Testing an Approach to Improve the Use of Evidence
Phase: NA
Conditions: Legislation, Policy, Child Abuse, Family and Household
Sponsor: Penn State University

 
Evaluation of the Research to 
Policy Collaboration Model 
 
NCT03671434 
 
November 25, 2019 

Page 2 of 26 (V.04/27/2017)  
Table of Contents 
1.0 
Objectives 
2.0 
Background 
3.0 
Inclusion and Exclusion Criteria 
4.0 
Recruitment Methods 
5.0 
Consent Process and Documentation 
6.0 
HIPAA Research Authorization and/or Waiver or Alteration of Authorization 
7.0 
Study Design and Procedures 
8.0 
Subject Numbers and Statistical Plan 
9.0 
Confidentiality, Privacy and Data Management 
10.0 
Data and Safety Monitoring Plan 
11.0 
Risks 
12.0 
Potential Benefits to Subjects and Others 
13.0 
Sharing Results with Subjects 
14.0 
Subject Stipend (Compensation) and/or Travel Reimbursements 
15.0 
Economic Burden to Subjects 
16.0 
Resources Available 
17.0 
Other Approvals 
18.0 
Multi-Site Research 
19.0 
Adverse Event Reporting 
20.0 
Study Monitoring, Auditing and Inspecting 
21.0 
Future Undetermined Research: Data and Specimen Banking 
22.0 
References 
 
 

Page 3 of 26 (V.04/27/2017)  
1.0 
Objectives 
 
1.1 
Study Objectives 
Describe the purpose, specific aims or objectives.  State the hypotheses to be tested. 
This mixed-methods study will evaluate the impact of the Research-to-Policy Collaboration (RPC) model 
on the use of scientific research in federal policymaking. Human Subjects research will be carried out to 
assess the RPC effects on participating researchers who are trained and coached by the model to 
respond to current policy opportunities and translate scientific research to public officials.  
 
A survey will be used to assess researchers reported policy competencies and motivation for conducting 
policy-relevant research. This study will also examine whether these outcomes vary as a function of 
collaborative experiences with public officials and hypothesizes that more productive and satisfying 
collaborations will improve researchers’ ongoing policy engagement and increases in policy-relevant 
research.  These surveys will be supplemented by qualitative interviews to discuss researchers’ 
experiences translating research and working with public officials. This includes discussion of (1) barriers 
and facilitators of participating in researcher-public official partnerships, (2) the types of interactions 
between researchers and public officials facilitated by the RPC, and (3) how the RPC affects researchers’ 
assumptions about and interactions with public officials.  
 
1.2 
Primary Study Endpoints 
State the primary endpoints to be measured in the study.  Clinical trials typically have a primary 
objective or endpoint. Additional objectives and endpoints are secondary.  The endpoints (or outcomes), 
determined for each study subject, are the quantitative measurements required by the objectives.  
Measuring the selected endpoints is the goal of a trial (examples: response rate and survival). 
 
This study will measure changes in participants’ policy knowledge and skills, policy engagement, and the 
extent to which research activities are informed by public officials’ needs.   
 
1.3 
Secondary Study Endpoints 
State the secondary endpoints to be measured in the study. 
 
Experiences collaborating with public official will be assessed among participants in the RPC intervention 
(experimental) condition. Aspects of these collaboration experiences that will be measured include 
satisfaction, perceived value and impact, and trust and respect.  
 
2.0 
Background  
 
2.1 
Scientific Background and Gaps 
Describe the scientific background and gaps in current knowledge. 
 
The persistent gap between research and policymaking is a multifaceted challenge borne in part out of 
limited interaction between researchers and public officials. Yet, interaction without adequate 
preparation for policy engagement (i.e., training and supports) may thwart researchers’ efforts to 
support public officials’ use of empirical evidence. Although varied policy training approaches for 
researchers exist, little empirical work has explored their effectiveness in improving policy knowledge 
and skills or supporting researchers’ enduring policy engagement. Furthermore, scant research has 
considered the extent to which facilitating policy experiences among researchers may shift researchers’ 
perspectives on how research evidence is produced, communicated, and disseminated.  

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2.2 
Previous Data 
Describe any relevant preliminary data. 
 
N/A 
 
2.3 
Study Rationale 
Provide the scientific rationale for the research. 
 
The RPC model is based on a growing literature around the use of scientific evidence in policymaking, 
which emphasizes the need to cultivate positive interactions and collaborations between researchers 
and public officials. A prominent facilitator for public officials’ use of research is the translation of 
relevant scientific findings in the context of trusting relationships with researchers. Public officials often 
turn to “experts” when addressing issues that are part of a political agenda. Therefore, connecting 
researchers to current policy opportunities and priorities in ways that engender trusting relationships 
aligns with known facilitators of public officials’ use of research evidence. However, such connections 
must be made tactfully, and enhancing researchers’ policy competencies can strengthen the success of 
their policy outreach. 
 
The success of connections between public officials and researchers may be improved by strengthening 
researchers’ policy knowledge and skills.  Much more research is needed to evaluate training 
approaches and enhance their effectiveness. Specifically, research is needed that evaluates the impact 
of training approaches by longitudinally tracking researchers’ reported confidence and skills, 
participation in policy efforts, and interactions with public officials. Efforts are also needed to explore 
the extent to which researchers’ policy competencies translate into public officials’ increased utilization 
of research findings. 
 
In addition to supporting public officials’ use of research evidence, researcher-public official 
partnerships may have the potential to improve the usefulness of research activities for public officials. 
Few supports are in place to help researchers proactively consider policy and practice implications prior 
to study development, even though research that is responsive to public officials’ needs may be more 
likely to be used by public officials in the future. Policy-informed research adjusts to prevailing policy 
priorities, shaping the questions that are investigated and how results are interpreted and 
communicated. A cultural shift toward more policy-informed research is needed, including the way it is 
produced, interpreted, and communicated—and opportunities for researcher-public official 
collaboration may support this shift. Some studies have shown that co-creation of research knowledge 
can strengthen the utility of findings for policymaking and implementation. However, the majority of 
partnerships applying research in a decision-making context focus on producing generating timely and 
actionable research, whereas there is a need to complement this knowledge base by investigating 
subtler partnerships in which research is distilled for co-interpretation of policy implications. 
3.0 
Inclusion and Exclusion Criteria 
Create a numbered list below in sections 3.1 and 3.2 of criteria subjects must meet to be eligible for study 
enrollment (e.g., age, gender, diagnosis, etc.). Indicate specifically whether you will include any of the 
following vulnerable populations: (You may not include members of these populations as subjects in your 
research unless you indicate this in your inclusion criteria.) Review the corresponding checklists to ensure that 
you have provided the necessary information. 
• 
Adults unable to consent 
o Review “CHECKLIST: Cognitively Impaired Adults (HRP-417)” to ensure that you have 
provided sufficient information. HRP-417 can be accessed by clicking the Library link in 
CATS IRB (http://irb.psu.edu). 
• 
Individuals who are not yet adults (infants, children, teenagers) 

Page 5 of 26 (V.04/27/2017)  
o If the research involves persons who have not attained the legal age for consent to 
treatments or procedures involved in the research (“children”), review the “CHECKLIST: 
Children (HRP-416)” to ensure that you have provided sufficient information. HRP-416 
can be accessed by clicking the Library link in CATS IRB (http://irb.psu.edu). 
• 
Pregnant women 
o Review “CHECKLIST: Pregnant Women (HRP-412)” to ensure that you have provided 
sufficient information. HRP-412 can be accessed by clicking the Library link in CATS IRB 
(http://irb.psu.edu). 
• 
Prisoners 
o Review “CHECKLIST: Prisoners (HRP-415)” to ensure that you have provided sufficient 
information.  HRP-415 can be accessed by clicking the Library link in CATS IRB 
(http://irb.psu.edu). 
• 
Neonates of uncertain viability or non-viable neonates 
o Review “CHECKLIST: Neonates (HRP-413)” or “CHECKLIST: Neonates of Uncertain Viability 
(HRP-414)” to ensure that you have provide sufficient information.  HRP-413 and HRP-414 
can be accessed by clicking the Library link in CATS IRB (http://irb.psu.edu). 
 
