Institutional Review Board
Review Preparatory to Research, Waiver of Authorization and/or Waiver of Informed Consent
If you will obtain written or an alteration of informed consent from research subjects and do not need an RPR or waiver for screening or recruitment purposes-
DO NOT COMPLETE THIS FORM
Principal Investigator:Department: / Phone: / Fax:
Email:
Study Title:
SECTION 1-Review Preparatory to Research (RPR)
Are you requesting a Review Preparatory to Research?
If yes, initial below complete questions 1, 3 and 7 in section 4.
If no, please go to section 2. If you completed an RPR prior to this IRB submission, please put the date of the RPR notification here: / Yes No
A Review Preparatory to Research may be obtained if all of the following are true:
1. The use or disclosure is sought solely to review protected health information as necessary to prepare a research protocol or for similar purposes preparatory to research.
2. No protected health information is to be removed from this institution in the course of review.
3. The protected health information for which use or access is sought is necessary for the research purposes.
4. The protected health information will not be written down or recorded prior to the subject signing a research consent form.
5. The information accessed through this RPR will not be used for any other purpose, including presentation or publication.
I certify that I will carry out the proposed data collection in compliance with the principles stated above. Investigator’s Initials ______
SECTION 2- Waiver of Authorization For Screening or Recruitment
Are you requesting a Waiver of Authorization for Screening?
If yes, initial below and complete questions 1-8 in section 4. / Yes No
You need a Waiver of Authorization for Screening or Recruitment purposes if any of the following are true:
1. The information to be recorded for screening/recruitment will be obtained from MMC, and the person recording it is not a MMC employee.
2. The sponsor is requesting screening logs which contain any one of the items on the list of identified information (last page of this document).
3. The information to be recorded for screening/recruitment is from another institution/office, the person recording the information is not an employee of that institution/office, AND the other institution/office is willing to accept a MMC IRB/Privacy Board waiver.
I certify that I will carry out the proposed data collection in compliance with the principles stated above. Investigator’s Initials ______
SECTION 3-Waiver of Informed Consent
Are you requesting a Waiver of Informed Consent?
If you are requesting a waiver of informed consent, you will also need to request a waiver of authorization and complete all questions 1-8 in section 4. / Yes No
A waiver of informed consent may be granted if all of the following are true:
1. The research involves no more than minimal risk to the subjects.
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects.
3. The research could not practically be carried out without the waiver or alteration.
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
In review of patient medical information it is important to ensure the highest standards of maintaining confidentiality. Therefore, depending upon the data elements being recorded (referred to as protected health information (PHI)), the study description should address confidentiality methods.
In order to access or use an individual’s PHI in the conduct of research without the express authorization of the individual, the Principal Investigator must provide certain information related to the health information requested. Whenever PHI is collected it is important to collect only the minimal amount necessary in order to conduct the research project.
SECTION 41. Please describe the reason why this research cannot be practicably conducted without a waiver.
2. Describe the research purpose.
3. Describe the data necessary for this research.
4. Does the use or disclosure of protected health information involve a risk to the individuals? Describe:
5. Will the use of the protected health information adversely affect the privacy and/or the welfare of the individuals?
6. Describe how the privacy risks to individuals whose protected health information is to be used or disclosed is reasonable in anticipation of the benefits.
7. Is this data being collected for disclosure (release) outside of Maine Medical Center?
If yes, to whom: / Yes No
8. Describe how you plan to protect the identifiers or links from improper use and disclosure.
INVESTIGATOR’S ASSURANCE
I certify that the information provided in this request for Waiver of Authorization is complete and correct.
I understand that as Principal Investigator, I have ultimate responsibility for the protection of the rights and welfare of human subjects and the ethical conduct of this research protocol. I agree to comply with all requirements of the IRB and Institutional policies and procedures, as well as with all applicable federal, state, and local laws regarding the protection of human subjects in research, including, but not limited to, the following:
· The project will be performed by qualified personnel according to the research protocol,
· Research personnel will maintain a copy of all questionnaires, survey instruments, interview questions, data collection instruments, and information sheets for human subjects for at least 6 years following termination of the project,
· Necessary review by the IRB will be sought if changes made in the research protocol may result in the research no longer meeting the criteria for exemption.
· In order for this waiver to be granted, you must present an adequate plan to destroy the identifiers or links at the earliest opportunity consistent with the conduct of the research.
· Approval of this waiver is contingent upon adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information is permitted.
· Investigator agrees to notify the IRB if a health or research justification for retaining the identifiers is identified.
· Investigator reviewed the Privacy Rule’s list of de-identified data and limited data set attached.
I have read and understand the above. I understand that notification will be forthcoming from the IRB to advise me of the action taken on this waiver.
Signature of Principal Investigator: Date:
______
In order to be considered “de-identified data” the data collected may not contain any of the following identifiers:
1. Names
2. All geographic subdivisions smaller than a State including:
a. Street address
b. City
c. County
d. Precinct
e. Zip codes and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publically-available data from the Bureau of the Census: (1) the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people, and (2) the initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000.
3. Telephone numbers
4. Fax numbers
5. E-mail addresses
6. Social Security numbers
7. Medical record numbers
8. Health plan beneficiary numbers
9. Account numbers
10. All elements of dates (except year) for dates related to an individual, including:
a. Birth dates
b. Admission date
c. Discharge date
d. Date of death
e. All ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older
11. Certificate/license numbers
12. Vehicle identifiers and serial numbers, including license plate numbers
13. Device identifiers and serial numbers
14. Web Universal Resource Locators (URL’s)
15. Internet Protocol (IP) address numbers
16. Biometric identifiers, including finger and voice prints
17. Full face photographic images and any comparable images
18. Any other unique identifying numbers, characteristics, or codes
Limited data sets
Some studies may need to retain a limited number of identifiers and, thus, not meet the strict HIPAA definition of “de-identified data.” However, these studies may present only minimal potential for identifying participants based on the data set. In such circumstances, HIPAA permits use of a “Limited Data Set” for research purposes. A Limited Data Set is PHI that excludes “direct identifiers” of the individual, relatives of the individual, employers, or household members.
A Limited Data Set must exclude:
1. Names / 8. Account Numbers2. Street Addresses / 9. Certificate/License Numbers
3. Phone and Fax Numbers / 10. Vehicle Identifiers/License Plates
4. Email Addresses / 11. Device Identifiers
5. Social Security Numbers / 12. Web URL’s
6. Medical Record Numbers / 13. Internet Protocols (IP)
7. Health Plan numbers / 14. Facial photos
A Limited Data Set may include one or more of the following:
1. Towns
2. Cities
3. States
4. Zip Codes and their equivalent geocodes. (Note that a zip code cannot be used if the area composing the zip code has fewer than 20,000 citizens.)
5. Dates including birth and death
6. Other unique identifying numbers, characteristics, or codes that are not expressly excluded. (Medical record numbers and pathology numbers are excluded).
7. Relevant medical information
Page 2 of 5 / SOP # IC 702-C Effective Date: 11/16/2010 Supersedes: 06/25/2002