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INSTITUTIONAL REVIEW BOARD (IRB): ITS ROLE AND RESPONSIBILITY IN MAKING RESEARCH ETHICAL 

Dr. Abu Sadat Mohammad Nurunnabi 

Bangladesh Medical Research Council, Dhaka, Bangladesh. 

Email: shekhor19@yahoo.com  

 

ABSTRACT: This is a review article prepared as a part of the assignment in the educational activity and training on 

research ethics titled “Ethical and Regulatory Aspects of Clinical Research” arranged by the Bangladesh Bioethics 

Society (BBS), Dhaka, Bangladesh, in collaboration with the Department of Bioethics of National Institutes of Health 

(NIH), Bethesda, Maryland, USA, through video conferencing between September 25 and November 13 of 2013. The 

search was confined to ‘Google’, ‘HINARI’ and ‘PubMed’ published articles. Besides, some guidelines on roles and 

responsibilities of Institutional Review Board (IRB) were taken into consideration. Key words used for searching were 

‘institutional review board’, ‘ethical review committee’ and ‘ethical research’. A total of 18 journal articles and some 

guidelines were selected for this writing. The systemic review from the databases revealed some important 

discussions on research, ethical research, roles and responsibilities of IRB/ERC and its challenges, and 

national/institutional research strategies. 

Key words: Institutional review board (IRB), ethical review committee (ERC), ethical research, research strategy. 

INTRODUCTION: An Institutional Review Board (IRB), also known as an independent ethics committee or ethical 

review board, is a committee that has been formally designated to approve, monitor, and review biomedical and 

behavioral research involving humans
1
. They often conduct some form of risk-benefit analysis in an attempt to 

determine whether or not research should be done. The number one priority of IRBs is to protect human participants 

from physical or psychological harm
2
. In the United States, the Food and Drug Administration (FDA) and Department 

of Health and Human Services (HHS) (specifically Office for Human Research Protections) regulations have 

empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. 

IRBs are responsible for critical oversight functions for research conducted on human participants that are "scientific," 

"ethical," and "regulatory"
3
. 

Although designed to protect the research participants, IRBs have been criticized by bioethicists for conflicts of 

interest resulting in lax oversight. As of 2005, the for-profit Western Institutional Review Board claimed to conduct the 

majority of reviews for new drug submissions to the FDA
4
. In a 2006 study of 575 IRB members at university medical 

centers, over one-third reported industry financial ties and over one-third admitted they "rarely or never" disclosed 

conflicts of interest to other board members
5
. A 2009 sting operation by the Government Accountability Office led 

Coast IRB to shut down after approving the fake product "Adhesiabloc", called "the riskiest thing I’ve ever seen on 

this board" by one of the IRBs not approving the fake products
6
. 

 

Originally, IRBs are committees at academic institutions and medical facilities to monitor research studies involving 

human participants, primarily to minimize or avoid ethical problems
7
. More accurately to say, conflict of interest of the 

researchers, indemnity for the protection of participants and confidentiality of data are widely accepted as core ethical 

issues in any research
8
. However, the Belmont Report

9
 exists because of the unfortunate history of unethical 

mailto:shekhor19@yahoo.com
http://en.wikipedia.org/wiki/Committee
http://en.wikipedia.org/wiki/Biomedical
http://en.wikipedia.org/wiki/Behavioral
http://en.wikipedia.org/wiki/Research
http://en.wikipedia.org/wiki/Risk-benefit_analysis
http://en.wikipedia.org/wiki/United_States
http://en.wikipedia.org/wiki/U.S._Food_and_Drug_Administration
http://en.wikipedia.org/wiki/United_States_Department_of_Health_and_Human_Services
http://en.wikipedia.org/wiki/United_States_Department_of_Health_and_Human_Services
http://en.wikipedia.org/wiki/Office_for_Human_Research_Protections
http://en.wikipedia.org/wiki/Conflicts_of_interest
http://en.wikipedia.org/wiki/Conflicts_of_interest
http://en.wikipedia.org/w/index.php?title=Western_Institutional_Review_Board&action=edit&redlink=1
http://en.wikipedia.org/wiki/Government_Accountability_Office
http://en.wikipedia.org/w/index.php?title=Coast_IRB&action=edit&redlink=1
http://en.wikipedia.org/w/index.php?title=Adhesiabloc&action=edit&redlink=1


Bangladesh Journal of Bioethics 2014; 5(1):5-10 

 

 6 

research conducted on human participants in earlier times. This review has been prepared to highlight some of the 

key issues on roles and responsibilities of IRB to make a research ethical. 