3.1 
Inclusion Criteria 
List the criteria that define who will be included in your study. 
 
Researchers who voluntarily enlist in the RPC will be asked to participate in the trial. All participants will 
be over 18 years old.  
 
3.2 
Exclusion Criteria 
List the criteria that define who will be excluded in your study. 
 
None.  
 
3.3 
Early Withdrawal of Subjects 
 
3.3.1 Criteria for removal from study 
Insert subject withdrawal criteria (e.g., safety reasons, failure of subject to adhere to protocol 
requirements, subject consent withdrawal, disease progression, etc.). 
 
Researchers who choose to stop participating in the study or the RPC itself. All study participants 
can choose to opt-out of the study at any time.  
 
3.3.2 
Follow-up for withdrawn subjects 
Describe when and how to withdraw subjects from the study; the type and timing of the data to 
be collected for withdrawal of subjects; whether and how subjects are to be replaced; the 
follow-up for subjects withdrawn from investigational treatment. 
 
No follow-up will be conducted with withdrawn subjects.  
 
4.0 
Recruitment Methods 
 

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4.1 
Identification of subjects 
Describe the methods that will be used to identify potential subjects or the source of the subjects.  If not 
recruiting subjects directly (e.g., database query for eligible records or samples) state what will be 
queried, how and by whom. 
StudyFinder:  If you intend to use StudyFinder (http://studyfinder.psu.edu) for recruitment purposes, 
please indicate this in section 4.1 along with any other methods for identifying subjects. Note that 
information provided in this protocol should be consistent with information provided on the 
StudyFinder page in your CATS IRB study. 
 
For Penn State Hershey submissions using Enterprise Information Management (EIM) for recruitment, 
attach your EIM Design Specification form on the Basic Information page in CATS IRB 
(http://irb.psu.edu). See HRP-103 Investigator Manual, “What is appropriate for study recruitment?” for 
additional information. 
 
Researchers voluntarily enlist to participate in the Research-to-Policy Collaboration (RPC), which recruits 
researchers from professional societies, committees or work groups, listservs, word-of-mouth, and 
referrals from other researchers. All those enlisted in the RPC are then invited to participate in the 
study. Those who agree to participate in the study are randomly assigned to an intervention group that 
receives the RPC or to a control group that receives a “light touch” policy engagement intervention. 
Those who do not agree to participate in the study will not be placed in the control group, but will be 
part of the RPC group alongside study participants who were randomly assigned to receive the RPC. 
 
4.2 
Recruitment process 
Describe how, where and when potential subjects will be recruited (e.g., approaching or providing 
information to potential subjects for participation in this research study). 
 
All researchers who voluntarily sign-up to participate in the RPC will be invited to participate in this 
study. Researchers enlist themselves in the intervention by completing an information form about their 
areas of expertise, an essential part of RPC implementation. Subsequent to the standard 
implementation intake form, research participants will be asked to participate in the study. Researchers 
can participate in the RPC even if they opt out of participating in the study.   
 
4.3 
Recruitment materials 
List the materials that will be used to recruit subjects. Add recruitment documents to your study in CATS 
IRB (http://irb.psu.edu) on the “Consent Forms and Recruitment Materials” page. For advertisements, 
upload the final copy of printed advertisements. When advertisements are taped for broadcast, attach 
the final audio/video tape. You may submit the wording of the advertisement prior to taping to preclude 
re-taping because of inappropriate wording, provided the IRB reviews the final audio/video tape. 
 
StudyFinder:  If you intend to use StudyFinder (http://studyfinder.psu.edu) for recruitment purposes, 
you do not need to upload a separate recruitment document for information placed on the StudyFinder 
site to your study in CATS IRB.  Necessary information will be captured on the StudyFinder page in your 
CATS IRB study. 
 
 RPC participants are recruited primarily via emails that are sent to individual researchers or via listservs 
for groups or organizations in which many members are researchers, and thus are eligible to 
participate in the RPC. Recruitment emails are adapted based on context and a standard flier 
will be attached to recruitment emails. The flier mentions the voluntary nature of the associated 
study. RPC participants may choose to participate in the study or they may decline study 
participation without that affecting their ability to participate in the RPC.  
 

Page 7 of 26 (V.04/27/2017)  
4.4 
Eligibility/screening of subjects 
If potential subjects will be asked eligibility questions before obtaining informed consent, describe the 
process. Add the script documents and a list of the eligibility questions that will be used to your study in 
CATS IRB (http://irb.psu.edu) on the “Consent Forms and Recruitment Materials” page. 
 
StudyFinder:  If you intend to use StudyFinder (http://studyfinder.psu.edu) for recruitment purposes, 
any scripts (phone, email, or other) used when contacting StudyFinder participants as well as any 
eligibility screening questions must be added to your study in CATS IRB (http://irb.psu.edu) on the 
“Consent Forms and Recruitment Materials” page. 
 
N/A 
 
5.0 
Consent Process and Documentation  
Refer to “SOP: Informed Consent Process for Research (HRP-090)”, for information about the process of 
obtaining informed consent from subjects.  HRP-090 can be accessed by clicking the Library link in CATS IRB 
(http://irb.psu.edu). 
 
5.1 
Consent Process  
  
5.1.1 Obtaining Informed Consent 
 
5.1.1.1 Timing and Location of Consent 
Describe where and when the consent process will take place. 
 
The study consent form is provided online immediately subsequent to a 
researcher enlisting in the RPC (which also occurs online) and prior to entering 
the online survey. RPC participants will then be asked to agree or decline 
participation in the study.  
 
5.1.1.2 Coercion or Undue Influence during Consent 
Describe the steps that will be taken to minimize the possibility of coercion or 
undue influence in the consent process. 
 
The consent form notes that study participation is voluntary and there is an 
option to decline participating in the study such that researchers may 
participate in the RPC without participating in the study.  
 
5.1.2 Waiver or alteration of the informed consent requirement 
If you are requesting a waiver or alteration of consent (consent will not be obtained, required 
information will not be disclosed, or the research involves deception), describe the rationale 
for the request in this section.  If the alteration is because of deception or incomplete 
disclosure, explain whether and how subjects will be debriefed. Add any debriefing materials or 
document(s) to your study in CATS IRB (http://irb.psu.edu) on the “Supporting Documents” 
page.  NOTE: Review the “CHECKLIST: Waiver or Alteration of Consent Process (HRP-410)” to 
ensure you have provided sufficient information for the IRB to make these determinations. 
HRP-410 can be accessed by clicking the Library link in CATS IRB (http://irb.psu.edu).  
 
Study participation involves deception regarding the extent of a professional development and 
policy engagement opportunity. Deception is necessary for internal validity because awareness 
of one’s condition in the experiment could lead to social desirability biases in survey responses.  

