Projects involving Human Subjects

Risk Assessment with COVID-19 (from ISEF)

https://www.societyforscience.org/isef/2021-resources/human-participant-research-with-covid-19-precautions/

Stu­dent researchers and super­vis­ing adults should be aware of guid­ance or reg­u­la­tions from the state, coun­ty and local offi­cials as well as their school dis­tricts or research facil­i­ties and abide with the most restric­tive require­ments with the utmost cau­tion and care. The safe­ty of the entire com­mu­ni­ty should be a priority.

Due to the spe­cial cir­cum­stances brought on by the COVID-19 pan­dem­ic, it is strong­ly rec­om­mend­ed that ALL stu­dents include in their risk assess­ment how they will mit­i­gate the spread of the dis­ease while con­duct­ing their exper­i­ment. Exam­ples of such mit­i­ga­tions include (but are not lim­it­ed to):

  • Wear­ing a face cov­er­ing and main­tain­ing a 6‑foot dis­tance from peo­ple not in the researcher’s imme­di­ate social bubble/pod/cohort. This is espe­cial­ly impor­tant when con­duct­ing human par­tic­i­pant projects.
  • Wash­ing hands frequently.
  • Keep­ing work space clean and dis­in­fect­ed. This is espe­cial­ly impor­tant if the stu­dent is work­ing in a shared space.
  • When work­ing with human par­tic­i­pants, con­sid­er vir­tu­al or online options and avoid in-per­son projects.

DEFINITION: Human sub­jects research includes projects involv­ing the following: 

  1. Human sub­jects par­tic­i­pat­ing in phys­i­cal activ­i­ties (phys­i­cal exer­tion, eating/drinking any sub­stance, any med­ical procedure), 
  2. Psy­cho­log­i­cal and opin­ion stud­ies (sur­vey, ques­tion­naire, test of any kind).
  3. Behav­ioral obser­va­tions of oth­ers.
  4. Stud­ies in which the researcher is the sub­ject of the research.

ALL projects involv­ing research with human sub­jects must be pre-approved by the LA Coun­ty Sci­ence Review Com­mit­tee (SRC) before exper­i­men­ta­tion is begun.

Pro­hib­it­ed Research and Disclosure

  1. Stu­dent researchers may NOT pub­lish or dis­play infor­ma­tion in a report that iden­ti­fies the human sub­ject direct­ly or through iden­ti­fiers linked to the sub­jects (includ­ing pho­tographs), with­out writ­ten consent.
  2. Stu­dents are pro­hib­it­ed from admin­is­ter­ing med­ica­tions and per­form­ing med­ical pro­ce­dures on human subjects.
  3. Stu­dents under the age of 21 are pro­hib­it­ed by fed­er­al and state law from using con­trolled sub­stances in their research project. These sub­stances include all forms of alco­hol, explo­sive mate­ri­als, tobac­co and firearms.

Reg­u­la­tions and Supervision

There are fed­er­al reg­u­la­tions that must pro­tect the rights and wel­fare of human sub­jects. There­fore, stu­dents must plan care­ful­ly before start­ing research that involves the use of human sub­jects in either behav­ioral or bio­med­ical stud­ies. This will pro­tect sub­jects from unnec­es­sary con­tact with phys­i­cal or psy­cho­log­i­cal harm or complications.

Please see the Human Sub­jects Webi­nar for more infor­ma­tion regard­ing projects involv­ing Human Subjects.

For your project, a Human Sub­ject Con­sent Form needs to be devel­oped in con­sul­ta­tion with the Stu­dent and the Teacher/Site Coor­di­na­tor, Des­ig­nat­ed Super­vi­sor or Qual­i­fied Sci­en­tist. This form will pro­vide infor­ma­tion to your research sub­ject (or parent/guardian) about your project and will doc­u­ment writ­ten “informed con­sent” and/or parental per­mis­sion. Every par­tic­i­pant and their parent/guardian will need to receive a ver­sion of this form and sign her or his con­sent at the bot­tom before start­ing a project involv­ing human sub­jects. This same infor­ma­tion will need to be entered online as a part of the research proposal.

Below are the resources need­ed for Research involv­ing Human Subjects:

Human Sub­jects Online Pre-Approval tem­plate (This is a fil­l­able PDF. Please down­load this doc­u­ment to your device and enter your respons­es in the giv­en box­es. You do not need to com­plete the form in one sit­ting. Choose Save to save your progress. Once you com­plete the form, get it approved by your adult super­vi­sor and site coor­di­na­tor BEFORE you go online to com­plete the online pre-approval form. You can then copy and paste your respons­es in the appro­pri­ate sec­tions of the online form.)

In addi­tion, Senior Divi­sion stu­dents need to com­plete the ISEF Human Informed Con­sent form and bring them to the fair.