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THE COMMITTEE ON HUMAN RESEARCH (CHR)

UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES

Research Using Human Biological Specimens (Revised April 2005)

• Brief Overview
• Summary Tables Showing Common Types of Research Involving Human Specimens

Table 1: De-identified or Coded Specimens
Table 2: Specimens with limited private information; investigator has no subject contact
Table 3: Specimens obtained for research and/or banking through subject contact using minimal risk procedures
Table 4: Specimens obtained for research and/or banking through subject contact using procedures that pose greater than minimal risk

• Research Using Human Specimens Without Identifiers
• Research Using Human Specimens: Minimal Risk- No Subject Contact

• CHR Application Requirements



• Informed Consent

• Research and/or Banking Involving Human Specimens: Minimal Risk- Subject Contact

• CHR Application Requirements



• Informed Consent

• Research and/or Banking Involving Human Specimens: Procedures Pose Greater Than Minimal Risk

• CHR Application Requirements



• Informed Consent

• Table: Consent Topics Pertaining to Specimen Collection for Research and/or Banking
• Table: Consent Requirements for Collecting Research Specimens from Minors
• Resources

Brief Overview: Research, Human Subjects and Biological Materials

Because the federal definition of human subject extends to people who are sources of biological specimens and identifiable private information, research with these materials requires either Exempt Certification or approval by the Committee on Human Research (CHR).

• The type of data considered to be private healthcare information along with a detailed discussion of all HIPAA regulations (45 CFR 164.512) is provided on the HIPAA website.

The CHR is committed to supporting investigators in fulfilling all regulatory responsibilities to ensure continued research with this valuable resource.

The level of CHR review and oversight is based on the level of risk the study poses. Specimen research risks potentially include one or both of the following:

• The risk of harm from procedures used to obtain specimens, and/or



• The risk associated with the loss of privacy and confidentiality due to personally identifiable information that may be associated with specimens.

To help investigators find information pertinent to their study, some of the most common types of research involving human specimens are summarized in the tables below. Links are provided to CHR application forms and, if needed, to more detailed information located in this document and elsewhere.

To access a summary table showing key study features, select the link that best describes the proposed study.

Research involves:

Table 1: De-identified or Coded Specimens – no subject contact, no access to private information

Table 2: Specimens with limited private information; investigator has no subject contact

Table 3: Specimens obtained for research and/or banking through subject contact using minimal risk procedures

Table 4: Specimens obtained for research and/or banking through subject contact using procedures that pose greater than minimal risk. Includes specimens collected as part of treatment studies or for banking and future use.

Summary Tables: Common Types of Research Involving Human Specimens

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Research Using Specimens Without Identifiers

It’s fairly common for researchers to receive specimens from banks and repositories that are either de-identified or coded. Studying human specimens without identifiers protects the identity of the subject/donor without compromising the goals of meaningful research. Each is described below.

• De-identified Specimens: Investigators need to be aware of the type of specimen-associated data that is considered de-identified (also termed de-linked or anonymous) versus information that is personally identifiable. The table below shows examples of each.

* Patient identifiers may be needed to access long-term follow up information

• Coded Specimens: Coded biological specimens means that:
  • Identifying information (such as name, social security number, medical record number) is replaced with a code comprised of numbers, letters, or a combination thereof; and
  
  
  
  • A key to decipher the code exists, enabling linkage of the identifying information with the specimens.



• CHR Requirements for Research Involving De-identified or Coded Specimens: According to recent guidance from the Office on Human Research Protections (OHRP), the human subject definition does not apply to research involving de-identified or, under specific conditions, to coded specimens.
  
  However, at UCSF, the Committee on Human Research (CHR) determines whether research involves human subjects and currently, the Exempt Certification application is the mechanism used by the CHR to make the determination. Through this application process the CHR assesses the study procedures to ensure that specimens are truly de-identified or, if the research involves only coded specimens, that adequate subject privacy protection measures are in place.
  