Page 8 of 26 (V.04/27/2017)  
The risk of deception is minimal because the intervention received by the control group is 
greater than that received in normal practice (i.e., no intervention, training, or engagement). 
Furthermore, it is not unusual for the intervention subjects (i.e., researchers) to be recruited for 
voluntary commitments that result in limited engagement due to limited organizational capacity 
(e.g., involvement in a policy committee that becomes inactive). The experience of control 
group participants is expected to be greater than or comparable to other experiences for which 
they might be recruited outside of the current study context; therefore, participation in the 
study will not adversely affect the rights and welfare of study participants. 
 
Survey participation involves little risk for participants, which involves the loss of confidentiality 
of their responses to the survey or interview. Confidentiality will be maintained to the degree 
permitted by the technology used. Specifically, no guarantees can be made regarding the 
interception of data sent via the Internet by any third parties. To minimize this risk, data files 
will be encrypted and direct identifiers will be removed from the data prior to storage and 
analysis. Furthermore, the questions asked are not of a sensitive nature, and data protection 
plans minimize threats to confidentiality; therefore, participation in the survey will not adversely 
affect the rights or welfare of participants. Because research participants will be recruited 
online, the majority of the intervention takes place online, and participants will be located 
across the United states, it is not viable to complete a written consent. Therefore, survey 
participants will be consented via an online survey. Consent is therefore implied. Participants 
are presented with consent information and must click “I agree” prior to entering the web-
based survey. An option for “I do not agree” would end the survey and indicate that the RPC 
participant does not agree to participate in the study. 
 
Observation participation involves minimal risk because the probability of harm or discomfort 
from the collection of observational data from public meetings is not greater than participating 
in the public meeting with no observation. Meeting attendees voluntarily elect to participate in 
these meetings, and meeting participants have complete control regarding with whom or the 
extent to which they share personal information. A waiver will not adversely affect the rights or 
welfare of subjects because meeting participants have the right to end participation in the 
observed meeting at any time, and the observer will be present as a passive participant who 
does not interfere with naturally occurring phenomenon. The observation is unobtrusive, as the 
observer will join the meeting in a similar manner as the meeting participants. Most meetings 
are expected to last around 30 minutes; therefore, a written consent procedure would detract 
time available for the meeting itself. Furthermore, written consent procedures would disrupt 
the nature of interactions that are of focus in the observation. No pertinent information of value 
to meeting participants will be gleaned from the observation. Observational field notes reflect 
process data regarding natural processes and interactions that occur during the intervention. No 
information will be obtained that is relevant to the welfare of observed participants. 
 
All study participants will be debriefed via email regarding their status as part of the RPC group 
or control group subsequent to the conclusion of the study, approximately one year following 
the baseline survey.  
 
5.2 
Consent Documentation 
 
5.2.1 
Written Documentation of Consent 
Refer to “SOP: Written Documentation of Consent (HRP-091)” for information about the process 
to document the informed consent process in writing.  HRP-091 can be accessed by clicking the 
Library link in CATS IRB (http://irb.psu.edu). 
 

Page 9 of 26 (V.04/27/2017)  
If you will document consent in writing, describe how consent of the subject will be documented 
in writing. Add the consent document(s) to your study in CATS IRB (http://irb.psu.edu) on the 
“Consent Forms and Recruitment Materials” page. Links to Penn State’s consent templates are 
available in the same location where they are uploaded and their use is required. 
 
N/A.  
 
5.2.2 
Waiver of Documentation of Consent (Implied consent, Verbal consent, etc.) 
If you will obtain consent (verbal or implied), but not document consent in writing, describe how 
consent will be obtained. Add the consent script(s) and/or information sheet(s) to your study in 
CATS IRB (http://irb.psu.edu) on the “Consent Forms and Recruitment Materials” page. Links to 
Penn State’s consent templates are available in the same location where they are uploaded and 
their use is required. Review “CHECKLIST: Waiver of Written Documentation of Consent (HRP-
411)” to ensure that you have provided sufficient information. HRP-411 can be accessed by 
clicking the Library link in CATS IRB (http://irb.psu.edu). 
 
If your research presents no more than minimal risk of harm to subjects and involves no 
procedures for which written documentation of consent is normally required outside of the 
research context, the IRB will generally waive the requirement to obtain written documentation 
of consent. 
 
Survey participation consent will be implied. Participants are presented with consent 
information and must click “I agree” prior to entering the web-based survey. An option for “I 
disagree” would end the survey and indicate that the RPC participant does not agree to 
participate in the study. 
Public meetings will be observed, involve minimal risk, no threats to the welfare of observation 
subjects, and informed consent procedures would interfere with naturally-occurring meeting 
processes that are the subject of study; therefore, observations of public meetings involve 
subjects who are exempt from written, verbal, or implied consent. 
 
5.3 
Consent – Other Considerations  
 
5.3.1 
Non-English Speaking Subjects 
Indicate what language(s) other than English are understood by prospective subjects or 
representatives. 
 
If subjects who do not speak English will be enrolled, describe the process to ensure that the 
oral and written information provided to those subjects will be in that language. Indicate the 
language that will be used by those obtaining consent. 
 
Indicate whether the consent process will be documented in writing with the long form of the 
consent documentation or with the short form of the consent documentation.  Review the 
“SOP: Written Documentation of Consent (HRP-091)” and the “Investigator Manual (HRP-103)” 
to ensure that you have provided sufficient information. HRP-091 and HRP-103 can be accessed 
by clicking the Library link in CATS IRB (http://irb.psu.edu). 
 
It is anticipated that all RPC participants will speak English fluently due to the nature of their 
engagement in U.S. domestic public policy. Therefore, we anticipate no study participants to be 
non-English speaking.  
 

Page 10 of 26 (V.04/27/2017)  
5.3.2 
Cognitively Impaired Adults 
Refer to “CHECKLIST: Cognitively Impaired Adults (HRP-417)” for information about research 
involving cognitively impaired adults as subjects. HRP-417 can be accessed by clicking the Library 
link in CATS IRB (http://irb.psu.edu). 
 
5.3.2.1 Capability of Providing Consent 
Describe the process to determine whether an individual is capable of consent. 
 
RPC participants, and consequently study participants, include high-functioning 
research faculty, professors, evaluators, and other skilled professionals who will 
have the capacity to provide consent.   
 
5.3.2.2 Adults Unable To Consent 
Describe whether and how informed consent will be obtained from the legally 
authorized representative.  Describe who will be allowed to provide informed 
consent. Describe the process used to determine these individual’s authority to 
consent to research. 
 
For research conducted in the state, review “SOP: Legally Authorized 
Representatives, Children and Guardians (HRP-013)” to be aware of which 
individuals in the state meet the definition of “legally authorized 
representative”. HRP-013 can be accessed by clicking the Library link in CATS IRB 
(http://irb.psu.edu). 
 
For research conducted outside of the state, provide information that describes 
which individuals are authorized under applicable law to consent on behalf of a 
prospective subject to their participation in the procedure(s) involved in this 
research.  One method of obtaining this information is to have a legal counsel or 
authority review your protocol along with the definition of “children” in “SOP: 
Legally Authorized Representatives, Children, and Guardians (HRP-013).” HRP-
013 can be accessed by clicking the Library link in CATS IRB (http://irb.psu.edu). 
 
N/A 
 
5.3.2.3 Assent of Adults Unable to Consent 
Describe the process for assent of the subjects.  Indicate whether assent will be 
required of all, some or none of the subjects.  If some, indicate which subjects will 
be required to assent and which will not.  
 
