Skip to main content

Protection of Human Subjects & Constitution of IRB

BayBiotech.NET
Scope: the policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research.
This policy does not affect any state, local or foreign laws or regulations which may otherwise be applicable and which provide additional protections for human subjects.
Exclusions:
 Research conducted in educational settings, examples: research on education instructional strategies, on comparison among instructional techniques, curricula, or classroom management methods.
 Research involving survey procedures, interview procedures or observation of public behavior, unless information is recorded in such a manner that human subjects can be identified.
 Research involving the collection of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers.
 Research and demonstration projects which are conducted for the approval of department or agency heads, and are designed to study, evaluate, or examine:
Public benefits, procedures for obtaining benefits or services under those programs;
 Taste and food quality evaluation and consumer acceptance studies,
Institutional Review Board: Each and every institution engaged in research on human subjects has a review board to determine the compliance of submitted research proposal with local, state and federal regulations with main focus to protect violations of human subjects in terms of privacy and confidentiality of information. Such review boards are called IRB (Institutional Review Board) and as per NCI’s definition, “IRB is a group of scientists, doctors, clergy, and consumers that reviews and approves the action plan for every clinical trial. There is an IRB at every health care facility that does clinical research. IRBs are designed to protect the people who take part in a clinical trial. IRBs check to see that the trial is well designed, legal, and ethical, does not involve unnecessary risks, and includes safeguards for patients”.
According to Title 45, part 46 an IRB must constitute of the following:

(1) Each IRB shall have at least five members, with varying backgrounds of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice in safeguarding the rights and welfare of human subjects.

(2) In order to determine the acceptability of proposed research in terms of institutional commitments and regulations, applicable local, state and federal law, and standards of professional conduct and practice, IRB shall include persons knowledgeable in these areas.

(3) If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.

(4) Every effort must be made to ensure that no IRB consists entirely of men or entirely of women.

(5) An IRB must not consist of entirely members from one profession.

(6) Each IRB shall include at least one member from scientific area and at least one member from nonscientific areas.

(7) IRB shall include at least one member who is not affiliated with the institution and is not part of the immediate family of a person affiliated with the institution.

(8) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest.

(9) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise.
For further readings, follow the link: http://www.hhs.gov/ohrp/documents/OHRPRegulations.pdf

Comments

Post a Comment

Popular posts from this blog

Harmonization by Doing (HBD): Japan & U.S. Collaboration

BayBiotech.NET HBD is an international cooperative effort by Japan and US for regulatory convergence for Medical Devices. The efforts are focused on to develop global clinical trials and address regulatory barriers for timely device approvals. To address the needs for additional evaluation, the HBD initiative is a pilot project launched jointly by FDA and MHLW-PMDA for the premarket review of device cardiovascular technology. Instead of taking a theoretical approach to harmonization, HBD is focused on Proof of concept by utilizing parallel development, application submissions and review of actual medical device projects. HBD Study intends to collect and analyze regulatory submission data from multiple applications in the U.S. and Japan. The purpose of the study is to further understand differences that may exist with format and content, to define best practices and to improve globally harmonized processes. To read more about the HBD program, follow the link: http://www.fda.gov/M...
Post a Comment
Read more

Amendments for High Risk Device Type Regulatory Pathway

BayBiotech.NET Government Accounting Office (“GAO”) has issued a long-awaited report evaluating the use of the 510(k) process by the Food and Drug Administration (“FDA” or the “Agency”) in the January of 2009. Report mainly focused on Preamendment class III devices. Although most high-risk class III medical devices are subject to the demanding premarket approval (“PMA”) process, preamendment class III devices may be cleared through the 510(k) pathway until FDA issues regulations requiring a PMA. Under the Safe Medical Devices Act of 1990, FDA was required either to reclassify preamendment class III devices into class I or II, or (2) issue regulations requiring PMA approval for the devices, GAO noted that 20 preamendment class III device types have not yet been addressed by the Agency. GAO has urged FDA to take required steps to address the remaining class III devices that continue to be eligible for 510(k) review. As a result of the report, FDA has committed to address al...
Post a Comment
Read more

Risk Based Clinical Monitoring

BayBiotech.NET FDA's recommendation of Risk Based Monitoring of Clinical Trials , as published in their Draft Guidance in August 2011. For the first time, FDA provided guidance on monitoring of clinical investigations in 1988 which was recently withdrawn, stated that the “most effective way” to monitor an investigation was to “maintain personal contact between the monitor and the investigator throughout the clinical investigation.” At the time the guidance was issued, sponsors had only limited ways to effect meaningful communication with investigators other than through on-site visits.   This guidance recommends an assessment by the sponsor for the need of 100% on-site monitoring. Such an assessment may be based on the complexity of the study protocol and not be generally applicable to all trial types. It explains the importance of remote monitoring facilitated by the use of electronic data capture system (EDC) and also emphasizes the need of the identifying crit...
1 comment
Read more