Background
Methods
Target population
Sample size
Sampling strategy
Survey questionnaire
Scenario | Description |
---|---|
Cluster-cluster trial (mass media advertising for colorectal cancer screening)
| A researcher at your institution is proposing a cluster randomized trial to evaluate a radio, television, and billboard advertising campaign aimed at increasing the proportion of community residents who receive colorectal cancer screening according to well-accepted national guidelines. Cluster randomization is used because the intervention (the advertising campaign) is delivered to the community as a whole. Twenty cities will be randomly assigned to either the intervention group or a control group receiving no intervention. A random sample of 500 residents in each city will be surveyed before the intervention, and a separate random sample of 500 residents in each city will be surveyed after the intervention, to determine the proportions that have been screened. The surveys will be conducted by telephone using random digit dialing. No personally identifying information will be collected in the surveys. |
Professional-cluster trial (professional education to reduce imaging)
| A researcher at your institution is proposing a cluster randomized trial to evaluate an educational intervention designed to reduce unnecessary requests for X-rays in accordance with well-accepted national guidelines (which have been widely available for two years) for patients with nontraumatic back and knee pain. All 250 general practices in the study area will be randomly assigned to either the educational intervention or a control group. The guidelines will be mailed to all general practitioners (GPs) in intervention and control practices, but intervention GPs will additionally receive regular reminder messages about the guidelines by mail, as well as feedback about the number of X-rays ordered by their whole practice compared with requests made by all GPs in the study. Study outcome 1 is the number of X-rays ordered per thousand patients using data routinely collected by radiology departments. These data will be sent to the researchers with GP identifiers included, to allow the researchers to prepare feedback to the practices about their number of X-ray requests. Study outcome 2 is the percentage of X-ray requests that are concordant with the guidelines, determined by researchers reviewing and collecting anonymized data from a randomly chosen subset of 100 patient records per practice. |
Individual-cluster trial (distribution of bed nets against malaria)
| A researcher at your institution is proposing a cluster randomized trial to evaluate a malaria prevention intervention. Thirty villages in Cambodia with a total population of 10,000 will be randomly assigned to either an intervention group in which insecticide-treated bed nets will be distributed to all residents (by delivering them to each household), or a control group in which no bed nets will be distributed to any residents. Cluster randomization is used because the bed nets can only be effective in preventing the spread of malaria if they are used by the majority of residents in a village and because the investigators feel that it would not be acceptable to distribute bed nets to only a random half of the residents in a village. Although insecticide-treated bed nets have previously been shown to be effective against malaria in most tropical and subtropical regions, there are differences in vector biting cycles and malaria epidemiology in South East Asia that raise questions about the effectiveness of the insecticide-treated bed nets in Cambodia. Village volunteers in both intervention and control villages will be trained to recognize malaria symptoms and administer standard anti-malarial treatment. Villagers will be told that they can consult the village malaria worker when unwell. Malaria prevalence will be determined before and after the intervention using blood tests from cross-sectional random samples of 250 people per village. |
Survey implementation
Data analysis
Ethics approval
Results
Response rates
Characteristics of respondents
Canada | United States | United Kingdom | Total | |
---|---|---|---|---|
(N = 60) | (N = 86) | (N = 43) | (N = 189) | |
Response rate | 39.2% (60/153) | 32.3% (86/266) | 35.0% (43/123) | 34.9% (189/542) |
Ethics committee characteristics
| ||||
Year established
| ||||
