national regulatory authorities (NRAs) and ethics committees to conduct clinical trials. NRAs are responsible for ensuring that clinical trials are scientifically sound, that they will result in data that will support regulatory decision making, and that the rights and safety of clinical trial participants are protected. All studies also must undergo ethics approval which, depending on the country and nature of the study, is granted by national and institutional ethics committees.

Regulatory approval pathways, including the order in which approvals need to be granted by ethics committees and NRAs, vary among countries and products. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) lists the following recommended components of clinical trial protocols in the Guideline for Good Clinical Practice E6(R1):

- General information
- Background information
- Trial Objectives and Purpose
- Trial Design
- Selection and Withdrawal of Subjects
- Treatment of Subjects
- Assessment of Efficacy
- Assessment of Safety
- Statistics
- Direct Access to Source Data/Documents
- Quality Control and Quality Assurance
- Ethics
- Data Handling and Recordkeeping
- Financing and Insurance
- Publication Policy
- Supplements

Given that not all countries follow ICH guidelines and that guidelines vary by country, it is important to identify country-level requirements to inform regulatory planning. The Global Health Regulatory Requirements Database, a Global Health Network member site, is a tool that can be used to learn about country-level regulatory requirements. The database contains consolidated access to country-level regulatory requirements in Africa, Asia, and Latin America. In addition to an overview of clinical trial requirements, the database contains a description of ethics review processes and contact information for NRA representatives.

The Global Health Regulatory Requirements Database is designed to help researchers and regulatory affairs professionals access the information they need to develop effective strategies for gaining approval to conduct clinical trials and market products. The database provides high-level information on regulatory requirements, timelines, costs, and other basic information required to create product development plans for new tools.  http://regulatory.ghtcoalition.org/