METHODS:This is a review article prepared as a part of the assignment in the educational activity and training on 

research ethics titled “Ethical and Regulatory Aspects of Clinical Research” arranged by the Bangladesh Bioethics 

Society (BBS), Dhaka, Bangladesh, in collaboration with the Department of Bioethics of National Institutes of Health 

(NIH), Bethesda, Maryland, USA, through video conferencing between September 25 and November 13 of 2013. The 

search was confined to Google, HINARI and PubMed published articles. Besides, some guidelines on roles and 

responsibilities of IRB were taken into consideration. Key words used for searching were ‘institutional review board’, 

‘ethical review committee’ and ‘ethical research’. A total of 18 journal articles and some guidelines were collected and 

selected for this writing. 

RESULTS: The systemic review from the databases revealed some important discussions on research, ethical 

research, roles and responsibilities of IRB/ERC and its challenges, and national/institutional research strategies. 

Research is defined as a systematic investigation designed to develop or contribute to generalized knowledge, or 

investigation designed to test a hypothesis
10

. The pursuit of new knowledge is considered one of the core missions of 

almost all institutions. To advance these missions, they must be committed to ensuring that research activities are 

conducted properly and consistently with the principles of openness, trust, and respect for the human participants. 

Any systematic investigation (including curricular evaluation) that is designed to develop or contribute to generalized 

knowledge, and which uses living humans or identifiable private information about living humans, qualifies as human 

subjects research
11

. Risk refers to the probability of harm or discomfort (these can be physical, psychological, social 

or economic) occurring as a result of participation in a research study. Both the probability and the magnitude of 

possible harm may vary from minimal to significant
12

. However, a risk is minimal when the probability and magnitude 

of harm or discomfort anticipated in the proposed research are not greater than those encountered in daily life
13

. The 

Department of Health and Human Services [45 CFR 46.111(b)] and Food and Drug Administration [21 CFR 

56.111(b)] regulations require that additional safeguards be in place to protect the rights and welfare of research 

subjects "when all or some of the subjects are likely to be vulnerable to coercion or undue influence". The regulations 

do not provide a definitive list of vulnerable populations; they leave it largely to the discretion of the IRB. Some 

populations/groups that may be considered "vulnerable" include: pregnant women, children, prisoners, mentally 

challenged individuals, economically or educationally disadvantaged individuals and groups, etc.
14

. Research that 

specifically targets a vulnerable population will receive a higher level of scrutiny than other protocols. This additional 

scrutiny is to insure that individuals are not being coerced into participation, that the consent process is culturally 

appropriate, etc. It is also important to remember that vulnerability must be considered in terms of the specific 

research proposed - not all groups are vulnerable in all situations
15

. 

Every research institute should formulate a policy statement, which should be made available to the IRB. It should 

mention the type of research it will undertake, e.g. pre-clinical toxicology, animal studies in pharmacology or 

pathology, epidemiological surveys, clinical trials involving patients and studies using healthy volunteers, depending 

on its resources and infrastructure
16

. This will help in deciding the types of studies to be avoided. The purpose of 

research i.e. the benefits to be expected from the point of view of its staff, clients, students, society in general or the 

local community and the institute itself should be revealed in this policy
16

.  



Bangladesh Journal of Bioethics 2014; 5(1):5-10 

 

 7 

Some IRB reviews are conducted by for-profit organizations known as 'independent' or 'commercial' IRBs. The 

responsibilities of these IRBs are identical to those based at academic or medical institutions, and they are governed 

by the same federal regulations. The composition of an IRB for the FDA's requirements
17

 is set in 21 CFR 56.107. 

