DeWitt Stetten, Jr. 
Page 3 
March 26, 1976 
4) Reserve the right of NIH to make visitations. 
I proposed in the December meeting of the Advisory 
Committee 1 that NIH include in the grant document a state- 
ment that it reserved the right of visitation. I chose 
the word "visitation" because it can imply education and 
assistance, an implication not carried by the word "inspec- 
tion." There is, however, some sanction in the possibility 
of visitation. 
Dr. Frederickson ' s memo suggests consideration of NIH 
assessment of P4 facilities. There may be advantages in 
such assessment, but there may also be a question of NIH's 
legal authority. This leads to the next type of problem. 
3. Implementation beyond NIH's Jurisdiction. 
NIH's jurisdiction has served as a base for 
development of guidelines, but is inadequate alon£ 
for adoption and implementation of safeguards. Brief 
comments follow successively on policy needs and ad- 
ministrative arrangements. 
a. Several policy objectives can be identified: 
(1) Legislating the guidelines for all lab- 
oratories in which recombinant research is con- 
ducted . 
For government research laboratories 
and grant agencies, this might be accomplished 
through agency adoption of the guidelines or poss- 
ibly through a presidential order. Legislation 
would probably be required to make the guide- 
lines binding in all private laboratories, and 
in instructional demonstations in public and 
private schools. 
(2) Educating all biological scientists in 
research or instructional activity on the exist- 
ence, importance and availability of the guidelines. 
Can this education, and the development of strong 
peer group attitudes toward compliance with the 
guidelines, be achieved through the scientific 
press alone? Or will the collaboration of govern- 
ment agencies in distribution of information be 
required? Must the education extend not only to 
scientists, but to occupational health and safety 
agencies and associations, and to public interest 
groups? 
[504] 
