Research

Human Research Protection Program Policy and Procedure Manual - Section 12

12 Special Topics

12.1 Mandatory Reporting

12.2 Brown University Students and Employees as Participants

12.3 Genetic Studies

12.4 Research Involving Coded Private Information or Biological Specimens

12.4.1 Who Should Determine Whether Coded Private Information or Specimens Constitutes Human Participants Research

 

12 Special Topics
12.1 Mandatory Reporting

While any person may make a report if they have reasonable cause to believe that a child or elder was abused or neglected, Rhode Island law mandates that certain persons who suspect child or elder abuse or neglect report this to the appropriate State agencies.

 

In situations where conditions of abuse or neglect might be revealed, mandated reporters should make themselves known as such to parents of children under age 18, to participants who are children, and to participants who are potential victims of abuse or neglect.

 

12.2 Brown University Students and Employees as Participants

When Brown University students and/or employees are being recruited as potential participants, researchers must ensure that there are additional safeguards for these participants. The voluntary nature of their participation must be primary and without undue influence on their decision. Researchers must emphasize to participants that neither academic status or grades, nor their employment, will be affected by their participation decision.

 

To minimize coercion, investigators should solicit participants through means such as bulletin board notices, flyers, advertisements, and announcements in classes or laboratories other than their own. When entering a classroom to recruit students and conduct research, e.g. administer a survey, investigators should do so at a time that would allow non-participating students the option of leaving the classroom, thereby alleviating pressure to participate.

 

12.3  Genetic Studies

Genetic research studies may create special risks to participants and their relatives. These involve medical, psychosocial, and economic risks, such as the possible loss of privacy, insurability, and employability, change in immigration status and limits on education options, and may create a social stigma. Knowledge of one's genetic make-up may also affect one's knowledge of the disease risk status of family members.

 

In studies involving genetic testing, several questions need to be addressed, including, but not limited to:

 

  1. Will test results be given?
  2. Will disease risk be quantified, including the limits on certainty of the testing?
  3. Will a change in a family relationship be disclosed, such as mistaken paternity?
  4. Does the participant or family member have the option not to know the results? How will this decision be recorded?
  5. Could other clinically relevant information be uncovered by the study? How will disclosure of this added information occur?
  6. Do any practical limitations exist on the participant's right to withdraw from the research, withdraw data, and/or withdraw DNA?
  7. Is the participant permitted to participate in the study while refusing to have genetic testing (such as in a treatment study with a genetic testing component)?

 

For DNA banking studies, several questions need to be addressed, including, but not limited to:

 

  1. Will DNA be stored or shared? If shared, will the participant's identity be known by the new recipient investigator?
  2. Will the participant be contacted in the future by the investigator to obtain updated clinical information?
  3. How can the participant opt out of any distribution or subsequent use of his/her genetic material?

 

12.4 Research Involving Coded Private Information or Biological Specimens

Brown University policy is based on the OHRP guidance document entitled, “Guidance on Research Involving Coded Private Information or Biological Specimens” (August 10, 2004 http://hhsstage.cit.nih.gov/ohrp/archive/humansubjects/guidance/cdebiol04.htm). This document:

 

  • Provides guidance as to when research involving coded private information or specimens is or is not research involving human participants, as defined under HHS regulations for the protection of human research participants (45 CFR part 46).
  • Reaffirms OHRP policy that, under certain limited conditions, research involving only coded private information or specimens is not human research.
  • Provides guidance on who should determine whether participants are involved in research.

 

For purposes of this policy, coded means that: (1) identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and (2) a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.

 

Under the definition of human participant in Section 2 of this policy, obtaining identifiable private information or identifiable specimens for research purposes constitutes human research.  Obtaining means receiving or accessing identifiable private information or identifiable specimens for research purposes. This includes an investigator’s use, study, or analysis for research purposes of identifiable private information or identifiable specimens already in the possession of the investigator.

 

In general, private information or specimens are considered to be individually identifiable when they can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems.  Private information or specimens are not considered to be individually identifiable when they cannot be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems.

 

Research involving only coded private information or specimens do not involve human participants if the following conditions are both met:

 

  1. the private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals;
    and
  2.  the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because, for example:
    • the key to decipher the code is destroyed before the research begins;
    • the investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased (note that the HHS regulations do not require the IRB to review and approve this agreement); data use agreement
    • there are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased; or
    • there are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.

 

In some cases an investigator who obtains coded private information or specimens about living individuals under one of the conditions cited in 2(a)-(d) above may (1) unexpectedly learn the identity of one or more living individuals, or (2) for previously unforeseen reasons now believe that it is important to identify the individual(s). If, as a result, the investigator knows, or may be able to readily ascertain, the identity of the individuals to whom the previously obtained private information or specimens pertain, then the research activity now would involve human participants.  Unless this research is determined to be exempt (See Section 7.2), IRB review of the research would be required.  Informed consent of the participants also would be required unless the IRB approved a waiver of informed consent (See Section 9.3).

 

12.4.1 Who Should Determine Whether Coded Private Information or Specimens Constitutes Human Participants Research

The investigator in consultation with the IRB Chair or RPO staff, as necessary, will determine if the research involving coded information or specimens requires IRB review. 

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