(a) 1 The IRB must have at least five members.  

(a) 2 The members must have enough experience, expertise, and diversity to make an informed decision on 

whether the research is ethical, informed consent is sufficient, and appropriate safeguards have been put in 

place. 

(a) 3 If the IRB works with studies that include vulnerable populations, the IRB should have members who 

are familiar with these groups. It is common for an IRB to include an advocate for prisoners when 

considering research that involves them. 

(b) 1 The IRB should include both men and women, as long as they aren't chosen specifically for their 

gender. 

(b) 2 The members of the IRB must not be all of the same profession. 

(c)  The IRB must include at least one scientist and at least one non-scientist. These terms are not defined 

in the regulations. 

(d) The IRB must include at least one person who is not affiliated with the institution or in the immediate 

family of a person affiliated with the institution. These are commonly called "Community Members." 

(e) IRB members may not vote on their own projects. 

(f) The IRB may include consultants in their discussions to meet requirements for expertise or diversity, but 

only actual IRB members may vote. 

To vote on a proposal, more than half of the members of the board must be present and there must be a nonscientist 

present. Exceptions for expedited review are available, where only the chair of the committee or a designee reviews 

research, but these are relatively narrow
17

. 

The primary ethical principles in human subjects review are outlined in the Belmont Report
9
, and include ‘respect for 

persons’, ‘beneficence’, and ‘justice’. It clearly explains the three principles that are the main tools that all IRB 

members should use to evaluate the ethics of specific research proposals. Respect for persons is the first principle 

which mandates that subjects voluntarily consent to participate in research, that they are adequately and thoroughly 

informed about the research and what is required, and that their privacy and confidentiality are protected. 

Beneficence is the second principle which mandates the risks of research are justified by potential benefits to the 

individual or society and that those risks are minimized. Justice is the third and final principle which mandates the 

equitable distribution of risks and benefits among those who may benefit from the research, meaning that one subset 

of a population should not take on all the burden of risk and reap all of the rewards; risks and rewards should be 

applicable and available to all subsets of a community. The IRB may only approve research for which there is a bona 

fide informed consent process for participants, for which the risks to subjects are balanced by potential benefits to 

society, and for which the selection of subjects presents a fair or just distribution of risks and benefits to eligible 

participants
18

. 

The IRB/ERC should review a proposed clinical trial within a reasonable time and document its views in writing, 

clearly identifying the trial, the documents reviewed and the dates for the following
19

: 

http://en.wikipedia.org/wiki/Belmont_Report
http://en.wikipedia.org/wiki/Bona_fide
http://en.wikipedia.org/wiki/Bona_fide
http://en.wikipedia.org/wiki/Informed_consent
http://en.wikipedia.org/wiki/Clinical_trial


Bangladesh Journal of Bioethics 2014; 5(1):5-10 

 

 8 

 approval/favourable opinion 

 modifications required prior to its approval/favourable opinion 

 disapproval/negative opinion 

 termination/suspension of any prior approval/favourable opinion 

According to International Conference on Harmonisation - Good Clinical Practice (ICH-GCP)
20

, an IRB should 

safeguard the rights, safety, and well-being of all trial subjects. the IRB should consider the qualifications of the 

investigator for the proposed trial, as documented by a current curriculum vitae and/or by any other relevant 

documentation the IRB requests. Moreover, the IRB/IEC should conduct continuing review of each ongoing trial at 

intervals appropriate to the degree of risk to human subjects, but at least once per year. The IRB may request more 

information when in the judgment of the IRB the additional information would add meaningfully to the protection of the 

rights, safety and/or well-being of the subjects. When a nontherapeutic trial is to be carried out with the consent of the 

subject's legally acceptable representative, the IRB should determine that the proposed protocol and/or other 

document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such 

trials. Where the protocol indicates prior consent of the trial subject or the subject's legally acceptable representative 

is not possible, the IRB/ERC should determine that the proposed protocol and/or other document(s) adequately 

addresses relevant ethical concerns and meets applicable regulatory requirements for such trials (i.e., in emergency 

situations). The IRB should review both the amount and method of payment to subjects to assure neither presents 

problems of coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not 

wholly contingent on completion of the trial by the subject. Last but not the least, the IRB should ensure the 

information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial 

subjects, is set forth in the written informed consent form and any other written information to be provided to subjects. 