  The conditions for specimen use and requirements for Exempt Certification (Category 4) are summarized below:
  • The specimens originated from existing sources such as an established repository, or
  
  
  
  • The specimens were collected as part of an IRB-approved specimen banking protocol, or
  
  
  
  • The sources are publicly available – such as the publicly-funded Cooperative Human Tissue Network (CHTN) or commercial entities.
  
  
  
  • The identity of individuals from whom the coded specimens were obtained cannot be readily ascertained by the investigators or collaborators because the researcher’s access to subject identities is prohibited by one of the following procedures:
    • The key to decipher the code is destroyed before the research begins; or
    
    
    
    • The investigators and holder of the key enter into a written agreement prohibiting the release of the key to the investigators, until the subject/individuals are deceased; or
    
    
    
    • There are IRB-approved written policies and operating procedures that prohibit the release of the key to the investigators, until the subject/individuals are deceased; or
    
    
    
    • There are other legal requirements prohibiting the release of the key to the investigators, until the subjects/individuals are deceased.

IMPORTANT NOTE: Publication and funding sources routinely ask that the CHR certify exempt status and are skeptical of statements that the research is exempt in the absence of a certification form.

• Informed consent: The recipient of coded specimens should ask the source for assurance that the specimens were obtained with a valid informed consent under an IRB-approved protocol. The specimens should be used within the scope of research described in the original consent.

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Research Using Human Specimens: Minimal Risk - No Subject Contact

Research involving previously collected specimens that have identifiers associated most likely qualifies for expedited review using the no-subject contact application form designed by the CHR.

• CHR Requirements for Expedited Review: No Subject Contact: The investigator cannot interact with subjects, and although access to private information is allowed, use of specimen-associated identifiers is restricted and privacy protection measures must be in place.
  • The private information requested is the minimum necessary to meet research goals, and
  
  
  
  • Private information will not be reused or inappropriately disclosed.
  
  
  
  • Data are secured by appropriate methods including:
    • The key to coded data is kept separately and securely
    
    
    
    • Data are kept in a locked file cabinet, office, or suite
    
    
    
    • Electronic data are password-protected or stored on a secure network
• Informed Consent: It usually is not necessary to obtain additional consent from donors of previously collected specimens, provided that the study meets the criteria for waving consent in minimal risk research required by OHRP (45 CFR 46) and by HIPAA (45 CFR 164.512):
• There are minimal risks for the subjects



• It would not be practicable to obtain consent



• The subjects’ rights and welfare would not be adversely affected, and



• It would not be appropriate to inform subjects about the study.

IMPORTANT NOTE: A waiver of consent/authorization is required if the investigator wishes to access the subject’s medical record in addition to analyzing previously obtained specimens. The waiver of consent/authorization is Part 5 of the Expedited Review: No Subject Contact application form.

Research and/or Banking Involving Human Specimens: Minimal Risk – Subject Contact

Research using human specimens qualifies for expedited review by the Committee on Human Research (CHR) if the study procedures pose no more than a minimal risk to participants. Protocols may include provisions for specimen banking for future research.

Some of the key CHR application requirements and conditions for informed consent/HIPAA authorization are discussed below.

• CHR Application Requirements: A minimal risk study that involves subject contact requires an Expedited Review Application, the tissue banking supplement form, consent and HIPAA authorization forms. Investigators will need to provide detailed information regarding:
  • Privacy Protection: The use of specimen-associated identifiers is restricted and privacy protection measures must be in place.
    • The private information requested is the minimum necessary to meet research goals, and
    
    
    
    • Private information will not be reused or inappropriately disclosed.
  
  
  
  • Data Security: Private information associated with human specimens must be secured by appropriate methods. Some acceptable data security methods include:
    • Keeping the key to coded data separately and securely; and/or
    
    
    
    • Securing data in a locked file cabinet, an office, or suite
    
    
    
    • Password-protecting electronic data storing on a secured network



• Informed Consent and HIPAA Authorization: Investigators conducting minimal risk research involving contact with participants must use CHR-approved consent materials.
  • Some important consent topics pertaining to specimen collection for research and/or banking are shown in the table below.
  
