IRBs and investigators are expected to be partners within the same institutional framework. The internal IRB is expected to be conversant with institutional ideals, review processes, commitments, space, and resources. The investigator understands the institutional culture and requirements. There is a built-in grapevine that allows rumors and innuendo to reach the ears of IRB members. To have the IRB internally also creates a built-in conflict of interest in which IRBs may be more eager to promote research that might not otherwise receive approval.
IRBs may be (a) within the same institutional framework (b) within the same facility but remote from the performance site (as in a system-wide IRB.) Alternatively, the IRB may be (c) remote from the site and connected contractually.
WHAT DO FEDERAL GUIDELINES SAY?
OPRR: “The IRB must have a working knowledge of the performance site. For example, if a university were to review for another local hospital they would need to have a working relationship and someone from the local hospital would need to have a membership on the IRB. That person should be a representative of the performance site and not be the PI or a member of the staff. He indicated that OPRR becomes very concerned about IRB review across state lines unless the IRB can demonstrate knowledge of the laws of the state.” (Tom Puglisi, OPRR, 4/97)
The FDA Information Sheet titled "Non-Local IRB Review" says: "regulations do not prohibit review of research by IRBs in locations other than where the research is to be performed (e.g., independent IRB or national IRB).
Therefore, an IRB may review studies that are not performed on-site as long as the 21 CFR parts 50 and 56 requirements are met."
HOW CAN LOCAL ISSUES BE ADDRESSED REMOTELY?
Site visits are one way to assess local issues. But this section is about doing review remotely. A diverse IRB membership that has traveled and lived in a variety of areas is essential for recognizing the diversity within the United States. However, because no state or city and few towns are totally homogenous, simple travel, while helpful, is insufficient.
A remote IRB must ask for information. This can be on the initial investigator questionnaire or through later questioning. The remote IRB can ask about recruitment methods to determine the kinds of incentives and influences being offered. It can also ask about the community and the alternatives available to the target group, their education level and the probability of insurance coverage.
The internet provides an interesting tool by which to look at census data, newspaper articles, license information and more.
KEY “LOCAL POINTS” TO CONSIDER:
Before “local issues” can be addressed, they need to be identified. What is a local issue?
1. Investigator Qualifications
• Is the investigator at least minimally qualified in the field of study? (e.g. an MD for a drug study, a chiropractor for a chiropractic study or a Ph.D. for a laboratory study)?
• Is the person qualified to do the procedures required by the protocol (e.g., trained in the use of an innovative piece of equipment, capable of handling a class for an education intervention)?
• Has the person gained knowledge through experience or education about the proper conduct of research? (GCP education is now a requirement for most studies).
• How many other time demands (e.g., travel or competing studies) are there?
2. Staff Qualifications
• Is the staff of sufficient size and quality to carry out the tasks?
• Is the staff appropriate to the culture in which they will work (no naïve interviewers going into communities where they should not be)?
• Is it clear how the tasks will be distributed?
• Is it clear what other groups (e.g. CRO, recruiter) are involved?
3. Facility Acceptability and Resources
• What kind of facility is it?
• Is it equipped to handle the study (e.g., size, staff, emergency equipment)?
• Is there an IRB with jurisdiction over the facility?
4. Standards of professional practice
• Does the protocol fit into the local standards of practice?
• What is the gold standard in the community?
5. Community standards
• Are there local or institutional ideals being abridged?
• Are there any local authorities who should be consulted?
6. Local laws and regulations
• Are there state laws or regulations applicable to conduct of this study?
• Does the institution or site have access to legal knowledge of the rules?
To assist in writing this, we searched the regulations found at 45 CFR 46 and 21 CFR 50/56 to see how the terms "local" and "community" were used. The term "local" was only used in reference to "local laws and regulations." The term "community" was used as shown below.
SEARCH FOR "COMMUNITY"
From 45 CFR 46
§ 46.107 IRB membership.
a) Each IRB shall have at least five members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members' including consideration of race, gender, cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
From 21 CFR 50
§ 50.24 Exception from informed consent requirements for emergency research
(7) Additional protections of the rights and welfare of the subjects will be provided, including, at least:
i) Consultation (which may include consultation carried out by the IRB itself) with representatives of the communities from which the subjects will be drawn;
ii) Public disclosure prior to the commencement of the study sufficient to describe the study and its risks and benefits;
iii) Public disclosure of sufficient information following completion of the study to apprise the community and researchers of the study and its results; and
iv) The establishment of an independent data and safety monitoring board.
From 21 CFR 56
§ 56.107 IRB membership.
a) Each IRB shall have at least five members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members' including consideration of race, gender, cultural sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. 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 the experienced in working with those subjects.
|Last Updated ( Friday, 07 April 2017 09:48 )|