Human Research Review Committee
(HRRC-IRB)
Supported by the
Human Research Protections Office
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Former Tips of the Month
Types of Review (Apr 08)
The code of federal regulations (45CFR46) define the types of review conducted by the IRB. Unfortunately the poor word choice of these regulations can be confusing.
Below are the definitions based on the regulations:
Full Committee Review - A full committee must review the study. Approvals generally take from 35 to 50 days (most institutions of our size take 45 to 70 days for approvals)
Expedited Review - This term does not refer to the time it takes to approve a study. Rather, expedited means that this study will not go before full committee. It must, however, go through staff pre-review, any modification necessary, and then a chair review. Depending on the amount of new studies submitted in a month, approvals can take from 25 to 35 days. To be submitted as expedited, the study must meet expedited criteria and be considered minimal risk.
Exempt Review - This type of review also requires staff pre-review and must meet exempt criteria and be considered minimal risk.
Interested in Advertising for your research through the UNMHSC? (Nov 07)
The UNMHSC Web development team has a site where you can post your study information if you are looking for participants.
However, before you post your information on the internet- remember:
1. Internet posting is the only type of advertisement that does not require prior approval of the HRRC, but only:
2. Limited information can be posted:
A) title; B) Purpose of the study C) Protocol Summary; D) basic eligibility criteria; E) Study site location(s); F) How to contact your site for further information.
3. Without HRRC approval you cannot post the amount a participant will receive for participating in the study, but you can use the line "Participants will be compensated for their time and inconvenience"
Only those with a UNMH Net ID and Password can post to the UNMHSC research listing site.
For more information on recruitment guidelines, see our recruitment manual section.
If you would like to include more information in your internet posting, you can submit it as an amendment to your study.
The Big Four for New Studies! (Oct 07)
There are four basic documents that MUST be submitted with every new study and prereview cannot commence until all of these documents are received.
1. Study Application (Exempt, Expedited, or Full)
2. Departmental Review Form (Completed by head/chair of department submitting the study!)
3. Conflict of interest statement (Completed by every investigator listed on Attachment 1)
4. Protocol (Not the same as the application, this is a living/working document)
For more information you can print out a checklist and/or visit the related web pages for the study submission
| Type of Submission | Checklist for submission (word docs) | Website for Forms |
| Exempt | Exempt Checklist | Exempt Forms |
| Expedited | Expedited Checklist | Expedited Forms |
| Full | Full Checklist | Full Forms |
Initial Review Fee Increase (Sep 07)
Effective January 2, 2008, initial application fees for sponsored research will be increased to $2,000. Although the costs associated with the HRRC review have escalated significantly, this represents the first increase in fees in over 8 years.
The new fee is comparable to fees charged by peer institutions for IRB review of new human research studies.
The HRRC Initial Review Fee covers initial review of the study application, modifications (amendments), and adverse event reporting for the initial approval period (one year or less as determined by the HRRC).
There is no increase in the annual Continuing Review Fee ($750).
The fee increase applies to new study submissions received in the HRRC office on or after January 2, 2008. Criteria for studies that are subject to HRRC fees remain the same as in the past and can be reviewed at our fees webpage.
Exploring New Research Questions/Objectives with Existing Research Data (Jun 07)
Data already collected for research may be useful in answering new questions that are generated during the course of data analysis.
If new/different objectives (use of data) are identified from that which was originally approved, it is required that the newly defined research question(s) be submitted to the HRRC.
This can be done by completing an Amendment/Change form and a revised protocol, if appropriate.
HRRC review of new research questions is required for several reasons including assuring:
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That proper informed consent was obtained
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That publications will not result in stigmatization of a subject population, and
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That the research is consistent with the ethical principles of human subject research
Issues surrounding identifiable information (May 07)
The HRRC Considers data to be:
Identifiable - any information alone, or in combination that can be used to individually identify the person or the person's data and/or specimen(s).
An Identifier - Information used to identify an individual.
Individually identifiable - When it meets one of the 18 elements defined by the HIPAA Privacy Rule.
Anonymous or Anonymized data and/or specimens - where no link to identifiers is maintained or available to any member of the research team under any circumstances. Data/specimens in which a link or linking list to identifiers was kept is only considered Anonymous or Anonymized by the HRRC when the link or linking list is permanently destroyed or where the investigator does not have access, under any circumstances, to the link or linking list.
HHS regulations explain that:
Individually identifiable - is where the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
Data and/or specimens can be coded or de-identifed:
Meaning that there is a link to at least one or more piece(s) of information, or combination of information, that could individually identify the person or the person's data and/or specimen. This link, or linking list is kept separate from the data/specimens. De-identification is often utilized as a means of protecting the confidentiality of the data and/or the privacy of the individual.
If the investigator plans to maintain individually identifiable data and/or specimens without coding or de-identifying the data and/or specimens additional measures of protection are often required by the HRRC
Sharing of Research Data (Apr 07)
All persons with access to identifiable or coded data must be listed as an investigator on the research study. This includes residents, medical students, and graduate students working on data analysis, publications, or dissertations.
In cases where data sharing is unapproved by the HRRC, permission to publish research data may be denied.
To add an investigator to a study, please submit the following documents to the HRRC Office for review:
Attachment 1: List of Investigators
Conflict of Interest form for each investigator
Length of Time to Retain Research Records (Mar 07)
Investigators frequently ask the HRRC to direct them on how long they should retain research records for investigator initiated studies.
The HRRC does not have a policy regarding investigator record retention; however, we advise investigators that record retention should be compliant with the HIPAA requirements, i.e., records should be maintained for a minimum of 6 years after closure of the study with the HRRC.
