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Part 2 – IRB Structure and Process

The Institutional Review Board (IRB)

Central to all regulations and most ethical codes is that a group or committee, external to the study management, must make an evaluation of the study. The NGHS IRB conducts this evaluation by assessing, to the best of its abilities, projects to determine that it is likely that the rights and welfare of the human subjects will be protected. As an institutional standing committee, the IRB is empowered with the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction.

IRB Membership

The Common Rule establishes the minimal membership requirements for any IRB. In brief, on any IRB there must be:

  • One male and one female,
  • One "scientist" and one "non-scientist",
  • One member of the institution and one person unaffiliated with the institution,
  • Consideration" of diversity of race, gender, cultural backgrounds and sensitivity to community attitudes.

Among these people there should be the ability, through knowledge or experience, to:

  • Promote respect for its advice and counsel,
  • Review the most common types of studies,
  • Review the inclusion of any vulnerable population regularly reviewed by the board,
  • Assess acceptability of a study in terms of institutional commitments and regulations, and
  • Assess applicable law and standards of professional conduct and practice.
NGHS IRB Jurisdiction
  • Studies either conducted by or participated in by staff members of NGHS, medical or non-medical, when they are representing NGHS,
  • Studies conducted within NGHS facilities or property,
  • Studies conducted using private information under the jurisdiction of NGHS,
  • Studies conducted in a private practice or by community investigators but using NGHS facilities or services for standard, non-investigational procedures.

Research/projects approved by NGHS IRB may be subject to further review and approval by other NGHS entities and/or officials. However, other NGHS entities and/or officials may not approve research disapproved by NGHS IRB.

IRB Appointment, Terms, Meetings and Policies
  • Members are appointed to two fiscal year terms. Appointments are made by NGHS Administration from recommendations submitted by the IRB.
  • The NGHS IRB meets the first Thursday of each month; all correctly completed forms should be submitted to the IRB Office at least 18 days prior to the monthly meeting time.
  • The operating policies adopted by the Board are available online at www.nghs.com
Study Review Criteria

Research impacts established processes and workload. NGHS expects principal investigators to be responsible for the coordination of all aspects of proposed research. Therefore, it is strongly recommended that the proposed research and implementation logistics be reviewed and discussed with appropriate levels of administration and leadership BEFORE submission of a review application to the NGHS IRB.

Despite IRB approval, a study may be disapproved by other NGHS entities (e.g. Radiation Safety Committee; Infection Control Committee) or by other administrative offices (e.g. Risk Management; Nursing Administration). Those decisions are separate and independent of the IRB decision. However, research disapproved by the NGHS IRB may not be approved by other entities of NGHS.

Four "macro" questions are involved in the review. These questions must be answered affirmatively by the IRB to allow the study to be conducted at NGHS. These requirements are imposed equally on all studies, regardless of discipline, over which the NGHS IRB has jurisdiction.

1. Are the Regulatory Study Review Criteria Met?

The seven criteria for IRB approval of research are found in 45 CFR 46.111 and in 21 CFR 56.111 . The criteria are:

Regulation

Discussion

1. Risks to subjects are minimized

(i) By using procedures consistent with sound research design and which do not unnecessarily expose subjects to risk, and

(ii) Whenever appropriate, by using procedures already being performed on the person for diagnostic or therapeutic reasons

 

Phrasing questions more gently can minimize risks. By combining study follow-up visits with clinically indicated visits, by examining the eligibility requirements or by having procedures (e.g., interviews or cardiac catheterization) carried out by an appropriately trained person.

2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.

In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies that subjects would receive even if not participating in the research.) The IRB should not consider possible long range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

This ratio is often clear to those in the immediate field but is unclear to outsiders. The study, however, must be justified to the diverse members of the IRB. (Hint: would you be able to write an article based on the information in the documents?)

Is the question clear? Why is the information needed? Is there a gap or a question in the current knowledge? Is this for replication? Who will benefit from the end result? In what ways could the individual subject in the study benefit? What are the risks to the subject?

The evaluation is incremental as are those that are added to therapeutic risks. Potential misuse of information may be a source of concern but should not be included in the evaluation of the study. The IRB may be sufficiently concerned to raise the discussion or to seek input from others.

This is often an area in which questions of study design are raised. A study that is not capable of yielding fruitful results (Nuremberg Code) should not be undertaken.