<1990 | 23 (42.6)a
| 66 (84.6) | 10 (27.0) | 99 (58.6) |
1990 to 1999 | 14 (25.9) | 9 (11.5) | 13 (35.1) | 36 (21.3) |
> = 2000 | 17 (31.5) | 3 (3.9) | 14 (37.8) | 34 (20.1) |
# Protocols/month (Median, Q1-Q3) | 5 (3 to 20) | 30 (10 to 60) | 8 (7 to 8) | 10 (5 to 37.5) |
Type of committee
b
| ||||
University | 18 (30.0) | 49 (57.0) | 8 (18.6) | 75 (39.7) |
Hospital/healthcare | 41 (68.3) | 41 (47.7) | - | 82 (56.2) |
National Research Ethics Service | - | - | 31 (72.1) | 31 (16.0) |
Other nonprofit | 2 (3.33) | 9 (10.5) | 0 | 11 (5.8) |
Other for-profit | 5 (8.3) | 2 (2.3) | 0 | 7 (3.7) |
Number of CRTs /year
| ||||
None | 18 (32.7) | 3 (8.1) | 27 (34.6) | 48 (28.2) |
1 to 5 | 35 (63.6) | 28 (75.7) | 38 (48.7) | 101 (59.4) |
>5 | 2 (3.6) | 6 (16.2) | 13 (16.7) | 21 (12.3) |
Have guidelines in place for CRTs | 0 | 3 (3.8) | 0 | 3 (1.7) |
Aware of guidelines for CRTs | 1 (1.8) | 3 (3.8) | 4 (10.8) | 8 (4.7) |
Ethics Chair characteristics
| ||||
Years experience as chair
| ||||
<2 | 9 (16.4) | 12 (15.2) | 9 (24.3) | 30 (17.5) |
2 to 5 | 27 (49.1) | 28 (35.4) | 12 (32.4) | 67 (39.2) |
>5 | 19 (34.5) | 39 (49.3) | 16 (43.2) | 74 (43.3) |
Years experience as member
| ||||
<6 | 26 (47.3) | 24 (30.4) | 13 (35.1) | 63 (36.8) |
6 to 10 | 18 (32.7) | 21 (26.6) | 16 (43.2) | 55 (32.2) |
>10 | 11 (20.0) | 34 (43.0) | 8 (21.6) | 53 (31.0) |
Highest degrees
c
| ||||
Doctorate | 24 (43.6) | 36 (45.0) | 17 (46.0) | 77 (44.8) |
Medical | 23 (41.8) | 43 (53.8) | 13 (35.1) | 79 (45.9) |
Masters | 16 (29.1) | 10 (12.5) | 11 (29.7) | 37 (21.5) |
Undergraduate | 4 (7.3) | 4 (10.8) | 2 (2.5) | 10 (5.8) |
Perceived need for guidelines
Canada | United States | United Kingdom | Total | |
---|---|---|---|---|
(N = 55) | (N = 79) | (N = 37) | (N = 175) | |
There is a need to develop ethics guidelines for CRTs | 45 (81.8) | 67 (84.8) | 32 (86.5) | 144 (84.2) |
Ethics committees need more information about ethical issues in CRTs | 52 (94.6) | 73 (92.4) | 33 (89.2) | 158 (92.4) |
Application forms ought to be designed separately for CRTs | 19 (35.2) | 24 (30.8) | 9 (24.3) | 52 (30.8) |
Types of review required for each scenario
Country | Type of review | Explanation |
---|---|---|
Canada | Full review | Full Board review would be recommended for the following reasons: a) community consent versus individual consent, b) there is an element of deception, c) the treatment/intervention received is determined by randomization, d) the telephone surveys deal with potentially sensitive topic (colorectal screening) and could result in situations where there is a need for follow-up medical and/or psychological care. |
Expedited | Review is necessary due to 'research’ component and to ensure privacy and patient rights are protected. Expedited as there is no experimental manoeuvre, screening is according to national guidelines. | |
No review | The researcher is outside our jurisdiction - They are using subjects who are unlikely to be our patients. At the beginning, consent is not required except at the municipal level. There is no financial liability to the hospital. There is no treatment intervention. I see this as no different from the telephone surveys I receive now at home. It would be polite and professionally correct to bring this to the ethics committee as an FYI. If the researcher wanted to add gravitas to his/her survey they might ask for the 'blessing’ of the ethics committee. However , as before, it not being done on hospital property, involves no patients and no therapeutic intervention. | |
United Kingdom | Full review | The exceptions are minimal risk studies with small numbers of participants, which have no contentious issues. In this case, 1,000 participants, approached by random 'cold-call’ telephone with verbal consent required and no prior information, would be rated by us as large and potentially contentious. |
Expedited review | The proposed trial deals with a situation where the normal practice is 'no intervention’; there’s no specific bowel screening promotion as described in the UK. Expedited review would be to address whether the materials provided to the Mayors/Officials of the cities involved enough information to understand the proposed research. There is low/no risk to participating citizens and the interventions would be considered 'light touch’ and of low risk; unless of course review of the proposed telephone interview guidelines revealed significant intrusive or alarming questions. | |