The way payment will be prorated should be specified. 

The purpose of institutional review boards or research ethics committees or ethical review committees is to ensure 

that studies involving human research participants are designed to conform the relevant ethical standards and that 

the rights and welfare of participants are protected
21

. Research ethics committees should not function under political 

control or one’s sweet will
22

. Ethics committees must be independent of research organizations. This independence 

relates to their decisions, not their operating processes
23

. In spite of the roles and responsibilities of IRBs, the fact is 

that many are overloaded, understaffed and faced with a variety of skeptical criticism. Many IRBs are lacking the 

resources and staff to carry out the hefty task of reviewing research
24,25

. 

BANGLADESH SCENARIO: It is praise-worthy that Bangabandhu Sheikh Mujib Medical University (BSMMU), the 

one and only medical university of the country, National Institute of Preventive and Social Medicine (NIPSOM), all the 

government medical colleges and different specialized government health institutes have got their own institutional 

review boards (IRBs) or ethical review committees (ERCs) for conducting research by the faculties, physicians, 

residents and students. However, several challenges have been identified in monitoring function of IRBs on ongoing 

research in terms of annual review, consent, adherence to protocol, data integrity, auditing and quality assurance
2
. 

Bangladesh Medical Research Council (BMRC), the focal point for all biomedical research in the country, has got a 

strong ‘National Research Ethics Committee’ to review the ethical aspects of a research project
26

. This committee 

was established in 1979. At present committee consists of 11 members. The clinicians, lawyers, laypersons and 

http://en.wikipedia.org/wiki/International_Conference_on_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Use
http://en.wikipedia.org/wiki/Good_Clinical_Practice


Bangladesh Journal of Bioethics 2014; 5(1):5-10 

 

 9 

religious leaders are included as members. The Committee is formed by the Executive Committee of the BMRC and 

has tenure of three years. The committee is registered in the Office for Human Resource Protection in the USA as an 

Official Institutional Review Board and it has federal wide assurance
2
. 

What is needed in our country is that all institutional review boards (IRBs) in Bangladesh should be operated in a 

standard fashion, providing an impartial, unbiased review and quick decision and thus facilitating a healthy 

atmosphere for ethical research in biomedical science in our country
8
. Directorate General of Health Services 

(DGHS), Bangladesh, published a ‘National Health Research Strategy’ in 2009 with technical assistance from 

Bangladesh Medical Research Council (BMRC) and World Health Organization (WHO) featuring different aspects of 

biomedical research which include institutional framework, priority setting, ethical clearance, financing, monitoring 

and evaluation, capacity development, dissemination and utilization of research results
27

. Understanding the function 

of the IRB requires an appreciation for the rules by which it is governed, as well as the history and circumstances that 

influenced the creation of those rules. Researchers who appreciate the IRB's purpose will be better equipped to 

navigate the labyrinth of research guidelines and regulations
28

. 

CONCLUSION: Biomedical research has expanded tremendously in the past few decades and consequently there 

has been growing interest in the ethical guidelines that are being followed for the protection of human participants. 

Toward that end and consistent with existing regulations, institutional review board should formulate policies and 

procedures to ensure that financial and non-financial relationships with sponsors or other external entities related to 

the conduct or review of research do not adversely affect the rights and welfare of research volunteers or the integrity 

of the research. 

REFERENCES:  

1. The Office of Human Research Protection. Institutional Review Board Guidebook. Chapter 3, Section A: 

Risk/Benefit Analysis. p. 1-10. Available from: http://www.saylor.org/site/wp-

content/uploads/2011/08/PSYCH202A-3.1.4-Institutional-Review-Board.pdf. [Retrieved November 30, 2013]. 

2. Talukder MHK, Hossain MZ, Akhter N, Perveen IA. Institutional Ethical Review Board (IERB): concept & 

contect. Bangladesh J Bioethics 2011; 2(2): 24-5. 