If you are the holder (sponsor) of an IND or an IDE being used in a research study, other requirements may apply and you should contact the appropriate branch of the FDA.
If you have specific questions regarding record
retention for non-sponsored studies, you may contact the HSC Compliance Office
at 272-2588.
Research Involving Partners or Family Members of Study Participants (Feb 07)
If your research involves partners or family members of study participants then the following guidelines apply to you:
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Identifiable information on the partner/family members may not be collected until they have signed an HRRC approved consent document and HIPAA form that allows health information to be collected (i.e. You cannot collect - Name, address, phone number, etc.)
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Investigators/staff cannot directly contact the partner/family member.
One acceptable method of contact is to provide the study participant with a letter that can be given to the partner/family member. The letter should contain information about the reason for the contact and how to get in touch with investigator or staff should the partner/family member choose to participate in the data collection or wish to obtain further information. The investigator should not initiate further contact with the partner/family member if there is no response to the letter.
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Investigators must supply the HRRC with information relating to the inclusion of partner/family member data:
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Specific information to be collected
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Proposed method of consent
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HIPAA documents
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Proposed letters to the partner/family member (requires final review and approval by the HRRC)
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Federal regulations require that IRBs address specific protections for protected populations including pregnant women, children, and newborns.
New Requirement for Human Research Protections Training (Jan 07)
If you haven't yet taken the new on-line training, make sure to schedule some time to do so.
This requirement includes all investigators and their research team (this includes any person who is responsible for the design, conduct, or reporting of a UNM human research activity)
Suggestions on completing the training:
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Sign up for our scheduled training time. This will give you a set time to complete the training as well as some interaction with other investigators, research coordinators, etc. For more information check out our CITI Class web page.
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Schedule a little time each day to work on the training - you can always return to the training to where you left off. FYI: the training is off-line from 1/4 to 1/7 for an upgrade. It will be available again on 1/8.
For more information on the CITI Program check out our CITI Web page.
New Requirements for Research Recruitment Materials (Dec 06)
Effective November 1, 2006 all new recruitment materials being submitted must include the HRRC study number.
This requirement includes all recruitment materials:
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Printed materials should contain the HRRC study number clearly posted in the lower left corner.
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Radio advertisements, Movie Theaters, Bill Boards, Buses, etc. - Researchers can be creative when they add the HRRC study number to non-printed recruiting materials.
Existing recruitment materials will be exempt from this requirement, unless there is a change submitted via the Amendment process. There will not be a requirement for materials to be updated with the HRRC # during continuing review.
For more information on recruitment materials - see our Subject Recruitment Guidelines/Section 11.2 of our HRRC Manual.
Help Your Progress Report Get Through the Review Process! (Nov 06)
Enrollment Target Numbers and Numbers of Subjects Enrolled
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Your Target Number should remain the same throughout the study, unless you have submitted an amendment form to change it.
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Number of Subjects Enrolled must equal total number of subjects enrolled from each progress report. Look back at prior progress reports and ensure you are reporting the correct numbers. If this is a multi-center trial, you will need to include all of the applicable target and enrollment numbers.
Yearly Renewal of a Research Study (Sep 06)
Submit your progress review report to the HRRC at least one month before the review period expires!
This will ensure that there will be enough time to get approval before your research period expires. It takes close to two weeks before a study can be considered by a committee and if there are any question about the study, it can take longer.
Principal Investigators are notified at least 60 days in advance of their study expiration. Don't delay in filing for your continuation and you won't be delayed in your research!
Are you unsure of which forms to complete for your research submission to the HRRC? You can call the main office number (272-1129) and your call will be directed to the appropriate person who can help you.
If you are a student or a non-frequent user of the HRRC, we strongly encourage you to make an appointment with a Human Protection Specialist to discuss your project prior to completing any forms. We may be able to save you time and effort by suggesting different approaches or simply by directing you to the proper forms.
Lastly, always use the most current forms on our website. We update forms on a regular basis to capture information necessary for study review by a chair or committee.
HIPAA Authorization for Research (Jun 06)
Did you know that researchers are required to obtain a signed HIPAA authorization form in addition to a signed Consent form from research subjects when collecting protected health information?
Protected Health Information (a.k.a. PHI) includes any identifiable health information collected during the course of a research study. PHI can include data such as a person's height and weight.
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If HIPAA authorization is "noted to the record*" at the HRRC, it is necessary for the research subject to sign and date this document
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If signed HIPAA authorization is required but not obtained from a subject, then that subject's data cannot be used for research purposes
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For more information regarding this, please contact the UNMHSC HIPAA Privacy Officer, Sophia Collaros, at 272-1493 or the HRRC Office at 272-1129.
*Please note that the HRRC only reviews HIPAA authorizations. These documents are not stamped by our office with approval/expiration dates and are not sent back to the investigator with the HRRC approval letter.
Consent Forms - Using short form of another language (May 06)
When a short form of another language is used:
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The subject must sign the short form only AND should be given a copy of BOTH the short form AND the English informed consent document "summary".
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The person obtaining informed consent (i.e. investigator) must sign the English Consent.
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The English consent "summary" must have a witness name/signature/date line.
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The witness must sign BOTH the short form AND the informed consent document. The translator may serve as the witness.
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If witness lines are present on a consent document, they must be completed.
Need a Consent Translated? (Apr 06)
Do you need a consent form translated into another language? The UNM Hospital offers translation services.
If you have any questions regarding translating a consent form, check out section 7.3 in our manual
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