If assent will not be obtained from some or all subjects, provide an explanation of 
why not. 
 
Describe whether assent of the subjects will be documented and the process to 
document assent.  The IRB allows the person obtaining assent to document assent 
on the consent document and does not routinely require assent documents and 
does not routinely require subjects to sign assent documents. 
 
N/A 
 

Page 11 of 26 (V.04/27/2017)  
5.3.3 
Subjects who are not yet adults (infants, children, teenagers)  
 
5.3.3.1 Parental Permission 
Describe whether and how parental permission will be obtained. If permission 
will be obtained from individuals other than parents, describe who will be 
allowed to provide permission.  Describe the process used to determine these 
individual’s authority to consent to each child’s general medical care. 
 
For research conducted in the state, review “SOP: Legally Authorized 
Representatives, Children and Guardians (HRP-013)” to be aware of which 
individuals in the state meet the definition of “children”. HRP-013 can be 
accessed by clicking the Library link in CATS IRB (http://irb.psu.edu). 
 
For research conducted outside of the state, provide information that describes 
which persons have not attained the legal age for consent to treatments or 
procedures involved in the research, under the applicable law of the jurisdiction 
in which research will be conducted.  One method of obtaining this information 
is to have a legal counsel or authority review your protocol along with the 
definition of “children” in “SOP: Legally Authorized Representatives, Children, 
and Guardians (HRP-013).” HRP-013 can be accessed by clicking the Library link 
in CATS IRB (http://irb.psu.edu). 
 
N/A. All RPC participants, and consequently study participants, will be over age 
18.  
 
5.3.3.2 Assent of subjects who are not yet adults 
Indicate whether assent will be obtained from all, some, or none of the children. If 
assent will be obtained from some children, indicate which children will be 
required to assent. When assent of children is obtained describe whether and how 
it will be documented. 
 
N/A 
 
6.0 
HIPAA Research Authorization and/or Waiver or Alteration of Authorization 
This section is about the access, use or disclosure of Protected Health Information (PHI). PHI is individually 
identifiable health information (i.e., health information containing one or more 18 identifiers) that is transmitted 
or maintained in any form or medium by a Covered Entity or its Business Associate. A Covered Entity is a health 
plan, a health care clearinghouse or health care provider who transmits health information in electronic form.  
See the “Investigator Manual (HRP-103)” for a list of the 18 identifiers.  HRP-103 can be accessed by clicking the 
Library link in CATS IRB (http://irb.psu.edu). 
 
If requesting a waiver/alteration of HIPAA authorization, complete sections 6.2 and 6.3 in addition to section 
6.1. The Privacy Rule permits waivers (or alterations) of authorization if the research meets certain conditions. 
Include only information that will be accessed with the waiver/alteration.  
 
6.1 
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures of PHI 
 
Check all that apply: 
  
Not applicable, no identifiable protected health information (PHI) is accessed, used or 
disclosed in this study. [Mark all parts of sections 6.2 and 6.3 as not applicable] 

Page 12 of 26 (V.04/27/2017)  
 
 
Authorization will be obtained and documented as part of the consent process. [If this is the 
only box checked, mark sections 6.2 and 6.3 as not applicable] 
 
 
Partial waiver is requested for recruitment purposes only (Check this box if patients’ medical 
records will be accessed to determine eligibility before consent/authorization has been 
obtained). [Complete all parts of sections 6.2 and 6.3] 
 
 
Full waiver is requested for entire research study (e.g., medical record review studies). 
[Complete all parts of sections 6.2 and 6.3] 
 
 
Alteration is requested to waive requirement for written documentation of authorization 
(verbal authorization will be obtained). [Complete all parts of sections 6.2 and 6.3] 
 
6.2 
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI 
 
6.2.1 
Access, use or disclosure of PHI representing no more than a minimal risk to the privacy of the 
individual 
 
6.2.1.1 Plan to protect PHI from improper use or disclosure 
Include the following statement as written – DO NOT ALTER OR DELETE unless this 
section is not applicable because the research does not involve a waiver of 
authorization. If the section is not applicable, remove the statement and indicate 
as not applicable.  
 
N/A 
 
6.2.1.2 Plan to destroy identifiers or a justification for retaining identifiers  
Describe the plan to destroy the identifiers at the earliest opportunity consistent 
with the conduct of the research. Include when and how identifiers will be 
destroyed. If identifiers will be retained, provide the legal, health or research 
justification for retaining the identifiers. 
 
N/A 
 
6.2.2 
Explanation for why the research could not practicably be conducted without access to and 
use of PHI 
Provide an explanation for why the research could not practicably be conducted without access 
to and use of PHI. 
 
N/A 
 
6.2.3 
Explanation for why the research could not practicably be conducted without the waiver or 
alteration of authorization 
Provide an explanation for why the research could not practicably be conducted without the 
waiver or alternation of authorization. 
 
N/A 
 
6.3 
Waiver or alteration of authorization statements of agreement 

Page 13 of 26 (V.04/27/2017)  
By submitting this study for review with a waiver of authorization, you agree to the following statement 
– DO NOT ALTER OR DELETE unless this section is not applicable because the research does not involve a 
waiver or alteration of authorization. If the section is not applicable, remove the statement and indicate 
as not applicable. 
 
N/A 
 
7.0 
Study Design and Procedures 
 
7.1 
Study Design 
Describe and explain the study design. 
 
This human subjects research involves a longitudinal randomized controlled trial and depth interviews of 
researchers who participate in the Research-to-Policy Collaboration (RPC). Researchers are recruited to 
participate in the RPC. When a researcher voluntarily enlists in the RPC, they provide information about 
themselves and their expertise as part of RPC implementation. Subsequently, RPC participants are 
invited to participate in the study. Those who agree to participate are randomly assigned to either the 
RPC intervention group or a blinded control group that receives a “light touch” intervention. The next 
step of RPC implementation involves creating a discussion forum for engaging researchers in training or 
policy efforts. Different discussion forums will be used for each group: the RPC group (including those in 
the study who were assigned the intervention as well as those who refused to participate in the study) 
and the control group. The control group will receive information sheets regarding how to engage in 
policy, whereas the RPC group will be actively engaged in a series of six voluntary one-hour webinars 
preparing researchers for policy engagement, and will receive solicitations for contributing to policy 
efforts via the discussion forum. These activities are designed to build researchers’ capacity for 
successful collaborative interactions with congressional staff around current policy priorities and specific, 
time-sensitive needs of congressional offices.  
 
Those in the RPC group who have expertise related to current congressional priorities and needs may be 
invited to participate in a Rapid Response Event, which brings researchers and congressional staff 
together face-to-face to meet in congressional offices (Washington, DC) and plan a collaborative 
response to a current policy issue. To clarify expectations for involvement and minimize the threat of 
disappointing those who are not invited to the Rapid Response Event, all RPC participants are repeatedly 
informed throughout the capacity-building stage (via trainings and the discussion forum) that this 
selection process will occur based on their participation in trainings, web-based engagement, and a 
match between their expertise and congressional needs. Subsequent to these meetings, RPC 
participants work collaboratively with one another and the congressional office to respond to the 
current policy issue. 
 
