Form 6a Adult Initial Review of Cooperative Group Protocol

NCI ADULT CIRB

REVIEWER WORKSHEET

Initial Review of Cooperative Group Protocol

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 NCI CIRB is protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or withdrawing from the NCI CIRB at any time. Refusal to participate will not affect your benefits in any way. The information collected will be kept private to the extent provided by law. Names and other identifiers will not appear in any report of the NCI CIRB. Information provided will be combined for all participants and reported as summaries. You are being requested to complete this instrument so that we can conduct activities involved with the operations of NCI CIRB Initiative.

NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN

Public reporting burden for this collection of information is estimated to average 4 hours 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:      

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

NCI Adult CIRB Application for Treatment Studies or NCI Adult/Pediatric CIRB Application for Ancillary Studies

Study Protocol

Cooperative Group Model Informed Consent Document(s)

Information Sheets

Investigator’s Brochure

Study instruments to be completed by participants

Recruitment materials

Other (specify      )

2. Does the study have scientific value?

• Is the study worthwhile?

     

3. Does the study have scientific validity?

Points to consider:

• Are the background assumptions that lead to the hypothesis valid?

• Is literature/background described to justify the trial?

• Is the hypothesis or research question clearly stated?

• Is the study design appropriate to prove the hypothesis?

(Consider sensitive and specific measures of difference, statistical testing, sample size)

     

4. Does the study have a valid scientific design and yet pose an inappropriate risk for subjects?

• Is there substantial evidence that one of the arms is inferior to another or to standard/conventional care or will deprive a subject of his/her right to receive a life-prolonging treatment?

• Is it possible that one arm will expose a subject to a serious risk of harm?

     

5. Are risks to subjects minimized?

• Does the research design minimize risks to subjects?

• Do the procedures expose subjects to unnecessary risks?

• Are procedures already being performed on the subjects for diagnostic or treatment purposes being used whenever appropriate?

• Can alternative procedures be used that would expose the subjects to fewer risks?

     

6. Are the risks to subjects reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result?*

Points to consider:

• What is the anticipated level of risk/discomfort/inconvenience to the subject?

• Is there the prospect of direct benefit to the subjects?

*Consider only those risks and benefits that may result from research as opposed to those that may result from therapies not involved in the research.

     

7. Is the selection of subjects equitable?

Points to consider:

• Who is to be enrolled?

• How will the subjects be identified and recruited?

• Are these subjects appropriate for the protocol?

• What is the rationale for the inclusion/exclusion of specific populations?

     

8. Are additional safeguards in place for subjects likely to be vulnerable to coercion or undue influence?

Point to consider:

• Are appropriate protections in place for vulnerable subjects (e.g., pregnant women, fetuses, socially – or economically – disadvantaged, decisionally impaired, extremely ill/desperate)?

     

9. Will informed consent be obtained from the research subjects or thei legally authorized representatives?

• Does the informed consent document include the eight required elements?

• Is the consent document understandable to subjects/legal guardian?
  Is the CIRB requested to waive or alter tany informed consent requirement?

     

10. Is there adequate provision for monitoring the data collected to ensure the safety of participants?

Point to consider:

• What research oversight process will be used to enhance subject safety? (e.g., data safety monitoring board)

     

10. Are there adequate provisions to protect the privacy of participants and to maintain the confidentiality of data?

Points to consider:

• Will personally-identifiable research data be protected to the extent possible from unauthorized access or use?

• Are any special privacy and confidentiality issues properly addressed, e.g., use of genetic information?

     

11.

12. Additional Remarks:      

Version 02/21/12