3. Emanuel EJ, Crouch RA, Arras JD, Moreno JD, Grady C. Ethical and Regulatory aspects of clinical 

research: readings and commentary. Baltimore: Johns Hopkins University Press; 2003: p.7-20. 

4. Elliott C, Lemmens T. Ethics for sale: For-profit ethical review, coming to a clinical trial near you. 

http://www.slate.com/articles/health_and_science/medical_examiner/2005/12/ethics_for_sale.html . 

[Retrieved November 30, 2013]. 

5. Alliance for Human Research Protection. Hospital IRBs are "On the Take"--Tainted by Conflicts of Interest - 

NEJM. Available from: http://www.ahrp.org/cms/content/view/402/100 [Retrieved November 30, 2013]. 

6. United States Government Accountability Office. Human subjects research: undercover tests show the 

institutional review board system is vulnerable to unethical manipulation. Available from: 

http://www.gao.gov/new.items/d09448t.pdf . [Retrieved November 30, 2013]. 

7. Wolf LE, Croughan M, Lo B. The challenges of IRB review and human subjects protections in practice-

based research. Med Care 2002; 40(6): 521-9. 

http://www.saylor.org/site/wp-content/uploads/2011/08/PSYCH202A-3.1.4-Institutional-Review-Board.pdf
http://www.saylor.org/site/wp-content/uploads/2011/08/PSYCH202A-3.1.4-Institutional-Review-Board.pdf
http://www.banglajol.info/index.php/BIOETHICS/article/view/9542
http://www.banglajol.info/index.php/BIOETHICS/article/view/9542
http://www.slate.com/articles/health_and_science/medical_examiner/2005/12/ethics_for_sale.html
http://www.ahrp.org/cms/content/view/402/100
http://www.gao.gov/new.items/d09448t.pdf
http://www.ncbi.nlm.nih.gov/pubmed?term=Wolf%20LE%5BAuthor%5D&cauthor=true&cauthor_uid=12021678
http://www.ncbi.nlm.nih.gov/pubmed?term=Croughan%20M%5BAuthor%5D&cauthor=true&cauthor_uid=12021678
http://www.ncbi.nlm.nih.gov/pubmed?term=Lo%20B%5BAuthor%5D&cauthor=true&cauthor_uid=12021678
http://www.ncbi.nlm.nih.gov/pubmed/12021678


Bangladesh Journal of Bioethics 2014; 5(1):5-10 

 

 10 

8. Nurunnabi ASM, Jahan MU, Tanira S. Ethical issues in public health research. Bangladesh J Bioethics 

2010; 1(3): 15-21. 

9. Rice TW. The historical, ethical, and legal background of human-subjects research. Respir Care 2008; 

53(10): 1325-9. 

10. Freshwater D, Sherwood G, Drury V. International research collaboration. Issues, benefits and challenges of 

the global network. J Res Nursing 2006; 11(4): 9295-303. 

11. Schwenzer KJ. Protecting vulnerable subjects in clinical research: children, pregnant women, prisoners, and 

employees. Respir Care 2008; 53(10): 1342-9 

12. Orticio LP. Protecting human subjects in research. Insight 2009; 34(3): 14-6. 

13. MacDougall DS. Human subject protection in clinical trials. J Int Assoc Physicians AIDS Care 1997; 3(1): 19-

23. 

14. Fleischman AR. Regulating research with human subjects: Is the system broken? Trans Am Clin Climatol 

Assoc 2005; 116: 91-102. 

15. National Institutes of Health. Guidelines for the conduct of research involving human subjects at the National 

Institutes of Health. 2004. http://ohsr.od.nih.gov/guidelines/GrayBooklet82404.pdf . [Retrieved November 19, 

2013]. 

16. Shrotri DS. Role of ethics committees in medical research. Indian J Med Ethics 2004; 1(4): 121. 

17. Code of Federal Regulations. Title 21: Food and Drugs. Chapter I: Food and Drug Administration, 

Department Of Health And Human Services. Subchapter A: General. Part 56: Institutional Review Boards. 