Participation in the study is voluntary among those enlisting in the RPC; opting out of the survey will not 
impact their ability to participate in the intervention. Study participants are asked to complete the 
survey approximately every three months for about one year:  (1) Baseline, (2) Subsequent to training, 
(3) Subsequent to policy engagement, and (4) Follow-up. Twenty-two study participants in the 
intervention group will be asked to complete in-depth qualitative interviews regarding their 
experiences:  11 will participate prior to RPC involvement and 11 will participate subsequent to their 
RPC involvement. Qualitative interviews will be recorded and transcribed. 
 
Observations of public meetings may involve three types of participants: (1) public officials, (2) 
researchers who have consented to study participation, and/or (3) researchers who are involved in the 
intervention but did not consent to study participation. Public meetings include: (1) those that occur in 

Page 14 of 26 (V.04/27/2017)  
public officials’ offices, which are located in congressional office buildings that are open to the public 
(i.e., any member of the public may visit any office at any time), and (2) online trainings that are open to 
the public, accessible through a URL on a publicly available website. 
 
7.2 
Study Procedures 
Provide a description of all research procedures being performed and when they are being performed 
(broken out by visit, if applicable), including procedures being performed to monitor subjects for safety 
or minimize risks.  Include any long-term follow-up procedures and data collection, if applicable.  
 
Describe where or how you will be obtaining information about subjects (e.g., medical records, school 
records, surveys, interview questions, focus group topics, audio or video recordings, data collection 
forms, and collection of specimens through invasive or non-invasive procedures to include the amount 
to be collected and how often). Add any data collection instruments that will be seen by subjects to your 
study in CATS IRB (http://irb.psu.edu) in the “Supporting Documents” page. 
 
7.2.1 
EXAMPLE: Visit 1 or Day 1 or Pre-test, etc. (format accordingly) 
Provide a description as defined above and format accordingly. 
 
Online surveys using Qualtrics will be administered at the time when researchers sign-up to 
participate in the RPC. Survey instruments are provided as a supporting document. The survey 
asks for demographic information and about prior policy experiences, recent policy 
engagement, policy-informed research activities, perceptions about engaging public officials, 
perceived self-efficacy engaging with public officials, reported policy knowledge and training 
needs, satisfaction in collaborating with public officials, value and impact of partnering with 
public officials, and trust and respect within researcher-public official partnerships.  
 
Qualitative interviews will occur prior to RPC implementation at the time of study enrollment. 
Interviews will occur by web-chat or phone, and will ask: 
• 
What are your experiences of working with policymakers? What worked well? What were 
some of the challenges? 
• 
What do you think the most useful kinds of evidence are for policymakers? Can you give 
examples?  
• 
What types of interactions or initiatives do you think would be most helpful to link 
researchers and policymakers?  
 
7.2.2 
EXAMPLE: Visit 2 or Day 2 or Post-test, etc. (format accordingly) 
Provide a description as defined above and format accordingly. 
 
The same survey protocol as used in the pre-test will be administered approximately every three 
months for about one year:  (2) Subsequent to training, (3) Subsequent to policy engagement, 
and (4) Follow-up. Efforts to minimize survey attrition will include tracking non-responses to 
follow-up surveys and requesting survey participation via individual emails twice per week until 
survey completion or until the 3-week window for survey participation ends or until the 
participant opts-out of participating in the survey. In the last week of the survey window, survey 
participants who have not yet participated or opted-out of participation will be contacted by 
phone to request their participation and to complete the survey over the phone if needed.  
 
Qualitative interviews will occur subsequent to the RPC implementation, approximately 9 
months following study enrollment, using web-chat or phone. These interviews will ask: 
• 
How did you become involved in the RPC? Is this your first involvement with policy? With 
legislation? If no, what are your previous experiences? 

Page 15 of 26 (V.04/27/2017)  
• 
What were your expectations and aspirations from involvement in the RPC? 
• 
Can you describe the interactions you’ve had with policymakers through the RPC?  (e.g. 
informal coffees, phone calls, formal meetings, etc). How does this compare to 
interactions outside the RPC? 
• 
What kinds of evidence have you seen and used as part of the RPC? How? Did this reflect 
your expectations? 
• 
What has worked well? What could have gone better? (Risks of interaction, perceptions 
and stereotypes) 
 
This study also involves non-human research data, drawing from public information regarding 
public officials’ use of research evidence, which will be obtained from legislators’ sponsored 
bills, public statements, and reported research use by public officials. Non-human research data 
will also support the interpretation of key findings from the current investigation that involve 
human subjects. 
 
This study also involves human research data that are exempt from consent processes. This 
involves observations of public meetings occurring through the RPC, including researcher 
trainings and meetings between researchers and public officials’ offices. Observations involve 
minimal risk to subjects because the probability of harm or discomfort from the collection of 
observational data from public meetings is not greater than participating in the public meeting 
with no observation. Meeting attendees voluntarily elect to participate in these meetings, and 
meeting participants have complete control regarding with whom or the extent to which they 
share personal information. Meeting participants have the right to end participation in the 
observed meeting at any time. The observation of public meetings is unobtrusive, as the 
observer will join the meeting in a similar manner as the meeting participants. Meeting 
durations are expected to last around 30 minutes; therefore, a written consent procedure would 
detract time from the meeting itself. Furthermore, written consent procedures would disrupt 
the nature of interactions that are of focus in the observation. No pertinent information of value 
to meeting participants will be gleaned from the observation. Observational data involve 
unstructured, qualitative field notes regarding natural processes and interactions that occur 
during the intervention. These public research data are process-oriented to enable internal 
evaluation and inform improvements to the RPC.  
 
7.3 
Duration of Participation 
Describe the duration of an individual subject’s participation in the study. 
 
Study participation lasts for up to two years or until the participant opts-out of the study.  
 
8.0 
Subject Numbers and Statistical Plan 
 
8.1 
Number of Subjects 
Indicate the total number of subjects to be accrued.  
 
If applicable, distinguish between the number of subjects who are expected to be enrolled and 
screened, and the number of subjects needed to complete the research procedures (i.e., numbers of 
subjects excluding screen failures.) 
 
We aim to enroll a maximum of 300 researchers in the baseline period of this study. The target number 
of study participants in the full study is 80, including 40 researchers in the intervention and 40 

Page 16 of 26 (V.04/27/2017)  
researchers in the control group. This level of oversampling is required because not all researchers will 
complete all phases of the intervention and oversampling will combat attrition from study participation. 
 
Twenty-two researchers from the intervention group will be selected to participate in depth-interviews 
(11 at pre-test and 11 at post-test). Researchers will be sampled purposively such that the sample is 
representative of those with or without prior policy experience and range in their attitudes toward 
policy engagement (e.g., skeptical or positive), which will be determined by survey data from the first 
time point.  
 
8.2 
Sample size determination 
If applicable, provide a justification of the sample size outlined in section 8.1 – to include reflections on, 
or calculations of, the power of the study. 
 
Statistical analyses are all powered at least at a 90% level to detect effect sizes of 0.2 or greater (power 
analysis conducted with Optimal Design plus Empirical Evidence). 
 
8.3 
Statistical methods 
Describe the statistical methods (or non-statistical methods of analysis) that will be employed. 
 
Surveys data will be analysed longitudinally by modelling change across 4 time points—including 
repeated measures and multilevel growth curve models (MLM) using MPlus. Missing data will be 
handled with multiple imputation.  
 
