2a. The Institutional Review Boards (IRB) are entrusted to protect the rights and safety of participants undergoing clinical research studies. The regulations formulated for reviewing, approving and conductiong research on humans generally refer to such independant boards like IRB. IRB has been recognised as one component of Human Research Protection Program (HRPP) of the Asssociation for the Accreditation of Human Research Protection Program (AAHRPP) formed in 2001. The IRB shoulkd have atleast FIVE members from diverse scientific and non-scientific backgrounds; professional domains, and cultural interests including gender, race and attitude toward community issues. Atleast one memebr should be from scientific area (having primary concern in scientific area such as physician, Ph D level physical or biological scientists) and atleast one from non-scientific area (FDA regulation: 21 CFR 56.107 (C)). Also atleast one member should not be affiliated with the institution directly or be a community member. Primary source of information: Jacobs M R (2014) Institutional Review Boards and Independant Ethics Committees, White paper. Technical report. b. Most IRB\'s consist of more than five members to encompass additional expertise while convening the meetings. As per the regulations of International Conference on Harmonisation (ICH), department of Health and Human sciences (DHHS) and the Food and Drug Administration (FAD), the memebers of IRB should have adequate expertise in assessing the quality of science, medical aspects of proposed research and the ethics of conducting studies.This implies the need to have atleast one member as physician. IRB can also approve an alternate member in the absence of the primary member. Even outside consultants can be invited to have opinion on scientific and ethical issues beyond the expertise of the convened committee, however, they do not have the right to vote for approving the research. When the research involve vulnerable populations such as children, prisoners, pregnant women, handicapped and mentally impaired, the individuals having expertise and understanding on the issue should be included. So also, the participants or subjects in the research study who can become potential vulnerable groups should also be considered. c. The IRB reviews the clinical trial protocols and ensure that the participants have minimal risks in relation to the benefits from the research. Such reviews are done before and during the trials. The IRB perform periodic reviews or continuing reviews through out the entire duration of the trial. Such reviews happen atleast once a year and cover the entire trials and not just changes. The IRB also seek additional information about the payments and compenations to study participants and informed consent process. Solution 2a. The Institutional Review Boards (IRB) are entrusted to protect the rights and safety of participants undergoing clinical research studies. The regulations formulated for.

1. 2a. The Institutional Review Boards (IRB) are entrusted to protect the rights and safety of
participants undergoing clinical research studies. The regulations formulated for reviewing,
approving and conductiong research on humans generally refer to such independant boards like
IRB. IRB has been recognised as one component of Human Research Protection Program
(HRPP) of the Asssociation for the Accreditation of Human Research Protection Program
(AAHRPP) formed in 2001.
The IRB shoulkd have atleast FIVE members from diverse scientific and non-scientific
backgrounds; professional domains, and cultural interests including gender, race and attitude
toward community issues. Atleast one memebr should be from scientific area (having primary
concern in scientific area such as physician, Ph D level physical or biological scientists) and
atleast one from non-scientific area (FDA regulation: 21 CFR 56.107 (C)). Also atleast one
member should not be affiliated with the institution directly or be a community member.
Primary source of information: Jacobs M R (2014) Institutional Review Boards and Independant
Ethics Committees, White paper. Technical report.
b. Most IRB's consist of more than five members to encompass additional expertise while
convening the meetings. As per the regulations of International Conference on Harmonisation
(ICH), department of Health and Human sciences (DHHS) and the Food and Drug
Administration (FAD), the memebers of IRB should have adequate expertise in assessing the
quality of science, medical aspects of proposed research and the ethics of conducting
studies.This implies the need to have atleast one member as physician. IRB can also approve an
alternate member in the absence of the primary member. Even outside consultants can be invited
to have opinion on scientific and ethical issues beyond the expertise of the convened committee,
however, they do not have the right to vote for approving the research.
When the research involve vulnerable populations such as children, prisoners, pregnant women,
handicapped and mentally impaired, the individuals having expertise and understanding on the
issue should be included. So also, the participants or subjects in the research study who can
become potential vulnerable groups should also be considered.
c. The IRB reviews the clinical trial protocols and ensure that the participants have minimal risks
in relation to the benefits from the research. Such reviews are done before and during the trials.
The IRB perform periodic reviews or continuing reviews through out the entire duration of the
trial. Such reviews happen atleast once a year and cover the entire trials and not just changes.
The IRB also seek additional information about the payments and compenations to study
participants and informed consent process.
Solution

2. 2a. The Institutional Review Boards (IRB) are entrusted to protect the rights and safety of
participants undergoing clinical research studies. The regulations formulated for reviewing,
approving and conductiong research on humans generally refer to such independant boards like
IRB. IRB has been recognised as one component of Human Research Protection Program
(HRPP) of the Asssociation for the Accreditation of Human Research Protection Program
(AAHRPP) formed in 2001.
The IRB shoulkd have atleast FIVE members from diverse scientific and non-scientific
backgrounds; professional domains, and cultural interests including gender, race and attitude
toward community issues. Atleast one memebr should be from scientific area (having primary
concern in scientific area such as physician, Ph D level physical or biological scientists) and
atleast one from non-scientific area (FDA regulation: 21 CFR 56.107 (C)). Also atleast one
member should not be affiliated with the institution directly or be a community member.
Primary source of information: Jacobs M R (2014) Institutional Review Boards and Independant
Ethics Committees, White paper. Technical report.
b. Most IRB's consist of more than five members to encompass additional expertise while
convening the meetings. As per the regulations of International Conference on Harmonisation
(ICH), department of Health and Human sciences (DHHS) and the Food and Drug
Administration (FAD), the memebers of IRB should have adequate expertise in assessing the
quality of science, medical aspects of proposed research and the ethics of conducting
studies.This implies the need to have atleast one member as physician. IRB can also approve an
alternate member in the absence of the primary member. Even outside consultants can be invited
to have opinion on scientific and ethical issues beyond the expertise of the convened committee,
however, they do not have the right to vote for approving the research.
When the research involve vulnerable populations such as children, prisoners, pregnant women,
handicapped and mentally impaired, the individuals having expertise and understanding on the
issue should be included. So also, the participants or subjects in the research study who can
become potential vulnerable groups should also be considered.
c. The IRB reviews the clinical trial protocols and ensure that the participants have minimal risks
in relation to the benefits from the research. Such reviews are done before and during the trials.
The IRB perform periodic reviews or continuing reviews through out the entire duration of the
trial. Such reviews happen atleast once a year and cover the entire trials and not just changes.
The IRB also seek additional information about the payments and compenations to study
participants and informed consent process.