  
  
  • For additional information, refer to the CHR website for:
    • Recruitment and consent information
    
    
    
    • A sample consent form for obtaining specimens
    
    
    
    • HIPAA guidance

IMPORTANT NOTE: If the proposed research falls outside the uses specified in an original consent form, the investigator will need to consent donors. The CHR must review and approve all materials used for re-consenting and strongly encourages subject contact to be made by letter, not by phone, and preferably by someone known to the donor who was involved in the original specimen collection.

Research and/or Banking Involving Human Specimens: Procedures Pose Greater Than Minimal Risk

A study proposing to collect specimens using procedures that pose greater than minimal risk to participants must undergo full committee review by the CHR. Protocols vary widely and may include specimen banking for future research. For example,

• Specimens will be collected - using procedures posing greater than minimal risk - as part of a larger protocol such as a clinical trial or intervention study.



• Greater than minimal risk procedures will be used to obtain additional specimens – materials in excess of that required for diagnosis or treatment.

Some of the key CHR application requirements and conditions for informed consent/HIPAA authorization are discussed below.

• CHR Application Requirements: Investigators involved in treatment studies or with the collection of specimens for banking and/or future research using procedures that pose greater than minimal risk are required to submit a Full Committee Review application, the tissue banking supplement form, and consent and HIPAA authorization forms. The type of specimen-related information required in the application and supplement includes:
  • Privacy Protection: The use of specimen-associated identifiers is restricted and privacy protection measures must be in place.
    • The private information requested is the minimum necessary to meet research goals, and
    
    
    
    • Private information will not be reused or inappropriately disclosed – investigators will need to list all recipients of private information.
  
  
  
  • Data Security: Private information associated with human specimens must be secured by appropriate methods. Some acceptable data security methods include:
    • Keeping the key to coded data separately and securely; and/or
    
    
    
    • Securing data in a locked file cabinet, an office, or suite
    
    
    
    • Password-protecting electronic data storing on a secured network



• Informed Consent and HIPAA Authorization Requirements: Investigators involved in specimen collection for research and/or banking purposes where the procedures used pose a greater than minimal risk to subjects must obtain consent using CHR-approved consent materials.
  • Some important consent topics pertaining to specimen collection for research and/or banking are shown in the table below.
  
  
  
  • For additional information, refer to the CHR website for:
    • Recruitment and consent information
    
    
    
    • A sample consent form for obtaining specimens
    
    
    
    • HIPAA guidance

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Table: Consent Topics Pertaining to Specimen Collection for Research and/or Banking

Consent forms used for studies proposing to collect specimens for research purposes should include the following topics, as applicable:

• Types of specimens that will be kept and the name of the institution/department/laboratory where specimens will be housed (a basic description of the repository)



• General descriptions of the types of research the specimens can be used for (e.g. cancer, diabetes, cardiovascular research)



• The duration of specimen retention



• Types of data or medical information will be collected with the specimens and for how long the information will be collected



• Who will have access to specimens and data (e.g. UCSF researchers only, other academic collaborators, industry sponsor)



• A description of the procedures for protecting the privacy of subjects and maintaining the confidentiality of data



• Statement that specimens may be used in the development of tests, products, or discoveries that may have potential commercial value and that subjects will not be paid or receive money



• Instructions for donors to request destruction of remaining samples in the future



• If genetic testing will be performed, include information about the consequences of DNA typing.

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CHR Requirements for Collecting Research Specimens from Minors

For detailed information on obtaining informed consent/assent for minors, refer to the CHR guidelines Minors in Research. The requirements for minors are age-dependent as shown in the table below:

IMPORTANT NOTE: If there is continued interaction with subjects who reach the age of majority (18 years of age in California), it would be appropriate to discuss in the consent form the continued storage and analysis of biological materials previously collected.

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Resources

Leslie E. Wolf and Bernard Lo, “Untapped Potential: IRB Guidance for the Ethical Research Use of Stored Biological Materials, “IRB: Ethics & Human Research 26 No. 4 (2004):1-8.

The Office for Human Research Protections