Box B
 
 

Box A Some of the risk related information that needs to be included in an informed consent form for research Purpose of study  Study methods  Foreseeable risks to participants, including severe adverse outcomes such as death and stroke Existence of risks that may not be foreseeable  Alternatives available in clinical care, whether or not patients elect to participate in the clinical study The fact that participants may not benefit from participation in the study Timeline of the study and duties of participant during the study, including laboratory and study testing needed for the research (and the risks of such testing and how the principal investigator will contact the patient and his or her provider regarding laboratory or study abnormalities) Whom to contact with scientific questions about the study—for example, the principal investigator or specific members of the research team Whom to contact with ethical questions about the conduct of the study Who will be given permission to access information related to the conduct of study Who will not be allowed to access information related to the study How data on participants will be protected during the study When participants’ data will be destroyed after the study is complete

 

Box B: Unique identifiers protected under US law If data on research subjects includes any of these identifiers they are covered by the Health Insurance Portability and Accountability Act 1996 and need to be protected Names All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the publicly available data from the bureau of the Census: The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20 000 people and The initial three digits of a zip code for all such geographic units containing 20 000 or fewer people is change to 000. All elements of dates (except year) for dates directly related to an individual including birth date, admission date, discharge data, date of death; and all ages over 89 and all elements of dates (including year) indicate of such age, except that such ages and elements may be aggregated into a single category of age 90 or older Telephone numbers Fax numbers Electronic mail addresses Social security numbers Medical record numbers Health plan beneficiary numbers Account numbers Certificate/license numbers Vehicle identifiers and serial numbers, including license plate numbers Device identifiers and serial numbers Web Universal Resource Locators (URLs) Internet Protocol (IP) address numbers Biometric identifiers, including finger and voice prints Full face photographic images and any comparable images Any other unique identifying number, characteristic, or code