Mount Auburn Hospital Office of Research
The purpose of the IRB is to protect the rights and welfare of individuals who are, or are about to become, Human Subjects in a research activity within the scope of the IRB’s authority
For all protocols that involve any contact with human subjects - whether through procedures, questionnaires, surveys, interviews, focus groups, tissue sample, cell lines or any material or data that may or may not be linked to human subjects - a determination must be made through the IRB office whether the proposal meets the definition of research with human subjects, and whether subsequent IRB review is required.
IRB Authority and Review:
The IRB has the responsibility and authority to approve, require modification (in order to secure approval), or disapprove all research activities covered by this Policy regardless of the source of the funding of the research. In order to approve research governed by this Policy, the IRB must review the full proposal, the consent form and all supplemental information such as, but not limited to the Investigator’s or Sponsor’s brochure and recruiting information.
Types of Research:
There are three categories of research done at Mount Auburn Hospital, all of which must turn in an application for research with IRB. Those three types are: Full Board Review, Expedited Research, and Exempt Research.
What is an investigator?
The term “investigator” is defined as an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB. For the purposes of the HHS regulations, OHRP interprets an “investigator” to be any individual who is involved in conducting human subject research studies. Such involvement would include:
- obtaining information about living individuals by intervening or interacting with them for research purposes;
- obtaining identifiable private information about living individuals for research purposes;
- obtaining the voluntary informed consent of individuals to be subjects in research; and
- studying, interpreting, or analyzing identifiable private information or data for research purposes.
Investigators can include physicians, scientists, nurses, administrative staff with the appropriate background and training to conduct the research required for each study. Some research studies are conducted by more than one investigator, and usually one investigator is designated the “principal investigator” with overall responsibilities for the study. In every human subjects research study, investigators have certain responsibilities regarding the ethical treatment of human subjects.
Mount Auburn Hospital is committed to conducting human subject research within all OHRP and FDA regulations and ethical principles, including the Declaration of Helsinki and the Belmont Report.