Qualitative interview data will be analyzed using a thematic process followed by an intensive discourse 
analysis. Data will be interpreted alongside observational data using an interpretive policy analysis to 
develop a data-driven theoretical framework for describing evidence use in the RPC.  
9.0 
Confidentiality, Privacy and Data Management  
For research being conducted at Penn State Hershey or by Penn State Hershey researchers only, the research 
data security and integrity plan is submitted using “HRP-598 – Research Data Plan Review Form Application 
Supplement”, which is available in the Library in CATS IRB (http://irb.psu.edu).  Refer to Penn State College of 
Medicine IRB’s “Standard Operating Procedure Addendum: Security and Integrity of Human Research Data”, 
which is available on the IRB’s website. In order to avoid redundancy, for this section state “See the Research 
Data Plan Review Form” in section 9.0 if you are conducting Penn State Hershey research and move on to 
section 10.  
 
For all other research, in the sections below, describe the steps that will be taken to secure the data during 
storage, use and transmission. 
 
9.1 
Confidentiality 
 
9.1.1 
Identifiers associated with data and/or specimens 
List the identifiers that will be included or associated with the data and/or specimens in any way 
(e.g., names, addresses, telephone/fax numbers, email addresses, dates (date of birth, 
admission/discharge dates, etc.), medical record numbers, social security numbers, health plan 
beneficiary numbers, etc.).   
 
If no identifiers will be included or associated with the data in any way, whether directly or 
indirectly, please indicate this instead.   
 

Page 17 of 26 (V.04/27/2017)  
Study participants will be assigned a unique ID that allows data to be connected longitudinally. 
Surveys and interviews will not be directly identifiable as ID codes will be used that are only 
identifiable by the research team. A key for ID codes will be kept in a separate file, which will 
include names, phone number, email address, and institutional affiliation. No other identifiable 
data will be collected in this study. 
 
9.1.1.1 Use of Codes, Master List 
If identifiers will be associated with the data and/or specimens (as indicated in 
section 9.1.1 above), describe whether a master record or list containing a code 
(i.e., code number, pseudonyms) will be used to separate the data collected from 
identifiable information, where that master code list will be stored, who will have 
access to the master code list, and when it will be destroyed.  
 
If identifiers are included or associated with the data as described in section 
9.1.1 above, but no master record or list containing a code will be used, it will be 
assumed by the IRB that the investigator plans to directly link the identifiers 
with the data.    
 
Identifiable information obtained through the Qualtrics study will be stripped 
from the data file prior to storage on the server. Only the research team will 
have access to the master list of ID codes. The master list of ID codes will be 
destroyed within three years of the end of the project.  
 
9.1.2 
Storage of Data and/or Specimens 
Describe where, how and for how long the data (hardcopy (paper) and/or electronic data) 
and/or specimens will be stored. NOTE: Data can include paper files, data on the internet or 
websites, computer files, audio/video files, photographs, etc. and should be considered in the 
responses.  Refer to the “Investigator Manual (HRP-103)” for information about how long 
research records must be stored following the completion of the research prior to completing 
this section. HRP-103 can be accessed by clicking the Library link in CATS IRB 
(http://irb.psu.edu).  
 
Please review Penn State’s Data Categorization Project for detailed information regarding the 
appropriate and allowable storage of research data collected according to Penn State Policy 
AD71. Although the IRB can impose greater confidentiality/security requirements (particularly 
for sensitive data), the IRB cannot approve storage of research data in any way or using any 
service that is not permissible by Penn State Policy AD71.   
 
All data collected as part of this proposal will be stored on password-protected servers or in 
locked filing cabinets and accessed only by the interviewer and project investigators. Personal 
identifying information will be stored separately from the study data, and data will be stored in 
an encrypted format. Interviews will be digitally recoded, transcribed, and stored in password-
protected servers to which only the research team will have access. 
 
9.1.3 
Access to Data and/or Specimens 
Identify who will have access to the data and/or specimens. This information should not conflict 
with information provided in section 9.1.1.1 regarding who has access to identifiable 
information, if applicable.    
 
Max Crowley, Taylor Scott, and the research team will have access to study data.  
 

Page 18 of 26 (V.04/27/2017)  
9.1.4 
Transferring Data and/or Specimens 
If the data and/or specimens will be transferred to and/or from outside collaborators, identify 
the collaborator to whom the data and/or specimens will be transferred and how the data 
and/or specimens will be transferred. This information should not conflict with information 
provided in section 9.1.1.1 regarding who has access to identifiable information, if applicable. 
 
N/A 
 
9.2 
Subject Privacy 
This section must address subject privacy and NOT data confidentiality. 
 
Indicate how the research team is permitted to access any sources of information about the subjects.  
 
Describe the steps that will be taken to protect subjects’ privacy interests. “Privacy interest” refers to a 
person’s desire to place limits on whom they interact with or to whom they provide personal information. 
 
Describe what steps you will take to make the subjects feel at ease with the research situation in terms of 
the questions being asked and the procedures being performed. “At ease” does not refer to physical 
discomfort, but the sense of intrusiveness a subject might experience in response to questions, 
examinations, and procedures. 
 
All personal information is self-reported and the sensitivity of information requested is minimal. 
Interaction among study participants occurs as a function of their voluntary participation in the RPC, not 
the study; thus, all interactions are voluntary. Therefore, study participants have complete control 
regarding with whom or the extent that they provide personal information.  
 
10.0 Data and Safety Monitoring Plan 
This section is required when research involves more than Minimal Risk to subjects. As defined in “SOP: 
Definitions (HRP-001)”, available in the Library in CATS IRB (http://irb.psu.edu), Minimal Risk is defined as the 
probability and magnitude of harm or discomfort anticipated in the research that are not greater in and of 
themselves than those ordinarily encountered in daily life or during the performance of routine physical or 
psychological examinations or tests.  For research involving prisoners, Minimal Risk is the probability and 
magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine 
medical, dental, or psychological examination of healthy persons. Please complete the sections below if the 
research involves more than minimal risk to subjects OR indicate as not applicable.  
 
10.1 
Periodic evaluation of data 
Describe the plan to periodically evaluate the data collected regarding both harms and benefits to 
determine whether subjects remain safe. 
 
N/A. This study involves Minimal Risk to participants.  
 
10.2 
Data that are reviewed 
Describe the data that are reviewed, including safety data, untoward events, and efficacy data. 
 
N/A. This study involves Minimal Risk to participants.  
 

Page 19 of 26 (V.04/27/2017)  
10.3 
Method of collection of safety information 
Describe the method by which the safety information will be collected (e.g., with case report forms, at 
study visits, by telephone calls and with subjects). 
 
N/A. This study involves Minimal Risk to participants.  
 
10.4 
Frequency of data collection 
Describe the frequency of data collection, including when safety data collection starts. 
 
N/A. This study involves Minimal Risk to participants.  
 
10.5 
Individuals reviewing the data 
Identify the individuals who will review the data. The plan might include establishing a data and safety 
monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the 
sponsor. 
 
N/A. This study involves Minimal Risk to participants.  
 
10.6 
Frequency of review of cumulative data 
Describe the frequency or periodicity of review of cumulative data. 
 
N/A. This study involves Minimal Risk to participants.  
 
10.7 
Statistical tests 
Describe the statistical tests for analyzing the safety data to determine whether harms are occurring. 
 
N/A. This study involves Minimal Risk to participants.  
 
10.8 
Suspension of research 
Describe any conditions that trigger an immediate suspension of research. 
 
N/A. This study involves Minimal Risk to participants.  
 
