Form 6V Reviewer Advertisement Checklist REV

N CI CIRB

REVIEWER WORKSHEET

CIRB Review of Recruitment Materials

OMB#: 0925 – 0625
Expiry Date: 01/31/2014
Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of your participation in the National Cancer Institute (NCI) Central Institutional Review Board (CIRB) Initiative is protected by The Privacy Act of 1974, as amended. The purpose of the information collection is to conduct reviews of clinical trial studies. Although your participation in NCI-sponsored research and completion of the forms is voluntary, if you wish to participate in the CIRB, you must complete all questions on the form. The information you provide will be combined for all participants and reported as summaries. It will be kept private to the extent provided by law.

NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for this collection of information is estimated to average 20 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0625). Do not return the completed form to this address.

STUDY ID:      

STUDY TITLE:      

NAME OF CIRB REVIEWER:      

DATE COMPLETED:      

Reminder to reviewers: Recruitment materials should be reviewed for the following three components:

• accuracy of the information presented,

• to ensure that the material is not coercive, and

• to ensure that the material does not promise a certainty of cure or benefit beyond what is outlined in the informed consent document and the protocol.

Remember that potential study participants will be given a consent document providing greater detail on the study and its foreseeable risks and benefits.

1. Indicate the documents reviewed (check all that apply):

Updated NCI Adult/Pediatric CIRB Application for Treatment Studies

Summary of CIRB Application revisions

Recruitment Material. Indicate the material reviewed:

Pamphlets

Webpage

Video

Other:      

2. Is a distribution plan provided (see section 5 of the CIRB Application)?

Yes. If yes, briefly describe the plan:      

No. If no, a distribution plan is required before the recruitment material can be approved.

3. Does the recruitment material include any exculpatory language?

Exculpatory language is “language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.” (45 CFR 46.116). Examples of exculpatory language can be found in the 1996 OPRR Letter “Exculpatory Language in Informed Consent Documents: Examples of Acceptable and Unacceptable Language” available at: http://www.hhs.gov/ohrp/policy/exculp.html.

Yes. If yes, identify the language and provide suggested revisions:      

No.

4. Does the recruitment material state or imply a certainty of a favorable outcome or other benefits beyond what is outlined in the informed consent document and protocol?

Yes. If yes, identify the language and provide suggested revisions:      

No.

5. Does the recruitment material include language that in any way appears to place undue influence on the potential study participant to enroll in the study? (i.e. access to free drugs or treatment, compensation, etc).

Yes. If yes, identify the language and provide suggested revisions:      

No.

6. Does the recruitment material suggest that the investigational article is safe, effective, equivalent, or superior to other options?

Yes. If yes, identify the language and provide suggested revisions:      

No.

7. Does the recruitment material refer to an investigational drug, biologic or device as a “new drug” or “new treatment” without explaining that the test article is investigational?

Yes. If yes, identify the language and provide suggested revisions:      

No.

8. Does the recruitment material emphasize any payment to be made to subjects or compensation for participation in the study?

Note that NCI-Sponsored research generally does not provide compensation for participation in a study. Nonetheless, if compensation is offered, it may be noted in recruitment materials but should not be emphasized over other elements of the material.

Yes. If yes, identify the language and provide suggested revisions:      

No.

9. Does the recruitment material promise “free treatment” when the intent is only to say participants will not be charged for taking part in the study?

Yes. If yes, identify the language and provide suggested revisions:      

No.

10. Recommendation to the CIRB

If a distribution plan is provided (per question 2) and there are no changes required to language in the recruitment materials (per questions 3 through 8) the recruitment material may be approved.

Approve

A distribution plan is provided and there are no required or suggested revisions.

Approve Pending Modifications

There are required changes to the recruitment materials (per questions 3 through 9).

Approve with Recommendations

The reviewer has identified potential improvements to the material but has determined that they are not required.

Table

There is insufficient information available to make a determination regarding the recruitment material, or substantive changes are required and warrants re-review by the convened CIRB.

Disapprove

The submitted material is inaccurate and does not meet the regulatory and CIRB SOP requirements for approval.

11. Comments

     

DRAFT version 11/26/12