Selection of subjects is equitable. In making this assessment, the IRB should take into account the purposes of the research and the setting in which the

The Belmont Report suggests that there should be justice in a study. The answers to this question are often found by combining the eligibility requirements with the

 

Regulation

Discussion

research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, handicapped, mentally disabled persons, or economically or educationally disadvantaged persons

 

statements of purpose. Although the original writers envisioned this concept to be exclusionary (that is, to exclude recruitment solely among the less autonomous), it has since been interpreted to also require inclusion. Thus, the question is whether any group is being unfairly targeted or excluded.

Is the recruitment process fair and equitable? Is the recruitment targeting only the most promising part of the population?

Can the question be answered fully with the subjects being sought? Is the subject pool overused (e.g. neonatal units)? Are people being unnecessarily excluded (e.g. women of child-bearing potential)?

4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with and to the extent required by 46.116.

This element refers to the process of consent.

Advertising and recruitment to subjects is a part of the consent process.

5. Informed consent will be appropriately documented, in accordance with and to the extent required by 46.117.

This element discusses the information aspects and the documentation.

6. When appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of subjects.

The role of Data Safety Monitoring boards and of study monitoring are relevant.

7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of files.

A major risk is that of harm done from loss of privacy. Provisions must be in place to guard data from both intended and unintended users.


2. Can the study be accomplished ethically given the resources and personnel involved?

Are the local conditions sufficient to support the study? Can a study that is ethical in one institution be unethical in another? There are several facets to the question.

a. Local Practices

In creating the IRB system the regulators expressed dependence upon the knowledge of the IRB members about what was happening locally. Knowledge might exist about such things as:

  • The fading skill of an expert
  • The competition for a scarce subject population
  • Rivalry between departments

A famous question arose several years ago when the NIH funded a study of AZT and fetal transmission of HIV. Although it had become standard to treat pregnant women with considerable amounts of AZT and then to treat the infant, it was almost unheard of in Africa. The trial, in Africa, proposed a placebo control against a reduced dose of AZT. Clearly the study would not be ethical in a place where full treatment was standard. Clearly, it is appropriate to find the lowest efficacious dose. Clearly, if a known effective regimen is available, it is unethical to use a placebo.

The question can be moved closer to Georgia. If a practice is known in San Francisco, or Alaska, is it transportable to Georgia? Or if it is studied in the NIH clinical study center, is it reasonable for NGHS? If the research base designs a protocol that "cannot be changed" is it necessarily appropriate for all sites?

If the study is randomized and depends upon equipoise between the arms, is that equipoise maintained with the practices at NGHS?

 

b. Resources:

If insurance cannot be billed, who will pay? If 500 subjects are asked for 5 years of blood samples, where will 2500 samples be stored? Is an MRI available?

One quite necessary resource is the individuals who will be invited to be research subjects. What is their availability? How can the right people be found?

c. Personnel:

Conducting research is not a right. It is a privilege allowed to those who have appropriate permission. The privilege can be denied for cause.

Only qualified people should conduct research. These are people who are expert in the field of inquiry and who are familiar with the requirements of ethical research. Doing research involves dedicated people who, with their multiple missions, still retain the basic ethical foundation to remember that the end does not justify the means.

      Are the people doing the study qualified to do what they are proposing to do? If special training is needed, has it been obtained? Are all study personnel expected to know the protocol details?

      Training in the ethical conduct of research is (becoming) required for all principal investigators. Certification is available for study coordinators.

d. Availability of services

Ambitious plans can be thwarted by a failure to have available resources. If clinical lab services are needed, who will pay for them? Does the clinical lab have time even if paid? If the protocol makes patients very ill and if nursing care is limited has the nursing service agreed?

3. Are all procedural requirements met?

Although the IRB functions independently of other organizational entities, it does function in coordination with them. Any successful research program requires the support of the entire institution as appropriate (e.g. Radiation Safety; OSHA; Accounting; Medical Staff).

Procedures may be done that are out of the ordinary. These often fall into the realm of the experimental or of innovative therapy. Professionals have the right and ability to innovate within the ethical confines of their profession. Not all new things need IRB review. Similarly, many things in life are risky. Not all risky things need IRB review.

4. Is this a study the institution and the people within it want to support?

Although the IRB may find no fault with a study, it may understand that it is not one that the institution may want to support. This would be an NGHS institutional decision to be made at the level of the CEO.

  • A highly risky study may involve more risk than the institution wants to assume.
  • An abortion study will never be approved in a catholic hospital.
  • A controlled study of an invalidated practice will not be likely in an institution that believes in that practice.
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