11.0 Risks 
List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the subjects related the 
subjects’ participation in the research.  For each potential risk, describe the probability, magnitude, duration, 
and reversibility. Consider all types of risk including physical, psychological, social, legal, and economic risks. If 
applicable, indicate which procedures may have risks to the subjects that are currently unforeseeable. If 
applicable, indicate which procedures may have risks to an embryo or fetus should the subject be or become 
pregnant. If applicable, describe risks to others who are not subjects. 
 
Please keep in mind that loss of confidentiality is a potential risk when conducting human subject research and 
should be addressed as such.  
 
This study involves little risk for participants, which involve the loss of confidentiality of their responses to the 
survey or interview and deception regarding the extent of a professional development and policy engagement 
opportunity. Confidentiality will be maintained to the degree permitted by the technology used. Specifically, no 
guarantees can be made regarding the interception of data sent via the Internet by any third parties. To 
minimize this risk, data files will be encrypted and direct identifiers will be removed from the data prior to 

Page 20 of 26 (V.04/27/2017)  
storage and analysis. Survey questions asked are not of a sensitive nature, and data protection plans minimize 
threats to confidentiality. The risk of deception is also minimal because the intervention received by the control 
group is greater than that received in normal practice (i.e., no intervention, training, or engagement). 
Furthermore, it is not unusual for the intervention subjects (i.e., researchers) to be recruited for voluntary 
commitments that result in limited engagement due to limited organizational capacity (e.g., involvement in a 
policy committee that becomes inactive). Therefore, the experience of control group participants is expected to 
be greater than or comparable to other experiences for which they might be recruited outside of the current 
study context.   
 
12.0 Potential Benefits to Subjects and Others 
 
12.1 
Potential Benefits to Subjects 
Describe the potential benefits that individual subjects may experience from taking part in the research. 
If there is no direct benefit to subjects, indicate as such. Compensation is not considered a benefit. 
Compensation should be addressed in section 14.0. 
 
There are no direct benefits of participating in this study.  
 
12.2 
Potential Benefits to Others 
Include benefits to society or others.  
 
This work has the potential to strengthen efforts to improve the use of research evidence in 
policymaking processes, as well as to inform how researchers are trained and prepared for policy 
engagement. Moreover, insights gleaned will inform the academic literature regarding how research is 
used in policymaking processes at the federal legislative level of governance.  
 
13.0 Sharing Results with Subjects 
Describe whether results (study results or individual subject results, such as results of investigational diagnostic 
tests, genetic tests, or incidental findings) will be shared with subjects or others (e.g., the subject’s primary care 
physicians) and if so, describe how it will be shared. 
 
N/A. There are no individual results of value to study participants.  
 
14.0 Subject Stipend (Compensation) and/or Travel Reimbursements 
Describe the amount and timing of any subject stipend/payment or travel reimbursement here. If there is no 
subject stipend/payment or travel reimbursement, indicate as not applicable.  
 
If course credit or extra credit is offered to subjects, describe the amount of credit and the available alternatives. 
Alternatives should be equal in time and effort to the amount of course or extra credit offered. 
 
If an existing, approved student subject pool will be used to enroll subjects, please indicate as such and indicate 
that course credit will be given and alternatives will be offered as per the approved subject pool procedures.  
 
Survey participants will be compensated $10 for completion of each survey time point (maximum of $40). 
Compensation will be made with an electronic Amazon gift card emailed to the provided email address. Study 
participants reflect a relatively elite group for which monetary incentives are not commiserate with fair-market 

Page 21 of 26 (V.04/27/2017)  
consultation rates (approximately $50-100 per hour); therefore, $10 per 20-minute survey (or a rate of $30 per 
hour) is not an unduly influence for participation.  
15.0 Economic Burden to Subjects 
 
15.1 
Costs  
Describe any costs that subjects may be responsible for because of participation in the research. 
 
Participants will not be affected by direct costs for participation in this study; however, indirect costs 
include participants’ time for participation. Participation in the survey is expected to require 
approximately 20 minutes, or a total of one hour of researchers’ time participating in all four of the 
surveys. Twenty-two participants who voluntarily agree to participate in depth qualitative interviews will 
spend an additional hour participating.  
 
15.2 
Compensation for research-related injury 
If the research involves more than Minimal Risk to subjects, describe the available compensation in 
the event of research related injury. 
 
If there is no sponsor agreement that addresses compensation for medical care for research subjects 
with a research-related injury, include the following text as written - DO NOT ALTER OR DELETE: 
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
available but will be provided at the usual charge. Costs for the treatment of research-related injuries 
will be charged to subjects or their insurance carriers.  
 
For sponsored research studies with a research agreement with the sponsor that addresses 
compensation for medical care for research-related injuries, include the following text as written - DO 
NOT ALTER OR DELETE: 
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
available but will be provided at the usual charge. Such charges may be paid by the study sponsor as 
outlined in the research agreement and explained in the consent form. 
 
This study involves Minimal Risk to participants.  
 
16.0 Resources Available 
 
16.1 
Facilities and locations 
Identify and describe the facilities, sites and locations where recruitment and study procedures will be 
performed.  
 
If research will be conducted outside the United States, describe site-specific regulations or customs 
affecting the research, and describe the process for obtaining local ethical review. Also, describe the 
principal investigator’s experience conducting research at these locations and familiarity with local 
culture. 
 
All recruitment is virtual using email. The RPC is primarily implemented remotely, including web-based 
trainings, engaging researchers’ responses to policy efforts via emails and a discussion forum, and 
working collaboratively on responses to legislative requests. Most meetings occur via phone or webchat 
except for the meetings that occur as part of the Rapid Response Event, which brings researchers and 

Page 22 of 26 (V.04/27/2017)  
congressional staff together face-to-face to plan a response to current policy efforts. Those meetings are 
held in congressional offices in Washington, DC. Observations will occur during web-based trainings as 
well as on-site during the Rapid Response Event. Surveys with researchers will occur online, or 
occasionally by phone as part of attrition-reduction efforts. 
 
16.2 
Feasibility of recruiting the required number of subjects 
Indicate the number of potential subjects to which the study team has access.  Indicate the percentage 
of those potential subjects needed for recruitment. 
 
It is anticipated that around 300 researchers will be recruited for the RPC. We believe that at least ¾ (n = 
225) of those may participate in the study at baseline, and approximately half of those individuals may 
complete the study (n = 112), which would over-sample for the current study.   
 
16.3 
PI Time devoted to conducting the research 
Describe how the PI will ensure that a sufficient amount of time will be devoted to conducting and 
completing the research. Please consider outside responsibilities as well as other on-going research for 
which the PI is responsible. 
 
The Primary Investigator, Max Crowley, is supported for 15% of FTE to work on this project, which will 
ensure that research and compliance activities are completed as specified by the sponsored research 
and as dictated by the IRB protocol.   
 
16.4 
Availability of medical or psychological resources 
Describe the availability of medical or psychological resources that subject might need as a result of 
their participation in the study, if applicable. 
 
This study involves Minimal Risk for participants.  
 
16.5 
Process for informing Study Team 
Describe the training plans to ensure members of the research team are informed about the protocol 
and their duties, if applicable. 
 
All research team members must complete the mandatory CITI training in human subjects research. The 
IRB protocol will be reviewed by all team members, and compliance will be monitored by the Primary 
Investigator. 
 
17.0 Other Approvals 
17.1 
Other Approvals from External Entities 
Describe any approvals that will be obtained prior to commencing the research (e.g., from cooperating 
institutions, community leaders, schools, external sites, funding agencies). 
 
