Sites-Irb | ASER - Academy of Science, Education & Research

ASER IRB Program

What is IRB?

IRB (Institutional Review Board) is an independent committee set up to protecting the rights and welfare of human research subjects recruited to participate in research studies. The committee assures that the study complies with the scientific and ethical standards. In order to help research staff understand the condition of subjects and human rights, IRB includes medical personnel, social justice, legal experts, and representatives of local organizations, non-governmental group, and non-medical professionals.

Why IRB?

IRB is responsible for protecting the rights and welfare of the human research subjects, it must be designed, reviewed, approved, and implemented in acceptable ethical principles and regulatory. The government requires any drug or device must be studied in research before it sells. Investigators cannot begin research with human subjects until a complete application has been submitted to the IRB, reviewed and approved.

The following definitions are provided to help investigators determine if their work requires IRB review and approval.

involving human subjects which means a living individual about whom an investigator conducting research obtains
using records gathered on human subjects
involving human tissue

Why ASER IRB

Mission Statements:

ASER is a non-profit organization which operates independently and has been in business since 1997. Our mission is to help facilitate potentially valuable research in a manner that safeguards the human participant, promotes compliance with the FDA regulations, and takes into consideration the ethics and scientific design of the protocol.

Our Board:

ASER IRB also has sufficient expertise such as appropriate specialists on board to evaluate the studies of design, risks and benefits.

In addition, ASER IRB Board members has a thorough understanding of conflict of interest principles. We can recognize and respond to a wide variety of conflict situations and reinforce this training frequently through continuing education. Detailed membership lists are available by contacting us directly.

As ASER IRB, our relationships with customers are based on and driven by our Mission Statement. Our board members and employees continually maintain high standards of quality, ethical integrity, and regard for human safety while being responsive to customer demands and needs with professional services. Customers and clients requested the flexibility to forward requests for approval of research with a shorter lead time, but still receive the high standards of scientific review, attention to detail, and responsiveness.

Helpful Links

Food and Drug Administration (FDA)

FDA Forms - Devices www.fda.gov/opacom/morechoices/fdaforms/cdrh.html
FDA Forms - Drugs www.fda.gov/opacom/morechoices/fdaforms/cder.html
21 CFR 50- Protection of Human Subjects www.access.gpo.gov/nara/cfr/waisidx_00/21cfr50_00.html

National Institutes of Health (NIH)

Office of Grants and Contracts grants.nih.gov/grants/oer.htm
National Human Genome Research Institute www.genome.gov/

Office for Human Subject Research Protection (OHRP)

IRB Guidebook www.hhs.gov/ohrp/irb/irb_guidebook.htm
OHRP Guidance (listed by topic) www.hhs.gov/ohrp/policy/index.html#topics
OHRP Compliance Oversight Procedures www.hhs.gov/ohrp/references/ohrpcomp.pdf
Human Subject Regulations Decision Charts www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm