PRIOR PRINTER'S NO. 2308 PRINTER'S NO. 3690
No. 1730 Session of 2007
INTRODUCED BY BLACKWELL, PARKER, SHIMKUS, BRENNAN, KIRKLAND,
JAMES, DePASQUALE, YOUNGBLOOD, MURT, SIPTROTH, HENNESSEY,
CURRY, JOSEPHS, BOYD, MUNDY, PALLONE AND SWANGER,
JULY 13, 2007
AS REPORTED FROM COMMITTEE ON HEALTH AND HUMAN SERVICES, HOUSE
OF REPRESENTATIVES, AS AMENDED, MAY 5, 2008
AN ACT
1 Prohibiting use of coercion and undue influence to gain <--
2 participation of special needs persons in certain research;
3 and imposing a penalty.
4 REQUIRING THE DEPARTMENT OF HEALTH TO ESTABLISH STANDARDS <--
5 GOVERNING PROTECTIONS FOR HUMAN SUBJECTS OF RESEARCH IN THIS
6 COMMONWEALTH; AND REQUIRING RESEARCHERS TO OBTAIN LEGALLY
7 EFFECTIVE INFORMED CONSENT FROM EACH RESEARCH SUBJECT OR THE
8 SUBJECT'S LEGALLY AUTHORIZED REPRESENTATIVE.
9 The General Assembly of the Commonwealth of Pennsylvania
10 hereby enacts as follows:
11 Section 1. Short title. <--
12 This act shall be known and may be cited as the Research
13 Consent Act.
14 Section 2. Definitions.
15 The following words and phrases when used in this act shall
16 have the meanings given to them in this section unless the
17 context clearly indicates otherwise:
18 "Interaction." Includes communication and interpersonal
19 contact between an investigator and a subject.
1 "Intervention." Includes physical procedures by which data
2 are gathered and manipulations of the subject's environment that
3 are performed for research purposes.
4 "Investigator." A person conducting research directly or
5 indirectly on behalf of any organization conducting
6 experimentation upon humans including, but not limited to,
7 pharmaceutical companies, universities, hospitals, whether
8 public or private, and governmental entities.
9 "Poor." An individual whose personal or family income falls
10 below two times the poverty level.
11 "Private information." Includes individually identifiable
12 information about behavior that occurs in a context in which an
13 individual can reasonably expect that no observation or
14 recording is taking place and individually identifiable
15 information provided for specific purposes by an individual
16 which the individual can reasonably expect will not be made
17 public.
18 "Research." A systematic investigation designed to develop
19 or contribute to generalized knowledge. The term includes, but
20 is not limited to, generalized research, development, testing
21 and evaluation.
22 "Special needs person." An individual who suffers from a
23 developmental disability, is mentally ill or poor, has substance
24 abuse intervention issues or has been convicted of a felony and
25 served time in prison as a result of committing the felony.
26 "Subject." A living individual about whom an investigator,
27 whether professional or student, conducting research obtains:
28 (1) data through intervention or interaction with the
29 individual; or
30 (2) identifiable private information.
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1 Section 3. Undue influence and coercion prohibited.
2 No investigator may involve a special needs individual as a
3 subject in research unless the investigator has obtained the
4 informed consent of the subject or the subject's legally
5 authorized representative in accordance with the provisions of
6 this act. An investigator shall seek consent only under
7 circumstances that provide the prospective subject or
8 representative sufficient opportunity to consider whether or not
9 to participate and minimize the possibility of coercion or undue
10 influence. Information given to the subject or representative
11 shall be in language understandable to the subject or
12 representative. No consent or consent form, whether oral or
13 written, may include exculpatory language through which the
14 subject or representative waives or appears to waive a legal
15 right or releases or appears to release the investigator,
16 sponsor, institution or an agent from liability for negligence.
17 Section 4. Penalty.
18 A violation of any provision of this act constitutes a felony
19 of the third degree.
20 Section 5. Effective date.
21 This act shall take effect in 60 days.
22 SECTION 1. SHORT TITLE. <--
23 THIS ACT SHALL BE KNOWN AND MAY BE CITED AS THE PROTECTIONS
24 FOR HUMAN SUBJECTS OF RESEARCH ACT.
25 SECTION 2. DEFINITIONS.
26 THE FOLLOWING WORDS AND PHRASES WHEN USED IN THIS ACT SHALL
27 HAVE THE MEANINGS GIVEN TO THEM IN THIS SECTION UNLESS THE
28 CONTEXT CLEARLY INDICATES OTHERWISE:
29 "DEPARTMENT." THE DEPARTMENT OF HEALTH OF THE COMMONWEALTH.
30 "HUMAN RESEARCH SUBJECT." A LIVING INDIVIDUAL ABOUT WHOM AN
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1 INVESTIGATOR CONDUCTING RESEARCH OBTAINS DATA THROUGH
2 INTERVENTION OR INTERACTION.
3 "INFORMED CONSENT." THE PROCESS OF PROVIDING THE KEY FACTS
4 ABOUT RESEARCH BEFORE HUMAN RESEARCH SUBJECTS DECIDE WHETHER OR
5 NOT TO PARTICIPATE. IT IS ALSO A CONTINUING PROCESS THROUGHOUT
6 THE RESEARCH TO PROVIDE INFORMATION TO HELP HUMAN RESEARCH
7 SUBJECTS DECIDE WHETHER OR NOT TO CONTINUE PARTICIPATION.
8 INFORMED CONSENT MUST BE SOUGHT UNDER CIRCUMSTANCES THAT
9 MINIMIZE THE POSSIBILITY OF COERCION OF UNDUE INFLUENCE.
10 "INVESTIGATOR." A PERSON CONDUCTING RESEARCH ON BEHALF OF
11 ANY ORGANIZATION CONDUCTING RESEARCH, INCLUDING, BUT NOT LIMITED
12 TO, PHARMACEUTICAL COMPANIES, UNIVERSITIES, HOSPITALS AND
13 GOVERNMENT ENTITIES.
14 "RESEARCH." A SYSTEMATIC INVESTIGATION, INCLUDING
15 DEVELOPMENT, TESTING AND EVALUATION DESIGNED TO DEVELOP OR
16 CONTRIBUTE TO GENERALIZED KNOWLEDGE. ACTIVITIES WHICH MEET THIS
17 DEFINITION CONSTITUTE RESEARCH FOR PURPOSES OF THIS ACT, WHETHER
18 OR NOT THEY ARE SUPPORTED UNDER A PROGRAM WHICH IS CONSIDERED
19 RESEARCH FOR OTHER PURPOSES.
20 SECTION 3. DEPARTMENT.
21 (A) ADOPTION OF STANDARD.--WITHIN SIX MONTHS OF THE
22 EFFECTIVE DATE OF THIS ACT, THE DEPARTMENT SHALL ADOPT A
23 PROTECTIONS FOR HUMAN SUBJECTS OF RESEARCH STANDARD. THE
24 STANDARD SHALL BE AT LEAST AS PRESCRIPTIVE AS THE STANDARD
25 PROMULGATED BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES AND
26 SHALL INCLUDE THE FOLLOWING, EXCEPT IN CASES WHERE THE
27 DEPARTMENT SPECIFICALLY APPROVES A WAIVER IN ACCORDANCE WITH
28 FEDERAL REGULATIONS OR SUBSECTION (D). NO INVESTIGATOR MAY
29 INVOLVE A HUMAN BEING AS A SUBJECT IN RESEARCH IN THIS
30 COMMONWEALTH UNLESS THE INVESTIGATOR HAS OBTAINED THE LEGALLY
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1 EFFECTIVE INFORMED CONSENT OF THE HUMAN RESEARCH SUBJECT OR THE
2 SUBJECT'S LEGALLY AUTHORIZED REPRESENTATIVE. AN INVESTIGATOR
3 SHALL SEEK SUCH CONSENT ONLY UNDER CIRCUMSTANCES THAT PROVIDE
4 THE PROSPECTIVE HUMAN RESEARCH SUBJECT OR THE SUBJECT'S
5 REPRESENTATIVE SUFFICIENT OPPORTUNITY TO CONSIDER WHETHER OR NOT
6 TO PARTICIPATE AND THAT MINIMIZE THE POSSIBILITY OF COERCION OR
7 UNDUE INFLUENCE. THE INFORMATION THAT IS GIVEN TO THE HUMAN
8 RESEARCH SUBJECT OR THE SUBJECT'S REPRESENTATIVE SHALL BE IN
9 LANGUAGE UNDERSTANDABLE TO THE SUBJECT OR THE SUBJECT'S
10 REPRESENTATIVE. NO INFORMED CONSENT, WHETHER ORAL OR WRITTEN,
11 MAY INCLUDE ANY EXCULPATORY LANGUAGE THROUGH WHICH THE HUMAN
12 RESEARCH SUBJECT OR THE SUBJECT'S REPRESENTATIVE IS MADE TO
13 WAIVE OR APPEAR TO WAIVE ANY OF THE SUBJECT'S LEGAL RIGHTS OR
14 RELEASE OR APPEAR TO RELEASE THE INVESTIGATOR, THE SPONSOR, THE
15 INSTITUTION OR ITS AGENTS FROM LIABILITY FOR NEGLIGENCE.
16 (B) INFORMATION REQUIRED.--IN SEEKING INFORMED CONSENT, ALL
17 OF THE FOLLOWING INFORMATION SHALL BE PROVIDED TO EACH HUMAN
18 RESEARCH SUBJECT, EXCEPT AS PROVIDED IN SUBSECTION (D):
19 (1) A STATEMENT THAT THE STUDY INVOLVES RESEARCH, AN
20 EXPLANATION OF THE PURPOSES OF THE RESEARCH, THE EXPECTED
21 DURATION OF THE SUBJECT'S PARTICIPATION, A DESCRIPTION OF THE
22 PROCEDURES TO BE FOLLOWED AND THE IDENTIFICATION OF ANY
23 PROCEDURES WHICH ARE EXPERIMENTAL.
24 (2) A DESCRIPTION OF ANY REASONABLY FORSEEABLE RISKS OR
25 DISCOMFORTS TO THE SUBJECT.
26 (3) A DESCRIPTION OF ANY BENEFITS TO THE SUBJECT OR TO
27 OTHERS WHICH MAY REASONABLY BE EXPECTED FROM THE RESEARCH.
28 (4) A DISCLOSURE OF APPROPRIATE ALTERNATIVE PROCEDURES
29 OR COURSES OF TREATMENT, IF ANY, THAT MIGHT BE ADVANTAGEOUS
30 TO THE SUBJECT.
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1 (5) A STATEMENT DESCRIBING THE EXTENT, IF ANY, TO WHICH
2 CONFIDENTIALITY OF RECORDS IDENTIFYING THE SUBJECT WILL BE
3 MAINTAINED.
4 (6) FOR RESEARCH INVOLVING MORE THAN MINIMAL RISK, AN
5 EXPLANATION AS TO WHETHER ANY COMPENSATION AND ANY MEDICAL
6 TREATMENTS ARE AVAILABLE IF INJURY OCCURS AND, IF SO, WHAT
7 THEY CONSIST OF OR WHERE FURTHER INFORMATION MAY BE OBTAINED.
8 (7) AN EXPLANATION OF WHOM TO CONTACT FOR ANSWERS TO
9 PERTINENT QUESTIONS ABOUT THE RESEARCH AND THE SUBJECT'S
10 RIGHTS, AND WHOM TO CONTACT IN THE EVENT OF A RESEARCH-
11 RELATED INJURY TO THE SUBJECT.
12 (8) A STATEMENT THAT PARTICIPATION IS VOLUNTARY AND THAT
13 REFUSAL TO PARTICIPATE WILL INVOLVE NO PENALTY OR LOSS OF
14 BENEFITS TO WHICH THE SUBJECT IS OTHERWISE ENTITLED.
15 (C) ADDITIONAL ELEMENTS OF INFORMED CONSENT.--WHEN
16 APPROPRIATE, ONE OR MORE OF THE FOLLOWING ELEMENTS OF
17 INFORMATION SHALL ALSO BE PROVIDED TO EACH HUMAN RESEARCH
18 SUBJECT:
19 (1) A STATEMENT THAT THE PARTICULAR TREATMENT OR
20 PROCEDURE MAY INVOLVE RISKS TO THE SUBJECT OR TO THE EMBRYO
21 OR FETUS, IF THE SUBJECT IS OR MAY BECOME PREGNANT, WHICH ARE
22 CURRENTLY UNFORSEEABLE.
23 (2) ANTICIPATED CIRCUMSTANCES UNDER WHICH THE SUBJECT'S
24 PARTICIPATION MAY BE TERMINATED BY THE INVESTIGATOR WITHOUT
25 REGARD TO THE SUBJECT'S CONSENT.
26 (3) ANY ADDITIONAL COSTS TO THE SUBJECT THAT MAY RESULT
27 FROM PARTICIPATION IN THE RESEARCH.
28 (4) THE CONSEQUENCES OF A SUBJECT'S DECISION TO WITHDRAW
29 FROM THE RESEARCH AND PROCEDURES FOR ORDERLY TERMINATION OF
30 PARTICIPATION BY THE SUBJECT.
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1 (5) A STATEMENT THAT SIGNIFICANT NEW FINDINGS DEVELOPED
2 DURING THE COURSE OF THE RESEARCH MAY RELATE TO THE SUBJECT'S
3 WILLINGNESS TO CONTINUE PARTICIPATION.
4 (6) THE APPROXIMATE NUMBER OF SUBJECTS IN THE STUDY.
5 (D) WAIVER.--THE DEPARTMENT MAY APPROVE A CONSENT PROCEDURE
6 WHICH DOES NOT INCLUDE OR WHICH ALTERS SOME OR ALL OF THE
7 ELEMENTS OF INFORMED CONSENT SET FORTH IN SUBSECTIONS (B) AND
8 (C) OR WAIVE THE REQUIREMENT TO OBTAIN INFORMED CONSENT,
9 PROVIDED THAT:
10 (1) THE RESEARCH OR DEMONSTRATION PROJECT IS TO BE
11 CONDUCTED BY OR SUBJECT TO THE APPROVAL OF STATE OR LOCAL
12 GOVERNMENT OFFICIALS AND IS DESIGNED TO STUDY, EVALUATE OR
13 OTHERWISE EXAMINE:
14 (I) PUBLIC BENEFIT OR SERVICE PROGRAMS;
15 (II) PROCEDURES FOR OBTAINING BENEFITS OR SERVICES
16 UNDER THOSE PROGRAMS;
17 (III) POSSIBLE CHANGES IN OR ALTERNATIVES TO THOSE
18 PROGRAMS OR PROCEDURES; OR
19 (IV) POSSIBLE CHANGES IN METHODS OR LEVELS OF
20 PAYMENT FOR BENEFITS OR SERVICES UNDER THOSE PROGRAMS.
21 (2) THE RESEARCH COULD NOT BE PRACTICABLY CARRIED OUT
22 WITHOUT THE WAIVER OR ALTERATION.
23 SECTION 4. RULES AND REGULATIONS.
24 THE DEPARTMENT SHALL PROMULGATE RULES AND REGULATIONS AS
25 NECESSARY TO CARRY OUT THE PROVISIONS OF THIS ACT.
26 SECTION 5. EFFECTIVE DATE.
27 THIS ACT SHALL TAKE EFFECT JULY 1, 2008.
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