Subpart B: Organization and Personnel. http://cfr.vlex.com/vid/56-107-irb-membership-19703309 . 

[Retrieved November 19, 2013]. 

18. Pech C, Cob N, Cejka JT. Understanding institutional review boards: practical guidance to the IRB review 

process. Nutr Clin Pract 2007; 22(6): 618-28. 

19. International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for 

human use. http://ichgcp.net/3-institutional-review-boardindependent-ethics-committee-irbiec  [Retrieved 

November 19, 2013]. 

20. Skolnick BE. Ethical and institutional review board issues. Adv Neurol 1998; 76: 253-62. 

21. Fairchild AL, Bayer R. Ethics and the conduct of public health surveillance. Science 2004; 303: 631-2. 

22. Wald SD. Bureaucracy of ethics applications. BMJ 2002; 329: 282-4. 

23. Pattison J, Stacey T. Research bureaucracy in the United Kingdom: seeking a balance: response from the 

Department of Health and COREC. BMJ 2004; 329(7466): 622. 

24. Kim WO. Institutional review board (IRB) and ethical issues in clinical research. Korean J Anesthesiol 2012; 

62(1): 3-12. 

25. Straight TM. Clinical research regulation: challenges to the institutional review board system. Clin Dermatol 

2009; 27(4): 375-83. 

26. Bangladesh Medical Research Council (BMRC). RICH. Dhaka: 2008. 

27. Directorate General of Health Services (DGHS). National Health Research Strategy. Ministry of Health and 

Family Welfare, Government of the People’s Republic of Bangladesh, Dhaka: 2009. 

28. Hart R, Belotto M. The institutional review board. Semin Nucl Med 2010; 40(5): 385-92. 

http://www.ncbi.nlm.nih.gov/pubmed?term=Rice%20TW%5BAuthor%5D&cauthor=true&cauthor_uid=18811995
http://www.ncbi.nlm.nih.gov/pubmed/18811995
http://www.ncbi.nlm.nih.gov/pubmed?term=Schwenzer%20KJ%5BAuthor%5D&cauthor=true&cauthor_uid=18811998
http://www.ncbi.nlm.nih.gov/pubmed/18811998
http://www.ncbi.nlm.nih.gov/pubmed?term=Orticio%20LP%5BAuthor%5D&cauthor=true&cauthor_uid=19708428
http://www.ncbi.nlm.nih.gov/pubmed/19708428
http://www.ncbi.nlm.nih.gov/pubmed?term=MacDougall%20DS%5BAuthor%5D&cauthor=true&cauthor_uid=11363958
http://www.ncbi.nlm.nih.gov/pubmed/11363958
http://ohsr.od.nih.gov/guidelines/GrayBooklet82404.pdf
http://www.issuesinmedicalethics.org/issue124.html
http://cfr.vlex.com/vid/56-107-irb-membership-19703309
http://www.ncbi.nlm.nih.gov/pubmed?term=Pech%20C%5BAuthor%5D&cauthor=true&cauthor_uid=18042949
http://www.ncbi.nlm.nih.gov/pubmed?term=Cob%20N%5BAuthor%5D&cauthor=true&cauthor_uid=18042949
http://www.ncbi.nlm.nih.gov/pubmed?term=Cejka%20JT%5BAuthor%5D&cauthor=true&cauthor_uid=18042949
http://www.ncbi.nlm.nih.gov/pubmed/18042949
http://ichgcp.net/3-institutional-review-boardindependent-ethics-committee-irbiec
http://www.ncbi.nlm.nih.gov/pubmed?term=Skolnick%20BE%5BAuthor%5D&cauthor=true&cauthor_uid=9408484
http://www.ncbi.nlm.nih.gov/pubmed/9408484
http://www.ncbi.nlm.nih.gov/pubmed?term=Hart%20R%5BAuthor%5D&cauthor=true&cauthor_uid=20674597
http://www.ncbi.nlm.nih.gov/pubmed?term=Belotto%20M%5BAuthor%5D&cauthor=true&cauthor_uid=20674597
http://www.ncbi.nlm.nih.gov/pubmed/20674597



