Management and tracking solution for specific patient consent attributes and permissions
A method of managing consent using a computing device, the consent is given by a subject to one or more events in one or more studies, wherein the consent and the plurality of activities are changeable, the method including: authoring one or more first data forms describing the one or more events and one or more selections responsive to the one or more events; authoring, for each of the plurality of subjects, one or more second data forms including description of a plurality of preferences; forming, for a first of the plurality of subjects, an Informed Consent Forms document by combining the one or more first data forms of a first of the one or more studies and one or more second data forms for the first subject; and generating a manifest indicating the one or more events in the first study to which the first subject has granted consent.
1. A computing-device implemented method, comprising:
presenting user-selectable attributes and user-selectable data fields to an administrator;
constructing an informed consent form (ICF) for participants of a medical study based on a first set of selections of the administrator;
receiving consent to the ICF from the participants of the medical study, wherein the ICF includes attributes of the medical study;
generating a record for each participant, wherein each record includes an identifier of the participant, the attributes of the ICF, and a version identifier that is unique to the ICF;
constructing a modified ICF based on a second set of selections of the administrator;
receiving consent to the modified ICF from one or more of the participants, wherein the modified ICF includes a modified attribute;
updating the records of the one or more participants for whom consent to the modified ICF is received to reflect the modified attribute and a version identifier that is unique to the modified ICF; and
generating a report based on the records of the participants from the medical study, wherein the report includes the participant identifiers and attributes for which the respective participants have consented.
2. The method of claim 1 , wherein the report further includes:
consent statuses of the respective participants.
3. The method of claim 2 , wherein the consent statuses are based on the version identifiers of the ICFs to which the respective participants consented.
4. The method of claim 1 , further comprising:
constructing a second ICF for a second medical study based on a third set of selections of the administrator;
wherein the generating a report comprises generating the report based on records of participants of the medical study and participants of the second medical study.
5. The method of claim 1 , further comprising:
associating a scannable code with each of the participants; and
associating the scannable codes with biological samples of the respective participants.
6. The method of claim 1 , further comprising:
receiving a code from a code scanning device; and
retrieving the record of one of the participants based on the code.
7. The method of claim 1 , further comprising:
searching the records to identify participants who have not consented to the modified ICF;
searching the records to determine uses of biological specimens for which respective participants have consented; and/or
searching the records to identify biological specimens for which a desired use is permitted.
8. The method of claim 1 , wherein the attributes include attributes related to collection, use, and/or disposition of biological samples of the participants.
9. The method of claim 1 , wherein the ICF further includes data fields to capture personal information of the participants.
10. The method of claim 1 , wherein the attributes include a type of biological specimen of the medical study.
11. The method of claim 10 , wherein the attributes include at least one of a blood type, genome sequence, or sample of blood.
12. A non-transitory computer readable media encoded with a computer program that comprises instructions to cause a processor to:
present user-selectable attributes and user-selectable data fields to an administrator;
construct an informed consent form (ICF) for participants of a medical study based on a first set of selections of the administrator;
receive consent to the ICF from the participants of the medical study, wherein the ICF includes attributes of the medical study;
generate a record for each participant, wherein each record includes an identifier of the participant, the attributes of the ICF, and a version identifier that is unique to the ICF;
construct a modified ICF based on a second set of selections of the administrator;
receive consent to the modified ICF from one or more of the participants, wherein the modified ICF includes a modified attribute;
update the records of the one or more participants for whom consent to the modified ICF is received to reflect the modified attribute and a version identifier that is unique to the modified ICF; and
generate a report based on the records of the participants from the medical study, wherein the report includes the participant identifiers and attributes for which the respective participants have consented.
13. The non-transitory computer readable media of claim 12 , wherein the report further includes:
consent statuses of the respective participants.
14. The non-transitory computer readable media of claim 13 , wherein the consent statuses are based on the version identifiers of the ICFs to which the respective participants consented.
15. The non-transitory computer readable media of claim 12 , further comprising instructions to cause the processor to:
construct a second ICF for a second medical study based on a third set of selections of the administrator; and
generate the report based on records of participants of the medical study and participants of the second medical study.
16. The non-transitory computer readable media of claim 12 , further comprising instructions to cause the processor to:
associate a scannable code with each of the participants; and
associate the scannable codes with biological samples of the respective participants.
17. The non-transitory computer readable media of claim 12 , further comprising instructions to cause the processor to:
receive a code from a code scanning device; and
retrieve the record of one of the participants based on the code.
18. The non-transitory computer readable media of claim 12 , further comprising instructions to cause the processor to:
search the records to identify participants who have not consented to the modified ICF;
search the records to determine uses of biological specimens for which respective participants have consented; and/or
search the records to identify biological specimens for which a desired use is permitted.
19. The non-transitory computer readable media of claim 12 , wherein the attributes include attributes related to collection, use, and/or disposition of biological samples of the participants.
20. The non-transitory computer readable media of claim 12 , wherein the ICF further includes data fields to capture personal information of the participants.