N/A  
 
17.2 
Internal PSU Committee Approvals 
 
Check all that apply: 
  Anatomic Pathology – Hershey only – Research involves the collection of tissues or use of pathologic 
specimens. Upload a copy of HRP-902 - Human Tissue For Research Form on the “Supporting 
Documents” page in CATS IRB. This form is available in the CATS IRB Library.   

Page 23 of 26 (V.04/27/2017)  
 
  Animal Care and Use – All campuses – Human research involves animals and humans or the use of 
human tissues in animals 
 
  Biosafety – All campuses – Research involves biohazardous materials (human biological specimens 
in a PSU research lab, biological toxins, carcinogens, infectious agents, recombinant viruses or DNA 
or gene therapy). 
 
  Clinical Laboratories – Hershey only – Collection, processing and/or storage of extra tubes of body 
fluid specimens for research purposes by the Clinical Laboratories; and/or use of body fluids that 
had been collected for clinical purposes, but are no longer needed for clinical use. Upload a copy of 
HRP-901 - Human Body Fluids for Research Form on the “Supporting Documents” page in CATS IRB. 
This form is available in the CATS IRB Library.  
 
  Clinical Research Center (CRC) Advisory Committee – All campuses – Research involves the use of 
CRC services in any way. 
 
  Conflict of Interest Review – All campuses – Research has one or more of study team members 
indicated as having a financial interest. 
 
  Radiation Safety – Hershey only – Research involves research-related radiation procedures. All 
research involving radiation procedures (standard of care and/or research-related) must upload a 
copy of HRP-903 - Radiation Review Form on the “Supporting Documents” page in CATS IRB. This 
form is available in the CATS IRB Library. 
 
  IND/IDE Audit – All campuses – Research in which the PSU researcher holds the IND or IDE or 
intends to hold the IND or IDE. 
 
  Scientific Review – Hershey only – All investigator-written research studies requiring review by the 
convened IRB must provide documentation of scientific review with the IRB submission. The 
scientific review requirement may be fulfilled by one of the following: (1) external peer-review 
process; (2) department/institute scientific review committee; or (3) scientific review by the Clinical 
Research Center Advisory committee.  NOTE: Review by the Penn State Hershey Cancer Institute 
Scientific Review Committee is required if the study involves cancer prevention studies or cancer 
patients, records and/or tissues. For more information about this requirement see the IRB website 
at: http://www.pennstatehershey.org/web/irb/home/resources/investigator  
 
18.0 Multi-Site Research 
If this is a multi-site study (i.e., the study will be conducted at other institutions each with its own principal 
investigator) and you are the lead investigator, describe the processes to ensure communication among sites in 
the sections below. 
 
18.1 
Communication Plans 
Describe the plan for regular communication between the overall study director and the other sites to 
ensure that all sites have the most current version of the protocol, consent document, etc.  Describe the 
process to ensure all modifications have been communicated to sites. Describe the process to ensure 
that all required approvals have been obtained at each site (including approval by the site’s IRB of 
record).   Describe the process for communication of problems with the research, interim results and 
closure of the study. 
 

Page 24 of 26 (V.04/27/2017)  
N/A 
 
18.2 
Data Submission and Security Plan 
Describe the process and schedule for data submission and provide the data security plan for data 
collected from other sites.  Describe the process to ensure all engaged participating sites will safeguard 
data as required by local information security policies. 
 
N/A 
 
18.3 
Subject Enrollment 
Describe the procedures for coordination of subject enrollment and randomization for the overall 
project. 
 
N/A 
 
18.4 
Reporting of Adverse Events and New Information 
Describe how adverse events and other information will be reported from the clinical sites to the overall 
study director. Provide the timeframe for this reporting. 
 
N/A 
 
18.5 
Audit and Monitoring Plans 
Describe the process to ensure all local site investigators conduct the study appropriately. Describe any 
on-site auditing and monitoring plans for the study. 
 
N/A 
 
19.0 Adverse Event Reporting 
 
19.1 
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB 
By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE:  
 
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board 
(IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) 
experienced by a subject or other individual, which in the opinion of the investigator is determined to be 
(1) unexpected; and (2) probably related to the research procedures. Harms (adverse events) will be 
submitted to the IRB in accordance with the IRB policies and procedures. 
 
20.0 Study Monitoring, Auditing and Inspecting 
 
20.1 
Auditing and Inspecting 
By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE:  
 
The investigator will permit study-related monitoring, audits, and inspections by the Penn State quality 
assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all study related 
documents (e.g., source documents, regulatory documents, data collection instruments, study data 
etc.).  The investigator will ensure the capability for inspections of applicable study-related facilities 
(e.g., pharmacy, diagnostic laboratory, etc.). 

Page 25 of 26 (V.04/27/2017)  
 
21.0 Future Undetermined Research: Data and Specimen Banking 
If this study is collecting identifiable data and/or specimens that will be banked for future undetermined 
research, please describe this process in the sections below.  This information should not conflict with 
information provided in section 9.1.1 regarding whether or not data and/or specimens will be associated with 
identifiers (directly or indirectly). 
 
21.1 
Data and/or specimens being stored 
Identify what data and/or specimens will be stored and the data associated with each specimen. 
 
All data will be handled in accordance with the consent procedures and IRB protocol. Identifiers will be 
stripped from the data files for archival storage. Identifying information will be destroyed within three 
years of the end of the project.  
 
21.2 
Location of storage 
Identify the location where the data and/or specimens will be stored. 
 
Archival data will be stored on SharePoint, PSU’s secure cloud file transfer server. 
 
21.3 
Duration of storage 
Identify how long the data and/or specimens will be stored. 
 
De-identified study data will be archived indefinitely. Identifying info will be destroyed within three 
years of the end of the project. 
 
21.4 
Access to data and/or specimens 
Identify who will have access to the data and/or specimens. 
 
Only the research team will have access to archival data. 
 
21.5 
Procedures to release data or specimens 
Describe the procedures to release the data and/or specimens, including: the process to request a 
release, approvals required for release, who can obtain data and/or specimens, and the data to be 
provided with the specimens. 
 
Identifying information will not be released. Only members of the research team will have access to 
archival data. 
 
21.6 
Process for returning results 
Describe the process for returning results about the use of the data and/or specimens. 
 
N/A 
 
22.0 References 
List relevant references in the literature which highlight methods, controversies, and study outcomes. 
 
Crowley, M.D. Scott, J.T. & Fishbein, D. (2017). Translating prevention research for evidence-based policymaking: 
Results from the Research-to-Policy Collaboration pilot. Prevention Science. 

Page 26 of 26 (V.04/27/2017)  
Dumont K. (2015). Leveraging knowledge: Taking stock of the William T. Grant Found Use Res Evid Grants Portf N 
Y NY William T Grant Found.  
Oliver, K., Innvar, S., Lorenc, T., Woodman, J., & Thomas, J. (2014). A systematic review of barriers to and 
facilitators of the use of evidence by policymakers. BMC Health Services Research, 14, 1-12.  
Scott, T., Larson, J., Buckingham, S., Maton, K., & Crowley, M. (in press). Bridging the research-policy divide: 
Pathways to engagement and skill development. American Journal of Orthopsychiatry. 
Singh, G. G., Tam, J., Sisk, T. D., Klain, S. C., Mach, M. E., Martone, R. G., & Chan, K. (2014). A more social science: 
barriers and incentives for scientists engaging in policy. Frontiers in Ecology and the Environment, 12, 
161–166. 
Tseng V. (2013). Forging common ground: fostering the conditions for evidence use. J Leis Res, 46, 6.