No review | Because it is the effectiveness of the advertising campaign that is to be evaluated and this in itself is not a medical intervention and I would regard the study as in support of delivering an established standard of normal care. | |
United States | Full review | I think the questions raised by the methodology, in particular the randomization to a community intervention without individual consent, would merit consideration by the full board. |
Expedited review | The study as described presents no more than minimal risk to the sample involved. The dependent measure is related to behavior. The study is not inviting participants to get a colorectal exam offered by the investigators. The study measures are related to the effectiveness of an information campaign. | |
No review | This is a survey, should be exempt 45 CFR 46.101 #2. |
Country | Type of review | Explanation |
---|---|---|
Canada | Full review | This study would require REB approval because there is an intervention, patient data is collected and consent is not planned. There is the onus to review fully given the lack of a consent process, regardless of the reason. |
Expedited | Meets all Tri-Council Policy Statement (TCPS) criteria for minimal risk. | |
No review | This seems to be more akin to a Quality Improvement study of whether an educational intervention and reminders about an accepted Clinical Guideline leads to greater acceptance and adoption of these practices. Our REB does not review these, but there is a process of review and support for these studies through our Quality and Risk Management Dept. All interventions and practices are clinically indicated and data is only aggregate. | |
United Kingdom | Full review | Because of the randomisation of practices. Otherwise could have been considered as a service evaluation and therefore not require review (potentially!) |
Expedited review | Minimal risk, using routinely collected data, assuming that patient data for outcome 2 are properly anonymised and secure, and do not require information that is outside normal clinical care. | |
No review | This is classic improvement methodology and would not need review. | |
United States | Full review | There is an issue of physicians being known to the researchers and the potential for data about their behavior that could be used to potentially harm the physician’s reputation due to information about his/her medical practices (x-rays). |
Expedited review | We would not consider an educational intervention as treatment. The educational intervention mailing established imaging guidelines is clearly minimal risk. Measuring radiology imaging by GP is not private information and routinely measured by many external entities. The outcome measures of number X-rays/thousand and anonymized medical records review would meet Expedited review categories. | |
No review | This seem to be primarily a trial to determine quality of care and use or misuse of diagnostic studies. No patient is harmed or helped by the study. It may help cost containment. It doesn’t need to come to the IRB. |
Identification of research subjects
Frequency (%) | ||
---|---|---|
Cluster-cluster trial
|
Yes
|
No
|
All city residents in the intervention arm | 50 (29.8)a
| 118 (70.2) |
All city residents in the control arm | 46 (27.9)a
| 119 (72.1) |
Residents exposed to the advertisements | 68 (39.5)a
| 104 (60.5) |
Residents in intervention arm receiving screening | 72 (42.1)a
| 99 (57.9) |
Residents participating in the telephone survey | 171 (90.0)a
| 19 (10.0) |
Professional-cluster trial
|
Yes
|
No
|
Patient-level:
| ||
All patients in the practices | 37 (22.6) | 127 (77.4)a
|
Patients presenting with back or knee pain | 63 (38.4) | 101 (61.6)a
|
Patients providing data for study outcome 1 | 64 (38.6) | 102 (61.5)a
|
Patients providing data for study outcome 2 | 104 (62.3)a
| 63 (37.7) |
Professional-level:
| ||
All GPs in intervention practices | 109 (66.9)a
| 54 (33.1) |
All GPs in control practices | 103 (63.6)a
| 59 (36.4) |
GPs whose patients present with back or knee pain | 127 (77.4)a
| 37 (22.6) |
Individual-cluster trial
|
Yes
|
No
|
Residents receiving bed nets | 158 (88.3)a
| 21 (11.7) |
Residents in control arm receiving no bed nets | 139 (79.9)a
| 35 (20.1) |
Residents providing blood samples | 177 (98.3)a
| 3 (1.7) |
Village malaria workers | 58 (36.7) | 100 (63.3)a
|